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Unimox

Amoxicillin Trihydrate

Powder for Suspension 125 mg/5 ml Allopathic Broad spectrum penicillins

Indications

Skin and skin sructure infections

Indication detailsView

Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include

Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
Venereal disease (i.e. acute uncomplicated gonorrhoea)
In dental abscess, it is used as short-term therapy.
It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.

Therapeutic classView

Broad spectrum penicillins

PharmacologyView

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

DosageView

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
Pneumonia: Recommended dose is 500-1000 mg three times daily.
Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
In renal impairment: it may be necessary to reduce the total daily dosage.

AdministrationView

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effectsView

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

ContraindicationsView

Amoxicillin is contraindicated in penicillin hypersensitive patients.

PrecautionsView

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

InteractionsView

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Pregnancy & lactationView

US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.

ReconstitutionView

Amoxycillin 500 mg Injection:

Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Unimox

Amoxicillin Trihydrate

Capsule 500 mg Allopathic Broad spectrum penicillins

Indications

Skin and skin sructure infections

Indication detailsView

Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include

Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
Venereal disease (i.e. acute uncomplicated gonorrhoea)
In dental abscess, it is used as short-term therapy.
It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.

Therapeutic classView

Broad spectrum penicillins

PharmacologyView

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

DosageView

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
Pneumonia: Recommended dose is 500-1000 mg three times daily.
Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
In renal impairment: it may be necessary to reduce the total daily dosage.

AdministrationView

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effectsView

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

ContraindicationsView

Amoxicillin is contraindicated in penicillin hypersensitive patients.

PrecautionsView

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

InteractionsView

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Pregnancy & lactationView

US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.

ReconstitutionView

Amoxycillin 500 mg Injection:

Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Unimox

Amoxicillin Trihydrate

Capsule 250 mg Allopathic Broad spectrum penicillins

Indications

Skin and skin sructure infections

Indication detailsView

Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include

Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
Venereal disease (i.e. acute uncomplicated gonorrhoea)
In dental abscess, it is used as short-term therapy.
It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.

Therapeutic classView

Broad spectrum penicillins

PharmacologyView

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

DosageView

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
Pneumonia: Recommended dose is 500-1000 mg three times daily.
Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
In renal impairment: it may be necessary to reduce the total daily dosage.

AdministrationView

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effectsView

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

ContraindicationsView

Amoxicillin is contraindicated in penicillin hypersensitive patients.

PrecautionsView

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

InteractionsView

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Pregnancy & lactationView

US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.

ReconstitutionView

Amoxycillin 500 mg Injection:

Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Unipim

Cefepime Hydrochloride

IM/IV Injection 1 gm/vial Allopathic Fourth generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:

Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Therapeutic classView

Fourth generation Cephalosporins

PharmacologyView

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

DosageView

Cefepime should be administered intravenously over approximately 30 minutes.

Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Side effectsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

ContraindicationsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

PrecautionsView

Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.

InteractionsView

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy & lactationView

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric usageView

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Overdose effectsView

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

ReconstitutionView

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

Amount of WFI to be added: 5 ml
Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

Amount of WFI to be added: 1.3 ml
Approximate available volume: 1.8 ml

1 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

Amount of WFI to be added: 2.4 ml
Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 12.5 ml

StorageView

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Unipim

Cefepime Hydrochloride

IM/IV Injection 500 mg/vial Allopathic Fourth generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:

Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Therapeutic classView

Fourth generation Cephalosporins

PharmacologyView

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

DosageView

Cefepime should be administered intravenously over approximately 30 minutes.

Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Side effectsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

ContraindicationsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

PrecautionsView

Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.

InteractionsView

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy & lactationView

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric usageView

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Overdose effectsView

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

ReconstitutionView

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

Amount of WFI to be added: 5 ml
Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

Amount of WFI to be added: 1.3 ml
Approximate available volume: 1.8 ml

1 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

Amount of WFI to be added: 2.4 ml
Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 12.5 ml

StorageView

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Uniplar

Paricalcitol

Capsule 1 mcg Allopathic Thyroid drugs & hormone

Indications

Secondary hyperparathyroidism

Indication detailsView

Chronic Kidney Disease Stages 3 and 4: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.

Chronic Kidney Disease Stage 5: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).

Therapeutic classView

Thyroid drugs & hormone

PharmacologyView

Paricalcitol is a synthetic, biologically active vitamin D2 analog of calcitriol. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

DosageView

The initial dose of this capsule for CKD stage 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.

