Kvamatel

Kvamatel – antiulcerous means, a blocker histamine _{H2 receptors}.

Form of release and structure

Dosage forms:

• Tablets, film coated: have the convex form, the engraving, on tablets of pink color - "F20", dark pink – "F40", on a break structure of white or almost white color is applied on one of the parties (on 14 pieces in blisters, in a cardboard box 2 blisters with tablets on 20 mg or 1 – on 40 mg);
• Lyophilisate for preparation of solution for intravenous (in/in) introductions: has almost white or white color, solvent – inodorous transparent colourless liquid (on 72,8 mg in glass colourless bottles, in a cardboard pack of 5 bottles complete with solvent in ampoules on 5 ml, in planimetric plastic packaging of 5 ampoules).

Active agent – famotidine:

• 1 tablet – 20 or 40 mg;
• 1 bottle – 20 mg.

Auxiliary components:

• Tablets: magnesium stearate, silicon dioxide colloid, K90 povidone, sodium carboxymethylstarch (type A), lactoses monohydrate, starch corn, talc;
• Lyophilisate: Mannitolum, aspartic acid.

In addition:

• Structure of a film cover of tablets: silicon dioxide colloid, ferrous oxide red, titanium dioxide, сепифильм 003 (cellulose microcrystallic (E460), OE macrogoal-40 stearate (E431), gipromelloz (E464)), macrogoal 6000;
• Solvent for lyophilisate: solution of sodium of chloride of 0,9%.

Indications to use

• Treatment in a phase of an aggravation and prevention of a recurrence at a peptic ulcer of a stomach and duodenum;
• Prevention and treatment of the symptomatic stomach ulcers and duodenum caused by stresses, reception of non-steroidal anti-inflammatory drugs, carrying out operations;
• The functional dyspepsia connected with the increased secretory function of a stomach;
• Erosive gastroduodenit;
• Reflux esophagitis;
• Prevention of a recurrence of bleeding from upper parts of the digestive tract (DT);
• Zollingera-Ellison's syndrome;
• Prevention of aspiration of a gastric juice when carrying out the general anesthesia (Mendelssohn's syndrome).

Contraindications

• Children's age;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to components of drug and other blockers histamine _{H2 receptors}.

With care Kvamatel sick with a renal and/or liver failure, cirrhosis with portosistemny encephalopathy in the anamnesis is recommended to appoint.

Route of administration and dosage

• Tablets: accept inside. Dosing and the period of treatment are appointed by the doctor on the basis of clinical indications. At an exacerbation of stomach ulcer and a duodenum: on 40 mg of 1 times a day in the evening or on 20 mg 2 times a day (in the morning and in the evening). If necessary increase in a daily dose up to 80-160 mg is allowed. Course of treatment from 4 to 8 weeks. For prevention of exacerbations of an ulcer: on 20 mg of 1 times a day in the evening. At treatment a reflux esophagitis: on 20 mg 2 times a day within 6 weeks, are in case of need possible increase in a daily dose up to 80 mg. Therapy of a syndrome of Zollingera-Ellison it is recommended to begin each 6 hours with 20-40 mg, in need of increase the daily dose can be brought to 480 mg. Prevention of aspiration of contents of a stomach in the period of the general anesthesia is carried out in the dose 40 mg accepted the night before and/or in the morning in day of operation;
• Lyophilisate for preparation of solution for (in/in) introductions: it is intended for jet or drop introduction only in the conditions of a hospital at patients with a severe form of a disease or at impossibility of oral administration of drug. Just before introduction it is necessary to part contents of one bottle of drug from 5-10 ml of solvent. Duration jet in/in introductions has to make not less than 2 minutes, infusions – 15-30 minutes. Stability of ready solution remains in the conditions of room temperature within 24 hours. One-time dosing should not exceed 20 mg. An average daily dose – on 20 mg 2 times at an interval of 12 hours. An initial dose at Zollingera-Ellison's syndrome – on 20 mg every 6 hours, then the dose is adjusted taking into account a clinical condition of the patient and secretion of hydrochloric acid. Prevention of aspiration of a gastric juice at the general anesthesia is carried out by way to introductions by 20 mg of Kvamatel the night before or in 2 hours prior to operation. As soon as possible the patient is recommended to be transferred to reception of tablets.

