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Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins and Vitamin-C deficiency especially during pregnancy and lactation.

Iron & Vitamin Combined preparations

Zinc sulfate precipitates protein and this is responsible for the astringent and weak antiseptic activity of Zn sulfate. It also produces mild vasodilation. Zinc sulfate can also be used orally or systemically as a zinc supplement. 220 mg of zinc sulfate (heptahydrate) contains 50 mg of elemental zinc.

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Nicotinamide is a vitamin B3 derivative. It is incorporated into coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are involved in multiple cellular metabolic pathways.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Recommended.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or haemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours.

Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdodage has been reported.

Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day have been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosages dose not cause any significant effect.

Store in a dry place below 25 °C. Protect from light.

This capsule is indicated for the treatment and prophylaxis of iron, folic acid, zinc, vitamin-B complex and vitamin-C deficiency, especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult: One capsule daily before food or as directed by the physician.

Use in Children & Adolescents: Upon consultation with a doctor, recommended to use in children & adolescents.

Allergic sensitization has been reported following oral administration of Folic acid. Oral iron preparation may cause constipation, particularly in older patients.

It is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in the presence of haemolytic anaemia.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, hemolytic anemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penicillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store at temperature not exceeding 30°C in a dry place. Protect from moisture.

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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