Famotidine

General characteristics. Structure:

Active agent: famotidine of 20 mg

Excipients: starch corn, cellulose microcrystallic, silicon dioxide, talc, magnesium stearate, sodium of a kroskarmelloz.

Structure of a cover: gipromelloza, macrogoal 6000, titanium dioxide (E171), talc, dye ferrous oxide brown.
 
Active agent: famotidine of 40 mg

Excipients: starch corn, cellulose microcrystallic, silicon dioxide, talc, magnesium stearate, sodium of a kroskarmelloz.

Structure of a cover: gipromelloza, macrogoal 6000, titanium dioxide (E171), talc, dye ferrous oxide brown.

Pharmacological properties:

Famotidine is a competitive antagonist of a histamine. Working on histamine H2 receptors of covering cells, considerably reduces the secretion of Acidum hydrochloricum caused by various irritants. Also basal secretion of Acidum hydrochloricum decreases. The caused secretion of a pepsinogen is to a lesser extent oppressed. Causes dozozavisimy suppression of products of hydrochloric acid and reduction of activity of pepsin. Significantly does not change gastrin level in plasma.
Duration of effect of drug at a single dose depends on a dose and makes from 12 to 24 h.

Pharmacokinetics. After intake it is quickly absorbed from a GIT. After intake of Cmax in a blood plasma it is reached during 1 - 3.5 h.
Linkng with proteins of plasma of 15-20%. Gets through a placental barrier and it is allocated with breast milk.
30-35% of famotidine are metabolized in a liver (with formation of S-oxide).
Elimination, generally happens through kidneys: 27-40% of drug are excreted with urine in not changed look. T1/2 is 2.5-4 h, at patients with KK lower than 30 ml/min. increase to 10-12 h.

Indications to use:

— peptic ulcer of a stomach and duodenum, prevention of a recurrence;
— erosive gastroduodenit;
— the functional dyspepsia associated with the increased secretory function;
— symptomatic and stressful ulcers of a GIT;
— reflux esophagitis;
— prevention of the recurrence connected with long reception of NPVS;
— Zollingera-Ellison's syndrome;
— system mastocytosis;
— polyendocrine adenomatosis;
— prevention of a recurrence of bleedings in the postoperative period;
— prevention of aspiration of a gastric juice at patients to whom operations under the general anesthesia (Mendelssohn's syndrome) are performed;
— prevention of an aspiration pneumonitis;
— dyspepsia with the epigastric or retrosternal pains arising at night or connected with meal.

Route of administration and doses:

Inside, without chewing, washing down with enough water.
Adults:
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 / сут.или on 40 mg of 1 time/days to night. If necessary the daily dose can be increased to 80-160 mg. Course of treatment of 4-8 weeks.
At the dyspepsia connected with the increased secretory function of a stomach appoint 20 mg of 1-2 times/days.
For the purpose of prevention of a recurrence of a peptic ulcer appoint 20 mg of 1 time/days before going to bed.
At a refpyuks-esophagitis - 20-40 mg 2 times / сут.в a current of 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 h and can be increased to 160 mg each 6 h.
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 of Famotidine should be swallowed without chewing, washing down with enough water.
At a renal failure if KK 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.
Children are more senior than 3 years:
At a peptic ulcer of a stomach and duodenum in an aggravation phase, a reflux esophagitis Famotidine is appointed to children with body weight more than 10 kg at the rate of 2 mg/kg/days divided in 2 receptions or on 20 mg of 2 times/days, but no more than 40 mg/days.

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 as Famotidin can mask symptoms.

Symptoms of a peptic ulcer of a duodenum can disappear within 1-2 weeks, therapy should be continued until scarring is not confirmed with data of an endoscopic or X-ray analysis.

Cancel Famotidine gradually because of risk of development of a syndrome of "ricochet" at sharp cancellation.

At prolonged treatment at the weakened patients, and also at a stress bacterial damages of a stomach with the subsequent spread of an infection are possible.

