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G-Penicillin V
Phenoxymethyl Penicillin [Penicillin V]
G-Penicillin V
Phenoxymethyl Penicillin [Penicillin V]
Indications
Vincent’s infection
Indication detailsView
For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:
- infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
- infections of the lower respiratory tract, e.g., bronchitis and pneumonia, bronchopneumonia.
- infections due to beta-hemolytic streptococci of group A, e.g., scarlet fever, erysipelas, rheumatic fever.
- skin infections, e.g., pyodermia, furunculosis, phlegmon, erysipeloid, erythema migrans, insofar as the micro-organisms are penicillin-susceptible.
- lymphadenitis and lymphangitis of bacterial origin.
- infections of the buccal cavity, gums or jaws, e.g., inflammatory infiltrates, delayed dentition stages II and III, antral fistulae, secondary bacterial infection with Gram-positive pathogens following virus-induced gingivitis or stomatitis.
Therapeutic classView
Benzylpenicillin & Phenoxymethyl penicillin
PharmacologyView
Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.
DosageView
The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.
Adults: 250-500 mg 6 hourly
Children (above 1 year):
Adults: 250-500 mg 6 hourly
Children (above 1 year):
- 125-250 mg 6 hourly
- 125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
- 250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly
- 62.5-125 mg 6 hourly.
- 125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.
AdministrationView
Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.
Side effectsView
Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
ContraindicationsView
Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.
PrecautionsView
The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
InteractionsView
Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Pregnancy & lactationView
Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.
Overdose effectsView
The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.
StorageView
Store in a cool and dry place, protect from light.
G-Penicillin V
Phenoxymethyl Penicillin [Penicillin V]
G-Penicillin V
Phenoxymethyl Penicillin [Penicillin V]
Indications
Vincent’s infection
Indication detailsView
For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:
- infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
- infections of the lower respiratory tract, e.g., bronchitis and pneumonia, bronchopneumonia.
- infections due to beta-hemolytic streptococci of group A, e.g., scarlet fever, erysipelas, rheumatic fever.
- skin infections, e.g., pyodermia, furunculosis, phlegmon, erysipeloid, erythema migrans, insofar as the micro-organisms are penicillin-susceptible.
- lymphadenitis and lymphangitis of bacterial origin.
- infections of the buccal cavity, gums or jaws, e.g., inflammatory infiltrates, delayed dentition stages II and III, antral fistulae, secondary bacterial infection with Gram-positive pathogens following virus-induced gingivitis or stomatitis.
Therapeutic classView
Benzylpenicillin & Phenoxymethyl penicillin
PharmacologyView
Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.
DosageView
The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.
Adults: 250-500 mg 6 hourly
Children (above 1 year):
Adults: 250-500 mg 6 hourly
Children (above 1 year):
- 125-250 mg 6 hourly
- 125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
- 250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly
- 62.5-125 mg 6 hourly.
- 125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.
AdministrationView
Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.
Side effectsView
Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
ContraindicationsView
Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.
PrecautionsView
The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
InteractionsView
Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Pregnancy & lactationView
Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.
Overdose effectsView
The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.
StorageView
Store in a cool and dry place, protect from light.
G-Phase
Metformin Hydrochloride
G-Phase
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
G-Phase
Metformin Hydrochloride
G-Phase
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
G-Phenobarbitone
Phenobarbital
G-Phenobarbitone
Phenobarbital
Indications
Tonic-clonic status epilepticus
Indication detailsView
Phenobarbital is indicated for the following conditions:
- Sedatives
- Hypnotics for the short-term treatment of insomnia
- Pre-anesthetics
- Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus, eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).
Therapeutic classView
Adjunct anti-epileptic drugs, Barbiturates
PharmacologyView
Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). Phenobarbital acts on GABAA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.
DosageView
Suggested doses of Phenobarbital for specific indications are as follows:
Pediatric Oral Dosage:
Pediatric Oral Dosage:
- Preoperative: 1 mg to 3 mg/kg.
