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Composition:

active ingredient: famotidine;

1 tablet contains Famotidine 20 mg;

excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, talc, stearic acid, sepifilm 752 White.

Dosage form. Coated tablets.

Basic physical and chemical properties: coated tablets, white in color, round in shape, with a biconvex surface.

Pharmacotherapeutic group. Remedies for the treatment of peptic ulcer disease and gastroesophageal reflux disease. H2 receptor antagonists. ATX code A02B A03.

Pharmacological properties.

Pharmacodynamics.

Famotidine is a blocker of H2-histamine receptors in the stomach wall, so it reduces the secretion of gastric juice. Under the action of the drug, both the concentration and the amount of gastric juice decreases, and, accordingly, the amount of pepsin. The effect of 20 mg and 40 mg Famotidine lasts for 10-12 hours. A single evening dose (20 mg or 40 mg) reduces basal and nocturnal gastric juice production. The degree of blocking of gastric juice release at night is 86-94% and lasts at least 10 hours.

When using the same dose in the morning, the degree of blocking of food – stimulated gastric juice secretion within 3-5 hours is 76-84%, and after 8-10 hours-25-30 %.

Famotidine practically does not affect either The "Hungry" level of gastrin, or its level after a meal.

Famotidine does not affect gastric emptying, pancreatic secretory function, or hepatic circulation and portal blood flow. Famotidine does not affect the liver cytochrome P450 enzyme system. Famotidine does not affect serum hormone levels. It has no androgenic effect.

Pharmacokinetics.

Absorption. Famotidine is absorbed quickly and completely. Bioavailability is 40-45% regardless of stomach contents.

Distribution in the body: after oral administration, the maximum concentration of Famotidine in blood plasma is observed in 1-3 hours. Repeated doses do not lead to accumulation of the drug. Binding to plasma proteins is insignificant – 15-20 %.

The plasma half−life is 2.3-3.5 hours. In the presence of severe renal failure, the elimination half-life may increase to 20 hours.

Metabolism: metabolized in the liver, the only known metabolite is sulfoxide.

Elimination: renal clearance of the drug is 250-450 ml per minute, which indicates tubular excretion. 25-30% of the oral dose is excreted unchanged in the urine. Only a small amount of Famotidine is excreted as sulfoxide.

The pharmacokinetic parameters of the drug in the body of a healthy elderly person and in a child do not significantly differ from the pharmacokinetic parameters in an adult.

Clinical characteristics.

Indications.

Benign stomach ulcer.

Peptic ulcer of the duodenum (treatment and Prevention of relapses).

Hypersecretory conditions, such as Zollinger – Ellison syndrome.

Treatment of gastroesophageal reflux disease (reflux esophagitis).

Prevention of the development of symptoms and erosions or ulcers associated with gastroesophageal reflux disease.

Contraindications.

Hypersensitivity to the active substance, other H2-histamine receptor antagonists, or other components of the drug.

Children's age, period of pregnancy or lactation (due to lack of necessary clinical experience).

Interactions with other drugs and other types of interactions.

The absorption of certain medications (for example, ketoconazole, amoxicillin, iron preparations) depends on the acidity of gastric juice. Therefore, Famotidine should be taken at least 2 hours after taking such medications.

Concomitant administration with other H2 receptor antagonists may significantly reduce the effectiveness of tolazoline. Although no interaction between Famotidine and tolazoline has been confirmed, it is likely that such an interaction will exist, so the effect of tolazoline should be checked at the beginning or after discontinuation of concomitant treatment. If the effect of tolazoline decreases, its dose should be carefully increased or Famotidine treatment should be discontinued.

Food and antacids do not significantly affect Famotidine therapy.

Famotidine does not affect the cytochrome P450 oxidase system of the liver, so the metabolism of oral anticoagulants, antipyrine, aminopyrine, theophylline, phenytoin, diazepam, ethanol and propranolol is not disrupted.

Probenecid may inhibit the release of Famotidine.

Application features.

Treatment with this drug can only be carried out after a proper medical examination in the following situations::

- in the presence of kidney or liver diseases;

- at the first appearance of heartburn, manifestations of hyperacid state, stomach pain or hyperacid state after eating in middle-aged or elderly patients, as well as when the nature of these complaints changes in patients of this age group;

- in the presence of digestive disorders with a decrease in body weight;

– in the presence of black bowel movements;

- in the presence of swallowing disorders and / or chronic abdominal pain;

- in the presence of concomitant diseases or with the simultaneous use of other medications.

Before starting treatment, the presence of malignant neoplasms in the stomach and duodenum should be excluded. Treatment with this medication may mask the symptoms of gastric carcinoma.

Symptoms of duodenal ulcer may disappear within 1-2 weeks, but therapy should be continued until scarring is confirmed by endoscopic or X-ray examination.
Famotidine is used with caution in acute porphyria (including in the Anamnesis), immunodeficiency.

In severe liver diseases, the drug is used with extreme caution in reduced doses.

In elderly patients with impaired liver or kidney function, impaired consciousness (confusion) may occur, which makes it necessary to reduce the dose.

Regular monitoring of the condition of patients (especially elderly patients and patients with a history of gastric and/or duodenal ulcers) who use the drug in combination with nonsteroidal anti-inflammatory drugs is necessary.

