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

Tablets 20 mg: corn starch 5,000 mg; magnesium stearate 1,250 mg; lactose monohydrate 46.500 mg; cellulose microcrystalline 51.925 mg; silicon dioxide colloidal, anhydrous 0.325 mg; shell: hypromellose 3,500 mg; polyethylene glycol 0.370 mg; titanium dioxide (E171) 1,800 mg; iron oxide yellow (E 172) 0.240 mg; iron oxide red (E 172) 0.090 mg.

Tablets 40 mg: corn starch 8,000 mg; magnesium stearate 2,500 mg; lactose monohydrate 74,000 mg; cellulose microcrystalline 74,500 mg; silicon dioxide colloid, anhydrous 1,000 mg; shell: hypromellose 7.004 mg; polyethylene glycol 0.999 mg; titanium dioxide (E171) 1.854 mg; iron oxide red (E 172) 0.196 mg.

Description:

Tablets 20 mg: pink round flat-coated tablets with a risk on one side.

Tablets 40 mg: reddish-pink round biconvex, coated tablets with a risk on one side.

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 synaise in her prostaglandins and the rate of regeneration. It does not significantly alter the level 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 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 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.

Carefully:

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

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.

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: possible - dry mouth, nausea, vomiting, abdominal pain, rarely - loss of appetite, increased activity of "liver" transaminases; in some cases, the development of hepatitis, acute pancreatitis.

From the nervous system: headache, dizziness; cases of development of hallucinations, confusion of consciousness, indistinctness of visual perception are described.

From the cardiovascular system: very rarely - lowering blood pressure, bradycardia.

Allergic reactions: skin rash, itching, anaphylactic shock.

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

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

Other: rarely - 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.

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, 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. 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-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 blockers_2-histaminoreceptor is recommended to be discontinued). During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.

Form release / dosage:

The coated tablets are 20 mg and 40 mg.

Packaging:

The tablets covered with a cover on 20 mg: 10 tablets per blister perforated from aluminum foil and PVC film (Al/PVC). For 2 blisters (20 tablets), together with the instructions for use are placed in a cardboard box.

The tablets covered with a cover on 40 mg: 10 tablets per blister perforated from aluminum foil and PVC film (Al/PVC). For 1 blister (10 tablets), together with the instructions for use are placed in a cardboard box.

Storage conditions:In a dark place, out of the reach of children, at a temperature of 15-25 ° C.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N015999 / 01

Date of registration:12.04.2010

The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia

Manufacturer: & nbsp

ALKALOID, AD Macedonia

Representation: & nbspALKALOID, AOALKALOID, AO

Information update date: & nbsp16.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)