Expiration date: 05/2025
The composition and form of issue:
Solution for injection. 1 ml contains:
ranitidine (ranitidine hydrochloride) 25 mg
auxiliary substances: sodium chloride potassium digidrogenfosfat disodium sodium gidrofosfat (anhydrous) nitrogen water for injections
in 2 ml ampoules in a box 5 ampoules.
Tablets, film-coated. 1 tablet contains:
ranitidine (ranitidine hydrochloride) 150 mg
300 mg
other ingredients: microcrystalline cellulose magnesium stearate croscarmellose sodium (dosage of 300 mg) metilgidroksipropilzelluloza titanium dioxide triacetin
blistere in 10 or 15 PCs in a carton 2 and 4 blisters respectively (tablets of 150 mg) in blister packs of 10 or 15 PCs in a box 1 or 2 blisters (tablets 300 mg).
Description pharmaceutical form:
Solution for injection: clear, colorless or pale yellow liquid.
Tablets 150 mg: white, round, biconvex coated tablets, one side engraved "GX EC2".
Tablets 300 mg: white, oval, biconvex tablets, coated tablets, one side engraved "GX EC3".
Effervescent tablets: round flat tablet with beveled edges from light yellow to almost white.
Pharmacological action:
Blocks histamine H2 receptors of the parietal cells of the gastric mucosa.
Pharmacokinetics:
After the/m of rapidly absorbed, Cmax (300-500 ng/ml) is achieved within 15 min after administration. When ingestion bioavailability of approximately 50%, Cmax in plasma achieved through 2-3 h after administration. Binding with plasma proteins does not exceed 15%. Partially metabolized in the liver. At/in the introduction of T1/2 is 2-3 h. write mainly kidneys unchanged by tubular secretion, a small amount — with feces. After intravenous injection of 3H-ranitidine 93% is excreted in the urine and 5% in feces in the first 24 hours, 70% of the dose is excreted in the urine unchanged. The metabolism of ranitidine is no different for parenteral administration, and the ingestion and proceeds with the formation of small amounts of N-oxide (6%), the S-oxide (2%), desmethylsertraline (2%) and analogue freeway acid (1-2%). Has the effect of "first passage" through the liver. Poor passes through GEB passes through the placenta, enters the breast milk (concentration in breast milk of women during lactation is higher than in plasma).
Description pharmacological action:
Decreases basal and stimulirovannuyu secretion of hydrochloric acid caused irritation of the baroreceptors, food load, action of hormones and biogenic stimulators (gastrin, histamine, pentagastrin). Reduces the volume of gastric juice and the content of hydrochloric acid increases the pH of the stomach contents, which reduces the activity of pepsin. Duration of action after a single dose 12 h
Indications:
- Treatment and prevention of relapse of gastric ulcer and duodenal ulcer
- stomach ulcers and duodenal ulcers associated with NSAIDs
- reflux-ezofagit, erosive esophagitis
- syndrome zollingerellison
- treatment and prevention of postoperative "stress" ulcers of the stomach
- prevention of recurrent bleeding from upper gastrointestinal tract
- prevention of aspiration of gastric juice during operations under General anesthesia (Mendelson's syndrome).
Contraindications:
Hypersensitivity to ranitidine or any component of the drug pregnancy, lactation children's age (till 12 years).
Caution: renal and/or hepatic failure, liver cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in anamnesis).
Application of pregnancy and breast-feeding:
During pregnancy and lactation should be used only in cases where the potential benefit to the mother outweighs the potential risk to the fetus or child (ranitidine crosses the placenta, enters the breast milk).
Side effects:
Solution for injection
Listed below side effects were observed in clinical trials or during routine treatment of patients with ranitidine. In many cases, communication with the receiving ranitidine is not installed.
Blood and lymph: changes in the blood count (leukopenia, thrombocytopenia), usually reversible, have been observed in a small number of patients. Reported rare cases of agranulocytosis or pancytopenia, sometimes with hypoplasia or aplasia of the bone marrow.
Cardiovascular system: bradycardia, tachycardia and AV blockade, rarely vasculitis.
The organ of vision: blurring of vision which can be related to changes in accommodation.
Gastrointestinal tract: rarely — diarrhoea.
Liver, biliary tract and pancreas: transient changes in liver function tests, rarely — hepatitis (hepatocellular, cholestatic or mixed) with or without jaundice, a usually reversible acute pancreatitis .
Musculoskeletal system: rarely — arthralgia and myalgia.
Neurology/psychiatry: headache, sometimes severe, and dizziness, and rare reversible mental confusion, depression and hallucinations (predominantly in severely ill and elderly patients), reversible involuntary movement disorders.
Allergic reactions/skin: rarely — erythema multiforme, alopecia, hypersensitivity reactions (urticaria, angioedema, fever, bronchospasm, hypotension, anaphylactic shock, chest pain).
Kidney: very rare — acute interstitial nephritis.
Reproduction: rarely — reversible impotence, symptoms of breast cancer in men.
Pills
From the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, acute pancreatitis.
Organs of hematopoiesis: leukopenia, agranulocytosis, pancytopenia, Hypo - and aplasia of the bone marrow, immune hemolytic anemia.
From the side of cardiovascular system: decrease in blood pressure.
From the nervous system: rarely — tinnitus, irritability, involuntary movements.
From the senses: blurred vision, paresis of accommodation.
From the musculoskeletal: arthralgia, myalgia.
Drug interactions:
When used in recommended doses, ranitidine does not inhibit cytochrome P450-oxygenase system of the liver and enhances the activity of drugs which are inactivated by this system, including diazepam, lidocaine, phenytoin, propranolol, theophylline and warfarin.
Smoking reduces the effectiveness of ranitidine.
Ranitidine increases in AUC and concentration of metoprolol in blood serum (respectively 80% and 50%), while T1/2 of metoprolol increased from 4.4 to 6.5 h
By increasing the pH of gastric contents while admission may decrease the absorption of Itraconazole and ketoconazole.
Inhibits the hepatic metabolism of phenazone, aminophenazone, diazepam, gexobarbitala, propranolol, lidocaine, phenytoin, theophylline, aminophylline, anticoagulants, glipizida, buformina, metronidazole, antagonists of calcium.
Drugs that suppress the bone marrow, increase the risk of neutropenia.
In concurrent usage with antacids, sucralfate in high doses may impair the absorption of ranitidine, so the interval between administration of these drugs should be at least 2 hours.
Method of application and dose:
In/in, in/m, inside.
Parenteral. Adults, slow (over 2 min)/injection at a dose of 50 mg, which is diluted to a volume of 20 ml and is administered every 6-8 hours, or intermittent on/in infusion at a rate of 25 mg/h for 2 h, with the re-introduction after 6-8 h, or/m injection at a dose of 50 mg every 6-8 hours
Prevention of bleeding from stress ulcers in the upper gastrointestinal tract in severely ill patients and prevention of recurrent bleeding from peptic ulcer: initial dose 50 mg by slow intravenous injection, followed by a long in/in infusion at a speed of 0,125–0,250 mg/kg/h. Parenteral therapy is continued until, until the patient can eat. Patients at risk may continue to use Santaka in tablets of 150 mg 2 times a day.
Prophylaxis of Mendelson's syndrome: the recommended dose of 50 mg I/m or slow I/45-60 min before anesthesia.
Children: no data on the use Santaka injections in children.
Use in renal insufficiency: in patients with severe renal failure (Cl creatinine less than 50 ml/min), marked accumulation and increased plasma concentrations of ranitidine, they Santaka recommended dose is 25 mg.
Solution Zantac injection is compatible with the following on/in infusion solutions:
0.9% sodium chloride solution
5% dextrose
0.18% sodium chloride and 4% dextrose solution
4,2% sodium bicarbonate solution
Hartman's solution.
Unused mixture must be destroyed within 24 hours after preparation.
As the studies on the compatibility of the solutions were conducted only in PVC infusion bags (in glass for sodium bicarbonate) and PVC systems, it is assumed that adequate stability can be achieved when using plastic bags.
Inside. The coated tablets: take with liquid, squeezed small amount of liquid.
Effervescent tablets: before taking dissolved in water (minimum 75 ml tablets 150 mg and not less than 150 ml tablet 300 mg).
Patients with renal insufficiency with Cl creatinine <50 ml/min the recommended dose is 150 mg/day.
Ulcers disease stomach and duodenal ulcers: for the treatment of exacerbations appoint 150 mg 2 times a day (morning and night) or 300 mg 1 time per day (at night). If necessary — 300 mg 2 times per day. The duration of treatment is 4-8 weeks. For the prevention of exacerbations administered 150 mg 1 time a day (at night).
Ulcers associated with NSAIDs: appoint 150 mg 2 times a day (morning and night) or 300 mg 1 time per day (at night) for 8-12 weeks. Prevent ulcers when taking NSAID — 150 mg 2 times a day (morning and evening).
Postoperative ulcers: 150 mg 2 times a day (morning and evening) for 4 -8 weeks.
Gastroesophageal reflux disease: 150 mg 2 times a day (morning and night) or 300 mg 1 time per day (at night). If necessary, the dose may be increased to 150 mg 4 times a day. The course of treatment is 8-12 weeks.
Syndrome zollingerellison: the initial dose is 150 mg 3 times a day. If necessary, the dose may be increased.
Prevention of recurrent bleeding: 150 mg 2 times a day (morning and evening).
Prevention of Mendelson's syndrome: administered at a dose of 150 mg 2 hours before anaesthesia, and preferably 150 mg the night before.
Overdose:
Symptoms: seizures, bradycardia, ventricular arrhythmias.
Treatment: symptomatic and supportive therapy. With the development of convulsions — diazepam/with bradycardia or ventricular arrhythmias — atropine, lidocaine. Effective hemodialysis.
Precautions:
Treatment with ranitidine may mask symptoms associated with carcinoma of the stomach, so patients with gastric ulcer should exclude possibility of malignancy before starting treatment.
Ranitidine is excreted via the kidneys, therefore, the concentration of the drug in plasma is increased in severe renal failure (in this case, you should adjust the dose).
Aware of rare cases of bradycardia with rapid parenteral administration Santaka that usually observed in patients with predisposing factors to the development of cardiac arrhythmias. Do not exceed the recommended rate of administration.
With increasing doses of antagonists of H2-receptors in the on/in the introduction and duration of treatment them more than 5 days, you may experience elevated liver enzymes.
In rare instances, ranitidine contributes to the development of an acute attack of porphyria, should avoid its prescription in patients with acute porphyria in history.
Long-term treatment of debilitated patients under stress possible bacterial lesions of the stomach with subsequent spread of infection.
The safety and effectiveness of ranitidine in children under 12 years have not been established.
During treatment should refrain from activities potentially hazardous activities, require high concentration and psychomotor speed reactions.
Blockers H2-wasteminimization should be taken through 2 h after administration of ketoconazole or Itraconazole avoid substantial reduction of their intake.
Can increase the activity of glutamyltranspeptidase.
May be the cause of false-positive reaction for holding the sample in protein in the urine. Blockers H2-wasteminimization can counter the effect of pentagastrin and histamine on acid-forming function of the stomach, so over the 24 h preceding the test, to apply them is not recommended.
Blockers H2-wasteminimization can inhibit the skin reaction to histamine, thus causing false negative results (before diagnostic skin tests to identify allergic skin reactions of immediate type, their use is recommended to stop).
During treatment should avoid eating food, drinks and other drugs that can cause irritation to the gastric mucosa.