Since cross-sensitivity between H2-receptor antagonists has been reported, the use of the drug in patients with hypersensitivity to other H2-receptor antagonists is contraindicated.

In the case of complex treatment with antacids, the interval between the use of the drug and antacids should be at least 1-2 hours.

If a dose of the drug is missed, it should be taken as soon as possible; do not double the dose if it is time to take the next dose.

If you are lactose intolerant, it should be taken into account that each tablet of 20 mg of Famotidine-Darnitsa contains 90.1 mg of lactose. Patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not use this medication.

Use during pregnancy or lactation.

Famotidine-Darnitsa is not used during pregnancy or lactation.

Ability to influence the reaction rate when driving vehicles or other mechanisms.

Caution should be exercised when driving vehicles or working with other mechanisms that require increased attention and speed of psychomotor reactions, as Famotidine can cause dizziness.

Dosage and administration.

Famotidine is most effective in the evening before going to bed. When taking Famotidine twice a day, one dose should be taken in the morning, the second – in the evening before going to bed.

The tablet is swallowed whole, without chewing, washed down with a glass of water. Famotidine is used regardless of food intake.

Peptic ulcer of the duodenum and stomach (benign).

2 tablets of 2 mg in the evening before bedtime, for 4-8 weeks.

Prevention of recurrent duodenal ulcers.

In order to prevent relapses, after achieving a therapeutic effect, a maintenance dose of 1 tablet of 20 mg is prescribed once a night for 1-4 weeks.

Gastroesophageal reflux disease (reflux esophagitis).

1 or 2 tablets of 20 mg (depending on the severity of the disease) 2 times a day. Treatment lasts for 6-12 weeks.

For gastroesophageal reflux disease associated with erosive esophagitis or ulcers – 40 mg 2 times a day for 6-12 weeks.

For the Prevention of recurrent symptoms and erosions or ulceration associated with gastroesophageal reflux disease (maintenance therapy).

Assign 20 mg 2 times a day.

Zollinger – Ellison Syndrome.

The dose of the drug is selected individually. Patients who have not previously been prescribed antisecretory medications are prescribed an initial dose of 1 tablet of 20 mg 4 times a day (every 6 hours). Patients who have previously used other histamine H2 receptor antagonists may immediately be prescribed a higher initial dose of 40 mg every 6 hours. In the future, the dose is adjusted depending on the level of gastric juice secretion, as well as the patient's clinical condition. Treatment should be carried out while the clinical symptoms of the disease are observed.

If necessary, the Daily Dose is increased gradually, depending on individual characteristics, until the optimal dose is reached.

According to available data, the highest doses of Famotidine taken by patients with severe forms of the disease were up to 160 mg every 6 hours.

Dosage for renal failure.

If the creatinine clearance is less than 30 mL/min, The level of creatinine in the blood serum is more than 3 mg/100 ml, The Daily Dose of the drug is reduced to 20 mg or the interval between administration is increased to 36-48 hours.

Treatment with this drug is canceled gradually due to the risk of developing rebound syndrome with abrupt withdrawal.

Dosage for the elderly.

For the elderly, no dose adjustment is required, with the exception of patients with renal insufficiency.

Children.

There are insufficient data on the safety and efficacy of Famotidine for the treatment of children.

Overdose.

Symptoms: possible vomiting, motor agitation, tremor, low blood pressure, tachycardia, collapse.

Treatment: discontinuation of the drug, induction of vomiting or/and gastric lavage. If necessary, adequate symptomatic and supportive therapy is carried out: for convulsions, diazepam is administered intravenously, for bradycardia – atropine, for ventricular arrhythmias – lidocaine. Hemodialysis is effective.

Adverse reactions.

From the side of the visual organs: inflammation of the conjunctiva.

From the side of the hearing organs and vestibular apparatus: ringing in the ears.

From the respiratory system, chest and mediastinal organs: airway obstruction, bronchospasm.

From the gastrointestinal tract: diarrhea, constipation, flatulence, abdominal pain, vomiting, nausea, taste disorders, anorexia, dry mouth, acute pancreatitis.

From the liver and biliary tract: cholestatic jaundice, pathological changes in the activity of liver enzymes, hepatitis.

From the side of metabolism, metabolism: anorexia.

Nervous system disorders: headache, dizziness, convulsions, paresthesia, balance disorders, mental disorders (agitation, hallucinations, confusion, depression, fear, insomnia, drowsiness, decreased libido).

From the cardiovascular system: atrioventricular block, arrhythmia, decreased blood pressure, bradycardia, palpitations, tachycardia.

From the blood and lymphatic system: thrombocytopenia, agranulocytosis, pancytopenia, Leukopenia, neutropenia.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, eye edema.

From the skin and subcutaneous tissue: severe skin reactions (Stevens – Johnson syndrome, toxic epidermal necrolysis), acne, urticaria, rash, hair loss, itching, redness, dry skin, exfoliative dermatitis, allergic dermatitis.

Musculoskeletal and connective tissue disorders: muscle spasms, joint pain.

From the reproductive system and breast function: impotence, gynecomastia*.

General disorders: increased fatigue, fever.

* Gynecomastia is extremely rare and is reversible if treatment is discontinued.

Tags: Famotidine