For patients with an impaired renal function (KK less than 30 ml/min. or level of creatinine in a blood plasma more than 3 mg/dl) at purpose of each of dosage forms of Kvamatel, recommends to reduce a daily dose about 20 mg, and in need of preservation of a usual dose – it is necessary to increase till 36-48 o'clock an interval between administrations of drug.

The dose of drug should be reduced at an abnormal liver function.

Side effects

Kvamatel's use can cause side effects:

• From cardiovascular system: bradycardia, arrhythmia, lowering of arterial pressure, atrioventricular block;
• From the alimentary system: dryness in a mouth, a loss of appetite, nausea, abdominal pains, vomiting, a meteorism, diarrhea or a lock; increase in activity of hepatic transaminases, acute pancreatitis, the cholestatic, hepatocellular or mixed hepatitis;
• From a nervous system: drowsiness, headache, increased fatigue, dizziness, confusion of consciousness, hallucination, depression, alarm, excitement;
• From system of a hemopoiesis: very seldom – a leukopenia, an agranulocytosis, thrombocytopenia, hypo - or a marrow aplasia, a pancytopenia;
• Dermatological reactions: xeroderma, alopecia, toxic epidermal necrolysis, ordinary eels;
• Allergic reactions: itch, skin rash, small tortoiseshell, bronchospasm, acute anaphylaxis, Quincke's disease;
• From a reproductive system: long reception in high doses – a gynecomastia, a giperprolaktinemiya, decrease in a libido, an amenorrhea;
• From sense bodys: sonitus, decrease in visual acuity;
• From a musculoskeletal system: muscular spasms, arthralgia;
• Others: fever.

Special instructions

At Kvamatel's appointment the doctor has to be convinced of absence at the patient of malignant new growths as administration of drug is capable to mask their symptoms.

During use of drug of the patient should not use the medicines, food stuffs and drinks capable to render irritant action on a mucous membrane of a stomach.

It is impossible to interrupt sharply treatment with famotidine – it can cause a withdrawal therefore at drug withdrawal the dose should be reduced gradually in the patient.

Against the background of long therapy in the conditions of a stress or at the weakened patients development of bacterial infections of a stomach is possible.

The patient with functional disturbances of a liver drug is appointed with care and in low doses.

In case of need simultaneous use, administration of drug is made only in 2 hours after a ketokonazol or an itrakonazol, it is also recommended to do 1-2 one-hour break at reception of antacids to exclude interaction of these medicines.

As Kvamatel can inhibit kislotostimuliruyushchy activity of a histamine and Pentagastrinum, it is recommended to stop administration of drug in 24 hours prior to test.

Skin tests at diagnosis of allergic skin reactions of immediate type should be carried out after drug withdrawal as blockers histamine _{H2 receptors} are capable to suppress skin reaction to a histamine and to distort results of researches.

During treatment by Kvamatel patients have to be careful at occupations potentially dangerous types of activity which performance demands speed of psychomotor reactions and high concentration of attention, including at control of vehicles and mechanisms.

Medicinal interaction

Kvamatel's action increases acidity in a stomach, it promotes decrease in absorption of an itrakonazol and ketokonazol and increase in absorption of clavulanic acid and amoxicillin against the background of administration of drug.

At a combination to the medicines oppressing a marrowy hemopoiesis, the probability of development of a neutropenia increases.

At a concomitant use with sukralfaty and antacids there is a famotidine absorption delay.

Terms and storage conditions

To store in the place protected from light at a temperature: tablets – to 30 °C, lyophilisate – 15-25 °C. To protect from children.

Period of validity: tablets – 5 years, lyophilisate – 3 years.