Entac Ampoule

Pharmacology: Ranitidine is a competitive reversible inhibitor of the action of histamine all the histamine H₂-receptors, including receptors on the gastric cells.
Ranitidine Injections is absorbed very rapidly after intramuscular (I.M.) Injection. Mean peak levels of 576 mg/mL occur within 15 minutes of less following a 50-mg I.M. dose. Absorption from I.M. sites is virtually complete, with a bioavailability of 90% to 100% compared with intravenous (I.V.) administration.

Ranitidine Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, Prophylaxis of stress ulceration in seriously ill, Prophylaxis recurrent hemorrhage from peptic ulcer, Prophylaxis of Medelson syndrome.

Adults: RANITIDINE Injection may be given as a slow (over 2 minutes) intravenous injection of 50 mg/2 mL every 6-8 hours and should be diluted to contain 50 mg in 20 mL or as an intermittent intravenous infusion at 25 mg/hour for two hours, repeated at 6-8 hours intervals or as an intramuscular injection of 50 mg every 6-8 hours.
In the prophylaxis of upper gastrointestinal hemorrhage from stress ulceration in seriously ill patients a priming dose of 50 mg as a slow intravenous injection followed by a continues intravenous infusion of 0.125 - 0.250 mg/kg/h may be preferred.
In the prophylaxis of hemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent hemorrhage in patients bleeding from peptic ulceration parenteral administration may be continued until oral feeding commences.
For prophylaxis of Mendelson's syndrome 50 mg by intramuscular or slow intravenous Injection 45 to 60 minutes before induction of general anaesthesia.
Infants and Young Children: In severe cases, ¼ of an ampoule 3 times daily.

Ranitidine is contraindicated for patients known to have hypersensitivity to the drug.

Symptomatic response to therapy with Ranitidine Injection does not preclude the presence of gastric malignancy.
Ranitidine is excreted primarily by the kidney dosage should be adjusted in patients with impaired renal function.
Observed patients with hepatic dysfunction since Ranitidine is metabolized in the Liver.
Bradycardia in association with rapid administration of ranitidine Injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.
Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute porphyria.

Transient pain at the site of I.M. injection has been reported.
Transient local burning or itching has been reported with I.V. administration of Ranitidine.
The relationship of therapy with Ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ranitidine.
Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia and vertigo. Rare cases of reversible mental confusion, agitation, depression and hallucinations have been reported predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.
Cardiovascular: As with other H₂-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, asystole. Atrioventricular block and premature ventricular beats.
Gastrointestinal: Constipation, diarrhea, nausea, vomiting, abdominal discomfort/pain and rare reports of pancreatitis.
Musculoskeletal: Rare reports of arthralgia and myalgias.
Hematologic: Blood count changes (leukopenia, granulocytopenia and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine: Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving Ranitidine, but the incidence did not differ from that in the general population.
Integumentary: Rash, including rare cases of erythema multiforme, and rarely, alopecia.
Other: Rare cases of hypersensitivity reactions (e.g. bronchospasm, fever, rash, eosinophilia) anaphylaxis. Angioneurotic edema, and small increases in serum creatinine.

Store at Temperatures not exceeding 30°C.
Shelf-life: 24 months.

Antacids, Antireflux Agents & Antiulcerants

A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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