Inran®
Ranitidine Hydrochloride

COMPOSITION:
Inran® 150 Tablet: Each film coated tablet contains Ranitidine Hydrochloride USP equivalent to Ranitidine 150mg.
Inran® 50 Injection: Each 2ml ampoule contains 50mg Ranitidine as Ranitidine Hydrochloride BP.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Inran® (Ranitidine) is a histamine H2-receptor antagonist. As a result of its H2-receptor blocking action Inran® (Ranitidine) promotes rapid and effective ulcer healing with sustained pain relief, both day and night by reduction of gastric acid output. After oral administration Ranitidine is rapidly absorbed from the GI tract. After IM administration the drug is absorbed very rapidly and almost completely from the site of injection. Therapeutic concentration, necessary to inhibit gastric secretion, is maintained for 6-8 hours both after IV/IM Injection.

CLINICAL INFORMATION:
Therapeutic Indications
Inran® tablet is indicated in the treatment of Gastric and Duodenal ulcer (Peptic Ulcer), Esophageal Reflux Diseases, Zollinger-Ellison Syndrome, Dyspepsia, Recurrent Ulcer, NSAID Gastropathy and ,In such condition where gastric acidity reduction is beneficial Doses and Administration 2-4 mg/kg twice daily, maximum 300 mg daily. Peptic ulcer150 mg 3 times daily and the dose is increased if necessary up to 6 g daily in divided doses.Zollinger-Ellison Syndrome 150 mg twice daily for up to 8 weeks and if necessary for up to 12 weeks Reflux Oesophagitis150 mg twice daily for up to 8 weeks NSAID-associated Ulcer 150 mg twice daily for up to 6 weeks Chronic Episodic Dyspepsia. The usual adult dosage is 150 mg twice daily taken in the morning and evening for up to 4 to 8 weeks.

Inran® injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50mg, after dilution to a volume of 20 ml per 50mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences. In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients a priming dose of 50mg as a slow intravenous injection followed by a continuous intravenous infusion of 0.125-0.250mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Inran® injection 50mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Use in Pregnancy & Lactation
Pregnancy: This drug should be used during pregnancy only if clearly needed.

Lactation:
Inran® (Ranitidine) is secreted in human milk. Caution should be exercised when Inran® (Ranitidine) is administered to a nursing mother.

Side effects:
Inran® (Ranitidine), the following side effects are observed. Minor: headache, dizziness, nausea, stomach pain, constipation, rash. Major: weakness, fever, sore throat, abnormal skin bruising, yellow color to skin or eyes, confusion, agitation.

Contraindications
Inran® (Ranitidine) is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

Precautions
It should be used with caution in patients with impaired renal function, hepatic dysfunction, pregnancy, lactating mothers and suspected malignancy.

PHARMACEUTICAL INFORMATION:
Storage conditions Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Inran® 150 Tablet: Each commercial box contains 10 x 10's tablets in Alu-Alu blister pack.
Inran® 50 Injection: Box containing 2x5's ampoules in Alu-PVC blister pack.