Kvamatel

General characteristics. Structure:

Lyophilisate:
each bottle contains:
Active agent: famotidine of 20 mg.

Excipients: aspartic acid - 8,8 mg, Mannitolum - 44,0 mg.
Solvent:
0,9% chloride sodium solution: each ampoule contains: sodium chloride - 45,0 mg, water for injections - to 5,0 ml.

Pharmacological properties:

Pharmacodynamics. Famotidine is a powerful competitive inhibitor of H2-histamine receptors.
The main clinically significant pharmacological effect of famotidine is the inhibition of gastric secretion. Famotidine reduces both concentration of hydrochloric acid, and volume of gastric secretion while changes of a pepsinia are proportional to the cosecreted volume.
At healthy volunteers and patients with hypersecretion famotidine inhibits basal and night secretion of hydrochloric acid and a pepsinogen, and also the secretion stimulated by introduction of Pentagastrinum, beta ashes, caffeine, insulin and a physiological reflex of a vagus nerve.
Secretion inhibition duration when using doses of 20 mg and 40 mg makes from 10 to 12 hours.
Famotidine practically does not exert impact on concentration of gastrin in serum on an empty stomach or after meal.
Famotidine does not exert impact on gastric emptying, exocrine function of a pancreas, a blood stream in a liver and portal system.
Famotidine does not exert impact on fermental system of P450 cytochrome in a liver.
Anti-androgenic influence of drug is noted.

Pharmacokinetics. The kinetics of famotidine has linear character.
Absorption. Квамател® it is intended only for intravenous administration.
Distribution. Linkng with proteins of plasma is expressed rather poorly (15 - 20%).
The elimination half-life makes 2,3 - 3,5 hours. At patients with a heavy renal failure time of semi-removal of famotidine can exceed 20 hours.
Biotransformation. Metabolism of famotidine happens in a liver. The only metabolite found in the person is sulphoxide.
Removal. Famotidine is removed by kidneys (65 - 70%) and by metabolism (30 - 35%). The renal clearance makes 250 - 450 ml/min. that indicates some degree of canalicular excretion. 65 - 70% of intravenously entered dose are found in urine in not changed look. A small part of the entered dose can be excreted in the form of sulphoxide.

Indications to use:

Квамател® it is shown at the following diseases:
- duodenum ulcer;
- stomach ulcer without malignancy;
- gastroesophageal reflux disease;
- other states which are followed by hypersecretion (for example, Zollingera-Ellison's syndrome);
- sheathe prevention of aspiration of acid gastric contents (Mendelssohn's syndrome) when carrying out anesthesia.

Route of administration and doses:

Квамател® it is intended only for intravenous administration.
Квамател® it is recommended for use at the hospitalized patients who have no opportunity to accept drug inside. Квамател® it can be used until performing peroral therapy does not become possible.
The recommended dose makes 20 mg intravenously (in/in) twice a day (each 12 hours).
At a peptic ulcer of a stomach and duodenum in an aggravation stage, hyper secretory states: in/in slowly, within 2 min. on 20 mg of 2 times/days in the diluted look; in/in infusion: slowly, within 15-30 min. on 20 mg of 2 times/days.
At a reflux esophagitis an initial dose - 20 mg of 2 times/days in/in slowly.
At Zollingera-Ellison's syndrome: the initial dose makes 20 mg in each 6 hours. Further: the dose of drug depends on the volume of secretion and a clinical condition of the patient.
At sheathe anesthesia for prevention of aspiration of acid gastric contents: Квамател® it is applied in a dose of 20 mg at morning in day of operation or, at least, in 2 hours prior to operation. The initial dose for intravenous administration cannot exceed 20 mg. For carrying out an intravenous injection contents of a bottle it is necessary to dissolve 0,9% of solution of sodium of chloride (a solvent ampoule) in 5 - 10 ml, and then to enter slowly (within not less than 2 minutes). At drug infusion solution should be entered for 15-30 minutes.
Solutions should be prepared just before introduction. It is possible to use only transparent colourless solutions. Use at a renal failure. As famotidine is excreted preferential by kidneys, at patients with a heavy renal failure it is necessary to observe precautionary measures. If the clearance of creatinine makes less than 30 ml/min., and serumal concentration of creatinine exceeds 3 mg / 100 ml, then the daily dose needs to be lowered to 20 mg or to increase intervals between introductions till 36-48 o'clock.

