Description
Description
Film-coated tablets 20 mg: round, biconvex tablets, film-coated, pale pink with a grayish tint on a break of white color.
Release form
Tablets, film-coated
packaging 20 pcs
Pharmacological action
Famotidine has an antiulcer effect. Blocker of H2-histamine receptors of the III generation. Suppresses basal and stimulated by histamine, gastrin and acetylcholine production of hydrochloric acid. Reduces pepsin activity. It enhances the protective mechanisms of the gastric mucosa, promotes the healing of damage associated with the action of hydrochloric acid (including scarring of stress ulcers) and the cessation of gastrointestinal bleeding by increasing the formation of gastric mucus and the content of glycoproteins in it, stimulation of secretion of bicarbonate by the gastric mucosa, endogenous synthesis of prostaglandins in it and the rate of regeneration. Does not significantly change the level of gastrin in plasma. Weakly inhibits the oxidase system of cytochrome P450 in the liver.
After oral administration, the action begins after 1 hour, reaches a maximum within 3 hours. The duration of the drug with a single dose depends on the dose and ranges from 12 to 24 hours.
Pharmacokinetics of
After oral administration, it is rapidly absorbed from the gastrointestinal tract, the maximum plasma concentration is reached within 1-3.5 hours. Bioavailability – 40-45%, increases when taken with food and decreases with antacids. Communication with plasma proteins – 15-20%.
30-35% of famotidine is metabolized in the liver (with the formation of S-oxide). It penetrates into the cerebrospinal fluid, through the placental barrier, excreted in breast milk.
Elimination mainly occurs through the kidneys: 27-40% of the drug is excreted unchanged in the urine. The elimination half-life is 2.5-4 hours, in patients with creatinine clearance below 30 ml per minute, it increases to 10-12 hours. In patients with severe renal failure (creatinine clearance below 10 ml / min), the elimination half-life increases to 20 hours.
Indications
Peptic ulcer and duodenal ulcer, prevention of relapse Erosive gastroduodenitis Functional dyspepsia, associated with increased secretory function Symptomatic and stressful ulcers of the gastrointestinal tract Reflux esophagitis prevention of relapses associated with prolonged use of non-steroidal anti-inflammatory drugs Zollinger-Ellison syndrome Systemic mastocytosis Polyendocrine adenomatosis Prevention of postoperative hemorrhage in patients with gastrointestinal surgery (Mendelssohn syndrome) Prevention of aspiration pneumonitis Dyspepsia with epigastrium bubbled or retrosternal pain occurring at night or associated with food intake.
Contraindications
Pregnancy, lactation, hypersensitivity to famotidine and other H2-histamine receptor blockers, children. With caution: hepatic and / or renal failure, cirrhosis of the liver with portosystemic encephalopathy (history), immunodeficiency.
Composition
1 tablet film-coated 20 mg, contains the active substance famotidine 20 mg. Excipients: corn starch – 16.0 mg, microcrystalline cellulose – 78.35 mg, silicon dioxide – 1.4 mg, talc – 5.625 mg, magnesium stearate – 1.125 mg, croscarmellose sodium – 2.5 mg. Shell: hypromellose – 2.5 mg, titanium dioxide – 1.53 mg, lactose monohydrate – 1.313 mg, macrogol-4000 – 0.5 mg, triacetin – 0.375 mg, iron oxide yellow [E172] – 0.021 mg, iron dye red oxide [E172] – 0.006 mg, dye iron oxide black [E172] – 0.005 mg.
Dosage and administration
Inside, without chewing, with plenty of water. Adults: In case of peptic ulcer of the stomach and duodenum in the acute phase, symptomatic ulcers, erosive gastroduodenitis, 20 mg 2 times a day or 40 mg 1 time per day are usually prescribed. If necessary, the daily dose can be increased to 80 – 160 mg. The course of treatment is 4-8 weeks. With dyspepsia associated with increased secretory function of the stomach, 20 mg is prescribed 1-2 times a day. In order to prevent recurrence of peptic ulcer, 20 mg are prescribed 1 time per day before bedtime. With reflux esophagitis 20-40 mg twice a day for 6-12 weeks. With Zollinger-Ellison syndrome, the dose of the drug and the duration of the course of treatment are set individually. The initial dose is usually 20 mg every 6 hours and can be increased to 160 mg every 6 hours. To prevent aspiration of gastric juice with general anesthesia, 40 mg is prescribed in the evening and / or in the morning before surgery. Famotidine tablets should be swallowed without chewing, drinking plenty of water. In renal failure, if creatinine clearance is less than 30 ml / min or serum creatinine content is more than 3 mg / 100 ml, the daily dose should be reduced to 20 mg.
