Famosang

General characteristics. Structure:

Active agent: famotidine of 20 mg or 40 mg.

Excipients - the cellulose microcrystallic (granulated) the lactose (granulated) starch corn, magnesium stearate, silicon dioxide colloid, a gipromelloza 5, titanium dioxide, a macrogoal 6000, dye ferrous oxide red (in a dosage of 20 mg), dye ferrous oxide yellow (in a dosage of 40 mg), симетикон an emulsion of 23%.

Pharmacological properties:

Blocker of N2-of histamine receptors of the III generation. Causes suppression basal and stimulated a histamine, gastrin and acetylcholine of products of hydrochloric acid (HC1). At the same time with decrease in products of hydrochloric acid and increase рН also activity of pepsin decreases. Strengthens protective mechanisms of a mucous membrane of a stomach due to increase in formation of gastric slime and the maintenance in it of glycoproteins, and also stimulation of secretion of a hydrocarbonate and endogenous synthesis in it of prostaglandins, slows down degranulation of mast cells, reduces the maintenance of a histamine in a periultserozny zone, stimulates processes of healing of an ulcer (including scarring of stressful ulcers), increasing quantity of the DNA-synthesizing cells of an epithelium and promoting the termination of gastrointestinal bleedings. Therapeutic doses do not exert impact on the main level of gastrin in a blood plasma. Poorly suppresses oksidazny system of P450 cytochrome in a liver.
At intake effect of famotidine begins in 1 h, reaches a maximum during 3 h й continues, depending on a dose, from 12 to 24 h. The single dose of 20 mg suppresses secretion on 10-12 h.

Pharmacokinetics. At intake absorption - incomplete; bioavailability makes 40-45%, increases at reception with food and decreases against the background of antacids. Communication with proteins of plasma - 15-20%. The maximum concentration in plasma after oral administration is reached in 1 - 3 hour. Gets into cerebrospinal fluid, through a placental barrier and into breast milk. An elimination half-life (T1/2) - 2,5-3,5 hours. At patients with a heavy renal failure (the clearance of creatinine (CC) - is lower than 10 ml/min.) T1/2 increases up to 20 h (dose adjustment is required). 30-35% of drug are metabolized in a liver with formation of S-oxide. Famotidine belongs to the weak bases and is hydrophilic medicinal substance which is almost not capable to get into fabrics (heart, bronchial tubes, the central nervous system, etc.) and to cause the by-effects inherent to H2-histamine receptors of the I generation. It is removed by kidneys by glomerular filtering and canalicular secretion. 25-30% of the dose accepted inside are found in urine in not changed look.

Indications to use:

• Treatment and prevention of a recurrence of a peptic ulcer of a stomach and 12-perstny gut.
• Treatment and prevention of symptomatic stomach ulcers and 12-perstny gut (NPVP-gastropathy, stressful, postoperative ulcers).
• Erosive gastroduodenit.
• The functional dyspepsia associated with the increased secretory function of a stomach.
• Reflux esophagitis.
• Zollingera-Ellison's syndrome, system mastocytosis, polyendocrine adenomatosis.
• Prevention of a recurrence of bleedings from upper parts of the digestive tract (DT).
• The prevention of aspiration of a gastric juice at the general anesthesia (Mendelssohn's syndrome).

Route of administration and doses:

Inside, without chewing, washing down with a small amount of water.
At aggravations 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 is treatment-4-8 weeks.
For prevention of aggravations of a peptic ulcer - on 20 mg of 1 times a day before going to bed.
At Zollingera-Ellison's syndrome - in an initial dose on 20-40 mg 4 times a day; if necessary it is possible to increase a daily dose to 240-480 mg. Treatment continue so long time how many it is necessary (severe forms of a syndrome - to 160 mg each 6 h).
At a reflux esophagitis an initial dose - 20 mg of 2 times/days to 6 weeks (in need of-20-40 mg 2 times a day to 12 weeks).
For the prevention of aspiration of gastric contents - 4C of mg on the eve of operation or in the morning in day of operation for 2 h before operation.
At other indications the dose of 20 mg of 2 times/days or 20-40 mg of 1 times a day before going to bed is most often applied.
Patients with the clearance of creatinine (CC) is lower than 10 have some on 20 mg before going to bed. The time interval between doses can be increased to 36-48 h.

Features of use:

Symptoms of a peptic ulcer 12 - a perstny gut can disappear within 1-2 weeks, therapy should be continued until scarring is not confirmed with data of an endoscopic or X-ray analysis Can mask the symptoms connected with a stomach carcinoma therefore before an initiation of treatment it is necessary to exclude existence of a malignant new growth. Cancel 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. Blockers of H2-histamine of 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 blockers of H2-histamine of receptors.
Blockers of H2-histamine receptors can suppress skin reaction to a histamine, resulting in false-negative results (before conducting diagnostic skin tests for identification of allergic skin reaction of immediate type use of blockers of H2-histamine of receptors 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 drug 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 the passed dose if there came time of reception of the following dose; not to double a dose. During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: dryness in a mouth, a loss of appetite, nausea, vomiting, abdominal pains, increase in activity of "hepatic" transaminases, a lock, diarrhea, jaundice, the hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From bodies of a hemopoiesis: neutropenia, leukopenia, thrombocytopenia, hemolitic anemia, agranulocytosis, pancytopenia.
Allergic reactions: urticaria, skin rash, itch, bronchospasm, Quincke's disease, mnogomorfny erythema, exfoliative dermatitis, Stephens-Johnson's syndrome, toxic epidermal necrolysis, acute anaphylaxis.
From cardiovascular system: lowering of arterial pressure (ABP), bradycardia, atrioventricular (AV) blockade, arrhythmia, vasculitis.
From a nervous system: headache, adynamy, drowsiness, sleeplessness, fatigue, concern, depression, nervousness, psychosis, dizziness, confusion of consciousness, hallucination, hyperthermia.
From sense bodys: a ring in ears.
From urinogenital system: at long reception of high doses - decrease in a potentiality and libido.
From a musculoskeletal system: arthralgia, mialgiya.
Others: xeroderma, alopecia, gynecomastia.

Interaction with other medicines:

Increases absorption of amoxicillin and clavulanic acid. Antacids and сукральфат slow down absorption. Reduces absorption of an itrakonazol and ketokonazol. The medicines oppressing marrow increase risk of development of a neutropenia.

Contraindications:

Hypersensitivity to famotidine and other components of drug.
Children's age (for this dosage form).
Hereditary diseases, such as intolerance of a galactose, deficit of lactase or glyukozo-galaktozny malabsorption.

With care
Liver and/or renal failure, cirrhosis with portosistemny encephalopathy (in the anamnesis), an immunodeficiency, pregnancy, the lactation period.

Pregnancy and period of a lactation
Use of famotidine at pregnancy, especially in the first trimester, and in the period of a lactation perhaps only in cases when the expected advantage for mother exceeds potential risk for a fruit and the child.

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 - intravenously (in/in) diazepam; bradycardia - atropine; ventricular arrhythmias - lidocaine. The hemodialysis is effective.

 

Storage conditions:

List B.
In the dry place protected from light at a temperature of 15-25 °C.
To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, on 20 mg or 40 mg. 10 tablets in the blister, 1 blister for tablets on 40 mg or 2 blisters for tablets on 20 mg in a cardboard pack together with the application instruction.