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Odmon
Montelukast Sodium
Odmon
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Odmon
Montelukast Sodium
Odmon
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Odmon
Montelukast Sodium
Odmon
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Odofex
Fexofenadine Hydrochloride
Odofex
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Odrel
Clopidogrel Bisulphate
Odrel
Clopidogrel Bisulphate
Indications
Unstable angina
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
DosageView
Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Side effectsView
Clopidogrel is generally well tolerated drug.
- Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
- Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
ContraindicationsView
Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
- As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
- Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
InteractionsView
- NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast 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
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose effectsView
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
StorageView
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
Odrel Plus
Clopidogrel + Aspirin
Odrel Plus
Clopidogrel + Aspirin
Indications
Transient ischemic attack
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial Infarction (STEMI)].
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
DosageView
The recommended oral dose is one tablet daily.
Side effectsView
This combination is generally well tolerated.
ContraindicationsView
This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- This combination may prolongs the bleeding time.
- Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of this combination.
- Reye's syndrome: Reye's syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving this combination or history of hypersensitivity to other thienopyridines
InteractionsView
Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.
Pediatric usageView
It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.
Overdose effectsView
Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.
StorageView
Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.
Odycin
Moxifloxacin Hydrochloride (Tablet)
Odycin
Moxifloxacin Hydrochloride (Tablet)
Indications
Acute bacterial sinusitis
Indication detailsView
Moxifloxacin is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.
DosageView
Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Side effectsView
Common side effects of Moxifloxacin include nausea, vomiting, diarrhea, headache and dizziness.
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.
PrecautionsView
Moxifloxacin may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents
InteractionsView
Moxifloxacin absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Moxifloxacin may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Moxifloxacin with them should be avoided.
Pregnancy & lactationView
US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.
Pediatric usageView
Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Odycin
Moxifloxacin Hydrochloride (Ophthalmic)
Odycin
Moxifloxacin Hydrochloride (Ophthalmic)
Indications
Ocular infections
Indication detailsView
The ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
- Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
- Aerobic Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilus parainfluenzae.
- Other microorganisms: Chlamydia trachomatis.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
DosageView
Eye Drops: One drop in the affected eye 3 times per day for 7 days.
Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.
Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.
Side effectsView
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
ContraindicationsView
Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.
PrecautionsView
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
InteractionsView
Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
Pregnancy & lactationView
Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin Hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin hydrochloride ophthalmic solution is administered to a nursing mother.
StorageView
Store bellow 25°C. Do not freeze. Store in cool and dry place, protected from light. Keep out of the reach of children. Do not touch dropper tip to any surface as this may contaminate this preparation. Do not use after one month of first opening.
Odycin D
Moxifloxacin Hydrochloride + Dexamethasone
Odycin D
Moxifloxacin Hydrochloride + Dexamethasone
Indications
Steroid-responsive inflammatory ocular conditions
Indication detailsView
Moxifloxacin & Dexamethasone eye drop is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.
Therapeutic classView
Ophthalmic Steroid preparations
PharmacologyView
This Eye Drops is a combination of a fourth generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexmethasone. Moxifloxacin controls infection by inhibitting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls the inflammation by inhibiting the release inflammatory mediators.
DosageView
In the prevention of infection and post-surgical ocular inflammation: Instill 1 drop, 4 times a day, in the eye to be operated, from 1 day before surgery until 15 days after surgery.
In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.
In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.
In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.
In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.
In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.
In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.
Side effectsView
Moxifloxacin: Conjunctivitis decreased visual acuity, dry eye, keratitis, Ocular discomfort, hyperemia, pain, Subconjunctival hemorrhage and tearing.
Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.
Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.
ContraindicationsView
Hypersensitivity to quinolones. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella & other viral diseases of cornea & conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Glaucoma & diseases causing thinning of cornea or sclera.
PrecautionsView
For ophthalmic use only. The solution should not be injected under the conjunctiva, nor introduced directly into the anterior chamber of the eye. Prolonged use of steroids may result in ocular hypertension
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when Moxifloxacin & Dexamethasone combination eye drops is given to nursing women.