Baseline intact parathyroid hormone (iPTH) Level: <500 pg/ml

Daily Dose: 1 mcg
Daily Dose: 2 mcg

Baseline intact parathyroid hormone (iPTH) Level: >500 pg/ml

Daily Dose: 2 mcg
Daily Dose: 4 mcg

Side effectsView

The most common adverse reactions (>5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema.

ContraindicationsView

Paricalcitol capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity.

PrecautionsView

Hypercalcemia: Excessive administration of paricalcitol capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment.

Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds.

Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. Paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR).

Aluminum overload and toxicity: Avoid excessive use of aluminum-containing compounds.

InteractionsView

Strong CYP3A inhibitors (e.g. ketoconazole) will increase the exposure of paricalcitol. Use with caution.
Cholestyramine, Mineral Oil: Intestinal absorption of paricalcitol may be reduced if administered simultaneously with cholestyramine or mineral oil. Take paricalcitol capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.

Pregnancy & lactationView

Limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy. In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (MRHD). Adverse reproductive outcomes were observed at doses that caused maternal toxicity. There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production.

StorageView

keep in a dry place away from light and heat. Keep out of the reach of children.

Uniplex

Vitamin B complex

Syrup Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView

Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi

Therapeutic classView

Specific combined vitamin preparations

PharmacologyView

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

DosageView

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Side effectsView

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

ContraindicationsView

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

InteractionsView

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

Pregnancy & lactationView

It is safe to use Vitamin-B complex in pregnancy and lactation.

Unipril

Ramipril

Tablet 1.25 mg Allopathic Angiotensin-converting enzyme (ACE) inhibitors

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:

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.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

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.

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.

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.

Unipril

Ramipril

Tablet 5 mg Allopathic Angiotensin-converting enzyme (ACE) inhibitors

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:

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.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

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.

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.

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.

Unipril

Ramipril

Tablet 2.5 mg Allopathic Angiotensin-converting enzyme (ACE) inhibitors

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:

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.

Concomitant use of ACE inhibitors and extracorporeal treatments leading to contact of blood with negatively charged surfaces must be avoided, since such use may lead to severe anaphylactoid reactions. Such extracorporeal treatments include dialysis or haemofiltration with certain high-fux (e.g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate.

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.

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.

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.

Uniquin

Chloroquine Phosphate

Tablet 250 mg Allopathic Anti-malarial drugs

Indications

Systemic lupus erythematosus (SLE)

Indication detailsView

Chloroquine Phosphate is indicated in the following cases:

Treatment of malaria
Prophylaxis and suppression of malaria
Treatment of amoebic hepatitis and abscess
Treatment of discoid and systemic and systemic lupus erythematosus
Treatment of rheumatoid arthritis

Therapeutic classView

Anti-malarial drugs

PharmacologyView

Chloroquine is used for malarial prophylaxis (as a suppressive) and in managing acute attacks of malaria. It is highly active against erythrocytic forms of P. vivax, P. malariae and P. falciparum. It influences Hb digestion by increasing intravesicular pH in malaria parasite cells and interferes with the nucleoprotein synthesis of the patient. It is also effective in extra intestinal amoebiasis. In RA chloroquine and more effectively hydroxychloroquine have a disease-modifying effect.

DosageView

Treatment of Malaria-

Partially immune adults:

A single dose of 4 tablets. In severe attacks, the dosage schedule for non-immune adults should be adopted.

Partially immune children:

Under 1 year: 1-2 single dose (in 5 ml spoonful)
1-3 years: 3-4 single dose (in 5 ml spoonful)
3-6 years: 4-6 single dose (in 5 ml spoonful)
6-9 years: 6-9 single dose (in 5 ml spoonful)

In severe attacks, the dosage schedule for non-immune children should be adopted.

Non-immune adults:

P. falciparum infections: 4 tablets initially, 2 tablets after 6 to 8 hours and then 2 tablets per day for 2 days
P. vivax group infections: A single dose of four tablets followed by a course of treatment with primaquine phosphate (15 mg base daily for fourteen days)

Non-immune Children:

Under 1 year:

1-2 initial dose (in 5 ml spoonful)
1 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)

1-3 years:

3-4 initial dose (in 5 ml spoonful)
1-2 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)

3-6 years:

4-6 initial dose (in 5 ml spoonful)
2-3 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)

6-9 years :

6-9 initial dose (in 5 ml spoonful)
3-5 dose to be taken 6 hours later and then daily for 2 days (in 5 ml spoonful)

Prophylaxis and suppression of Malaria-

Adults: 2 tablets taken once a week, on the same day each week, during exposure to risk and continued for 6 weeks after leaving the malarious area.

