Ранитидин-Акри®

General characteristics. Structure:

Active ingredient: 0,1674 g of ranitidine of a hydrochloride that is equivalent to 0,15 g of ranitidine.

Excipients: sugar milk (lactose), cellulose microcrystallic, potato starch, starch sodium glycollate (sodium carboxymethylstarch), polyvinylpirrolidone (povidone), aerosil (silicon dioxide colloid), magnesium stearate.

Structure of a cover: ready mix "Opadray AMB".

Pharmacological properties:

Pharmacodynamics. Ranitidine — a blocker histamine H2 receptors of covering cells of a mucous membrane of a stomach. Reduces the basal and stimulated secretion of hydrochloric acid caused by irritation of baroreceptors, food loading, effect of hormones and biogenic stimulators (gastrin, a histamine, Pentagastrinum).

Ranitidine reduces the volume of a gastric juice and content of hydrochloric acid in it, raises рН stomach contents that leads to pepsin decrease of the activity. After oral administration in therapeutic doses does not influence prolactin level. Inhibits microsomal enzymes of a liver. Action duration after a single dose till 12 o'clock.

Pharmacokinetics. It is quickly soaked up, meal does not influence extent of absorption. At intake bioavailability of ranitidine makes about 50%. The maximum concentration in plasma are reached in 2-3 hours after administration of drug. Communication with proteins of plasma does not exceed 15%. It is slightly metabolized in a liver with formation of a dismetilranitidin. Has effect of "the first passing" through a liver. Speed and extent of elimination depend on a condition of a liver a little.

Elimination half-life after intake — 2,5 hours, at clearance of creatinine of 20-30 ml/min. — 8-9 hours. The insignificant quantity — with a stake is removed generally with urine in not changed look. Badly gets through a blood-brain barrier. Gets through a placenta. It is allocated with breast milk (concentration in breast milk at women in the period of a lactation higher, than in plasma).

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 (NPVP); reflux esophagitis, erosive esophagitis; Zollingera-Ellison's syndrome; treatment and prevention of postoperative, "stressful" ulcers of upper parts of digestive tract; prevention of a recurrence of bleedings from upper parts of digestive tract; prevention of aspiration of a gastric juice at operations under the general anesthesia (Mendelssohn's syndrome).

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 — 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. 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. Therapy duration — as required.

Prevention of recurrent bleedings. On 150 mg 2 times a day. Therapy 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 the dose decline can be required. The patient 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 ulcer.

Ranitidine, as well as all H2-gistaminoblokatory, 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 is 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 of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Can increase activity of a glutamattranspeptidaza.

Blockers 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 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-gistamino-retseptorov 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.

From bodies of a hemopoiesis: a leukopenia, thrombocytopenia, an agranulocytosis, 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, 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, decrease in a libido, decrease in a potentiality.

Allergic reactions: urticaria, skin rash, Quincke's disease, acute anaphylaxis, bronchospasm, multiformny exudative erythema.
Others: alopecia, giperkreatininemiya, increase in activity of a glutamattranspeptidaza, acute porphyria.

Interaction with other medicines:

Smoking reduces efficiency of 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 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, diazepam, hexobarbital, propranolol, diazepam, lidocaine, Phenytoinum, theophylline, Aminophyllinum, indirect anticoagulants, a glipizida, Buforminum, metronidazole, antagonists of calcium oppresses.

The medicines oppressing marrow increase risk of a neutropenia.
At simultaneous use with antacids, sukralfaty in high doses ranitidine absorption delay 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 period. Children's age up to 12 years (efficiency and safety are not established).

With care. A renal and/or liver failure, cirrhosis with portosistemny encephalopathy in the anamnesis, an acute porphyria (including in the anamnesis).

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:

In dry, protected from light and the place, unavailable to children, at a temperature not above 25 °C. A period of validity - 2 years.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in a blister strip packaging. 1, 2, 3 or 5 blister strip packagings together with the application instruction place in a pack from a cardboard.