- Anticonvulsant: 1 mg to 6 mg/kg per day
- Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
- Bedtime hypnotic: 100 mg to 320 mg.
- Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.
- 15 to 20 mg/kg IV over 10 to 15 min.
- Preoperative Sedation:1 to 3 mg/kg IM/IV;
- Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days. Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly. Maxium IV rate 60 mg/min.
- Insomnia: 100 to 320 mg IM/IV;
- Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
- Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.
Side effectsView
The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.
ContraindicationsView
Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.
PrecautionsView
Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Phenobarbital should be administered with caution and initially reduced doses.
InteractionsView
The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.
Pregnancy & lactationView
Pregnancy Category D. Phenobarbital can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.
Overdose effectsView
The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
G-Phenobarbitone
Phenobarbital
G-Phenobarbitone
Phenobarbital
Indications
Tonic-clonic status epilepticus
Indication detailsView
Phenobarbital is indicated for the following conditions:
- Sedatives
- Hypnotics for the short-term treatment of insomnia
- Pre-anesthetics
- Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus, eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).
Therapeutic classView
Adjunct anti-epileptic drugs, Barbiturates
PharmacologyView
Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). Phenobarbital acts on GABAA receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.
DosageView
Suggested doses of Phenobarbital for specific indications are as follows:
Pediatric Oral Dosage:
Pediatric Oral Dosage:
- Preoperative: 1 mg to 3 mg/kg.
- Anticonvulsant: 1 mg to 6 mg/kg per day
- Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
- Bedtime hypnotic: 100 mg to 320 mg.
- Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.
- 15 to 20 mg/kg IV over 10 to 15 min.
- Preoperative Sedation:1 to 3 mg/kg IM/IV;
- Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days. Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly. Maxium IV rate 60 mg/min.
- Insomnia: 100 to 320 mg IM/IV;
- Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
- Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.
Side effectsView
The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.
ContraindicationsView
Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.
PrecautionsView
Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Phenobarbital should be administered with caution and initially reduced doses.
InteractionsView
The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.
Pregnancy & lactationView
Pregnancy Category D. Phenobarbital can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.
Overdose effectsView
The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
G-Prazosin
Prazosin Hydrochloride
G-Prazosin
Prazosin Hydrochloride
Indications
Hypertension
Indication detailsView
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
Therapeutic classView
Alpha adrenoceptor blocking drugs
PharmacologyView
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
DosageView
Hypertension:
- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
- Maximum dose: 20 mg in divided doses.
- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
- Subsequent dosage increases should be made gradually depending upon the patient's response.
- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
- Usual maintenance dosage: 1 mg or 2 mg twice daily.
- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
- The usual maintenance dosage: 2 mg twice daily.
AdministrationView
May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
Side effectsView
The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
ContraindicationsView
Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
PrecautionsView
In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
InteractionsView
- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
Pregnancy & lactationView
Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
Pediatric usageView
Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
StorageView
Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
G-Prazosin
Prazosin Hydrochloride
G-Prazosin
Prazosin Hydrochloride
Indications
Hypertension
Indication detailsView
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
Therapeutic classView
Alpha adrenoceptor blocking drugs
PharmacologyView
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
DosageView
Hypertension:
- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
- Maximum dose: 20 mg in divided doses.
- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
- Subsequent dosage increases should be made gradually depending upon the patient's response.
- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
- Usual maintenance dosage: 1 mg or 2 mg twice daily.
- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
- The usual maintenance dosage: 2 mg twice daily.
AdministrationView
May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
Side effectsView
The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
ContraindicationsView
Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
PrecautionsView
In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
InteractionsView
- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
Pregnancy & lactationView
Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
Pediatric usageView
Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
StorageView
Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
G-Prazosin
Prazosin Hydrochloride
G-Prazosin
Prazosin Hydrochloride
Indications
Hypertension
Indication detailsView
Hypertension (Primary and Secondary Hypertension). Raynaud's phenomenon and Raynaud's disease, Congestive heart failure (Prazosin may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides) & Benign prostatic hyperplasia (For the symptomatic treatment of urinary obstruction due to BPH and in patients awaiting prostatic surgery).
