Famotidine
Producer: SC Balkan Pharmaceuticals SRL (Balkans Pharmasyyutikals) Republic of Moldova
Code of automatic telephone exchange: A02BA03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 20 mg or 40 mg of famotidine in 1 tablet.
Antiulcerous means.
Pharmacological properties:
Pharmacodynamics. Blocks histamine H2 receptors, inhibits basal and stimulated secretion of hydrochloric acid; suppresses activity of pepsin.
From a GIT it is absorbed not completely, bioavailability makes 40–45%, increases under the influence of food and decreases at use of antacids. Linkng with proteins of plasma — 15–20%. Cmax is reached during 1–3 h 30–35% metabolized in a liver with formation of S-oxide and removed by kidneys by glomerular filtering and canalicular secretion. 25–30% of the dose accepted inside, and 65–70% entered in/in are found in urine in not changed look. T1/2 from plasma patients have 2,5–3 h, with a heavy renal failure (creatinine Cl
Pharmacokinetics. After intake action begins in 1 h, reaches a maximum during 3 h and continues 10–12 h. In conditions the maximum effect develops in introductions in 30 min. The single dose (10 and 20 mg) suppresses secretion on 10–12 h.
Indications to use:
Treatment and prevention of aggravations of a peptic ulcer of a stomach and duodenum; treatment and prevention of the symptomatic stomach ulcers and a duodenum (tied with reception of NPVS, stressful, postoperative); erosive gastroduodenit, a reflux esophagitis, Zollingera-Ellison's syndrome, bleeding from upper parts of a GIT (as a part of complex treatment) and prevention of a recurrence of bleeding from upper parts of a GIT, a system mastocytosis, polyendocrine adenomatosis, the prevention of aspiration of a gastric juice when carrying out the general anesthesia (Mendelssohn's syndrome).
The functional dyspepsia associated with the increased secretory function of a stomach. A symptomatic treatment of the dyspepsia connected with a hyperoxemia of a gastric juice (including heartburn, an acid eructation).
Route of administration and doses:
Inside, in / century. Inside, at an aggravation of a peptic ulcer of a stomach and duodenum on 40 mg for the night or on 20 mg 2 times/days (in the morning and in the evening), if necessary the daily dose can be increased to 80–160 mg, course duration — 4–8 weeks; for the purpose of prevention of aggravations — on 20 mg of 1 times a day for the night. At a reflux esophagitis — 20–40 mg 2 times a day in techeniye6-12 week, Zollingera-Ellison's syndrome — a dose of drug and duration of a course of treatment establish individually.
At emergence of heartburn or other symptoms of dyspepsia — 10 mg (1 tab.); it is not necessary to apply more than 2 tab. a day.
In/in (struyno or kapelno), a usual dose — on 20 mg each 12 h; the single dose should not exceed 20 mg. At Zollingera-Ellison's syndrome an initial dose — 20 mg each 6 h, adjust further a dose; for prevention of aspiration of gastric contents before the general anesthesia: 20 mg on the eve of operation or not less than for 2 h till its beginning.
Features of use:
Use at pregnancy and feeding by a breast. Category of action on a fruit on FDA — B.
To patients with renal failures (Cl of creatinine is lower than 30 ml/min.) the daily dose is reduced to 20 mg. Children are not recommended to appoint drug.
At therapy of a peptic ulcer of a stomach and duodenum it is necessary to exclude at the patient existence of a malignant tumor (a research of a bioptat from area of an ulcer). With care apply at abnormal liver functions.
Side effects:
From bodies of a GIT: dryness of a mucous membrane of an oral cavity, loss of appetite, nausea, vomiting, abdominal pain, increase in activity of hepatic transaminases, lock, diarrhea, jaundice; the hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From cardiovascular system and blood (a hemopoiesis, a hemostasis): decrease in the ABP, bradycardia, AV blockade, arrhythmia, vasculitis, neutropenia, leukopenia, thrombocytopenia, hemolitic anemia, agranulocytosis, pancytopenia; at parenteral administration — an asystolia.
From a nervous system and sense bodys: a headache, an adynamy, drowsiness, sleeplessness, fatigue, concern, a depression, nervousness, psychosis, dizziness, confusion of consciousness, a hallucination, a hyperthermia, 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.
Allergic reactions: urticaria, skin rash, itch, bronchospasm, Quincke's disease, mnogomorfny erythema, exfoliative dermatitis, Stephens-Johnson's syndrome, toxic epidermal necrolysis, acute anaphylaxis.
Others: bronchospasm, xeroderma, alopecia, gynecomastia; local reactions — irritation in the place of an injection.
Interaction with other medicines:
At a concomitant use of famotidine and a ketokonazol absorption of a ketokonazol can decrease. In case of use of famotidine with antacids the break between their reception has to be not less than 1-2 h.
Contraindications:
Hypersensitivity, pregnancy, feeding by a breast.
Restrictions to use. Cirrhosis with hepatic encephalopathy, children's age.
Overdose:
Symptoms: aggravation of side effects.
Treatment: gastric lavage, symptomatic or maintenance therapy.
Storage conditions:
To store at a temperature of 15-25 °C, in dry, protected from light and the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets of 20 mg and 40 mg, 20 tablets in each blister, on one, two or three blisters together with the application instruction in cardboard packaging.