Гистак®

General characteristics. Structure:

Active ingredient: ranitidine; 1 tablet contains hydrochloride ranitidine, is equivalent ranitidine of 150 mg;
excipients: cellulose microcrystallic, sodium of a kroskarmelloz, silicon dioxide colloid, magnesium stearate, talc, gipromelloza, ethyl cellulose, castor oil, titanium dioxide (Е 171).

Pharmacological properties:

Pharmacodynamics. Ranitidine - the antagonist of H2 receptors. The mechanism of effect of drug consists in suppression of basal and stimulated secretion of hydrochloric acid in a stomach that leads to reduction of volume of a secret and content of pepsin in it. Ranitidine strengthens protective mechanisms of a mucous membrane of a stomach and promotes healing of its damages caused by effect of acid. Promotes healing of the cankers of a mucous membrane of a stomach caused to NPVP. Ranitidine also normalizes a tone of the lower gastroesophageal sphincter, warning a gastroesophageal reflux. Drug has rather big duration of action therefore reception of 1 tablet effectively suppresses secretion of gastric acid more than 12 hours.
 
Pharmacokinetics. Ranitidine is quickly soaked up after intake, the maximum concentration in a blood plasma is reached within two hours. The use of food significantly does not reduce drug absorption. The elimination half-life of ranitidine makes 2 - 3 hours. Ranitidine is emitted with kidneys preferential in not changed look, insignificant киькисть drug is removed in the form of metabolites (ranitidine is partially metabolized in a liver). Daily excretion of ranitidine and its metabolites makes 40% of the accepted dose, 8% are brought out of an organism in the form of metabolites, the rest - is excreted with a stake.

Indications to use:

Treatment and prevention of aggravations of a peptic ulcer of a stomach and duodenum.
Stomach ulcer and a 12-perstny gut, connected with reception of non-steroidal anti-inflammatory drugs (NPVS). It can be applied to prevention of ulcers at reception of NPVS.
Reflux esophagitis.
Zollingera-Ellison's syndrome.
Treatment and prevention of postoperative, "stressful" ulcers of upper parts of a GIT.
Prevention of a recurrence of bleedings from upper parts of a GIT.

Route of administration and doses:

Inside, irrespective of meal, without chewing, washing down with a small amount of liquid.

Peptic ulcer of a stomach and 12-perstny gut. For treatment of aggravations appoint 150 mg 2 times a day (in the morning and in the evening) or 300 mg to night. If necessary - on 300 mg 2 times a day. Duration of a course of treatment is 4-8 weeks. For prevention of aggravations appoint 150 mg to night, to the smoking patients - 300 mg for the night. The ulcers connected with reception of NPVP. Appoint 150 mg 2 times a day or 300 mg to night within 8-12 weeks. Prevention of formation of ulcers at reception of NPVP - on 150 mg 2 times a day.

Postoperative and "stressful" ulcers of an ulcer. Appoint 150 mg 2 times a day within 4-8 weeks.

Erosive reflux esophagitis. Appoint 150 mg 2 times a day or 300 mg to night. If necessary the dose can be increased to 150 mg 4 times a day. Course of treatment of 8-12 weeks. Long preventive therapy - 150 mg 2 times a day.

Zollingera-Ellison's syndrome. The initial dose makes 150 mg 3 times a day, if necessary the dose can be increased. Treatment duration - as required.

Prevention of recurrent bleedings. On 150 mg 2 times a day. Treatment duration - as required.

Prevention of development of a syndrome of Mendelssohn. Appoint in a dose 150 mg in 2 hours prior to the general anesthesia, and also, 150 mg the night before are desirable.

In the presence of the accompanying abnormal liver function can be required a dose decline. For patients with a renal failure at clearance of creatinine less than 50 ml/min. the recommended dose makes 150 mg a day.

Features of use:

Treatment by ranitidine can mask the symptoms connected with a stomach carcinoma therefore before an initiation of treatment it is necessary to exclude existence of cancer - an ulcer. Гистак®, as well as all H2-gistaminoblokatory. it is undesirable to cancel sharply (a syndrome of "ricochet").

