Index of drugs

Ranitidine is used parenterally in patients who can not be treated with the oral form of the drug in the following indications: peptic ulcer of the stomach and duodenum; reflux oesophagitis; Zollinger-Ellison syndrome; prevention of bleeding from stress ulceration in seriously ill; prevention of recurrent bleeding from peptic ulcer; prevention of Mendelson syndrome (before general anesthesia in patients at risk of acid aspiration, especially in women who give birth). Children (from 6 months to 18 years): short-term treatment of peptic ulcer; treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux.

1 ampoule (2 ml) contains 50 mg of Ranitidine as hydrochloride.

A specific histamine H receptor antagonist₂ in the stomach mucosa. It inhibits both basic and postprandial secretion of hydrochloric acid and reduces the secretion of pepsin in gastric juice. After intramuscular administration, it is rapidly absorbed and the maximum concentration in blood occurs within 15 minutes. T_0,5 is 2-3 hours. It binds to plasma proteins at 15%. It is excreted in the urine, mainly unchanged. The metabolism of ranitidine after oral and intravenous administration is similar. In neonates (less than 1 month of age) plasma clearance after intravenous administration may be reduced and T_0,5 elongate. In patients over 50 years of age T_0,5 it is prolonged (3-4h), systemic exposure to the drug and its accumulation are 50% higher, which indicates increased bioavailability of ranitidine in people over 50 years of age.

Hypersensitivity to ranitidine or other ingredients of the preparation.

Avoid using this medicine in patients with a history of acute porphyria. Use cautiously in impaired renal function and in patients predisposed to arrhythmias. In elderly patients, patients with diabetes or immunodeficiency, there may be an increased risk of pneumonia during the increased severity of this disease.

Ranitidine can be administered during pregnancy and breastfeeding only if clearly necessary.

Uncommon: abdominal pain, constipation, nausea (these symptoms usually disappear during continuing therapy). Rare: hypersensitivity reactions (urticaria, angioneurotic edema, fever, bronchospasm, hypotension, chest pain), transient liver enzymes, skin rash, increase in serum creatinine (usually insignificant, return to normal when continuing therapy) ). Very rare: transient decreases in the number of leukocytes and platelets, usually transient cases of agranulocytosis or aplastic anemia, sometimes with partial or total bone marrow suppression, anaphylactic shock, transient entanglement, depression and hallucinations, mainly in severely ill and elderly patients, pain and dizziness headache, transient involuntary movements, transient blurred vision, possibly as a result of disturbed accommodation, cardiac output and atrioventricular block, asystole, vasculitis, acute pancreatitis, diarrhea, usually transient hepatitis (cellular, tubular or mixed) with jaundice or without jaundice, erythema multiforme, alopecia, joint and muscular pain, acute interstitial nephritis, transient impotence, gynecomastia and menopausal men.

Adults. A dose of 50 mg, after reconstitution with 20 ml of the appropriate solution, is given by slow intravenous injection (lasting over 2 min). This dose can be repeated every 6-8 h, given as a slow intravenous injection, an intravenous infusion administered for 2 h at a rate of 25 mg / h or intramuscular injection (50 mg / 2 ml).In the prevention of upper gastrointestinal bleeding from stress ulceration in particularly seriously ill patients, it is recommended to initially administer a dose of 50 mg by slow intravenous injection followed by a continuous infusion at a dose of 0.125-0.25 mg / kg / h. In the prevention of bleeding from stress ulceration in severely ill patients or in the prevention of recurrent bleeding in patients with peptic ulcer, parenteral therapy continues until oral nutrition is started. Patients at risk for Mendelson syndrome should receive ranitidine 50 mg by intramuscular or intravenous injection 45-60 minutes before the start of general anesthesia.
In renal insufficiency with a creatinine clearance below 50 ml / min, the drug should be administered in doses of 25 mg. Infants / children (aged from 6 months to 11 years): administered as a slow intravenous infusion (lasting over 2 minutes) up to a maximum dose of 50 mg every 6-8 hours.Treatment of exacerbation of gastric ulcer and gastroesophageal reflux. In the treatment of peptic ulcer and gastroesophageal reflux, pediatric infusions should be administered in doses that are effective in the treatment of these diseases in adults and effectively inhibit the secretion of acid in the group of seriously ill children. The starting dose (2.0 mg / kg or 2.5 mg / kg, maximum 50 mg) should be administered as a slow intravenous infusion over 10 min, either by syringe followed by rinsing with 3 ml of physiological saline for 5 min or after dissolving in saline to a volume of 20 ml. Maintaining the pH of the stomach pH> 4 can be achieved by periodic infusions at a dose of 1.5 mg / kg every 6-8 h. Alternatively, the treatment can be administered with an introductory dose of 0.45 mg / kg followed by a constant infusion of 0.15 mg / kg / h .Prevention of stress ulcer in seriously ill patients. The recommended dose for the prevention of stress ulcer is 1 mg / kg (max. 50 mg) every 6-8 hours. Alternatively, the treatment can be administered with 125-250 μg / kg / h as a continuous infusion. The preparation can be administered with the following infusion fluids: 0.9% NaCl solution, 5% Glucose solution, 0.18% NaCl solution and 4% glucose solution, 4.2% sodium bicarbonate solution.