Servipep 40 mg - 10's Strip Tablet

Summary:

Indications of Servipep 40 mg
Servipep 40 mg is indicated in- Gastric ulcer Duodenal ulcer Anastomotic ulcer Acute stress ulcer Reflux esophagitis and Zollinger-Ellison syndrome. Servipep 40 mg is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.
Theropeutic Class
H2 receptor antagonist
Pharmacology
Servipep 40 mg is a histamine H2-receptor antagonist. Servipep 40 mg 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 Servipep 40 mg is slowly reversible, since the drug dissociates slowly from H2-receptor.
Dosage and Administration of Servipep 40 mg
Duodenal ulcer: 40 mg at night for 4 to 8 weeksBenign gastric ulcer: 40 mg at night for 4 to 8 weeks; Maintenance therapy: 20 mg at night
for preventing the recurrences of duodenal ulcerationGastro-oesophageal reflux disease: 20 mg twice daily for 6 to 12 weeks Zollinger Ellison syndrome: The recommended starting dose is 20 mg every six hours.
Dosage should then be adjusted to individual response. Doses up to 160 mg every six hours have been administered to some patients without the development of significant adverse effectsDosage can be administered irrespective of meals. Antacids may be given concomitantly if needed.
Dosage of Servipep 40 mg
Tablet: For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Servipep 40 mg 20 mg twice daily (after breakfast and after supper or before bed time) or Servipep 40 mg 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 Servipep 40 mg 20 mg orally twice a day (after breakfast and after supper or before bed time).
Also Servipep 40 mg 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 Servipep 40 mg 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, Servipep 40 mg Injection Premixed or Servipep 40 mg Injection may be administered until oral therapy can be instituted.
The recommended dosage for Servipep 40 mg Injection Premixed and Servipep 40 mg 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 Servipep 40 mg 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.
Interaction of Servipep 40 mg
No clinically important drug interactions have been identified. Servipep 40 mg does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.
Contraindications
Known hypersensitivity to any component of the drug.
Side Effects of Servipep 40 mg
Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.
Pregnancy and Lactation
Pregnancy: There are no adequate, well controlled studies on Servipep 40 mg in pregnancy, but it is known to cross the placenta and should be prescribed only if clearly needed.Lactation: It is not known whether Servipep 40 mg is secreted into human milk, nursing mothers should either stop nursing or stop taking the drug.
Precautions and Warnings
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.
Storage Conditions
Keep below 30°C temperature, away from light and moisture. Keep out of the reach of children.
Mode Of Action
Servipep 40 mg is a histamine H2-receptor antagonist. Servipep 40 mg 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 Servipep 40 mg is slowly reversible, since the drug dissociates slowly from H2-receptor.