Therapeutic classView
Alpha adrenoceptor blocking drugs
PharmacologyView
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Rebound elevation of blood pressure does not occur following abrupt cessation of Prazosin therapy.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
The therapeutic efficacy of Prazosin in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Prazosin in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients. Prazosin reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease. In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hyperplasia. Clinical studies have shown that Prazosin therapy is not associated with adverse changes in the serum lipid profile.
DosageView
Hypertension:
- Recommended starting dose: 0.5 mg (in the evening), twice or thrice daily for 3 to 7 days. This dose should be increased to 1 mg twice or three times daily for a further 3 to 7 days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Prazosin alone of up to 15 mg daily in divided doses.
- Maximum dose: 20 mg in divided doses.
- The dosage of the other drug should be reduced to a maintenance level and Prazosin initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily.
- Subsequent dosage increases should be made gradually depending upon the patient's response.
- The recommended starting dose: 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's response, based on careful monitoring of cardiopulmonary signs and symptoms.
- Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
- The recommended starting dosage: 0.5 mg twice daily given for a period of 3 to 7 days and should be adjusted according to the patient's clinical response.
- Usual maintenance dosage: 1 mg or 2 mg twice daily.
- The recommended dosage: 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response.
- The usual maintenance dosage: 2 mg twice daily.
AdministrationView
May be taken with or without food. Starting dose is best taken within dinner, at least 2-3 hr before retiring. Maintenance doses may be taken with or without meals.
Side effectsView
The most common side effects of Prazosin are allergic reaction, depression, nervousness, insomnia, Hallucinations, dizziness, drowsiness, headache, faintness, syncope, paraesthesia, worsening of pre-existing narcolepsy, blurred vision, eye pain, reddened sclera, vertigo, tinnitus, palpitations etc.
ContraindicationsView
Prazosin is contraindicated in patients with known sensitivity to Prazosin & other quinazolines or any of the excipients.
PrecautionsView
In patients with benign prostatic hyperplasia: Prazosin is not recommended for patients with a history of micturition syncope. It should not normally be administered to patients already receiving another alpha-1-antagonist.
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
In patients with congestive heart failure: Prazosin is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease.
In patients with hypertension: Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy
InteractionsView
- Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors): Concomitant use f PDE-5 inhibitors (e.g. Sildenafil, Tadalafil, Vardenafil) and Prazosin may lead to symptomatic hypotension in some patients.
- Adding Prazosin to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure.
Pregnancy & lactationView
Pregnancy category C. It should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when Prazosin is administered to nursing mothers.
Pediatric usageView
Patients with moderate to severe grades of renal impairment: Evidence to date shows that Prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Patients with hepatic dysfunction: it is recommended that therapy should be initiated at 0.5 mg daily and that dosage should be increased cautiously.
Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
StorageView
Keep away from light and moisture, store below 30°C. Keep away from reach out of the children.
G-Prednisolone
Prednisolone
G-Prednisolone
Prednisolone
Indications
Wiskott-Aldrich syndrome
Indication detailsView
Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.
Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.
Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.
Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.
Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).
Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.
Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.
Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.
Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.
Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).
Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.
DosageView
Adult-
Nephrotic Syndrome:
Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.
Allergic Conditions:
Pediatric-
Asthma:
Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
Nephrotic Syndrome:
- Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
- Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.
Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.
Allergic Conditions:
- Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
- Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
- Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
- Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
- Day 5: 5 mg PO before breakfast and at bedtime.
- Day 6: 5 mg PO before breakfast.
Pediatric-
Asthma:
- 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
- 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
- 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
- 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.
Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
Side effectsView
Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.
