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

auxiliary substancesa: lactose monohydrate, potato starch, croscarmellose sodium (impellose), silicon dioxide colloid (aerosil), magnesium stearate;

composition of the shell: hypromellose, macrogol (polyethylene glycol), titanium dioxide E 171, for the dosage of 40 mg iron dye oxide yellow E172.

Description:

1 the tablet contains:

active substance: famotidine 0.0200 g or 0.0400 g;

Excipients: lactose monohydrate, potato starch, croscarmellose sodium (impellosis), Silica colloidal dioxide (aerosil), magnesium stearate;

shell composition: hypromellose, macrogol (polyethylene glycol), titanium dioxide E 171, for the dosage of 40 mg iron dye oxide yellow E172.

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

ATX: & nbsp

A.02.B.A.03 Famotidine

Pharmacodynamics:

H₂-gystamine receptor blocker III 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 the 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. 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. Connection with plasma proteins - 15-20%. About 30-35% 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:

- Peptic ulcer of the 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 non-steroidal anti-inflammatory drugs (NSAIDs), 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:

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

Carefully:

Cirrhosis of the liver with portosystemic encephalopathy in history, impaired liver function, renal failure.

Dosing and Administration:

Inside.

With gastric ulcer and duodenal ulcer in the phase of exacerbation, symptomatic ulcers, erosive gastroduodenitis is usually prescribed by 20 mg 2 once 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, 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. Tablets should be swallowed without chewing, squeezed with enough 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.

Side effects:From the digestive system: dry mouth, nausea, vomiting, abdominal pain, loss of appetite, increased activity of "liver" transaminases, hepatitis, acute pancreatitis.

From the nervous system: headache, dizziness, hallucinations, confusion.

From the cardiovascular system: decrease in arterial pressure, atrioventricular block, bradycardia.

Allergic reactions: dry skin, urticaria, skin itch, skin rash, bronchospasm, angioedema, anaphylactic shock.

On the part of the organs of hematopoiesis: rarely - leukopenia, 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, blurred vision, ringing in the ears.

Other: rarely - fever, arthralgia, myalgia.

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, the absorption of ketoconazole and itraconazole may decrease.

With simultaneous use with antacid agents,sucralfate there is a decrease in the intensity of absorption of famotidine, therefore 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 channel blockers, tricyclic antidepressants.

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 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. H₂-gistaminoreceptors, blockers can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, so within 24 hours,preceding the test, apply H₂-gistaminoreceptor blockers are not recommended.

H₂-gistaminoreceptors, blockers 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, use of H₂-gastaminoreceptor blockers it is recommended to stop).

During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.

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

During the treatment period, care should be taken when driving vehicles and other activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

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

Packaging:

10 tablets per contour cell pack.

For 1, 2 or 3 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:Without recipe

Registration number:P N003721 / 01

Date of registration:20.12.2010

The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia

Manufacturer: & nbsp

BIOKOM, CJSC Russia

Information update date: & nbsp14.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)