Famotidine (a blocker histamine H2 receptors) should be accepted in 2 h after reception of an itrakonazol or a ketokonazol in order to avoid considerable reduction of their absorption.

Counteracts influence of Pentagastrinum and histamine on acid-forming function of a stomach therefore during 24 h preceding the test it is not recommended to apply Famotidine.

Famotidine suppresses 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 of Famotidine 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.

Efficiency of Famotidine in inhibition of night secretion of acid in a stomach can decrease as a result of smoking.

Increase in a dose of drug owing to the increased clearance can be required by patients with burns.

In case of the admission of a dose, it needs to be accepted as soon as possible; not to accept if there came time of reception of the following dose; not to double a dose. In the absence of improvements consultation of the doctor is necessary.

Side effects:

From the alimentary system: dryness in a mouth, nausea, vomiting, an abdominal pain, a meteorism, a lock, diarrhea, appetite disturbance; increase in activity of liver enzymes, hepatitis, acute pancreatitis.

From TsNS: headache, dizziness, sleeplessness, concern, sonitus; increased fatigue, drowsiness, depression, nervousness, psychosis; illegibility of visual perception, accommodation paresis; confusion of consciousness, hallucination, hyperthermia.

From cardiovascular system: bradycardia, arrhythmia, vasculitis, decrease in the ABP, AV blockade.

Dermatological reactions: xeroderma, alopecia, ordinary eels, skin rash, itch, bronchospasm,
antionevrotichesky hypostasis, acute anaphylaxis, other manifestations of a hyper sensitization.

From system of a hemopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, marrow aplasia.

From a reproductive system: at long reception of high doses - a giperprolaktinemiya, a gynecomastia, an amenorrhea,
decrease in a libido, impotence.

Others: fever, muscular pains, joint pains, increase in level of urea in blood.

Interaction with other medicines:

Increases absorption of amoxicillin and clavulanic acid.
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.
At simultaneous use to the antiacid means containing magnesium and aluminum 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 h.
Owing to increase рН stomach contents at a concomitant use absorption of a ketokonazol and itrakonazol can decrease.
The medicines oppressing marrow increase risk of development of a neutropenia.
Metabolism in a liver of diazepam, hexobarbital, propranolol, lidocaine, Phenytoinum, theophylline, indirect anticoagulants oppresses.

Contraindications:

— pregnancy;
— lactation period;
— children's age up to 3 years with body weight less than 20 kg (for this dosage form);
— hypersensitivity to famotidine and other blockers histamine H2 receptors.

With care: a liver and/or renal failure, cirrhosis with portosistemny encephalopathy (in the anamnesis), an immunodeficiency, children's age.

Use of the drug FAMOTIDINE at pregnancy and feeding by a breast
During pregnancy and in the period of a lactation use of drug is contraindicated.

Use at abnormal liver functions
With care: a liver failure, cirrhosis with portosistemny encephalopathy (in the anamnesis).

Use at renal failures
At a renal failure if KK 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.

Use for children
Children are more senior than 3 years:
At a peptic ulcer of a stomach and duodenum in an aggravation phase, a reflux esophagitis Famotidine is appointed to children with body weight more than 10 kg at the rate of 2 mg/kg/days divided in 2 receptions or on 20 mg of 2 times/days, but no more than 40 mg/days.
It is contraindicated: children's age up to 3 years with body weight less than 20 kg (for this dosage form).

Overdose:

Symptoms: vomiting, motive excitement, tremor, decrease in the ABP, tachycardia, collapse.

Treatment: at oral administration induction of vomiting or/and a gastric lavage is shown. Symptomatic and maintenance therapy: at spasms - in/in diazepam; at bradycardia - atropine; at ventricular arrhythmias - lidocaine. The hemodialysis is effective.

Storage conditions:

List B. To store in the place, unavailable to children, at a temperature from 15 °C to 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tablets, покр. film obol., 20 mg: 20 or 30 pieces.

Tablets, покр. film obol., 40 mg: 20 or 30 pieces.