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

Excipients: corn starch 16.0 mg, microcrystalline cellulose 78.35 mg, silicon dioxide 1.4 mg, talc 5.625 mg, magnesium stearate 1.125 mg, croscarmellose sodium 2.5 mg;

shell: hypromellose 2.5 mg, titanium dioxide 1.53 mg, lactose monohydrate 1.313 mg, macrogol-4000 0.5 mg, triacetin 0.375 mg, iron dye oxide yellow [El72] 0,021 mg, iron dye red oxide [E172] 0.006 mg, iron dye ferric oxide [E172] 0.005 mg.

1 tablet, film-coated, 40 mg contains:

active substance: famotidine 40 mg;

Excipients: corn starch 32.0 mg, microcrystalline cellulose 156.7 mg, silicon dioxide 2.8 mg, talc 11.25 mg, magnesium stearate 2.25 mg, croscarmellose sodium 5.0 mg;

shell: liposome monohydrate 2,625 mg, macrogol-4000 1.0 mg, triacetin 0.75 mg, iron dye oxide yellow [E172] 0.375 mg, ferric oxide red oxide [E172] 0.125 mg, iron dye oxide black [E172] 0.015 mg.

Description:

Tablets, film-coated, 20 mg: round, biconcave tablets, film-coated, pale pink with a grayish hue of color, on a broken white color.

Tablets, film-coated, 40 mg: round, biconcave tablets, covered with a film sheath, pale brown with a slightly pinkish hue of color, on a broken white color.

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

ATX: & nbsp

A.02.B.A.03 Famotidine

Pharmacodynamics:

Famotidine is a competitive antagonist of histamine. Acting on histamine H₂receptors of parietal cells significantly reduces the secretion of hydrochloric acid caused by various stimuli. The basal secretion of hydrochloric acid also decreases. To a lesser degree, the induced secretion of pepsinogen is inhibited. Causes dose-dependent suppression of production of hydrochloric acid and a decrease in the activity of pepsin. It does not significantly alter the level of gastrin in the plasma. 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. Binding to 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. It penetrates through the placental barrier and is excreted in breast milk.

Indications:

- Peptic ulcer of stomach and duodenum, prevention of relapses;

- Erosive gastroduodenitis;

- Functional dyspepsia associated with an increased secretory function;

- Symptomatic and stressful gastrointestinal ulcers;

- Reflux esophagitis;

- prevention of relapses associated with long-term use of non-steroidal anti-inflammatory drugs;

- Zollinger-Ellison syndrome;

- Systemic mastocytosis;

- Polyendocrine adenomatosis,

- Prevention of bleeding recurrences in the postoperative period.

- Prevention of aspiration of gastric juice in patients undergoing general anesthetic surgery (Mendelssohn syndrome);

- Prevention of aspiration pneumonitis;

- Dyspepsia with epigastric or retrosternal pain arising at night or associated with eating.

Contraindications:

Pregnancy, lactation, hypersensitivity to famotidine and other blockers H₂-gystamine receptors, children's age.

Carefully:

Hepatic and / or renal failure, cirrhosis with portosystemic encephalopathy (in the anamnesis), immunodeficiency.

Pregnancy and lactation:

During pregnancy and lactation, the use of the drug is contraindicated.

Dosing and Administration:

Inside, not liquid, squeezed enough water

Adults:

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 - 60 mg. The course of treatment is 4-8 weeks.

With dyspepsia associated with increased secretory function of the stomach, prescribe 20 mg 1-2 times a day.

In order to prevent relapses of peptic ulcer appoint 20 mg once a day before bedtime.

With reflux esophagitis 20-40 mg twice daily 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 aspiration of gastric juice in general anesthesia appoint 40 mg in the evening and / or in the morning before the operation. Famotidine tablets should be swallowed without chewing, pouring enough water.

With 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:

- Dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, anorexia;

- Increased activity of "hepatic" enzymes, hepatitis, acute pancreatitis;

- Headache, dizziness, insomnia, anxiety, tinnitus;

- Increased fatigue, drowsiness, depression, nervousness, psychosis;

- Blurred vision, paresis of accommodation;

- Confusion, hallucinations, hyperthermia;

- Fever;

- bradycardia, arrhythmia, vasculitis, lowering of arterial pressure, antrioventricular blockade;

- Muscle pain, joint pain;

- Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitivity;

- Increased levels of urea in the blood, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.

- With prolonged intake of large doses, hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, impotence.

Overdose:

Symptoms: vomiting, motor excitation, tremor, lowering blood pressure, tachycardia, collapse.

Treatment: when taken orally, induction of emesis or / and gastric lavage is indicated.

Symptomatic and supportive therapy: with convulsions - in / in diazepam; with bradycardia - atropine; at ventricular arrhythmias - lidocaine. Hemodialysis is effective.

Interaction:

Increases the absorption of amoxicillin and clavulanic acid.

Compatible with 0,18 and 0,9% solution NaCl, 4 and 5% dextrose solution, 4.2% sodium bicarbonate solution.

With simultaneous use with antacid agents containing magnesium and aluminum, sucralfate decreases the intensity of absorption of famotidine, therefore a break between taking these drugs should be at least 1-2 hours.

Due to the increase in the pH of the contents of the stomach with simultaneous administration, the absorption of ketoconazole and itraconazole may decrease.

Drugs that depress the bone marrow increase the risk of developing neutropenia.

Inhibits the metabolism in the liver of diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, indirect anticoagulants.

Special instructions:

Before starting treatment, it is necessary to exclude the possibility of having a malignant disease of the esophagus, stomach or duodenum, since Famotidine can mask symptoms.

Symptoms of peptic ulcer 12 - the duodenum can disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or X-ray data.

Cancel Famotidine gradually due to the risk of developing the "rebound" syndrome with a sharp cancellation.

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. Famotidine (blocker H₂-gistaminovyh receptors) should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

Counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, apply Famotidine Not recommended.

Famotidine inhibits the skin reaction to histamine, thus leading to false-negative results (before conducting diagnostic skin tests to detect allergic skinimmediate reaction, use of famotidine should be discontinued).

During treatment, avoid eating foods, drinks, etc. drugs, which can cause irritation of the gastric mucosa.

The efficacy of famotidine 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.

If there is no improvement, consult a doctor.

Form release / dosage:

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

Packaging:

For 10 tablets covered with a film sheath in a blister of PVC / AL.

2 or 3 blisters with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N 014077/01

Date of registration:17.06.2008

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

HEMOFARM, LLC Russia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Famotidine (Famotidine)