(i) ROUTE OF ADMINISTRATION
Oral

(ii) DOSAGE AND ADMINISTRATION

Absorption and bioavailability of ranitidine are not altered by food.

Duodenal ulcer: 300mg once daily at bedtime. After 4-8 weeks, daily maintenance doses are given at 150 mg at bedtime.

Acute benign gastric ulcer: Same as for duodenal ulcer both in the acute stage and for maintenance.

Gastro-esophageal reflux: 150mg twice daily for up to 8 weeks.
Erosive oesophagitis: 150mg four times daily.

Zollinger-Ellison syndrome: 150mg twice daily for upto 8 weeks.
Prophylaxis of recurrent haemorrhage in stress.

Ulceration: 150mg twice daily.

Prevention of acid aspiration: In patients at risk of acid aspiration during general anaesthesia, 150 mg can be given orally 2 hours before induction or at the start of labour. This dose may be repeated every 6 hours as required.

In impaired renal function: In patients with creatinine clearance less than 50 ml/minute the dose is reduced to 150 mg every 24 hours. The dose may be given if necessary every 12 hours with great caution. Haemodialysis removes ranitidine from circulation. Ranitidine should be given at the end of haemodialysis.

Paediatrics: Safety and efficacy of ranitidine in children younger 12 years of age has not been established.

(iii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Ranitidine 300 mg tablets is indicated for the following conditions:
1.Duodenal ulcer: For healing of acute ulcer and maintenance therapy after healing.
2.Active benign gastric ulcer.
3.Gastro-oesophageal reflux and erosive oesophagitis.
4.Stess ulcer: For prophylaxis of bleeding from stress ulcer.
5.Prevention of recurrent bleeding from peptic ulcers.
6.Hypersecretory conditions such as Zollinger-Ellison syndrome.
7.Prevention of acid aspiration during general anaesthesia in patients at risk particularly women in labour.

(iv) DESCRIPTION OF DOSAGE FORM

Health 2000 Ranitidine 300 mg tablet is an anti-ulcerative agent. Ranitidine is an H2 (histamine) receptor antagonist that inhibits gastric acid secretion by blocking the histamine receptor on the gastric parietal cell.

(v) CONTRAINDICATIONS

In impaired renal function:
See dosage and administration

(vi) SIDE EFFECTS

The extensive use of ranitidine has led to a variety of side effects reported with it. But in most cases, a cause and effect relationship is not clear.
H2 receptors have very limited distribution outside the stomach and this limits the incidence of side effects due to ranitidine. The incidence is low and most of the side effects are of a minor nature. No potentially life-threatening adverse reactions have been reported.
Headache, dizziness, constipation, diarrhoea and nausea have been reported with ranitidine. Rash has been reported in a few patients.
Rarely malaise, somnolence or insomnia, mental confusion hallucinations, agitation, depression have been reported mostly in severely ill elderly patients. Blurred vision has been noted rarely.
As with other H2 receptor antagonists rare occurrence of bradycardia, tachycardia, AV block and premature ventricular beats have been reported.
Increase in serum transaminase values and hepatitis with or without jaundice have occurred in few patients.
Unlike cimetidine, ranitidine does not have any anti-androgenic effect. In fact, cimetidine-induced gynaecomastia and impotence have resolved when ranitidine was submitted for cimetidine.
Hypersensitivity has occurred rarely with symptoms of bronchospasm, fever, rash, angioeder ma and anaphylaxis.

(vii) TOXIC EFFECTS

Mutagenecity,Teratogenecity and Carcinogenecity:

Ranitidine crosses into the cerebrospinal fluid to a very low extent.Ranitidine may cross the placental barrier. After an intravenous injection or an oral dose of ranitidine during pregnancy, the concentration of ranitidine in the umbilical chord corresponds to the maternal serum concentration. Twelve hours after delivery, the blood concentration of ranitidine was very low in the infant.
Preclinical safety data
Animal studies do not indicate any special risks for humans in terms of acute toxicity, general toxic effects, reproduction effects, mutagenecity, genotoxicity, or carcinogenicity

Ranitidine 300 mg tablets