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

1 tablet, film-coated, 150 mg contains the active substance: ranitidine 150 mg (in the form of ranitidine hydrochloride, 167.41 mg); auxiliary substances:

cellulose microcrystalline (PH 101) - 81.81 mg, croscarmellose sodium - 1.27 mg, silicon dioxide colloid - 1.27 mg, magnesium stearate - 2.26 mg; shell: hypromellose-5.00 mg, triacetin-1.84 mg, titanium dioxide E 171 - 1.27 mg, talc - 4.88 mg.

1 tablet, film-coated, 300 mg contains the active substance: ranitidine 300 mg (in the form of ranitidine hydrochloride 334.83 mg); auxiliary substances:

cellulose microcrystalline (PH 101) - 112.82 mg, croscarmellose sodium - 4.60 mg, silicon dioxide colloid - 3.20 mg, magnesium stearate - 4.60 mg; the membrane: hypromellose-9.35 mg, triacetin-3.32 mg, talc-8.00 mg, titanium dioxide E 171 - 2.31 mg, brown-lacquer: (dye sunset yellow E 110, dye azorubin E 122, dye black E 151) -0.02 mg.

Description:

Tablets, film-coated 150 mg: round biconvex tablets covered with a film coat, from white to yellowish-white color, characteristic odor.

Film-coated tablets 300 mg: round biconvex tablets covered with a film membrane, pale pink color, characteristic odor.

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:

Ranitidine is a blocker of H2-histamine receptors of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid caused by stimulation of baroreceptors, nutritional load, action of hormones and biogenic stimulants (gastrin, histamine, acetylcholine, pentagastrin, caffeine). 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. The duration of action after a single dose is up to 12 hours.

Pharmacokinetics:

Rapidly absorbed from the gastrointestinal tract, food intake does not affect the extent of absorption.When administered, the bioavailability of ranitidine is 50%. The connection with plasma proteins does not exceed 15%. Partially metabolized in the liver. The maximum plasma concentration is achieved 2 hours after taking the tablets coated with a coat and ranges from 36 to 94 ng / ml. The half-life is 2-3 hours. 35% of the accepted dose is excreted in the urine unchanged, a small amount - with feces.

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 (GIT); 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 up to 14 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

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, 300 mg twice a day. The duration of the course of treatment is 4-8 weeks. To prevent exacerbations appoint 150 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.

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.

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

Prevention of recurrent bleeding. 150 mg twice a day.

Prevention of the development of Mendelssohn syndrome. Assign ranitidine in a dose of 150 mg for 2 hours before anesthesia, and also, preferably 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 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 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:

Due to the increase in the pH of the contents of the stomach with simultaneous intake may reduce the absorption of itraconazole and ketoconazole.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, nifedipine, warfarin, diazepam, lidocaine, lignocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, bupormine, metronidazole.

With simultaneous use with procainamide, it is possible to increase its concentration in the blood plasma because of the decrease in its excretion by the kidneys.

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.

Drugs that depress the bone marrow increase the risk of neutropenia. Smoking reduces the effectiveness of ranitidine.

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 long-term treatment of weakened patients under 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 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.

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 H2-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 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:

Film-coated tablets, 150 mg and 300 mg.

Tablets of 150 mg:

For 4, 6 or 10 tablets, coated with a film sheath, into a contour mesh package made of AL / AL, laminated with PVC and polyamide film.

For 5 contour packs of cells for 4 or 6 tablets or 2 or 3 contour packs of 10 tablets with instructions for use in a pack of cardboard.

Tablets 300 mg:

For 4.6 or 10 tablets, film-coated, in the bilateralAluminum strip with PVC film inside. 5 strips of 4 or 6 tablets or 2 or 3 Strips of 10 tablets with instructions for use in a pack of cardboard

Packaging:

Tablets of 150 mg:

For 4, 6 or 10 tablets, coated with a film sheath, into a contour mesh package made of AL / AL, laminated with PVC and polyamide film.

For 5 contour packs of cells for 4 or 6 tablets or 2 or 3 contour packs of 10 tablets with instructions for use in a pack of cardboard.

Tablets 300 mg:

For 4.6 or 10 tablets, film-coated, in the bilateralAluminum strip with PVC film inside. 5 strips of 4 or 6 tablets or 2 or 3 Strips of 10 tablets with instructions for use in a pack of cardboard

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

List B.

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 N014316 / 01

Date of registration:01.10.2007

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Information update date: & nbsp15.03.2013

Illustrated instructions

Instructions

Ranitidine (Ranitidine)