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

Excipients: microcrystalline cellulose, low molecular weight palivinylpyrrolidone (povidone low molecular weight), magnesium stearate, oidragit E-100 (methacrylic acid copolymer), polyethylene glycol 4000 (macrogol), titanium dioxide, talc.

Description:

Round, biconcave tablets, coated with white or white shell with a creamy shade of color.

Pharmacotherapeutic group:H2-histamine receptor blocker

ATX: & nbsp

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

A.02.B.A.02 Ranitidine

Pharmacodynamics:

Ranitidine - a blocker of histamine H₂receptors of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, caused by irritation of baroreceptors, food load, action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Ranitidine reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin. After oral administration in therapeutic doses does not affect the level of prolactin. Inhibits microsomal enzymes.

Duration of action after a single dose of up to 12 hours.

Pharmacokinetics:

Quickly absorbed, eating does not affect the degree of absorption. When administered orally, the bioavailability of ranitidine is approximately 50%. Maximum plasma concentrations are achieved 2-3 hours after admission. The connection with plasma proteins does not exceed 15%. It is slightly metabolized in the liver with the formation of desmethylranitidine. and S- oxide ranitidine. Has the effect of "first pass" through the liver. The speed and degree of elimination depend little on the condition of the liver. Half-life after oral administration - 2.5 hours, with clearance of creatinine 20-30 ml / min - 8-9 hours. It is excreted mainly with urine in unchanged form, a small amount - with feces. Poorly penetrates the blood-brain barrier. Penetrates through the placenta. Excreted in breast milk (concentration in breast milk in women during lactation is higher than in plasma).

Indications:

Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum; gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); reflux-esophagitis, erosive esophagitis: Zollinger-Ellison syndrome; treatment and prevention of postoperative, "stressful" ulcers of the upper gastrointestinal tract; prevention of recurrence of bleeding from the upper sections of the gastrointestinal tract; prevention of aspiration of gastric juice in operations under general anesthesia (Mendelssohn syndrome).

Contraindications:

Hypersensitivity to ranitidine or other components of the drug. Pregnancy, lactation. Children under 12 years.

With caution - renal and / or liver failure, cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in the anamnesis).

Dosing and Administration:

Inside, regardless of food intake, without chewing, squeezed a small amount of liquid.

Ulcer disease of the stomach and duodenum. For treatment of exacerbations appoint 150 mg twice a day (morning and evening) or 300 mg at night. If necessary, 300 mg twice a day.The duration of the course of treatment is 4-8 weeks. To prevent exacerbations appoint 150 mg at night, smoking patients - 300 mg at night.

Ulcers associated with taking 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.

Postoperative and "stressful" ulcers. Assign 150 mg twice a day for 4-8 weeks.

Erosive reflux esophagitis. 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. Prolonged preventive therapy -150 mg 2 times a day.

Zollinger-Ellison syndrome. The initial dose is 150 mg 3 times a day, if necessary, the dose can be increased. Duration of treatment - as needed. Prevention of recurrent bleeding. 150 mg twice a day. Duration of treatment - as needed.

Prevention of the development of Mendelssohn syndrome. Assign a dose of 150 mg 2 hours before general anesthesia, and also, preferably 150 mg the night before.

If there is a concomitant liver function disorder, a dose reduction may be required.

For patients with renal insufficiency with creatinine clearance less than 50 ml / min, the recommended dose is 150 mg per day.

Side effects:

From the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain; rarely - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

From the hematopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.

From the cardiovascular system: lowering blood pressure, bradycardia, arrhythmia, atrio-ventricular blockade.

From the nervous system: increased fatigue, drowsiness, headache, dizziness; rarely - confusion, tinnitus, irritability, hallucinations (mainly in elderly patients and severe patients), involuntary movements.

From the senses: blurred vision, paresis of accommodation.

From the musculoskeletal system: arthralgia, myalgia.

On the part of the endocrine system: hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, impotence.

Allergic reactions: urticaria, skin rash, angioedema,

anaphylactic shock, bronchospasm, multiforme exudative erythema.

Other: alopecia, hypercreatininaemia, increased activity, increased activity of glutamate transpeptidase, acute porphyria.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. With the development of seizures - diazepam intravenously, with

bradycardia or ventricular arrhythmias - atropine, lidocaine. Hemodialysis is effective.

Interaction:

Smoking reduces the effectiveness of ranitidine.

Increases the concentration of metoprolol in the blood serum by 50%, while the half-life of metoprolol increases from 4.4 to 6.5 hours.

Due to the increase in the pH of the contents of the stomach with simultaneous intake may reduce the absorption of itraconazole and ketoconazole. Blockers of H2-histamine-receptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant decrease in their absorption.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital. propranolol, diazepam, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, calcium antagonists. Drugs that depress the bone marrow increase the risk of neutropenia.

With simultaneous use with antacids, sucralfate in high doses, it is possible to slow the absorption of ranitidine, so a break between taking these drugs should be at least 2 hours.

Special instructions:

Treatment with ranitidine may mask the symptoms associated with carcinoma of the stomach, so before starting treatment it is necessary to exclude the presence of cancer-ulcers.

Ranitidine, like all H2-gistaminoblokatory, undesirably abruptly cancel (syndrome "bounce").

With long-term treatment of weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

Safety and efficacy of ranitidine in children younger than 12 years of age have not been established.

There is evidence that ranitidine can cause acute attacks of porphyria.

AT period of treatment, it is necessary to refrain from practicing potentially dangerous species activities that require increased concentration of attention and you were fast psychomotor reactions.

May increase the activity of glutamate transpeptidase.

May be the cause of a false positive response to a sample for protein in urine. The blockers of H2-histamine-receptors can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, so it is not recommended to use H2-histamine-receptor blockers within 24 hours preceding the test. The H2-histamine-receptor blockers can suppress the skin reaction to histamine, thus leading to false positive results (it is recommended to stop the use of H2-histamine-receptor blockers before conducting diagnostic skin tests to detect an immediate allergic skin reaction).

During treatment, avoid eating foods, drinks and other drugs that can cause irritation of the gastric mucosa.

Effect on the ability to drive transp. cf. and fur:AT period of treatment, it is necessary to refrain from practicing potentially dangerous species activities that require increased concentration of attention and you were fast psychomotor reactions.

Form release / dosage:

Tablets, coated with a coat of 150 mg.

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 4 or 10 tablets in a contour non-cellular package of paper with a polymer coating.

For 20 tablets in a can of polymer or a bottle of polymer.

Each jar, bottle, 2 or 5 contour non-jawed packages, 2 contour mesh packages together with instructions for use are placed in a pack of cardboard.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 4 or 10 tablets in a contour non-cellular package of paper with a polymer coating.

For 20 tablets in a can of polymer or a bottle of polymer.

Each jar, bottle, 2 or 5 contour non-jawed packages, 2 contour mesh packages together with instructions for use are placed in a pack of cardboard.

Storage conditions:

List B. In a dry, protected from light and out of reach of children, at a temperature of no higher than 25 ° C.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001103

Date of registration:28.05.2010

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp28.05.2010

Illustrated instructions

Instructions

Ranitidine (Ranitidine)