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

Each tablet contains 0.15 g of ranitidine (as hydrochloride). Excipients: microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate, hydroxypropylmethylcellulose, vaseline oil, castor oil, titanium dioxide.

Description:

Tablets coated with a coat, white or white with a creamy shade of color.

Pharmacotherapeutic group:H2-histamine receptor antagonist

ATX: & nbsp

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

A.02.B.A.02 Ranitidine

Pharmacodynamics:

Ranitidine is a blocker of histamine Hg-receptors 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. Duration of action after a single dose of 12 hours.

Pharmacokinetics:

When administered orally, the bioavailability of ranitidine is approximately 50%. Binding to plasma proteins does not exceed 15%. Partially metabolized in the liver. Maximum plasma concentrations are achieved 2-3 hours after admission. It is excreted mainly with urine in unchanged form, a small amount - with feces. Penetrates through the placenta. Excreted in breast milk.

Indications:

Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum; gastric and duodenal ulcers associated with NSAID administration; reflux-esophagitis, erosive esophagitis; Zollinger-Ellison syndrome; treatment and prevention of postoperative, "stressful" stomach ulcers; prevention of recurrent bleeding from the upper gastrointestinal tract; prevention of aspiration of gastric juice in anesthesia surgery (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:

Stomach ulcer and duodenal ulcer. For the treatment of exacerbations appoint 0.15 g 2 times a day (morning and evening) or 0.3 g at night. If necessary - 0.3 g 2 times a day. The duration of the course of treatment is 4-8 weeks. To prevent exacerbations appoint 0.15 g per night.

Ulcers associated with taking NSAIDs. Assign 0.15 g 2 times a day or 0.3 g per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 0.15 g 2 times a day.

Postoperative ulcers. Assign 0.15 g 2 times a day for 4-8 weeks. Gastroesophageal reflux disease. Assign 0.15 g 2 times a day or 0.3 g at night. If necessary, the dose can be increased to 0.15 g 4 times a day. The course of treatment is 8-12 weeks.

Zollinger-Ellison syndrome. The initial dose is 0.15 g 3 times a day, if necessary, the dose can be increased.

Prevention of recurrent bleeding. To 0.15 g 2 times a day.

Prevention of the development of Mendelssohn syndrome. Assign ranitidine in a dose of 0.15 g for 2 hours before anesthesia, and also, preferably 0.15 g in the evening before.

Ranitidine is taken regardless of food intake, without chewing, squeezed with a small amount of liquid.

Patients with renal insufficiency with creatinine clearance less than 50 ml / min the recommended dose is 0.15 g per day.

Side effects:

On the part of the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, acute pancreatitis.

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

From the cardiovascular system: lowering blood pressure.

From the nervous system: rarely - noise in the ears, irritability, involuntary movements.

From the senses: blurred vision, paresis of accommodation. From the musculoskeletal system: arthralgia, myalgia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment is symptomatic. With the development of seizures - diazepam in / in, with bradycardia or ventricular arrhythmias - atropine, lidocaine. Hemodialysis is effective.

Interaction:

Smoking reduces the effectiveness of ranitidine.

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. Due to the increase in the pH of the contents of the stomach, simultaneous intake may decrease the absorption of itraquinazole and ketoconazole.

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 disrupt 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 sharply to cancel (syndrome "ricochet").

With prolonged treatment of weakened patients under stress, bacterial lesions of the stomach are possible with subsequent spreadinginfection. 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.

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Blockers H₂-gistaminoreceptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

May increase the activity of glutamate transpeptidase.

It can be the cause of a false positive response to a sample of protein in the urine.

Blockers H₂-gistaminoreceptors can counteract the influence of pentahister and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, use blockers H₂- Histamine-receptor is not recommended.

Blockers H₂-gistaminoreceptors can suppress the skin reaction to histamine, thus leading to false positive results (before conducting diagnostic skin tests to detect an allergic skin reaction of immediate type, the use of blockers H₂-gistamino-receptor is recommended to stop).

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

Form release / dosage:

The tablets covered with a cover, on 0,15 g.

60 tablets in cans of glass, cans of glass of dark glass, cans of polymer.

For 10 tablets per package, the contour is planar.

For 4, 10 tablets in the package are cellulose contour.

For 1, 2, 4, 5 packs or 1 bank in packs of cardboard.

Packaging:

60 tablets in cans of glass, cans of glass of dark glass, cans of polymer.

For 10 tablets per package, the contour is planar.

For 4, 10 tablets in the package are cellulose contour.

For 1, 2, 4, 5 packs or 1 bank in packs of cardboard.

Storage conditions:

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:P N001648 / 02

Date of registration:27.10.2008

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp27.10.2008

Illustrated instructions

Instructions

Ranitidine-Ferein® (Ranitidine-Ferein®)