Instructions for Famotidine-Darnitsa film-coated tablets 20 mg No. 20
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
Film-coated tablets.
Main physicochemical properties: film-coated tablets, white in color, round in shape, with a biconvex surface.
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. H2 receptor antagonists. ATC code A02B A03.
Pharmacological properties
Pharmacodynamics
Famotidine is a blocker of H2-histamine receptors of the stomach wall, therefore it reduces the secretion of gastric juice. Under the action of the drug, both the concentration and the amount of gastric juice are reduced, and accordingly, the amount of pepsin. The effect of 20 mg and 40 mg of famotidine lasts for 10−12 hours. A single evening dose (20 mg or 40 mg) reduces basal and nocturnal secretion of gastric juice. The degree of blocking of gastric juice secretion at night is 86−94% and lasts at least 10 hours.
When the same dose is used 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 has virtually no effect on either the "fasting" level of gastrin or its level after a meal.
Famotidine does not affect gastric emptying, pancreatic secretory function, hepatic blood flow and portal blood flow. Famotidine does not affect the cytochrome P450 enzyme system of the liver. Famotidine does not affect serum hormone levels. It does not have an androgenic effect.
Pharmacokinetics
Absorption: Famotidine is rapidly and completely absorbed. Bioavailability is 40-45% regardless of gastric contents.
Distribution in the body: after oral administration, the maximum concentration of famotidine in the blood plasma is observed after 1-3 hours. Repeated doses do not lead to cumulation of the drug. The connection with plasma proteins is insignificant - 15-20%.
The plasma half-life is 2.3-3.5 hours. In the presence of severe renal failure, the half-life may increase to 20 hours.
Metabolism: metabolized in the liver, the only known metabolite is the sulfoxide.
Excretion: Renal clearance of the drug is 250-450 ml per minute, indicating tubular excretion. 25-30% of an oral dose is excreted unchanged in the urine. Only a small amount of famotidine is excreted as the sulfoxide.
The pharmacokinetic parameters of the drug in the body of a healthy elderly person and a child do not differ significantly from the pharmacokinetic parameters in an adult.
Indication
Benign gastric ulcer. Peptic ulcer of the duodenum (treatment and prevention of relapse). Hypersecretory conditions such as Zollinger-Ellison syndrome. Treatment of gastroesophageal reflux disease (reflux esophagitis). Prevention of the development of symptoms and erosions or ulceration associated with gastroesophageal reflux disease.
Contraindication
Hypersensitivity to the active substance, other H2-histamine receptor antagonists or other components of the drug.
Children's age, pregnancy or breastfeeding (due to lack of necessary clinical experience).
Interaction with other medicinal products and other types of interactions
The absorption of some drugs (e.g. ketoconazole, amoxicillin, iron preparations) depends on the acidity of gastric juice. Therefore, famotidine should be taken at least 2 hours after taking such drugs.
Concomitant administration with other H2-receptor antagonists may significantly reduce the efficacy of tolazoline. Although no interaction between famotidine and tolazoline has been confirmed, it is likely that such an interaction will exist, therefore the effect of tolazoline should be checked at the beginning or after discontinuation of concomitant treatment. If the effect of tolazoline is reduced, its dose should be increased cautiously 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, therefore the metabolism of oral anticoagulants, antipyrine, aminopyrine, theophylline, phenytoin, diazepam, ethanol and propranolol is not impaired.
Probenecid may inhibit the release of famotidine.
Application features
in the presence of kidney or liver diseases; in the first appearance of heartburn, manifestations of hyperacidity, stomach pain or hyperacidity after eating in middle-aged or elderly patients, as well as in the change in the nature of these complaints in patients of this age group; in the presence of indigestion with weight loss; in the presence of black stools; in the presence of swallowing disorders and/or chronic abdominal pain; in the presence of concomitant diseases or with simultaneous use of other medications.
Before starting treatment, the presence of malignant neoplasms in the stomach and duodenum should be excluded. Treatment with this drug may mask the symptoms of gastric carcinoma.
Symptoms of duodenal ulcer may resolve within 1–2 weeks, but therapy should be continued until scarring is confirmed by endoscopic or X-ray examination.
Famotidine should be used with caution in acute porphyria (including a history of it), immunodeficiency.
In severe liver diseases, the drug is used with extreme caution in reduced doses.
Elderly patients with impaired liver or kidney function may experience impaired consciousness (confusion), which necessitates a dose reduction.
Regular monitoring of patients (especially elderly patients and patients with a history of gastric and/or duodenal ulcer) 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 for the next dose.
In case of lactose intolerance, it should be noted that each 20 mg tablet of Famotidine-Darnitsa contains 90.1 mg of lactose. Patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or operating other mechanisms that require increased attention and speed of psychomotor reactions, as famotidine may cause dizziness.
Use during pregnancy or breastfeeding
Famotidine-Darnitsa is not used during pregnancy or breastfeeding.
Method of administration and doses
Famotidine is most effective in the evening before bedtime. When taking famotidine twice daily, one dose should be taken in the morning and the other in the evening before bedtime.
The tablet is swallowed whole, without chewing, with a glass of water. Famotidine is used regardless of meals.
Peptic ulcer of the duodenum and stomach (benign).
2 tablets of 20 mg in the evening before bedtime, for 4−8 weeks.
Prevention of duodenal ulcer recurrence.
To prevent relapses after achieving a therapeutic effect, a maintenance dose of 1 tablet of 20 mg is prescribed once at 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 ulcer – 40 mg 2 times a day for 6-12 weeks.
For the prevention of recurrence of symptoms and erosions or ulceration associated with gastroesophageal reflux disease (maintenance therapy).
Prescribe 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 drugs 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 be immediately 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 clinical condition of the patient. Treatment should be carried out as long as 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 existing data, the highest doses of famotidine taken by patients with severe forms of the disease were up to 160 mg every 6 hours.
Dosage in renal failure.
If creatinine clearance is less than 30 ml/min, serum creatinine level is more than 3 mg/100 ml, the daily dose of the drug is reduced to 20 mg or the interval between doses is increased to 36-48 hours.
Treatment with this drug is discontinued gradually due to the risk of developing rebound syndrome with abrupt withdrawal.
Dosage for the elderly.
No dose adjustment is required for the elderly, except in patients with renal insufficiency.
There is insufficient data on the safety and effectiveness of famotidine in the treatment of children.
Overdose
Symptoms: possible vomiting, motor agitation, tremor, decreased blood pressure, tachycardia, collapse.
Treatment: drug withdrawal, induction of vomiting and/or 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 organs of vision: conjunctival inflammation.
From the side of the organs of hearing and vestibular apparatus: ringing in the ears.
Respiratory, thoracic and mediastinal disorders: airway obstruction, bronchospasm.
Gastrointestinal: diarrhea, constipation, flatulence, abdominal pain, vomiting, nausea, taste disturbances, anorexia, dry mouth, acute pancreatitis.
From the liver and biliary tract: cholestatic jaundice, pathological changes in the activity of liver enzymes, hepatitis.
Metabolism: anorexia.
Nervous system: 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.
Blood and lymphatic system disorders: thrombocytopenia, agranulocytosis, pancytopenia, leukopenia, neutropenia.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, eye swelling.
Skin and subcutaneous tissue disorders: 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 mammary gland function: impotence, gynecomastia*.
General disorders: increased fatigue, increased body temperature.
* Gynecomastia is extremely rare and reversible upon discontinuation of treatment.
Expiration date
3 years.
Storage conditions
Store out of the reach of children, in the original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a contour blister pack; 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
