Unique Pharma Lab


Full Prescribing Info
Ranitidine hydrochloride.
FC tablet: Each film coated tablet contains: Ranitidine Hydrochloride equivalent to Ranitidine 150 mg/300 mg.
150mg & 300mg: Orange coloured round, biconvex, film-coated tablet packed in blister of 10 tablets, 20 such blisters are packed in a printed carton.
Solution for injection: Each 2 ml ampoule contains: Ranitidine Hydrochloride equivalent to Ranitidine 50 mg.
Excipients/Inactive Ingredients: Solution for injection: Phenol 0.5% w/v (As preservative).
Pharmacology: Pharmacodynamics: Histamine H2-receptor Antagonist, Rantac is a competitive reversible inhibitor of the action of Histamine at the Histamine H2-receptor including receptors on the gastric cells.
Ranitidine inhibits daytime and nocturnal basal gastric acid secretion, as well as gastric acid secretion stimulated by food, histamine and pentagastrin. Basal and nocturnal secretions are most sensitive to inhibit by ranitidine, responding almost completely to doses of 100 mg or less.
Ranitidine does not affect pepsin secretion or pantagastrin stimulated intrinsic factor secretion and has little or no effect on fasting or postprandial serum gastrin.
Mechanism of Action: Rantac is a highly effective, rapidly acting histamine H2 antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volumes of secretion, the acid and pepsin content.
Pharmacokinetics: FC tablet: Absorption of the oral Ranitidine is not significantly impaired by the administration of food. Concomitant administration of antacids may reduce its absorption. Propantheline slightly delays and increases peak blood levels, probably by delaying gastric emptying and transit time. Serum protein binding averages 15% Hepatic metabolism results in three metabolites. Elimination half-life is 2 to 3 hours and duration of action is 8 to 12 hours. The principal route of excretion is the urine and active tubular excretion. Accumulation of the drug occurs in renal impairment; elimination half-life increases to 8 to 10 hours. Ranitidine is removed by hemodialysis and peritoneal dialysis.
Solution for injection: Ranitidine is very rapidly absorbed after Intramuscular (IM) injection. Mean peak levels of 576 ng/ml occur within 15 minutes or less following a 50-mg IM dose. Absorption from IM sites is virtually complete, with a bioavalability of 90% to 100% compared with Intravenous (IV) administration.
Distribution: the volume of distribution is about 1.4 L/Kg. Serum protein binding averages 15%.
Metabolism: In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to < 4 % of the dose. Other metabolites are the S-oxide (1 %) and the desmethyl ranitidine (1 %). The remainder or the administered dose is round in the stool.
Excretion: Following IV injection, approximately 70% of the dose is recovered in urine as unchanged drug. Renal clearance averages 530 mL/min with a total clearance or 760 mL/min. The elimination half life is 2.0 to 2.5 hours.
Duodenal ulcer, benign gastric ulcer, post-operative ulcer, Zollinger Ellison Syndrome, systemic mastocytosis, reflux esophagitis and chronic episodic dyspepsia.
Dosage/Direction for Use
FC tablet: 150 mg twice daily or 300 mg once at bed time.
Solution for injection: Intramuscular Injection: 50mg (2 ml) every six to eight hours (No dilution necessary).
Intravenous Injection: 50 mg (2ml) every six to eight hours, diluted to a total volume to 20 ml with either 0.9% sodium Chloride Injection or 5% Dextrose Injection and Inject over a period of not less than 5 minutes, or as intermittent intravenous infusion at 25mg per hour for 2 hours, repeated at 6 to 8 hours intervals.
Mode of Administration: FC tablet: Oral.
Solution for injection:
Intravenous/Intramuscular Administration.
Rantac is highly specific in action and accordingly no particular problems are expected following overdosage with the drug.
Symptomatic and supportive therapy should be given as appropriate.
The drug may be removed from the plasma by haemodialysis.
FC tablet: There are no known contraindications to the use of Rantac tablet, except for patients known to have hypersensitivity to the drug.
Solution for injection: Contraindicated for patients known to be hypersensitivity to the drug.
Special Precautions
Treatment with a histamine H2-antagonists may mask the symptoms associated with carcinoma of the stomach and therefore may delay diagnosis of this condition. Accordingly where gastric ulcer is suspected the possibility of malignancy should be excluded before therapy with Rantac is instituted. Since Rantac is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since Rantac is metabolised in liver. Rantac should be used during pregnancy or in nursing mothers only if considered necessary.
Use In Pregnancy & Lactation
Solution for injection: Pregnancy category B reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ranitidine. There are, however, no adequate and well controlled studies in pregnant women.
Ranitidine is secreted in human milk. Caution should be exercised when ranitidine is administered to a nursing mother.
Side Effects
FC tablet: Ranitidine is well tolerated, producing minor adverse effects such as headache, diarrhea and constipation in less than 5% of patients. The frequency and profile of these effects are similar to those seen in patients receiving placebo. Serious and treatment limiting adverse effects occur rarely, with elderly and seriously ill patients being more susceptible, or appear to be idiosyncratic, hepatotoxicity, with raised hepatic enzyme levels and biopsy-proven hepatocellular changes, has been seen rarely. Haematological changes, such as thrombocytopenia, agranulocytosis and general myelosuppression, have been reported sporadically in a small number of patients. Central nervous system adverse effects of mental confusion, severe headache, hallucinations and mania have also occurred in small number of patients, but rarely in patients without predisposing risks. A variety of idiosyncratic reactions have been reported in individuals, including fever, rashes, bradycardia, heart block, gouty arthritic attacks, erosive diogenites and gynecomastia. Seriously ill patients and those with renal insufficiency may require close monitoring for unusual effects.
Solution for injection: There is no clinically significant interference with endocrine, gonadal, liver function, or the central nervous system. Transient pain at the site of IM injection has been reported. Transient local burning or itching has been reported with IV administration. Headache seems to be related to administration of ranitidine.
Drug Interactions
FC tablet: Hepatic metabolism of metoprolol, theopylline, warfarin and anti-muscranic may be decreased when used concurrently with Ranitidine possibly resulting in delayed elimination of these drugs and increased blood concentrations.
Ranitidine may increase the hypoglycemia effect of glipizide. One of the Glipizide, glyburide patients developed severe hypoglycemia after taking ranitidine. This did not occur in two studies with gluyburide or tolbutamide thus dosage adjustment may be needed.
Solution for injection: Increased or decreased prothrombin times have been reported during concurrent use of ranitidine and warfarin. In ranitidine-triazolam drug-drug interaction study, triazolam plasma concentrations were higher during b.i.d dosing of ranitidine than triazolam given alone.
Store below 30°C. Protect from light.
Solution for injection: Do not freeze.
Shelf-Life: 3 years from the date of manufacture.
ATC Classification
A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
FC tab (orange coloured round, biconvex) 150 mg x 5 x 2 x 10's. 300 mg x 5 x 2 x 10's. Soln for inj 50 mg/2 mL (a straw coloured clear solution, free from foreign particles in amp) x 10's.
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