Kvamatel

General characteristics. Structure:

Active ingredient: each tablet film coated contains 20 mg or 40 mg of famotidine.

Excipients: silicon dioxide colloid; magnesium stearate; K 90 povidone; sodium carboxymethylstarch. type A; talc; starch corn; lactoses monohydrate.
Structure of a cover: ferrous oxide red, silicon dioxide colloid, titanium dioxide, macrogoal 6000; сепифилм 003 (OE macrogoal-40 stearate (or mono and diester of stearic acid and PEG-40 OK) (E431) + cellulose microcrystallic (E460) + gipromelloz (E464)).

Pharmacological properties:

Pharmacodynamics. H2 blocker - histamine receptors. Suppresses secretion of hydrochloric acid, basal and stimulated gastrin, a histamine and acetylcholine, at the same time pH of contents of a stomach increases and activity of pepsin decreases. Famotidine poorly influences microsomal enzymes of a liver.
After intake effect of drug begins in 1 h, reaches a maximum during 3 h, duration of effect of 12-24 h depending on a dose.

Pharmacokinetics. Absorption is incomplete, maximum concentration - in 1-3 h and makes 0,07-0,1 mg/l. Bioavailability - 40-45%, increases at meal and decreases at reception of antacids. Communication with proteins of plasma of 10-20%.
Plasma elimination half-life - 2,3-3,5 h, and at clearance of creatinine <10 ml/min. can reach 20 h (dose adjustment is required). 30-35% of drug are metabolized in a liver with formation of S-oxide. At intake of 30-35% of famotidine it is removed by kidneys in not changed look.
Famotidine gets through placental, hematoencephalic barriers and into breast milk.

Indications to use:

Peptic ulcer of a 12-perstny gut and stomach in an aggravation phase, prevention of a recurrence.
Treatment and prevention of the symptomatic stomach ulcers and 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 an aggravation of a peptic ulcer of a stomach and a 12-perstny gut on 40 mg of 1 times a day, before going to bed or on 20 mg 2 times a day. If necessary it is possible to increase a daily dose to 80-160 mg; duration of treatment is 4-8 weeks.
For prevention of an aggravation of a peptic ulcer on 20 mg of 1 times a day before going to bed.
At Zollingera-Ellison's syndrome initial dose of 20 - 40 mg each 6 hours; if necessary it is possible to increase a daily dose to 240 - 480 mg.
At a reflux esophagitis an initial dose of 20 mg 2 times a day; if necessary it is possible to use drug on 40 mg 2 times a day.

For prevention of aspiration of a gastric juice during the general anesthesia: 40 mg on the eve of operation or in the morning in day of operation.
At a renal failure if clearance of creatinine <30 ml/min. or creatinine of blood> 3 mg / 100 ml, a daily dose it is necessary to reduce to 20 mg or to increase an interval between receptions to 36-48 h.

Features of use:

Famotidine can mask symptoms of a carcinoma of the stomach therefore before to start treatment by famotidine, it is necessary to exclude existence of a malignant new growth.
Like all blockers of H2 receptors, at the sharp termination of treatment famotidine can cause a withdrawal therefore treatment is stopped, gradually reducing its dose.
To patients with the broken function of a liver appoint reduced doses, being careful.
At prolonged treatment of the weakened patients, and also at a stress bacterial damages of a stomach with further spread of an infection are possible.
Blockers of H2 receptors should be accepted after 2 hours after reception of an itrakonazol and a ketokonazol in order to avoid essential deterioration in their absorption.
Blockers of H2 receptors can inhibit kislotostimuliruyushchy action of Pentagastrinum and histamine therefore in 24 hours prior to test it is necessary to refuse purpose of famotidine.
Blockers of H2 receptors suppress skin reaction to a histamine, resulting in false-negative results of skin tests therefore before conducting diagnostic skin tests on an imediate-type allergy it is necessary to stop famotidine reception.
During treatment it is necessary to avoid the use of the food stuffs, drinks and medicines causing irritation of a mucous membrane of a stomach.

Vliyanne on ability to drive the car and to perform the works connected with the increased risk of traumatism
During treatment by famotidine it is necessary to be careful at control of motor transport and at other types of activity requiring special attention and speed of psychomotor reactions.

Side effects:

From digestive organs: dryness in a mouth, nausea, vomiting, abdominal pains, a loss of appetite; increase in activity of transaminases of a liver, the hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From bodies of a hemopoiesis: very seldom an agranulocytosis, a pancytopenia, a leukopenia, thrombocytopenia, hypo - or a marrow aplasia.
Allergic reactions: urticaria, skin rash, itch, bronchospasm, Quincke's disease, acute anaphylaxis.
From cardiovascular system: arrhythmia, atrioventricular block, bradycardia, lowering of arterial pressure.
From a nervous system: headache, dizziness, increased fatigue, drowsiness, hallucinations, confusion of consciousness.
From sense bodys: decrease in visual acuity, sonitus.
From bodies of urinogenital system: at prolonged use of high doses - an amenorrhea, decrease in a libido.
From a musculoskeletal system: mialgiya, arthralgia.
Others: fever, an alopecia, ordinary eels, a xeroderma, at prolonged use of high doses - a giperprolaktinemiya, a gynecomastia.

Interaction with other medicines:

Owing to increase in pH of contents of a stomach famotidine reduces absorption of a ketokonazol and itrakonazol.
Antacids and сукральфат slow down famotidine absorption, it is necessary to observe 1-2 one-hour break between receptions of these drugs.
At the combined use of famotidine and medicines oppressing marrow the risk of development of a neutropenia increases.
Famotidine increases absorption of amoxicillin and clavulanic acid.

Contraindications:

Hypersensitivity to famotidine and other blockers of H2 - histamine receptors, pregnancy, the lactation period, children's age.

WITH CARE
Liver or renal failure, cirrhosis with portosistemny encephalopathy in the anamnesis.

Overdose:

Symptoms: vomiting, motive excitement, tremor, lowering of arterial pressure, tachycardia, collapse.
Treatment: gastric lavage, symptomatic and maintenance therapy; hemodialysis.

Storage conditions:

List B. To store at a temperature not above 30 °C, in the place protected from light. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets are film coated, 20 mg and 40 mg
Tablets of 20 mg: 14 tablets, film coated in the Al/PVC blister; 2 blisters in a cardboard box with the enclosed application instruction.

Tablets of 40 mg: 14 tablets, film coated in the A1/PVC blister; 1 blister in a cardboard box with the enclosed application instruction.