Ulcin

Description

DESCRIPTION

FORMULATION

Each mL contains:

Ranitidine (as hydrochloride) …………………… 25 mg

PHARMACOLOGY

Ranitidine (ULCIN Injection) is a specific, rapidly acting histamine H2 – receptor antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both volume of the acid and pepsin content of the secretion.

PHARMACOKINETICS

Ranitidine is rapidly absorbed following intramuscular injection, with peak plasma concentration occurring in about 15 minutes. It is weakly bound, about 15%, to plasma proteins. The elimination half-life is about 2 to 3 hours and is increased in renal impairment. A small portion of ranitidine is metabolized in the liver to the N-oxide, S-oxide, and desmethylranitidine; the N-oxide is the major metabolite but accounts for only about 4 to 6% of a dose. Approximately 30% of an oral dose and 70% of an intravenous dose is excreted unchanged in the urine in 24 hours, primarily by active tubular secretion; there is some excretion in the feces. Ranitidine crosses placental barrier and is distributed into breast milk.

INDICATIONS

Ranitidine (ULCIN Injection) is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux esophagitis, Zolliger-Ellison Syndrome, and the following conditions: where reduction of gastric secretion and acid output is desirable, the prophylaxis of gastrointestinal hemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent hemorrhage in patients with bleeding peptic ulcers and before general anesthesia in patients considered to be at risk of acid aspiration, particularly obstetric patients during labor (Mendelson’s syndrome).

DOSAGE AND ADMINISTRATION

Ranitidine (ULCIN Injection) may be given either as a slow (over one minute) intravenous injection of 50 mg, which may be repeated every 6-8 hours; or as an intermittent intravenous injection at a rate of 25 mg per hour for 2 hours, the infusion may be repeated at 6-8 hour intervals; Or as an intramuscular injection of 50 mg (2 mL) every 6-8 hours.

In the prophylaxis of hemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent hemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences. Patients considered to be still at risk may then be treated with Ranitidine (ULCIN Tablets) 150 mg twice daily.

In patients considered to be at risk of developing acid aspiration syndrome, Ranitidine (ULCIN Injection) 50 mg may be given intramuscularly or by slow intravenous injection (over one minute) 45 to 60 minutes before induction of general anesthesia.

Ranitidine (ULCIN Injection) has been shown to be compatible with the following intravenous infusion fluids:

• 0.9% Sodium Chloride BP
• 5% Dextrose BP
• 0.18% Sodium Chloride and 4% Dextrose BP
• 4.2% Sodium Bicarbonate BP and Hartmann’s Solution

The unused admixtures of Ranitidine (ULCIN Injection) with infusion fluids should be discarded 24 hours after preparation.

The use of Ranitidine (ULCIN Injection) in children has not been evaluated.

CONTRAINDICATIONS

RANITIDINE is contraindicated in patients known to have hypersensitivity to the drug.

PRECAUTIONS

Treatment with a histamine H2-receptor antagonist may mask the symptoms associated with carcinoma of the stomach and therefore may delay diagnosis of the condition.

In severe renal impairment, plasma levels of ranitidine are increased. Accordingly, it is recommended in such patients that Ranitidine (ULCIN Injection) be administered in doses of 25 mg.

ADVERSE EFFECTS

Transient and reversible changes in liver function tests can occur.

There have been occasional reports of reversible hepatitis (hepatocellular, hepatocanicular or mixed) with or without jaundice.

Reversible blood count changes (leucopenia and thrombocytopenia) have occurred in a few patients. Rare cases of agranulocytosis or of pancytopenia, sometimes with marrow hyperplasia, have been reported.

Hypersensitivity reactions (urticaria, angioneurotic adema, bronchospasm, hypotension) have been reported rarely.

Bradycardia, headache, sometimes severe and dizziness have been reported in a very small proportion of patients.

DRUG INTERACTIONS

RANITIDINE does not inhibit the hepatic cytochrome P450 linked mixed function oxygenase enzyme system. Accordingly, RANITIDINE does not potentiate the action of drugs which are oxidized or inactivated by this enzyme. These include diazepam, lignocaine, phenytoin, propranolol, theophylline and warfarin.

PREGNANCY AND LACTATION

RANITIDINE crosses the placenta but therapeutic doses administered to obstetric patients in labor or undergoing caesarian section have been without any adverse effect on labor, delivery or subsequent neonatal progress.

RANITIDINE is also excreted in human breast milk, should be used during pregnancy only if considered essential.

OVERDOSAGE

Since there is no specific antidote for overuse of histamine H2 receptor antagonist, symptomatic and supportive therapy should be given as appropriate. The drug may be removed from the plasma by hemodialysis.

AVAILABILITY

ULCIN 25 mg/mL (50 mg/2mL) Solution for IM/IV Injection is available in box of 10’s.

STORAGE

Store at temperatures not exceeding 25°C. Protect from light.