Famotidin-AKOS
Producer: JSC Sintez Russia
Code of automatic telephone exchange: A02BA03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: famotidine - 20 mg or 40 mg. Excipients: lactose (sugar milk), starch corn, calcium stearate (calcium stearate), talc, gipromelloz (oksipropilmetiltsellyuloz), кросповидон (коллидон CL-M); Cover: gipromelloz (oksipropilmetiltsellyuloz), titanium dioxide (titanium dioxide), macrogoal 4000 (polyethyleneglycol 4000, poly(ethylene oxide) 4000), propylene glycol, talc.
Pharmacological properties:
Blocker of H2-histamine receptors of the III generation. Suppresses basal and stimulated a histamine, gastrin and acetylcholine products of hydrochloric acid. 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 Pg, promotes healing of its damages (including to scarring of stressful ulcers) and to the termination of gastrointestinal bleedings. Poorly suppresses oksidazny system of P450 cytochrome in a liver. After intake action begins in 1 h, reaches a maximum during 3 h and continues, depending on a dose, from 12 to 24 h.
Pharmacokinetics. At intake absorption - incomplete; bioavailability - 40-45%, increases at reception with food and decreases against the background of antacids. Communication with proteins of plasma - 15-20%. Time necessary for achievement of the maximum concentration - 1-3 h. Gets into cerebrospinal fluid, through a placental barrier and into breast milk. An elimination half-life - 2,5-3,5 h; at patients with a heavy renal failure (the clearance of creatine is lower than 10 ml/min.) increases up to 20 h (dose adjustment is required), 30-35% of drug are metabolized in a liver with formation of S-oxide. It is removed by kidneys by glomerular filtering and canalicular secretion. 25-30% of the dose accepted inside are found in urine in an invariable look.
Indications to use:
Peptic ulcer of a stomach and 12-perstny gut, the hyperacidity of a gastric juice, heartburn (connected with a hyperacidity), symptomatic and stressful ulcers of digestive tract, erosive reflux esophagitis, NPVP-gastropathy, 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.
Aspiration pneumonitis (prevention).
Dyspepsia with the epigastric or retrosternal pains arising at night or connected with meal.
Route of administration and doses:
Inside. 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. Treatment duration - 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 (if necessary - 20-40 mg 2 times a day to 12 weeks).
For the prevention of aspiration of gastric contents - 40 mg on the eve of operation or in the morning in day of operation.
Patients with clearance of creatinine is lower than 10 have some inside, 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 of a 12-perstny gut can disappear during 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.
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 blockers of H2-histamine of receptors is recommended to be stopped).
During treatment it is necessary to avoid the use of food stuffs, drinks, etc. 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.
Side effects:
From the alimentary system: dryness in a mouth, nausea, vomiting, a loss of appetite, an abdominal pain, increase in activity of "hepatic" transaminases, a lock, diarrhea, jaundice, the hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From a nervous system: headache, adynamy, drowsiness, sleeplessness, fatigue, concern, depression, nervousness, psychosis, dizziness, confusion of consciousness, hallucination, hyperthermia.
From cardiovascular system: lowering of arterial pressure, bradycardia, atrioventricular block, arrhythmia, vasculitis.
Allergic reactions: urticaria, skin rash, itch, bronchospasm, angionevroticheky hypostasis, mnogomorfny erythema, exfoliative dermatitis, Stephens-Johnson's syndrome, toxic epidermal necrolysis, acute anaphylaxis.
From bodies of a hemopoiesis: neutropenia, leukopenia, thrombocytopenia, hemolitic anemia, agranulocytosis, pancytopenia.
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: bronchospasm, xeroderma, alopecia, gynecomastia.
Interaction with other medicines:
Increases absorption of amoxicillin and clavulanic acid.
Antacids and сукральфат slows down absorption.
Reduces absorption of an itrakonazol and ketokonazol.
The medicines oppressing marrow increase risk of development of a neutropenia.
Contraindications:
Hypersensitivity, children's age.
With care - a liver and/or renal failure, cirrhosis with
portosistemny encephalopathy (in the anamnesis), an immunodeficiency, pregnancy, the period
lactations.
Category of action on a fruit of Century.
Use at pregnancy It is contraindicated.
Overdose:
Symptoms: vomiting, motive excitement, tremor, lowering of arterial pressure, tachycardia, collapse.
Treatment: at oral administration induction of vomiting or/and a gastric lavage, a symptomatic and maintenance therapy is shown.
Storage conditions:
In the place protected from light, at a temperature not above 25 °C. Period of validity of 5 years. Not to use after the period of validity specified on packaging.
Issue conditions:
According to the recipe
Packaging:
10 pieces - planimetric strip packagings (2) - packs cardboard.