Class: Gastrointestinal System
Dosage Form: Tablets
Description: H2-receptor antagonist for treatment of peptic ulcer
Ranitidine hydrochloride…………150 mg
Rantidol is a specific, rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. Rantidol has a relatively long duration of action and so a single 150 mg. dose effectively suppresses gastric acid secretion for twelve hours.
Absorption of ranitidine after oral administration is rapid and peak plasma concentrations are usually achieved within two hours of administration. Absorption is not significantly impaired by food or antacids. The elimination half-life of ranitidine is approximately two hours. Ranitidine is excreted via the Kidneys mainly as the free drug and in minor amounts as metabolites.
Rantidol Tablets are indicated for the treatment of:
- Duodenal ulcer
- Benign gastric ulcer
- Post-operative ulcer
- Reflux esophagitis
- Zollinger-Ellison syndrome
Rantidol is also indicated in the following conditions where reduction of gastric secretion and acid output is desirable:
- Prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patient
- Prophylaxis of recurrent hemorrhage in patients with bleeding peptic ulcers
- Before general anesthesia in patients considered to be at risk of acid aspiration (Mendaleson’s syndrome), particularly obstetric patients during labor
In patients with hypersensitivity to ranitidine.
The following side effects are to be noted:
- Transient and reversible changes in liver functions may occur, (reversible hepatitis – hepatocellular, hepatocanalicular – or mixed with or without jaundice)
- Reversible leucopenia and thrombocytopenia have occurred rarely
- Hypersensitivity reactions (urticaria, angioneurotic oedema, bronchospasm, hypotension) have been seen rarely following the parenteral and oral administration
Dosage and Administration:
- The usual dosage is one 150 mg tablet twice daily, taken in the morning and evening
- Patients with duodenal or gastric ulcerations may be treated with a single bedtime dose of 300 mg
- It is not necessary to time the dose in relation to meals
- In most cases of duodenal ulcers, benign gastric ulcers and post-operative ulcers, healing occurs in four weeks
- Healing usually occurs after a further 4 weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy
- Maintenance treatment at a reduced dosage of one 150 mg
- Tablet at bedtime is recommended for patients who have responded to short-term therapy, particularly those with a history of recurrent ulcer
- In the management of reflux esophagitis, the recommended course of treatment is one 150 mg tablet twice daily for up lo 8 weeks
- In patients with Zollinger–Ellison syndrome, the starting dose is 150 mg three times daily and this may be increased if necessary patients with this syndrome have been given increasing doses up to 6 g per day and these doses have been well tolerated
- Experience with Rantidol tablets in children are limited and such use has not been fully evaluated in clinical studies, it has, however, been used successfully in children aged 8-18 years in doses up to 150 mg twice daily without adverse effect
Rantidol is very specific in action and accordingly no particular problems are expected following over-dosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.
Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. Accordingly, where gastric ulcer is suspected the possibility of malignancy should be excluded before therapy with Rantidol tablets is initiated.
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal failure. Accordingly, it is recommended that the therapeutic regimen for Rantidol in such patients to be 150 mg, at night for 4 to 8 weeks.
Rantidol has been used without adverse effect in patients with renal transplants.
Pack of 2 strips of 10 tablets each.
Store at room temperature.