Shandong Xier Kangtai


Full Prescribing Info
Ranitidine hydrochloride.
Each mL contains: Ranitidine (as Hydrochloride) 25 mg.
The active ingredient in RANIVEX is ranitidine hydrochloride (HCl), a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, hydrochloride.
The empirical formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87. RANIVEX Injection is a clear, colorless to yellow, nonpyrogenic liquid. The yellow color of the liquid tends to intensify without adversely affecting potency. The pH of the injection solution is 6.7 to 7.3.
Pharmacology: Pharmacokinetics: Ranitidine is readily absorbed from the gastrointestinal tract with peak concentrations in plasma occurring about 2 to 3 hours, after administration by mouth. Food does not significantly impair absorption of Ranitidine. The bioavailability of Ranitidine following oral administration is about 50% due to first-pass metabolism. Ranitidine is rapidly absorbed following intramuscular infection and has a bioavailability of about 90-100%. The elimination half-life from plasma is around 2-3 hours and Ranitidine is weakly bound about 15% to plasma proteins.
A small proportion of Ranitidine is metabolized in the liver to the N-oxide, S-oxide, and desmethyl-Ranitidine; the N-oxide is the major metabolite but accounts for only about 4% of a dose.
Approximately 30% of an oral dose and 70% of an intravenous dose is excreted unchanged in the urine by active transport in 24 hours; there are some extension in the feces. Clearance is markedly reduced in severe renal impairment. Ranitidine crosses the placental barrier and is distributed into breast milk. It does not readily cross the blood-brain barrier but adverse effects on the CNS have been reported.
Ranitidine (RANIVEX) is a histamine H2-Receptor Antagonist. It is in the treatment of duodenal and benign gastric ulceration, recurrent and gastric ulceration. It may be used as prophylaxis of stress ulceration and recurrent hemorrhage from peptic ulcer before general anesthesia in patients considered to be at risk of acid aspiration, particularly obstetric patients during labor (Mendelson's syndrome). It is also recommended for the treatment of Zollinger Ellison Syndrome.
Dosage/Direction for Use
Usual adult dose: 50 mg I.M./Slow I.V. injection may be repeated every 6-8 hours. It should be given slowly over not less than 2 minutes, should be diluted to contain 50 mg in 20 mL.
Intermittent I.V. Infusion: recommended dose is 25 mg/hour given for 2 hours which may be repeated every 6-8 hours.
Dose for management and stress-related ulceration of GIT 50 mg may be given I.M./Slow I.V., 45-60 minutes before the induction of anesthesia.
Patients with severely impaired renal function suggested dose 25 mg parenteral I.M./I.V.
Or as directed by the Physician.
Ranitidine is contraindicated in patients with known hypersensitivity to the drug and should be avoided during pregnancy.
H2-Receptor Antagonists might mask symptoms of gastric cancer.
Special Precautions
Ranitidine should be used with caution in patient with cardiovascular disease. The dosage of Ranitidine should be reduced in patients with severely impaired renal and hepatic function. It should be used also with caution with pregnant women and neonates.
Use In Pregnancy & Lactation
Contraindications: Ranitidine should be avoided during pregnancy.
Precautions: It should be used also with caution with pregnant women and neonates.
Adverse Reactions
The common side effects of Ranitidine injection are hypotension, muscular tremor, and rapid respiration. Diarrhea, dizziness, tiredness, loss of color vision and skin rashes, it increased intra ocular pressure associated with Ranitidine, blood disorders, and hepatotoxicity.
Drug Interactions
Ranitidine does not seem to affect cytochrome P450 to any great extent and therefore is considered to have little effect on the Metabolism of other drugs. The absorption of Ranitidine is reported to be impaired by the concomitant administration of sucralfate.
Store at temperatures not exceeding 30°C. Protect from light.
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).
Soln for inj (amp) 25 mg/mL (clear, colorless to yellow, nonpyrogenic liquid) x 2 mL x 10's.
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