Side effects
Dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, loss of appetite Increased activity of liver enzymes, hepatitis, acute pancreatitis Headache, dizziness, insomnia, anxiety, tinnitus Increased fatigue, drowsiness, depression, nervousness, psychosis Blurred visual perception, paresis of accommodation Confusion, hallucination, hypertension bradycardia, arrhythmia, vasculitis, lowering blood pressure, antrioventricular blockade Muscle pain, joint pain Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchus AZM, angioneurotic edema, anaphylactic shock, and other manifestations of hypersensitivity Increased urea blood levels, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia of the bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am impaired appetite. Increased activity of liver enzymes, hepatitis, acute pancreatitis. Headache, dizziness, insomnia, anxiety, tinnitus. Fatigue, drowsiness, depression, nervousness, psychosis. Blurred visual perception, paresis of accommodation. Confusion, hallucinations, hyperthermia. arrhythmia, vasculitis, lowering blood pressure, antrioventricular blockade Muscle pains, joint pains Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, an ionevrotichesky edema, anaphylactic shock, and other manifestations of hypersensitivity Increased urea blood levels, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia of the bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am impaired appetite. Increased activity of liver enzymes, hepatitis, acute pancreatitis. Headache, dizziness, insomnia, anxiety, tinnitus. Fatigue, drowsiness, depression, nervousness, psychosis. Blurred visual perception, paresis of accommodation. Confusion, hallucinations, hyperthermia. arrhythmia, vasculitis, lowering blood pressure, antrioventricular blockade Muscle pains, joint pains Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, an ionevrotichesky edema, anaphylactic shock, and other manifestations of hypersensitivity Increased urea blood levels, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia of the bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am hepatitis, acute pancreatitis Headache, dizziness, insomnia, anxiety, tinnitus Increased fatigue, drowsiness, depression, nervousness, psychosis Blurred visual perception, paresis of accommodation Confusion, hallucinations, hyperthermia Fever, bradycardia, arrhythmia, low blood pressure, arrhythmia, blockade Muscle aches, joint pains Dry skin, alopecia, acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of gi persensitization Increased blood urea, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am hepatitis, acute pancreatitis Headache, dizziness, insomnia, anxiety, tinnitus Increased fatigue, drowsiness, depression, nervousness, psychosis Blurred visual perception, paresis of accommodation Confusion, hallucinations, hyperthermia Fever, bradycardia, arrhythmia, low blood pressure, arrhythmia, blockade Muscle aches, joint pains Dry skin, alopecia, acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of gi persensitization Increased blood urea, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am tinnitus Increased fatigue, drowsiness, depression, nervousness, psychosis Blurred visual perception, paresis of accommodation Confusion, hallucinations, hyperthermia Fever, bradycardia, arrhythmia, vasculitis, decreased blood pressure, anrioventricular blockade Muscular pain, joint pain, joint pain acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitivity An increase in blood urea, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am tinnitus Increased fatigue, drowsiness, depression, nervousness, psychosis Blurred visual perception, paresis of accommodation Confusion, hallucinations, hyperthermia Fever, bradycardia, arrhythmia, vasculitis, decreased blood pressure, anrioventricular blockade Muscular pain, joint pain, joint pain acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitivity An increase in blood urea, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am hyperthermia Fever, bradycardia, arrhythmia, vasculitis, lowering blood pressure, antrioventricular block Muscle pain, joint pain Dry skin, alopecia, common acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, blood pressure increase, other manifestations leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am hyperthermia Fever, bradycardia, arrhythmia, vasculitis, lowering blood pressure, antrioventricular block Muscle pain, joint pain Dry skin, alopecia, common acne, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, blood pressure increase, other manifestations leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, am thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia. With prolonged use of large doses – hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.
Drug Interaction
Antacids impair absorption (a break of at least 1-2 hours between taking antacids and famotidine is recommended).
Storage Conditions
In a dry, dark place at 15 to 25 ° C. Keep out of reach of children.
Shelf life
3 years. Do not use after the expiration date indicated on the package.
Deystvuyushtee substance
Famotidine
Pharmacy terms
Prescription
dosage form
tablets
Possible product names
FAMOTIDIN 0, 02 N20 TABLE P / O / HEMOPHARM /
Famotidine 0.02 N20 TABLE P / O / OZONE
Famotidine 20mg Tablet P / capt.ob X20 (R)
Famotidine 20mg No. 20
FAMOTIDIN 20MG. No. 20 TAB. P / O / HEMOFARM /
