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

Excipients: lactose (sugar milk), potato starch, povidone low molecular weight (polyvinylpyrrolidone low molecular weight medical), calcium stearate monohydrate (calcium stearic acid 1-water), stearic acid, hypromellose (hydroxypropylmethylcellulose), povidone medium molecular weight (polyvinylpyrrolidone median medical), titanium dioxide dioxide), polysorbate 80 (tween-80), tropeolin O.

Description:

The tablets covered with a film membrane of yellow color, biconvex. At the break the tablet is white.

Pharmacotherapeutic group:glands of the stomach secretion lowering agent - H2-histamine receptor blocker

ATX: & nbsp

A.02.B.A.03 Famotidine

Pharmacodynamics:

Block H₂-gystamine receptors of the third generation. Suppresses basal and hydrochloric acid products stimulated by histamine, gastrin and acetylcholine. Reduces the activity of pepsin.

Strengthens the protective mechanisms of the mucous membrane of the stomach by increasing the formation of gastric mucus, increasing the content of glycoproteins in it, stimulating the secretion of bicarbonate, endogenous synthesis of prostaglandins.Increases the rate of regeneration of the gastric mucosa and promotes the healing of its damages (including the cessation of gastrointestinal bleeding and cicatrization of stress ulcers). It does not significantly alter the level of gastrin in the plasma. It weakly suppresses the oxidase system of cytochrome P450 in the liver. After oral administration, the effect begins after 1 hour, reaches a maximum within 3 hours. The duration of the drug in a single dose depends on the dose and is from 12 to 24 hours.

Pharmacokinetics:

After ingestion, the drug is rapidly absorbed from the gastrointestinal tract. After taking the maximum concentration in the blood plasma is achieved within 1-3.5 hours. Bioavailability is 40-45%, increases with admission and decreases with antacids. The connection with plasma proteins is 15-20%. 30-35% of famotidine are metabolized in the liver (with formation S-oxide). Elimination mainly occurs through the kidneys: 27-40% of the drug is excreted in the urine unchanged. The half-life is -2.5-4 hours. In patients with creatinine clearance below 30 ml / min, the elimination half-life increases to 10-12 hours, in patients with severe renal insufficiency (creatinine clearance below 10 ml / min) - up to 20 hours.It penetrates through the placental barrier and is excreted in breast milk.

Indications:

Treatment and prevention of gastric ulcer and duodenal ulcer.

Treatment and prevention of symptomatic gastric and duodenal ulcers (associated with the use of nonsteroidal anti-inflammatory drugs, stressful, postoperative ulcers).

Erosive gastroduodenitis.

Functional dyspepsia associated with increased secretory function of the stomach.

Reflux esophagitis.

Zollinger-Ellison syndrome.

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 to the components of the drug.

Carefully:Pregnancy, lactation, childhood, kidney failure, liver failure, liver cirrhosis with portosystemic encephalopathy in the anamnesis.

Dosing and Administration:

Tablets should be swallowed without chewing, squeezed with enough water.

With peptic ulcer of stomach and duodenum in the phase of exacerbation, symptomatic ulcers,Erosive gastroduodenitis is usually prescribed at 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.

When reflux-esophagitis - 20-40 mg 2 times 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 60 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.

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

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 cardiovascular system: lowering of blood pressure, bradycardia, atrioventricular 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 musculoskeletal system: arthralgia, myalgia.

Other: dry skin, alopecia, gynecomastia.

Overdose:

Symptoms: vomiting, motor excitement, tremor, lowering of arterial pressure, tachycardia, collapse.

Treatment: gastric lavage, symptomatic therapy, hemodialysis.

Interaction:

Due to the increase in the pH of the contents of the stomach with simultaneous administration, ketoconazole absorption may decrease.

With simultaneous use with antacids, sucralfate, the absorption of famotidine decreases, so a break between taking these drugs should be at least 1-2 hours.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, lidocaine, phenytoin, theophylline, indirect anticoagulants, glipizide, buformin, metronidazole, caffeine, blockers of "slow" calcium channels. Increases the absorption of amoxicillin and clavulanic acid.

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

Special instructions:

Famotidine, like all H₂-gistaminoblokatory, it is undesirable to abruptly abolish (typical syndrome "ricochet").

Before starting treatment, it is necessary to exclude the possibility of having a malignant neoplasm of the esophagus or duodenum.

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

Use with caution in patients with impaired liver function.

Blockers H₂-gistaminoreceptors can counteract the influence of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, use blockers H₂-gistaminovyh receptors is not recommended.

Blockers H₂-gistaminoreceptors can suppress a skin reaction to histamine, thus leading to false negative results (before conducting diagnostic skin tests to detect an allergic skin reaction of an immediate type, the use of H blockers₂-gistaminovyh receptors it is recommended to stop).

During treatment, avoid eating foods, drinks and medicines that cause irritation of the gastric mucosa.

Form release / dosage:

Tablets, film-coated, 20 mg.

Packaging:

For 10 or 20 tablets in a planar cell pack.

2 or 3 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N003396 / 01

Date of registration:25.05.2009

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)