ContraindicationsView
Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.
PrecautionsView
Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.
InteractionsView
The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.
Pregnancy & lactationView
This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.
Overdose effectsView
Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.
StorageView
Store in a cool and dry place, protected from light. Keep out of the reach of the children.
G-Ramipril
Ramipril
G-Ramipril
Ramipril
Indications
Thrombotic cardiovascular (CV) events
Indication detailsView
Ramipril indicated in the following cases:
- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
- Congestive heart failure; also in combination with diuretics.
- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
DosageView
Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
AdministrationView
Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
Side effectsView
Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
ContraindicationsView
Ramipril must not be used
- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
- in patients with a history of angioedema.
- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
- in patients with hypotensive or haemodynamically unstable states.
- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
- during pregnancy.
PrecautionsView
Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
InteractionsView
Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
Pregnancy & lactationView
Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
Pediatric usageView
Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Overdose effectsView
Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
StorageView
Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
G-Ramipril
Ramipril
G-Ramipril
Ramipril
Indications
Thrombotic cardiovascular (CV) events
Indication detailsView
Ramipril indicated in the following cases:
- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
- Congestive heart failure; also in combination with diuretics.
- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
DosageView
Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
AdministrationView
Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
Side effectsView
Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
ContraindicationsView
Ramipril must not be used
- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
- in patients with a history of angioedema.
- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
- in patients with hypotensive or haemodynamically unstable states.
- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
- during pregnancy.
PrecautionsView
Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
InteractionsView
Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
Pregnancy & lactationView
Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
Pediatric usageView
Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Overdose effectsView
Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
StorageView
Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
G-Ranitidin
Ranitidine Hydrochloride
G-Ranitidin
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
G-Salbutamol
Salbutamol
G-Salbutamol
Salbutamol
Indications
Emphysema
Indication detailsView
Salbutamol is indicated as a bronchodilator for use in-
- Asthma
- Chronic Bronchitis
- Emphysema and
- Other conditions associated with airways obstruction.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibers. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.
DosageView
Salbutamol tablet or syrup-
Children:
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Adults:
Salbutamol Inhalation Capsule:
Children:
- 2-6 years: 2.5 ml syrup, 3-4 times daily
- 6-12 years: 5 ml syrup, 3-4 times daily
- Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
- Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
- Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
- Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
- Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
- Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.
Adults:
- Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
- The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
- Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
- As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
- All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.
Salbutamol Inhalation Capsule:
- Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
- Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.
- Adults: 400 microgram
- Child: 200 microgram, 15-30 minutes prior to any physical exertion.
Side effectsView
Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
PrecautionsView
Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed angle glaucoma, and in those receiving antihypertensive therapy.
Pregnancy & lactationView
The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
G-Salbutamol
Salbutamol
G-Salbutamol
Salbutamol
Indications
Emphysema
Indication detailsView
Salbutamol is indicated as a bronchodilator for use in-
- Asthma
- Chronic Bronchitis
- Emphysema and
- Other conditions associated with airways obstruction.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibers. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.
DosageView
Salbutamol tablet or syrup-
Children:
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Adults:
Salbutamol Inhalation Capsule:
Children:
- 2-6 years: 2.5 ml syrup, 3-4 times daily
- 6-12 years: 5 ml syrup, 3-4 times daily
- Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
- Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
- Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
- Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
- Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
- Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.
Adults:
- Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
- The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
- Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
- As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
- All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.
Salbutamol Inhalation Capsule:
- Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
- Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.
- Adults: 400 microgram
- Child: 200 microgram, 15-30 minutes prior to any physical exertion.
Side effectsView
Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
PrecautionsView
Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed angle glaucoma, and in those receiving antihypertensive therapy.
Pregnancy & lactationView
The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
G-Salbutamol
Salbutamol
G-Salbutamol
Salbutamol
Indications
Emphysema
Indication detailsView
Salbutamol is indicated as a bronchodilator for use in-
- Asthma
- Chronic Bronchitis
- Emphysema and
- Other conditions associated with airways obstruction.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibers. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.
DosageView
Salbutamol tablet or syrup-
Children:
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Adults:
Salbutamol Inhalation Capsule:
Children:
- 2-6 years: 2.5 ml syrup, 3-4 times daily
- 6-12 years: 5 ml syrup, 3-4 times daily
- Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)
Salbutamol Respirator Solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
Method-1 (Intermittent Administration):
- Adults (and the elderly): 0.5 ml-1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in the hospital. 0.5-1 ml solution should be diluted to final volume of 2-4 ml with sterile normal saline solution. It will take time about 10 minutes.
- Salbutamol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebulizer and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.
- Children under 12 years of age: 0.5 ml of the solution diluted to 2.0-4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.
Salbutamol nebulizer solution: To be used with a suitable nebulizer device under the direction of a physician. The solution must not be injected or ingested.
- Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in the hospital.
- Children under 12 years: 2.5 mg up to 4 times a day. A higher dose up to 5 mg four times a day may be used if required.
Adults:
- Salbutamol I.V. infusion solution is used to prepare a solution for continuous intravenous infusion. It should not be injected undiluted. A suitable solution for infusion may be prepared by diluting 5 mL of Salbutamol I.V. infusion solution (1000 mcg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 mcg/mL.
- The only recommended diluents are Sodium Chloride Injection, or Sodium Chloride and Dextrose Injection.
- Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Infusion rates can be started at 5 mcg of salbutamol/min., and can be increased to 10 mcg/min., and 20 mcg/min. at 15 - 30 minute intervals, if necessary.
- As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
- All unused admixtures of Salbutamol infusion solution with infusion fluids should be discarded 24 hours after preparation.
Salbutamol Inhalation Capsule:
- Adults: For the relief of bronchospasm and for managing intermittent episodes of asthma, one or two inhalation capsule may be administered as a single dose. The usual recommended dosage of Salbutamol inhalation capsule for inhalation for adults for maintenance or prophylactic therapy is the contents of one 200 microgram capsule every 4 to 6 hours using a device. In some patients, the contents of two 200 microgram capsules inhaled every 4 to 6 hours may be required. Large doses or more frequent administration is not recommended. The use of salbutamol powder for inhalation can be continued as medically indicated to control recurring/intermittent episodes of bronchospasm.
- Children: One Salbutamol inhalation capsule is the recommended dose for relief of acute bronchospasm in the maintenance of episodic asthma or before exercise of children 4 years of age and older. One inhalation should be administered for three or four times a day for routine maintenance or prophylactic therapy. This dosage may be increased to inhalation of two inhalation capsule, if necessary. The bronchodilator effect of each administration of inhaled Salbutamol inhalation capsule lasts for at least four hours. Such patients should be warned not to increase the dose of inhaler, but should seek medical advice immediately.
- Adults: 400 microgram
- Child: 200 microgram, 15-30 minutes prior to any physical exertion.
Side effectsView
Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.
PrecautionsView
Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed angle glaucoma, and in those receiving antihypertensive therapy.
Pregnancy & lactationView
The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
G-Tetracycline
Tetracycline Hydrochloride (Topical)
G-Tetracycline
Tetracycline Hydrochloride (Topical)
Indications
Minor cuts
Indication detailsView
First aid to help prevent skin infection in minor cuts, scrapes, and burns.
Therapeutic classView
Topical Antibiotic preparations
PharmacologyView
Tetracycline passively diffuses through porin channels in the bacterial membrane and reversibly binds to the 30S ribosomal subunit, preventing binding of tRNA to the mRNA-ribosome complex, and thus interfering with protein synthesis.
DosageView
Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.
Side effectsView
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
ContraindicationsView
Do not use
- in eyes
- over large areas of the body
- longer than 1 week unless directed by doctor
PrecautionsView
May be harmful is swallowed. Do not use if allergic to any ingredient listed on this label.
InteractionsView
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription medicine.
Pregnancy & lactationView
Pregnancy: Studies have not been done in humans. In studies in rats and rabbits, chlortetracycline and tetracycline topical preparations have not been shown to cause birth defects or other problems. However, studies in rabbits have shown meclocycline to cause a slight delay in bone formation.
Breast feeding: It is not known whether tetracycline topical preparations pass into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using any of these medicines and who wish to breast-feed should discuss this with their doctor.
Breast feeding: It is not known whether tetracycline topical preparations pass into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using any of these medicines and who wish to breast-feed should discuss this with their doctor.
Pediatric usageView
Pediatric: Tetracycline topical solution has been tested on a limited number of children 11 years of age or older and has not been shown to cause different side effects or problems in children than it does in adults. Although there is no specific information about the use of topical chlortetracycline or topical meclocycline in children, they are not expected to cause different side effects or problems in children than they do in adults.
Geriatric: Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of topical tetracyclines in the elderly.
Geriatric: Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of topical tetracyclines in the elderly.
StorageView
Keep our of reach of children. If swallowed, get medical help or contact a Poison control Center right away. Keep product refrigerated to preserve its effectiveness and color
G-Tetracycline
Tetracycline Hydrochloride (Ophthalmic)
G-Tetracycline
Tetracycline Hydrochloride (Ophthalmic)
Indications
Ocular infections
Indication detailsView
Tetracycline ointment is indicated as followings-
- Treatment of bacterial conjunctivitis
- Treatment of trachoma (by preference use oral azithromycin for this indication)
- Prevention of chlamydial and gonococcal neonatal conjunctivitis
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Tetracycline exhibits its bacteriostatic action by reversibly binding to the 30S subunits of the ribosome, thus preventing protein synthesis and arresting cell growth. It has a broad spectrum of antimicrobial activity including Chlamydiaceae, Mycoplasma spp., Rickettsia spp., spirochaetes, many aerobic and anaerobic gm+ve and gm-ve pathogenic bacteria and some protozoa.
DosageView
Wash the eyes with boiled and cooled water before each application. Use sterile sodium chloride 0.9% for newborns. Apply tetracycline 1% into the conjunctival sac of both eyes:
- Conjunctivitis: one application 2 times daily for 7 days
- Trachoma: one application 2 times daily for 6 weeks
- Prevention of neonatal conjunctivitis: one single application immediately after birth
Side effectsView
Burning, irritation, visual disturbances, superinfections, photosensitivity, hypersensitivity
ContraindicationsView
Do not use in patients with hypersensitivity to tetracyclines. May cause allergic reactions; stop treatment in the event of a serious reaction.
PrecautionsView
Hepatic impairment. Avoid exposure to sunlight. Periodic evaluation of renal, hepatic and haematological system during prolonged therapy.
InteractionsView
Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
Pregnancy & lactationView
Pregnancy Category- D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
StorageView
Store below 25°C. Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not keep outdated medicine or medicine no longer needed.
G-Tetracycline
Tetracycline Hydrochloride (Oral)
G-Tetracycline
Tetracycline Hydrochloride (Oral)
Indications
Uncomplicated gonorrhoea
Indication detailsView
Tetracycline is the drug of choice in the following infections :
- Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
- Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
- Chlamydial Infections: Chlamydia psittaci: This organism is the cause of psittacosis (ornithosis), a systemic illness contracted from infected birds. The pneumonia associated with it may be extensive, and severe systemic upset and death are common.Headache is a prominent early symptom.
- Non-gonococcal or non specific urethritis: Inflammation of the urethra not resulting from gonococcal, chlamydial, or other specific infectious agents.
- Lyme disease
- Brucellosis
- Miscellaneous infections, including granuloma inguinale, cholera, glanders, relapsing fever and V. vulnifians.
- Urinary Tract Infections with susceptible organisms (including the acute urethral syndrome in women).
- Bronchitis in patients with known underlying chronic lung diseases.
- Pelvic inflammatory disease and other sexually transmitted diseases (STDs) regimen.
- Travelers diarrhoea.
- Acne vulgaris
- Prostatitis.
- As an alternative agent in the penicillin allergic patient with syphilis.
- Anaerobic infections with susceptible organisms.
Therapeutic classView
Tetracycline group of drugs
PharmacologyView
Tetracycline has its main mechanism of action on protein synthesis, and an energy-dependent active transport system pumps the drug through the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell, Tetracycline binds specifically to the 30s ribosomes and inhibit bacterial protein synthesis.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
DosageView
The usual adult oral dosage of Tetracycline is 1-2 g daily given in 2-4 divided doses. The usual oral dosage of Tetracycline for children older than 8 years of age in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some clinicians recommended that children should receive 0.6-1.2 g/m2 daily.
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Side effectsView
Teeth and bone: Tetracycline can cause depression of bone growth, permanent graybrown discoloration of the teeth and enamel hypoplasia when given during tooth development (i.e. during the later half of pregnancy, during infancy and in childhood).
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
ContraindicationsView
Tetracycline Hydrochloride is contraindicated in patients hypersensitive to any of the member of tetracycline groups, since cross-sensitivity may occur Tetracycline Hydrochloride should be avoided in patients with systemic lupus erythematosus. Tetracycline Hydrochloride is considered to be contraindicated in renal impairment, particularly if severe ; if it must be given, doses should be reduced.
PrecautionsView
Care should be taken if Tetracycline Hydrochloride is given to patients with impaired liver function and high doses should be avoided. Potentiality hepatotoxic drugs (including erythromycin, chloramphenicol, isoniazide and sulphonamides) should not be given concomitantly.
InteractionsView
Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
Pregnancy & lactationView
Tetracycline should not be used during pregnancy because of the risk of hypertoxicity in the mother as well as the effects on the developing foetus. Use in pregnancy potentially during breast-feeding and in children up to the age of 8, or some authorise say 12 years, may result in impaired bone growth and permanent discoloration of the child's teeth.
StorageView
Store between 20-25° C.
G-Theophylline
Theophylline
G-Theophylline
Theophylline
Indications
Status asthmaticus
Indication detailsView
Theophylline is indicated for the-
- Control of acute asthma.
- Management of chronic asthma (For both Symptomatic and prophylactic treatment).
- For controlling nocturnal asthma and early morning wheezing.
- Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease.
- Control of apnea of pre-maturity.
Therapeutic classView
Bronchodilator, Theophylline & related drugs
PharmacologyView
Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours
DosageView
The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :
metabolism of theophylline. The recommended maintenance dose within accepted therapeutic range is as follows :
- 16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
- 12 years-15 years: 13 mg/Kg/day
- 9-11 years: 16 mg/Kg/day
- 1 year-8 years: 24-24 mg/Kg/day
- 6 months-1 year: 12-18 mg/Kg/day
- 1-6 months: 10 mg/Kg/day.
Side effectsView
Generally side effects are rare at normal dosage. It may include gastrointestinal discomfort, headache, nausea, insomnia and hypotension. CNS stimulation and diuresis may also occur, especially in children.
ContraindicationsView
Theophylline is contraindicated in patients with hypersensitivity to Theophylline or any other component of the product.
PrecautionsView
Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The dose of Theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.
InteractionsView
Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may therefore be necessary to increase dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics and hypoxia, so serum potassium levels should be monitored in such instances.
Pregnancy & lactationView
It is not known whether Theophylline can cause foetal harm when administered to pregnant woman. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.
Pediatric usageView
Pediatrics use: The clearance of Theophylline is very low in neonates. Careful attention to dosage selection and monitoring of serum Theophylline concentrations are required in pediatric patients.
StorageView
Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.