At prolonged treatment of the weakened patients in the conditions of a stress bacterial damages of a stomach with the subsequent spread of an infection are possible. Safety and efficiency of ranitidine at children are younger than 12 years are not established. There are data that ranitidine can cause bad attacks of a porphyria. During treatment it is necessary to abstain from occupations potentially dangerous types activity demanding the increased concentration of attention and speed of psychomotor reactions.

Can increase activity of a glutamattranspeptidaza.

Blockers of H2-gistaminoretseptorov can counteract influence of Pentagastrinum and histamine on acid-forming function of a stomach therefore within 24 hours preceding the test it is not recommended to apply blockers H2-gistaminoretseptorov.

Blockers of H2-gistaminoretseptorov can suppress skin reaction to a histamine, resulting, thus, in false positive results (before conducting diagnostic skin tests for identification of allergic skin reaction of immediate type use of blockers of H2-gistaminoretseptorov is recommended to be stopped).

During treatment it is necessary to avoid the use of food stuffs, drinks and other medicines which can cause irritation of a mucous membrane of a stomach.

Side effects:

From the alimentary system: nausea, dryness in a mouth, a lock, vomiting, diarrhea. abdominal pains: seldom - the hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis, increase in activity of "hepatic" transaminases.

From bodies of a hemopoiesis: a leukopenia, thrombocytopenia, аграиулоцитоз, a pancytopenia, hypo - and a marrow aplasia, immune hemolitic anemia.

From cardiovascular system: lowering of arterial pressure. bradycardia, arrhythmia, atrioventricular block.

From a nervous system: increased fatigue, drowsiness, emotional lability, alarm, depression, nervousness, headache, dizziness; seldom - confusion of consciousness, a sonitus, irritability, hallucinations (generally at elderly patients and heavy patients), the involuntary movements.

From sense bodys: illegibility of visual perception, accommodation paresis.

From a musculoskeletal system: arthralgia. mialgiya.

From endocrine system: giperprolaktinemiya, gynecomastia, amenorrhea, impotence, decrease in a libido.

Allergic reakiiya: skin rash, small tortoiseshell, Quincke's disease, acute anaphylaxis, bronchospasm, multiformny exudative erythema.

Others: alopecia, giperkreatininemiya, increase in activity of a glutamattranspeptidaza, acute porphyria. exfoliative dermatitis, vasculitis, hyperthermia.

Interaction with other medicines:

Smoking reduces efficiency of ranitidine.

Ranitidine increases concentration of a metoprolol in blood serum by 50%, at the same time the elimination half-life of a metoprolol raises from 4,4 to 6,5 h.
Owing to increase рН stomach contents at a concomitant use absorption of an itrakonazol and ketokonazol can decrease. Blockers of H2-gistaminoretseptorov should be accepted in 2 hours after reception of an itrakonazol or a ketokonazol in order to avoid considerable reduction of their absorption.
Metabolism in a liver of phenazone, Aminophenazonum oppresses. diazspama, hexobarbital, propranolol, diazepam, lidocaine, Phenytoinum, theophylline, Aminophyllinum, indirect anticoagulants, glipizid, Buforminum, metronidazole, antagonists of calcium.
The medicines oppressing marrow increase risk of development of a neutropenia.
At simultaneous use with antacids, sukralfaty in high doses ranitidine absorption disturbance therefore the break between reception of these drugs has to be not less than 2 hours is possible.

Contraindications:

Hypersensitivity to ranitidine or other components of drug
Pregnancy
Lactation
Children's age up to 12 years.

About care - a renal and/or liver failure, cirrhosis with portosistemny encephalopathy in the anamnesis, an acute porphyria (including in the anamnesis), immunity oppression.

Overdose:

Symptoms: spasms, bradycardia, ventricular arrhythmias.
Treatment: symptomatic. At development of spasms - diazepam intravenously, at bradycardia or ventricular arrhythmias - atropine, lidocaine. The hemodialysis - is effective.

Storage conditions:

To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets coated 150 mg.

On 10 tablets in a strip from aluminum foil. 1, 2 or 10 strips with the application instruction in a cardboard pack.

On 10 tablets in the blister from the aluminum foil laminated by a PVC film. 1,2 or 10 blisters with the application instruction in a cardboard pack.