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

shell composition: hypromellose (hydroxypropylmethylcellulose), macrogol (polyethylene glycol), glycerol (glycerol), talc, titanium dioxide, lactose (milk sugar).

Description:

Tablets covered with a film coating of white or white with a grayish or yellowish hue of color, round, biconvex. On the break the tablets are white or almost white in color.

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 gastric mucosa and promotes the healing of damage associated with the action of hydrochloric acid (including the cessation of gastrointestinal bleeding and cicatrization of stress ulcers) by increasing the formation of gastric mucus,the content of glycoproteins in it, the stimulation of the secretion of bicarbonate by the gastric mucosa, the endogenous synthesis of prostaglandins in it, and the rate of regeneration. Essentially does not change the concentration of gastrin in the plasma. It weakly inhibits 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 oral administration, it is rapidly absorbed from the gastrointestinal tract. After oral administration, the maximum concentration in the blood plasma is reached within 1-3.5 hours. Bioavailability - 40-45%, increases with admission with food and decreases with the use of antacids. The connection with plasma proteins is 15-20%. 30-35% of famotidine is 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. Half-life is 2.5-4 hours, in patients with creatinine clearance below 30 ml / min, it increases to 10-12 hours. In patients with severe renal failure (creatinine clearance below 10 ml / min), it increases to 20 hours. It penetrates through the placental barrier and is excreted in breast milk.

Indications:

- Ulcer disease of duodenum and stomach in the phase of exacerbation, prevention of relapses.

- Treatment and prevention of symptomatic gastric ulcer and duodenum 12 (associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), stress, post-operative ulcer).

- Functional dyspepsia associated with increased secretory function of the stomach.

- Reflux-esophagitis, erosive esophagitis.

- Zollinger-Ellison syndrome.

- Erosive gastroduodenitis.

- Prevention of relapse of bleeding from the upper gastrointestinal tract.

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

Contraindications:

Pregnancy, lactation, hepatic insufficiency, children's age, hypersensitivity to the components of the drug.

Carefully:

Cirrhosis portosystemic encephalopathy with a history of abnormal liver function, renal failure, immunodeficiency.

Dosing and Administration:

Inside. 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.

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 160 mg every 6 hours.

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, nausea, vomiting, abdominal pain, loss of appetite, increased activity of "liver" transaminases, constipation, diarrhea, jaundice, hepatitis, acute pancreatitis.

From the nervous system: headache, dizziness, asthenia, drowsiness, insomnia, fatigue, anxiety, depression, nervousness, psychosis, hyperthermia; cases of development of hallucinations, confusion of consciousness, indistinctness of visual perception are described.

Co cardiovascular system: decrease in arterial pressure, atrioventricular blockade, bradycardia, arrhythmia, vasculitis.

Allergic reactions: urticaria, pruritus, bronchospasm, angioedema, multi polymorphic erythema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock.

From the hematopoiesis: rarely - leukopenia, neutropenia, thrombocytopenia; in isolated cases - agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.

On the part of the reproductive system: with prolonged intake of large doses of hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, impotence.

From the sense organs: paresis of accommodation, ringing in the ears.

Other: rarely - fever, arthralgia, myalgia, alopecia, dry skin.

Overdose:

Symptoms: vomiting, motor anxiety, 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 metabolism in the liver phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, lidocaine, phenytoin, theophylline, anticoagulants, glipizide, buformin, metronidazole, caffeine blockers "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:

Before starting treatment, it is necessary to exclude the possibility of having a malignant disease of the esophagus, stomach or duodenum. Famotidine-Acry®, like all H₂-gistaminoblokatory, undesirably sharply to cancel (syndrome "ricochet"). With long-term treatment in weakened patients, under stress conditions, bacterial lesions of the stomach are possible with the subsequent spread of infection. Blockers H₂-gistaminoreceptors can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach,therefore, within 24 hours preceding the test, use blockers H₂-gistaminoreceptors is not recommended. Blockers H₂-gistaminoreceptors can suppress the skin reaction to histamine, thus leading to false-negative results (before conducting diagnostic skin tests to detect an allergic skin reaction of immediate type, the use of H blockers₂-gistaminoreceptors it is recommended to stop). During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.

Form release / dosage:

Tablets, film-coated, 20 mg.

Packaging:

10 tablets per contour cell pack.

2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the 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 after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001957 / 01

Date of registration:11.08.2008

Date of cancellation:2018-02-06

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp06.02.2018

Illustrated instructions

Instructions

Famotidine-Acry® (Famotidin-Akri®)