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

auxiliary substances (core): magnesium stearate - 1.90 mg; potato starch - 16.82 mg, povidone (polyvinylpyrrolidone) - 6.36 mg, microcrystalline cellulose - 53.92 mg, lactose monohydrate (milk sugar) - 100.00 mg;

auxiliary substances (shell): hypromellose - 7.50 mg, titanium dioxide - 2.03 mg, dye quinoline yellow - 0.19 mg; polysorbate-80 - 1.28 mg.

1 tablet of 40 mg contains:

active substance: famotidine - 40 mg;

auxiliary substances (core): magnesium stearate - 2.10 mg; potato starch - 16,00 mg, povidone (polyvinylpyrrolidone) - 7,00 mg, microcrystalline cellulose - 53,90 mg, lactose monohydrate (sugar milk) - 100,00 mg;

auxiliary substances (shell): hypromellose - 7.50 mg, titanium dioxide - 2.22 mg, polysorbate-80 - 1.28 mg.

Description:

Tablets are round, biconvex, covered with a film coating of yellow (for a dosage of 20 mg) or white (for a dosage of 40 mg). On the cross-section, two layers are visible: the core and the film shell.

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, stimulating the secretion of bicarbonate by the gastric mucosa, 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 digestive tract. After oral administration, the time to reach the maximum concentration in the blood plasma (TC_mOh) 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 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 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.Lactose intolerance, lactase deficiency or glucose-galactase malabsorption.

Carefully:

Cirrhosis of the liver with portosystemic encephalopathy in the anamnesis, renal failure.

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 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 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, constipation, diarrhea, loss of appetite, increased activity of "liver" transaminases, cholestatic jaundice, hepatitis, acute pancreatitis.

From the nervous system: headache, dizziness, asthenia, drowsiness, insomnia, fatigue, depression, agitation, ringing in the ears, hallucinations, confusion, blurred vision.

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

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

On the part of the organs of hematopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.

From the side of the reproductive system: with prolonged intake of large doses, hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, decreased potency.

Other: acne, alopecia, fever, arthralgia, myalgia.

Overdose:

Symptoms: possibly aggravation of side effects.

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.

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, like all blockers H₂-gistaminovyh receptors, it is undesirable to abruptly cancel (syndrome "rebound").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 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-gistaminovyh receptors 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 blockers H₂-gistaminovyh receptors it is recommended to stop). During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa. The effectiveness of the drug in inhibiting night secretion of hydrochloric acid in the stomach can decrease as a result of 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.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 20 mg and 40 mg.

Packaging:

For 10, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50, 60, 100, 120 or 180 tablets into a polymer container for medicines.

One container or 1, 2, 3, 4, 5, 6, 8, 10, 12 or 18 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light 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:LS-001456

Date of registration:12.09.2011

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp14.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)