Use for children:
Safety and efficiency of drug at children are not established.
Use for elderly patients:
Dose adjustment depending on age is not required.

Features of use:

Before therapy by famotidine or if there is no such opportunity, before transition to peroral treatment it is necessary to exclude existence of a malignant new growth of a stomach.
At a liver failure of Kvamatel® it is necessary to use with care in a reduced dose.
As in case of use of blockers of H2-histamine of receptors cross-responsiveness, use of Kvamatela® for the patients having in the anamnesis hypersensitivity to other blockers of H2-histamine receptors was described demands care.

Influence on ability to control of motor transport and work with the equipment
Patients should be careful at control of motor transport and work with the equipment as during treatment there can be dizziness and be observed increased fatigue.

Side effects:

The following undesirable phenomena were described in very exceptional or exceptional cases. However in many cases the causal interrelation with therapy is not established by famotidine.
- Hematologic disturbances. Agranulocytosis.
- Leukopenia
- Pancytopenia
- Thrombocytopenia
- Immune disturbances. Anaphylaxis
- Disbolism and food. Anorexia
- Mental disorders. Depression
- Gallyutsinats and excitement
- Alarm
- Confusion of consciousness 
- Neurologic disturbances. Headache
- Dizziness  
- Disturbances from acoustic organs and balance. A ring in ears 
- Cardial disturbances. Arrhythmia
- Atrioventricular block 
- Respiratory disturbances, diseases of a thorax and mediastinum. Bronchospasm 
- Digestive disturbances. Diarrhea. Lock. Sensations of discomfort in a stomach. Nausea. Vomiting
- Dryness in a mouth 
- Gepatobiliarny disturbances. Cholestatic jaundice 
- Diseases of skin and hypodermic cellulose. Acne rash
- Alopecia
- Quincke's disease
- Xeroderma
- Toxic epidermal necrolysis
- Small tortoiseshell
- Itch 
- Skeletal and muscular disturbances, diseases of connecting fabric. Arthralgia
- Muscular spasms 
- Reproductive disturbances, diseases of mammary glands. Gynecomastia * 
- System disturbances and complications in an injection site. Increased fatigue
- Fever 
- The aberrations revealed at laboratory inspection. An activity deviation - "hepatic" enzymes

* The gynecomastia meets very seldom and at the termination of treatment has reversible character.

Interaction with other medicines:

Let's combine from 0,18% and 0,9% solution of sodium of chloride, 4 and 5% solution of a dextrose, 4,2% Natrii hydrocarbonas solution.
Increases absorption of amoxicillin and clavulanic acid.
Antacids and сукральфат slow down famotidine absorption.
Reduces absorption of an itrakonazol and ketokonazol.
The medicines oppressing marrow increase risk of development of a neutropenia.

Contraindications:

Hypersensitivity to active ingredient or any of excipients, pregnancy, the lactation period, children's age.

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

Use at pregnancy and in the period of a lactation
Famotidine gets through a placenta.
Controlled researches at the person were not conducted.
Квамател® it is not recommended to use during pregnancy.
Famotidine cosecretes with breast milk at the person; in this regard breastfeeding during use of Kvamatela® should be stopped.

Overdose:

At patients with a syndrome of pathological hypersecretion doses to 800 mg a day throughout the period over one year were used that was not followed by emergence of the serious undesirable phenomena.
Overdose treatment: symptomatic and maintenance therapy; monitoring of a condition of the patient.

Storage conditions:

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

Issue conditions:

According to the recipe

Packaging:

On 72,80 mg of lyophilisate (there correspond 20 mg of active ingredient) in a colourless glass bottle (the I hydrolytic class) with the rubber bung closed by an aluminum cap. On 5 ml of solvent (0,9% chloride sodium solution) in a colourless glass ampoule (the I hydrolytic class) with a point for a break. On a bottle and an ampoule paste the label.
On 5 bottles and 5 ampoules in planimetric plastic packaging.
On 1 planimetric plastic packaging in a cardboard pack with the application instruction.