FAMOTIDINE of 40 mg

General characteristics. Structure:

Active ingredient: famotidine – 0,0200 g or 0,0400 g;

excipients: lactoses monohydrate, potato starch, croscarmellose sodium (primelloza), silicon dioxide colloid (aerosil), magnesium stearate; structure of a cover: a gipromelloza, a macrogoal (polyethyleneglycol), titanium E 171 dioxide, for a dosage of 40 mg dye ferrous oxide yellow E172.  

DESCRIPTION. Tablets, film coated, color, white or white with a grayish shade (for a dosage of 20 mg) or yellow color (for a dosage of 40 mg), round, biconvex. On cross section color of a kernel of a tablet white or white with a yellow shade.

Pharmacological properties:

Pharmacodynamics. H2 - histamine receptors a blocker of the III generation. Suppresses basal and stimulated a histamine, gastrin and acetylcholine products of hydrochloric acid. Reduces activity of pepsin. Strengthens protective mechanisms of a mucous membrane of a stomach and promotes healing of its damages connected with influence of hydrochloric acid (including to the termination of gastrointestinal bleedings and scarring of stressful ulcers) by increase in formation of gastric slime, the maintenance in it of glycoproteins, stimulation of secretion of a hydrocarbonate a mucous membrane of a stomach, endogenous synthesis in it of prostaglandins and speeds of regeneration. Significantly does not change concentration of gastrin in plasma. Poorly inhibits oksidazny system of P450 cytochrome in a liver. After intake action begins in 1 hour, reaches a maximum within 3 hours. Duration of effect of drug at a single dose depends on a dose and makes from 12 to 24 hours.

Pharmacokinetics. After intake it is quickly absorbed from digestive tract. After intake the maximum concentration in a blood plasma is reached within 1-3,5 hours. Bioavailability - 40-45%, increases at reception with food and decreases against the background of reception of antacids. Communication with proteins of plasma - 15-20%. About 30-35% of famotidine are metabolized in a liver (with formation of S-oxide). Elimination, generally happens through kidneys: 27-40% of drug are removed with urine in not changed look. The elimination half-life - 2,5-4 hours, at patients with clearance of creatinine lower than 30 ml/min. increases till 10-12 o'clock. At patients with a heavy renal failure (the clearance of creatinine is lower than 10 ml/min.) it increases till 20 o'clock. Gets through a placental barrier and it is allocated with breast milk.

Indications to use:

- A peptic ulcer of a 12-perstny gut and a stomach in an aggravation phase, prevention of a recurrence.

- Treatment and prevention of the symptomatic stomach ulcers and a 12-perstny gut (connected with reception of non-steroidal anti-inflammatory drugs (NPVP), stressful, postoperative ulcers).

- Erosive gastroduodenit.

- The functional dyspepsia associated with the increased secretory function of a stomach.

- Reflux esophagitis.

- Zollingera-Ellison's syndrome.

- Prevention of a recurrence of bleedings from upper parts of digestive tract.

- The prevention of aspiration of a gastric juice at the general anesthesia (Mendelssohn's syndrome).

Route of administration and doses:

Inside. At a peptic ulcer of a stomach and a 12-perstny gut in an aggravation phase, symptomatic ulcers, an erosive gastroduodenit usually appoint 20 mg 2 times a day or on 40 mg of 1 times a day to night. If necessary the daily dose can be increased to 80-160 mg. A course of treatment - 4-8 weeks. At the dyspepsia connected with the increased secretory function of a stomach appoint 20 mg 1-2 times a day. For the purpose of prevention of a recurrence of a peptic ulcer appoint 20 mg of 1 times a day before going to bed. At a reflux esophagitis - 20-40 mg two times a day within 6-12 weeks. At Zollingera-Ellison's syndrome the dose of drug and duration of a course of treatment are established individually. The initial dose usually makes 20 mg each 6 hours and can be increased to 160 mg each 6 hours. For prevention of aspiration of a gastric juice at the general anesthesia appoint 40 mg in the evening and/or in the morning before operation. Tablets should be swallowed without chewing, washing down with enough water. At a renal failure if the clearance of creatinine makes less than 30 ml/min. or the content of creatinine in blood serum more than 3 mg / 100 ml, it is necessary to reduce a daily dose of drug to 20 mg.

Features of use:

Before an initiation of treatment it is necessary to exclude a possibility of existence of a malignant disease of a gullet, stomach or duodenum. Famotidine, as well as all H2-gistaminoblokatory, is undesirable to cancel sharply (a syndrome of "ricochet"). At prolonged treatment at the weakened patients, in the conditions of a stress, bacterial damages of a stomach with the subsequent spread of an infection are possible. H2-gistaminoretseptorov blockers 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 H2-gistaminoretseptorov blockers. H2-gistaminoretseptorov blockers can suppress skin reaction to a histamine, resulting, thus, in false-negative results (before conducting diagnostic skin tests for identification of allergic skin reaction of immediate type use H2-gistaminoretseptorov of blockers 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. Influence on ability to drive the car and other mechanisms. During treatment it is necessary to be careful at control of motor transport and at other types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: dryness in a mouth, nausea, vomiting, abdominal pains, appetite loss, increase in activity of "hepatic" transaminases, hepatitis, acute pancreatitis. From a nervous system: headache, dizziness, hallucinations, confusion of consciousness. From cardiovascular system: lowering of arterial pressure, atrioventricular block, bradycardia. Allergic reactions: xeroderma, urticaria, skin itch, skin rash, bronchospasm, Quincke's disease, acute anaphylaxis. From bodies of a hemopoiesis: seldom - a leukopenia, thrombocytopenia; in isolated cases - an agranulocytosis, a pancytopenia, a hypoplasia, a marrow aplasia. From reproductive system: at long reception of high doses - a giperprolaktinemiya, a gynecomastia, an amenorrhea, decrease in a libido, impotence. From sense bodys: paresis of accommodation, an illegibility of visual perception, a ring in ears. Others: seldom - fever, an arthralgia, a mialgiya.

Interaction with other medicines:

Owing to increase рН stomach contents at a concomitant use absorption of a ketokonazol and itrakonazol can decrease. At simultaneous use with antiacid means, sukralfaty there is a decrease in intensity of absorption of famotidine therefore the break between reception of these drugs has to make not less than 1-2 hours. Metabolism in a liver of phenazone, Aminophenazonum, diazepam, hexobarbital, propranolol, a metoprolol, lidocaine, Phenytoinum, theophylline, indirect anticoagulants, a glipizida, Buforminum, metronidazole, caffeine, blockers of "slow" calcium channels, tricyclic antidepressants oppresses. Increases absorption of amoxicillin and clavulanic acid. The medicines oppressing marrow increase risk of development of a neutropenia.

Contraindications:

Pregnancy, the lactation period, liver failure, children's age, hypersensitivity to drug components.

Overdose:

Symptoms: vomiting, motive excitement, tremor, lowering of arterial pressure, tachycardia, collapse.

Treatment: gastric lavage, symptomatic therapy, hemodialysis.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, on 20 mg and 40 mg. On 10 tablets in a blister strip packaging. On 1, 2 or 3 blister strip packagings together with the application instruction in a pack from a cardboard.