Famotidine - instructions for use, dose, side effects, contraindications

atExcipients: Idraw: starch potato variety "Extra", microcrystalline cellulose, sodium carboxymethyl starch (primogel), povidone (medium molecular weight polyvinylpyrrolidone, collidon 25), magnesium stearate, siliconcolloidal dioxide (aerosil); aboutbolo: hypromelose (hydroxypropylmethylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000).

Description:

The tablets covered with a film membrane white with a grayish shade of color, round, biconcave.

ATX: & nbsp

A.02.B.A.03 Famotidine

Pharmacodynamics:

Suppresses basal and hydrochloric acid products stimulated by histamine, gastrin and acetylcholine. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin decreases. Strengthens the protective mechanisms of the mucous membrane of the stomach by increasing the formation of gastric mucus and the content of glycoproteins in it, as well as stimulating the secretion of bicarbonate and endogenous synthesis of prostaglandins in it, contributing to the healing of its damages (including cicatrization of stress ulcers) and the cessation of gastrointestinal bleeding . It weakly suppresses the oxidase system of cytochrome P450 in the liver.After oral administration, the effect begins within 1 hour, reaches a maximum within 3 hours and continues, depending on the dose, from 12 to 24 hours. A single dose (10 and 20 mg) inhibits secretion for 10-12 hours.

Pharmacokinetics:

At intake absorption - incomplete; bioavailability - 40-45%, increases with admission with food and decreases on the background of antacids. The connection with plasma proteins is 15-20%. Time to reach the maximum concentration (TC_max) - 1-3 hours Penetrates into the cerebrospinal fluid, through the placental barrier and into breast milk. The half-life (T_1/2) - 2.5-3.5 h; in patients with severe renal failure (CC - below 10 ml / min) increases to 20 hours (dose adjustment is required). 30-35% of the drug is metabolized in the liver with education Soxide. It is excreted by the kidneys through glomerular filtration and tubular secretion. 25-30% of the dose taken internally is found in the urine in unchanged form.

Indications:

Treatment and prevention of relapses of peptic ulcer of stomach and duodenum.

Treatment and prevention of symptomatic gastric and duodenal ulcers (NSAIDs-gastropathy, stressful, postoperative ulcers).

Erosive gastroduodenitis.

Functional dyspepsia associated with increased secretory function of the stomach.

Reflux esophagitis.

Zollinger-Ellison syndrome, systemic mastocytosis, polyendocrine adenomatosis.

Prevention of recurrence of bleeding from the upper sections of the gastrointestinal tract.

Prevention of aspiration of gastric juice in general anesthesia (Mendelssohn syndrome).

Contraindications:

Hypersensitivity, children under 3 years.

Carefully:

Hepatic and / or renal failure, cirrhosis of the liver with portosystemic encephalopathy (in the anamnesis), immunodeficiency, child age, pregnancy, lactation.

Dosing and Administration:

With peptic ulcer of stomach and duodenum in the phase of exacerbation, symptomatic ulcers, erosive gastroduodenitis usually prescribed 20 mg twice a day or 40 mg once a day at night. 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, appoint 20 mg 1-2 times a day.

In order to prevent recurrences of peptic ulcer, 20 mg once a day before bedtime is prescribed.

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 the aspiration of gastric juice with general anesthesia appoint 40 mg in the evening and / or in the morning before the operation. Famotidine tablets should be swallowed without chewing, with plenty of water.

In renal failure, if the creatinine clearance is less than 30 ml / min or the creatinine content in the serum is more than 3 mg / 100 ml, the daily dose of the drug should be reduced to 20 mg.

Children: inside, with exacerbations of peptic ulcer of the stomach and duodenum - 0.5 mg / kg / day at bedtime or 1-2 mg / kg / day divided into 2 divided doses.

Side effects:

From the digestive system: dry mouth, decreased appetite, nausea, vomiting, abdominal pain, increased activity of "liver" transaminases, constipation, diarrhea, jaundice, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

From the hematopoiesis: neutropenia, leukopenia, thrombocytopenia, hemolytic anemia, agranulocytosis, pancytopenia.

Allergic reactions: urticaria, skin rash, itching, bronchospasm, angioedema,erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock.

From the side of the heart-cardiovascular system: lowering blood pressure, bradycardia, AV blockade, arrhythmia, vasculitis.

From the nervous system: headache, asthenia, drowsiness, insomnia, fatigue, anxiety, depression, nervousness, psychosis, dizziness, confusion, hallucinations, hyperthermia.

From the sense organs: tinnitus.

From the genitourinary system: at long reception of greater or big doses - depression of a potency and a libido.

From the side of the musculoskeletal system: arthralgia, myalgia.

Other: bronchospasm, dry skin, alopecia, gynecomastia.

Overdose:

Symptoms: possibly exacerbating side effects.

Treatment: gastric lavage, symptomatic therapy.

Interaction:

Increases the absorption of amoxicillin and clavulanic acid.

Antacids and sucralfate slow absorption.

Reduces the absorption of itraconazole and ketoconazole.

Drugs that depress the bone marrow increase the risk of developing neutropenia.

Special instructions:

Symptoms of duodenal ulcer can disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or X-ray data. It can mask symptoms associated with gastric carcinoma, so before starting treatment, it is necessary to exclude the presence of malignant neoplasm . They are being canceled gradually because of the risk of developing the "rebound" syndrome with a sharp cancellation.

With long-term treatment in weakened patients, as well as under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

Blockers H₂-gistaminovyh receptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

Counteracts the effects of pentagastrin and histamine on acid-forming function of the stomach, therefore, within 24 hours preceding the test, use blockers H₂-gistaminovyh receptors is not recommended.

It suppresses the skin reaction to histamine, thus causing it. to false negative results (before conducting diagnostic skin tests to detect an allergic skin reaction of immediate type, use of blockers H₂-gistaminovyh receptors it is recommended to stop).

During treatment, avoid eating foods, drinks, etc. medications that can cause irritation of the gastric mucosa.

The effectiveness of the drug in inhibiting night secretion of acid in the stomach can be reduced by smoking.

Patients with concomitant burns may need to increase the dose due to increased clearance.

If a dose is missed, it must be taken as soon as possible; Do not take if it is time to take the next dose; do not double the dose. If there is no improvement, consult a doctor.

Form release / dosage:Tablets, film-coated, 20 mg and 40 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

For 1, 2, 3 or 5 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004413/10

Date of registration:18.05.2010

The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Information update date: & nbsp16.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)