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

cellulose microcrystalline, potato starch, silicon dandoxide colloidal (Aerosil), povidone (Kollidon 25), magnesium stearate, Opadry AMB: polyvinyl alcohol, soy lecithin, xanthan gum, talc, titanium dioxide (E 171).

Description:

Round biconvex tablets coated with a coat, white or white with a creamy shade of color.

Pharmacotherapeutic group:a drug that reduces the secretion of the glands of the stomach - H2-histamine receptor blocker

ATX: & nbsp

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

A.02.B.A.02 Ranitidine

Pharmacodynamics:

The blocker of H2-histamine receptors of the second generation. The mechanism of action is associated with blockade of H2-histamine receptors in membranes of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, caused by irritation of baroreceptors, food load, the 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. Does not affect the concentration of gastrin in the blood plasma. After oral administration in therapeutic doses does not affect the level of prolactin. Inhibits microsomal enzymes (weaker than cimetidine). Practically does not suppress "hepatic" enzymes associated with cytochrome P450. Duration of action after a single dose of up to 12 hours.

Pharmacokinetics:

Rapidly absorbed from the gastrointestinal tract, food intake does not affect the extent of absorption. When administered orally, the bioavailability of ranitidine is approximately 50%. The maximum concentration in the blood plasma is reached in 2-3 hours after administration. 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 depends little on the condition of the liver. It is excreted mainly with urine in unchanged form, a small amount - with feces.Half-life after oral intake is 2.5 hours, with creatinine clearance of 20-30 ml / min - 8-9 hours.

Poorly penetrates the blood-brain barrier. Penetrates through the placental barrier. Excreted in breast milk (concentration in breast milk during lactation is higher than in blood 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 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.

Carefully:

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

Dosing and Administration:

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

Peptic ulcer disease of the stomach and lven-n-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. For the prevention of exacerbations appoint 150 mg at night, smoking patients - 300 mg per night.

Ulcers associated with taking an NSAID.

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.

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 is 150 mg twice a day.

Zollinger-Ellison Syndrome.

The initial dose is 150 mg 3 times a day, if necessary, the dose can be increased. If necessary, the dose can be increased to 6 g / day.

Postoperative and "stressful" ulcers.

Assign 150 mg twice a day for 4-8 weeks.

Prevention of recurrent bleeding.

Assign 150 mg twice a day.

Prevention of the development of Menlelson's syndrome.

Assign a dose of 150 mg 2 hours before the general anesthesia and 150 mg the night before. 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 - hepatitis (hepatocellular, cholestatic, mixed), acute pancreatitis.

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

From the cardiovascular system: lowering of blood pressure, bradycardia, vasculitis, arrhythmia, atrio-ventricular block.

From the nervous system: increased fatigue, headache,

dizziness, drowsiness, insomnia, emotional lability, anxiety, anxiety, depression, hyperthermia; rarely - confusion, tinnitus, irritability, hallucinations (mainly in elderly patients and severe patients), involuntary movements.

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

From the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased potency and / or libido.

Allergic reactions: urticaria, skin rash, itching, angioedema, anaphylactic shock, bronchospasm, multiforme exudative erythema (including Stevens-Johnson syndrome).

Other: alopecia, hypercreatininaemia, increased activity

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.

With simultaneous admission, the absorption of itraconazole and ketoconazole decreases. Blockers H2-gistaminovyh receptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

Inhibits the metabolism in the liver of phenazone, 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. Antacids, sucralfate slow the absorption of ranitidine, so the break between taking these drugs should be at least 2 hours.

Special instructions:

Ranitidine treatment can mask the symptoms associated with carcinoma of the stomach, so before starting treatment it is necessary to exclude the presence of malignant neoplasm. Ranitidine, like all H2-histamine receptor blockers, it is undesirable to abruptly abolish (in order to avoid the syndrome of "ricochet").

With prolonged treatment weakenedMr.In patients with stress, bacterial lesions of the stomach are possible with the subsequent spread of infection. There is evidence that ranitidine can cause acute attacks of porphyria.

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

May increase the activity of glutamate transpeptidase.

May be the cause of a false positive reaction when carrying out a sample for protein in the urine. The blockers of Hg-histamine receptors can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, their use is not recommended.

It can suppress the skin reaction to histamine, thus leading to false positive results (it is recommended to stop ranitidine before performing diagnostic skin tests to detect an immediate allergic skin reaction).

During treatment should avoid eating foods, beverages and other medicines that can cause irritation of the mucous membrane of the stomach

Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration atnimania and the speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 150 mg.For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. 2 contour mesh packs 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. 2 contour mesh packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

List B. In a 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 expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000973 / 01

Date of registration:19.11.2007

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

Shchelkovo Vitamin Plant, OJSC Russia

Information update date: & nbsp19.11.2007

Illustrated instructions

Instructions

Ranitidine (Ranitidine)