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

Sheath: methylcellulose-8, titanium dioxide, tropeoline O or oidragit E 100, talc, titanium dioxide, polyethylene oxide 4000, calcium stearate, tropeoline O.

Description:

The tablets covered with a cover, from yellow to orange-yellow color, in diameter 10 ± 0,3 mm, height of 4,2 ± 0,4 mm. Two layers are visible on the cross-section.

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 an antagonist of histamine H2 receptors in 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 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. Binding to 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 ingestion - 2.5 hours, with creatinine clearance of 20-30 ml / min - 8-9 hours. It is excreted mainly with urine in unchanged form, a small amount - with feces. Badly penetrates the BBB. 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 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:

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. Duration of treatment - 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. Prophylaxis of ulceration during NSAID intake is 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 a dose of 0.15 g for 2 hours before anesthesia, and also, preferably 0.15 g 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 50ml / min the recommended dose is 0.15 g 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, thrombocyto singing,

agranulocytosis, pancytopenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.

From the side of the cardiovascular system: lowering blood pressure, bradycardia, arrhythmia, AV blockade.

From the nervous system: increased fatigue, drowsiness; 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: hyperprolactinemia, gynecomastia,

amenorrhea, decreased libido, impotence.

Allergic reactions: urticaria, skin rash, angioedema, anaphylactic shock, bronchospasm, erythema multiforme.

Other: alopecia, hypercreatininaemia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: 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 T1 / 2 metoprolol increased from 4.4 to 6.5 h.

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

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:

Ranitidine, like all H₂-gistaminoblokatory, undesirably sharply to cancel (syndrome "ricochet").

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.

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 allergic immediate reaction type, the use of blockers H₂-histamine-receptor is recommended to stop).

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

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

Form release / dosage:

Tablets covered with a film membrane 150 mg., 10 tablets in a planar cell package; One or two contour packagings along with the instructions for use are placed in a pack of cardboard.

Packaging:

10 tablets in a planar cell package; One or two contour packagings along with the instructions for use are placed in a pack of cardboard.

Storage conditions:

List B, Keep in a dry place, protected from light and 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:П N014531 / 01-2002

Date of registration:12.12.2008

The owner of the registration certificate:HEALTH PHARMACEUTICAL COMPANY, LTD. HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine

Manufacturer: & nbsp

HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine

Information update date: & nbsp29.08.2011

Illustrated instructions

Instructions

Ranitidine (Ranitidine)