Aceptin-R 150 mg (Tablet)

Indications

• 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 particularly obstetric patients

Pharmacology

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.

Dosage & Administration

• Tablet & Syrup:
  • Usual dosage is 150 mg twice daily for active duodenal and benign gastric ulcer
  • 300 mg as a single daily dose at night for 4 to 8 weeks for active duodenal and benign gastric ulcer
  • 150 mg twice daily for reflux esophagitis up to 8 weeks
  • 300 mg at bedtime for reflux esophagitis up to 8 weeks
  • 150 mg 3 times daily for Zollinger Ellison syndrome
  • Increased dosage for Zollinger Ellison syndrome if necessary
  • 150 mg twice daily for episodic dyspepsia
  • 300 mg at bedtime for episodic dyspepsia up to 6 weeks
  • 150 mg at night for maintenance to prevent recurrences
  • 2-4 mg/kg twice daily for children with peptic ulcer, maximum 300 mg daily
  • Oral, IV injection & IV infusion dosages provided
• IV Injection & IV Infusion: Various dosages based on the indication, route of administration, and patient population

Interaction

• Delayed absorption and increased peak serum concentration with propantheline bromide
• Minimally inhibits hepatic metabolism of certain drugs
• May alter absorption of pH-dependent drugs
• May reduce bioavailability with antacids

Contraindications

Patients hypersensitive to Ranitidine

Side Effects

Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain

Pregnancy & Lactation

• Ranitidine crosses the placenta
• No evidence of impaired fertility or harm to the fetus
• Use during pregnancy only if considered essential
• Excreted in human breast milk
• Caution should be exercised when administered to a nursing mother

Precautions & Warnings

Reduced dosage for patients with impaired renal and hepatic function

Use in Special Populations

Similar ulcer healing rates in elderly patients as in younger patients; no difference in adverse effects

Overdose Effects

No particular problems expected following overdosage with the drug; Symptomatic and supportive therapy as appropriate; Removal from the plasma by haemodialysis if required

Therapeutic Class

H2 receptor antagonist

Reconstitution

Instructions for reconstitution of Aceptin-R for slow IV injection, intermittent slow IV infusion, continuous IV infusion, and special conditions like Zollinger-Ellison syndrome

Storage Conditions

Store in a cool and dry place. Protect from light

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