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

Excipients: microcrystalline cellulose, aerosil (colloidal silicon dioxide), potato starch, maltodextrin, magnesium stearate, croscarmellose sodium;

excipients for the shell: Opadrai II (series 85) [polyvinyl alcohol, macrogol (polyethylene glycol), talc, titanium dioxide].

Description:

Tablets covered with a film coating of white or white with a yellowish or creamy hue of color, round, biconvex. On the cross section, the inner layer is white or almost 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. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin decreases. 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. The maximum concentration in the blood plasma is reached within 1-3.5 hours. The bioavailability of famotidine is 40-45%, slightly changing in the presence food and decreases on the background 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:

- Treatment and prevention of relapses of peptic ulcer of stomach and duodenum.

- 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 (including heartburn, acidic eructation).

- Reflux esophagitis.

- Zollinger-Ellison syndrome.

- Prevention of recurrence of bleeding from the upper gastrointestinal tract (GIT).

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

Contraindications:

Children under 12 years of age (due to a lack of sufficient experience in the use of the drug), individual hypersensitivity to the drug components.

Carefully:

Hepatic failure, cirrhosis with portosystemic encephalopathy in history, renal failure, immunodeficiency, old age.

Pregnancy and lactation:

Use in pregnancy is possible only if the potential benefit to the mother exceeds the risk to the fetus.

Penetrates into breast milk. During lactation, it is necessary to cancel the use of the drug or stop breastfeeding.

Dosing and Administration:

Inside, not liquid, squeezed enough water.

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.

To prevent relapse of peptic ulcer of the stomach and duodenum: 20 mg once 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 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. 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.

For the prevention of recurrent bleeding from the upper gastrointestinal tract - 20 mg twice a day for 3-4 weeks.

Side effects:

From the digestive system: dry mouth, nausea, vomiting, abdominal pain, loss of appetite.In some cases, an increase in the activity of transaminases in the blood plasma.

From the nervous system: headache, dizziness, tinnitus, transient mental disorders.

From the cardiovascular system: rarely - arrhythmia.

On the part of the organs of hematopoiesis: rarely - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the side 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.

Allergic reactions: possible urticaria, skin itching, skin rash, bronchospasm.

Other: fever, arthralgia, myalgia.

Overdose:

Symptoms: vomiting, motor excitation, 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 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 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:

Symptoms of duodenal ulcer can disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or X-ray data. May mask symptoms associated with carcinoma of the stomach, so before starting treatment, you must exclude the presence of malignant neoplasm. They are being canceled gradually because of the risk of developing the "rebound" syndrome with a sharp cancellation.

With long-term treatment of weakened patients, as well as under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection. Blockers of H2-histamine receptors should be taken 2 hours after the administration of itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.It counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach.

Suppresses 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 blockers H₂-gistaminovyh receptors it is recommended to stop).

During treatment, avoid eating foods, drinks and other medicines (LS), which can cause irritation of the gastric mucosa.

The effectiveness of the drug in inhibiting night secretion of acid in the stomach can be reduced by smoking.

Patients with burns may need to increase the dose of the drug 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:

There are no data on the effect of the drug on the ability to drive vehicles or perform work that requires concentration and increased attention.

Form release / dosage:

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

Packaging:

By 7, 10, 14 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 1, 2, 3, 4 or 10 contour mesh packages with instructions for use 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:

2 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:LS-000123

Date of registration:18.03.2010

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Famotidine-OBL (Famotidin-OBL)