Pediatric usageView
Use in the elderly: No change in dosage is required when the product is administered in elderly patients.
Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
Overdose effectsView
No information is available on overdosage with this product in humans.
StorageView
Store in a cool place, below 30°C, protected from light. Once the container is opened the contents must be used within 28 days and may be stored at room temperature up to 30°C. Discard after the 28 days. Keep out of reach of children.
Ofex
Cefixime Trihydrate
Ofex
Cefixime Trihydrate
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
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.
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.
Ofex
Cefixime Trihydrate
Ofex
Cefixime Trihydrate
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
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.
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.
Ofex
Cefixime Trihydrate
Ofex
Cefixime Trihydrate
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
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.
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.
Off-H
Ranitidine Hydrochloride
Off-H
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Ofkof
Dextromethorphan + Pseudoephedrine + Triprolidine
Ofkof
Dextromethorphan + Pseudoephedrine + Triprolidine
Indications
Non-productive cough
Indication detailsView
This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- Non-productive cough due to minor throat or bronchial irritation
- Runny Nose
- Sneezing
- Itching of the nose or throat
- Itchy & watery eyes
- Nasal congestion
Therapeutic classView
Combined cough suppressants
PharmacologyView
This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.
DosageView
Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.
6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.
Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.
6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.
Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.
Side effectsView
It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.
ContraindicationsView
It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment
PrecautionsView
This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.
InteractionsView
Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.
Pregnancy & lactationView
There are no specific data on use of this combination during pregnancy & lactation.
Overdose effectsView
In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.
StorageView
Store in a cool and dry place (below 30°C temperature), away from light. Keep out of the reach of children.
Oflacin
Ofloxacin (Oral & Injection)
Oflacin
Ofloxacin (Oral & Injection)
Indications
Uncomplicated cystitis
Indication detailsView
Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
- Gastrointestinal Tract: Enteric fever, shigellosis.
- Multi-drug-resistant Tuberculosis.
- Skin and skin structures: Uncomplicated skin and skin structure infections.
- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
Therapeutic classView
4-Quinolone preparations, Aural Anti-bacterial preparations
PharmacologyView
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
DosageView
Intravenous (Adult):
- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Oral (Adult):
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
- Shigellosis: 400 mg single dose.
- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Elderly: No adjustment of dosage is required in the elderly.
AdministrationView
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
Side effectsView
Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
ContraindicationsView
Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
PrecautionsView
Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
InteractionsView
Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
Pregnancy & lactationView
The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.
Pediatric usageView
Renal Impairment:
- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
Overdose effectsView
Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
StorageView
Store between 15-30° C. Protect from light.
Oflacin
Ofloxacin (Oral & Injection)
Oflacin
Ofloxacin (Oral & Injection)
Indications
Uncomplicated cystitis
Indication detailsView
Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
- Gastrointestinal Tract: Enteric fever, shigellosis.
- Multi-drug-resistant Tuberculosis.
- Skin and skin structures: Uncomplicated skin and skin structure infections.
- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
Therapeutic classView
4-Quinolone preparations, Aural Anti-bacterial preparations
PharmacologyView
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
DosageView
Intravenous (Adult):
- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Oral (Adult):
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
- Shigellosis: 400 mg single dose.
- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Elderly: No adjustment of dosage is required in the elderly.
AdministrationView
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
Side effectsView
Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
ContraindicationsView
Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
PrecautionsView
Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
InteractionsView
Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
Pregnancy & lactationView
The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.
Pediatric usageView
Renal Impairment:
- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
Overdose effectsView
Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
StorageView
Store between 15-30° C. Protect from light.
Ofmit
Ondansetron
Ofmit
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Ofmit
Ondansetron
Ofmit
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Ofpain
Ketorolac Tromethamine
Ofpain
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ofpain
Ketorolac Tromethamine
Ofpain
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.