Children (Syrup): The following doses should be taken once a week, on the same day each week, during exposure to risk and continued for 6 weeks after leaving the malarious area.

Under 1 year: 1 single dose (in 5 ml spoonful)
1-3 years: 2 single dose (in 5 ml spoonful)
3-6 years: 2-3 single dose (in 5 ml spoonful)
6-9 years: 3-5 single dose (in 5 ml spoonful)

Children (Tablets): For practical purpose, children over 12 years may be treated as adults and for those below this age, the following proportions may be applied.

Under 1 year: ⅛ adult dose (¼ tablet)
1-4 years: ¼ adult dose (½ tablet)
4-8 years: ½ adult dose (1 tablet)
8-12 years: ¾ adult dose (1.5 tablet)

Side effectsView

Choroquine is well tolerated at the standard dosage regimens, side effects such as headache and gastrointestinal disturbances which may occur are not of a serious nature. Where prolonged high dose is required side effects can be of greater severity and patients may develop skin eruptions, occasional depigmentation or loss of hair, difficulty in accommodation, blurring of vision. Corneal opacities disappear completely when the drug is stopped. Rarely thrombocytopenia, agranulocytosis and aplastic anemia have been reported.

The most serious toxic hazard of prolonged therapy with doses is the occasional development of irreversible retinal damage. For this reason considerable caution is needed in the use of choroquine for long-term high dosage therapy and such use should only be considered when no other drug is available. Defects in visual accommodation may occur on first taking choloquine and patients should be warned regarding driving or operating machinery.

ContraindicationsView

There is no absolute contraindication to the use of chloroquine.

PrecautionsView

Caution is necessary when giving choroquine to patients with porphyria who also have hepatic dysfunction or cirrhosis as the drug may precipitate severe constitutional symptoms and an increase in the amount of porphyrins excreted in the urine. This reaction is especially apparent in alcoholics. Patients receiving choloquine continuously at higher dose levels for a period longer than 12 months or at weekly intervals for a period of more than 3 years as prophylactic against malaria (or the consumption exceeds 1.6 g/Kg) should undergo ophthalmic examination at three months interval.

InteractionsView

Concomitant therapy with phenylbutazone predisposes to dermatitis, antagonises effect of neostigmine and pyridostigmine, reduces bioavailability of ampicillin. Cimetidine inhibits metabolism of chloroquine raising plasma levels.

Pregnancy & lactationView

As with all other drugs, the use of choroquine during pregnancy should be avoided if possible, unless in the case of threatening infections, in the judgment of the physician, when the potential benefit outweighs the risk.

Pediatric usageView

Amoebic hepatitis: Four tablets daily for two days followed by one tablet twice daily for two or three weeks.

Lupus erythomatosus: One tablet twice daily for one to two weeks followed by a maintenance dose of one tablet daily.

StorageView

Store at room temperature in a dry place, away from light.

Unirab

Rabeprazole Sodium

Capsule (Delayed Release) 20 mg Allopathic Proton Pump Inhibitor

Indications

Gastric ulcer

Indication detailsView

Rabeprazole Gastro-resistant tablets are indicated for the treatment of:

Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
Zollinger-Ellison Syndrome
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

DosageView

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

AdministrationView

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Side effectsView

In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.

PrecautionsView

Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
Co-administration of atazanavir with Rabeprazole is not recommended.
Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

InteractionsView

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

Pregnancy & lactationView

US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, 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.

Pediatric usageView

Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.

Overdose effectsView

The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Unisaline

Oral Rehydration Salt [Powder]

Oral Powder 10.25 gm Allopathic Oral electrolytes preparations

Indication detailsView

Oral Rehydration Salt replacement of fluid and electrolyte loss due to-

Acute diarrhea
Vomiting
Dehydration

Other conditions of fluid loss or lack of intake in patients of all age groups.

Therapeutic classView

Oral electrolytes preparations

PharmacologyView

This is the preparation of oral rehydration salt. It is composed of anhydrous glucose, sodium chloride, potassium chloride and sodium citrate (as dihydrate). This is a single formulation of glucose based oral rehydration salt to treat or prevent dehydration from diarrhea of any etiology, including cholera and in individuals of any age. This also prevents acidosis due to electrolyte imbalance.

DosageView

Daily dose should be equivalent to patients' fluid requirement for maintenance and replenishment of losses. During this therapy, mother should not stop breastfeeding to their child and normal food should be continued in case of adults.

Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.

Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.

Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.

AdministrationView

Disperse the full contents of the sachet in 500 mL (1/2 liter) of pure drinking water.
Do not mix the oral saline with hot water or heat the prepared solution.
Discard the unused prepared oral saline after 12 hours of preparation.

PrecautionsView

Depressed renal function, severe continuing diarrhea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline.

InteractionsView

There are no known drug interactions and none well documented.

StorageView

Do not store above 30°C temperature. Keep away from light and wet places. Keep out of reach of children.

Unisaline Fruity

Oral Rehydration Salt [Flavored]

Oral Powder Allopathic Oral electrolytes preparations

Indications

Vomiting

Indication detailsView

Indicated for Diarrhea, Dehydration, Vomiting, Fluid and Electrolytes imbalance

Therapeutic classView

Oral electrolytes preparations

PharmacologyView

Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes.

It is also used as diluents for infusion of compatible drug additives.

Dextrose is a monosaccharide that is used as a source of calories and water for hydration. It helps to reduce loss of body protein and nitrogen. It also promotes glycogen deposition in the liver. When used with insulin, it stimulates the uptake of potassium by cells, especially in muscle tissue, thus lowering serum potassium levels.

Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.

DosageView

Daily dose should be equivalent to patients fluid requirement for maintenance and replenishment of losses. During saline therapy mother should not stop breast-feeding to their child and normal food should be continued in case of adults.

Children less than 2 years: After each loose stool or vomiting 10 to 20 spoonful (50-100 ml) of prepared saline.

Children 2 to 10 years: After each loose stool or vomiting 100-200 ml of prepared oral saline.

Adult and children above 10 years: After each loose stool or vomiting 200-400 ml of prepared saline.

Side effectsView

No significant side effects.

ContraindicationsView

Patients with known hypersensitivity.

PrecautionsView

Depressed renal function, severe continuing diarrhoea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline. Reconstitue saline should be used within 6 hours.

InteractionsView

There are no known drug interactions and none well documented.

Pregnancy & lactationView

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Unisef

Cefixime Trihydrate

Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Unisef

Cefixime Trihydrate

Capsule 400 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Unisef

Cefixime Trihydrate

Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Unitac

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

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.

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.

StorageView

Store in a cool and dry place. protect from light.

Univer

Ivermectin (Tablet)

Tablet 6 mg Allopathic Anthelmintic

Indication detailsView

Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.

Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).

Therapeutic classView

Anthelmintic

PharmacologyView

Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.

DosageView

For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.

Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg

Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

Dosage Guidelines for Ivermectin for Strongyloidiasis:

Body Weight (kg) 15-24: Dose 3 mg/kg
Body Weight (kg) 25-35: Dose 6 mg/kg
Body Weight (kg) 36-50: Dose 9 mg/kg
Body Weight (kg) 51-65: Dose 12 mg/kg
Body Weight (kg) 66-79: Dose 15 mg/kg
Body Weight (kg) >80: Dose 200 mcg/kg

Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

Dosage Guidelines for Ivermectin for Onchocerciasis:

Body Weight (kg) 15-25: Dose 3 mg/kg
Body Weight (kg) 26-44: Dose 6 mg/kg
Body Weight (kg) 45-64: Dose 9 mg/kg
Body Weight (kg) 65-84: Dose 12 mg/kg
Body Weight (kg) >85: Dose 150 mcg/kg

Side effectsView

Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.

Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

ContraindicationsView

It is contraindicated in patients who are hypersensitive to any component of this product.

PrecautionsView

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.

InteractionsView

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Pregnancy & lactationView

Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

StorageView

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.

Univit-B

Vitamin B complex

Tablet Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView

Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi

Therapeutic classView

Specific combined vitamin preparations

PharmacologyView

Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.

DosageView

Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.

Side effectsView

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.

ContraindicationsView

Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.

InteractionsView

As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy

Pregnancy & lactationView

It is safe to use Vitamin-B complex in pregnancy and lactation.

Indications

Indications

Indications

Indications

Indications

Indications

Indications

Indications

Indications

Indications

Indications

Treatment of Malaria-Partially immune adults:

Partially immune children:

Non-immune adults:

Non-immune Children:

Prophylaxis and suppression of Malaria-

Indications

Indications

Indications

Indications

Indications

Indications

Ranitidine Tablet & Syrup:

Ranitidine IV injection & IV Infusion:

Indications

Treatment of Malaria-

Partially immune adults: