Ranitidine-LekT - instructions for use, dose, side effects, contraindications

Ranitidine hydrochloride (in terms of ranitidine) - 168 mg (150 mg). Excipients: microcrystalline cellulose - 105 mg, potato starch - 18 mg, low molecular weight povidone (low molecular weight polyvinylpyrrolidone 8000 ± 2000) - 3 mg, silicon dioxide colloid - 3 mg, magnesium stearate - 3 mg, (butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1: 2: 1]) - 3.2 mg, macrogol-6000 - 0.41 mg, talcum powder - 4.1 mg, titanium dioxide 1.6 mg, calcium stearate 0.6 mg, dye quinoline yellow 0.09 mg.

Description:

Round, biconvex tablets, film-coated, yellow or yellow with a greenish tinge. On the cross-section the nucleus is from white to light yellow.

Pharmacotherapeutic group:Gland of the stomach secretion lowering agent - H2 - histamine receptor blocker

ATX: & nbsp

A.02.B.A Blockers of histamine H2-receptors

A.02.B.A.02 Ranitidine

Pharmacodynamics:

Suppresses the basal and stimulated by histamine, gastrin and acetylcholine (to a lesser extent) the secretion of hydrochloric acid. Promotes an increase in the pH of gastric contents, reduces the activity of pepsin. Duration of the drug at a single intake of about 12 hours.

Pharmacokinetics:

When administered orally, the bioavailability of ranitidine is approximately 50%. The maximum concentration in the blood plasma is achieved after 3 hours. After oral administration. Ranitidine partially metabolized in the liver. It is excreted mostly through the kidneys (60-70%). The half-life period is 2-3 hours.

Indications:

prevention and treatment of gastric ulcer and / or duodenal ulcer;
Zollinger-Ellison syndrome;
symptomatic ulcers;
stress ulcers;
reflux esophagitis;
prevention of postoperative ulcers.

Contraindications:

Hypersensitivity, lactation, children under 12 years.

Carefully:

Renal and / or hepatic insufficiency, cirrhosis of the liver with encephalopathy (in the anamnesis), acute porphyria (including in the anamnesis), suppression of immunity, pregnancy.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only if the expected benefit for the mother exceeds the potential risk to the fetus.

During lactation, refrain from breast-feeding with ranitidine.

Dosing and Administration:

Stomach ulcer and duodenal ulcer. For treatment of exacerbations appoint 150 mg twice a day (morning and evening) or 300 mg at night. If necessary, the daily dose of the drug can be increased to 450 mg.

To prevent peptic ulcer disease and / or duodenal ulcer, 150 mg of the drug is prescribed 1 time per day before bedtime.

Zollinger-Ellison syndrome. The initial dose of the drug is 150 mg 3 times a day. If necessary, the dose of the drug can be increased to 600-900 mg per day.

Ulcers associated with non-steroidal anti-inflammatory drugs NSAIDs. Assign 150 mg twice a day or 300 mg per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 150 mg 2 times a day.

Prevention of stressful ulcer. Assign 150 mg twice a day. Gastroesophageal reflux disease. Assign 150 mg twice a day or 300 mg at night. If necessary, the dose can be increased to 150 mg 4 times a day. The course of treatment is 8-12 weeks.

Postoperative ulcers. Assign 150 mg twice a day. Healing usually occurs within 4 weeks.

Side effects:

On the part of the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, jaundice, increased activity of "liver" transaminases, rarely - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

On the part of the hematopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, neuropyenia, immune hemolytic and aplastic anemia.

From the cardiovascular system: lowering blood pressure, bradycardia, tachycardia, vasculitis, arrhythmia, atrioventricular blockade.

From the side of the nervous system: headache, dizziness, hyperthermia, fatigue, drowsiness; insomnia, emotional lability, anxiety, anxiety, depression, nervousness, rarely - confusion, tinnitus, irritability, hallucinations (mainly in elderly patients and seriously ill patients), involuntary movements.

From the senses: blurred vision, paresis of accommodation.

From the musculoskeletal system: arthralgia, myalgia.

On the part of the endocrine system: giperprolaktinemiya, gynecomastia, amenorrhea, decreased impotence and / or libido.

Allergic reactions: urticaria, skin rash, itching, angioedema, anaphylactic shock, bronchospasm, multiform exudative erythema, incl. Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.

Other: alopecia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. When taken orally, induce vomiting or / and gastric lavage. With the development of seizures - diazepam in / in, with bradycardia - atropine, ventricular arrhythmias - lidocaine. Hemodialysis is effective.

Interaction:

Increases AUC and the concentration of metoprolol in the serum (respectively, 80 and 50%), while the half-life of metoprolol increases from 4.4 to 6.5 hours.

Reduces the absorption of itraconazole and ketoconazole.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metapropanol, nifedipine, warfarin, diazepam, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, bouformin, metronidazole, slow calcium channel blockers.

Increases the concentration of procainamide.

Compatible with 0.9% sodium chloride solution, 5% dextrose solution, 4% dextrose solution, 4.2% sodium bicarbonate solution.

Antacids, sucralfate slow the absorption of ranitidine (with the simultaneous use of a gap between the intake of antacids and ranitidine should be at least 1-2 hours).

Drugs that depress the bone marrow increase the risk of neutropenia.

Smoking reduces the effectiveness of ranitidine.

Special instructions:

Symptoms of duodenal ulcer 12 - the duodenum can disappear within 1-2 weeks, therapy should be continued until confirmed by endoscopic or X-ray data. May mask symptoms associated with carcinoma of the stomach, so before starting treatment, you must exclude the presence of malignant neoplasm. Ranitidine, it is undesirable to abruptly cancel (syndrome "rebound"). With long-term treatment of weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection. Blockers of H2-histamine receptors should be taken 2 hours after the administration of itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

May be the cause of a false positive reaction when carrying out a sample for protein in the urine. Increases the level of creatinine, glutamate transpeptidase and transaminase in the blood serum. Counteracts the effects of pentagastrin and

histamine on the acid-forming function of the stomach, therefore it is not recommended to apply it within 24 hours preceding the test. Suppresses the skin reaction to histamine, resulting in the so-called. to false-negative results (before using diagnostic skin tests to detect an allergic skin reaction of immediate type, it is recommended to stop the use of the drug).

The effectiveness of the drug in inhibiting night secretion of acid in the stomach can be reduced by smoking. During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa. If there is no improvement, consult a doctor. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Effect on the ability to drive transp.cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 150 mg.

10 tablets in a planar cell pack 2 or 5 contour mesh packages together with the instruction for use are placed in a cardboard package.

Packaging:10 tablets in a planar cell pack 2 or 5 contour mesh packages together with the instruction for use are placed in a cardboard package.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 - of the year.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001613

Date of registration:28.03.2012

The owner of the registration certificate:Tyumen Chemical - Pharmaceutical Plant, OJSC Tyumen Chemical - Pharmaceutical Plant, OJSC Russia

Manufacturer: & nbsp

Tyumen Chemical - Pharmaceutical Plant, OJSC Russia

Information update date: & nbsp28.03.2012

Illustrated instructions

Instructions

Ranitidine-LekT (Ranitidine-LekT)