Famotidine tablets p/o 20mg №10×2

Name:
Famotidine. Release form: 20 mg and 40 mg film-coated tablets. MNNFamotidine. FTSH2-histamine receptor blocker.
Description:
: Yellow film-coated tablets for the 20 mg dosage and pink for the 40 mg dosage, with a biconvex surface. The cross section shows two layers. Composition – one tablet with a dosage of 20 mg contains: active substance – famotidine – 20 mg; excipients – lactose monohydrate, microcrystalline cellulose, calcium stearate, opadry II (including polyvinyl alcohol, partially hydrolyzed; talc: macrogol 3350 (polyethylene glycol); lecithin (soy); yellow coloring pigment (contains titanium dioxide E 171, iron oxide yellow E 172, aluminum lacquer based on quinoline yellow E 104)); – one tablet with a dosage of 40 mg contains: active ingredient – famotidine – 40 mg; excipients – lactose monohydrate, microcrystalline cellulose, calcium stearate, opadry II (including polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350 (polyethylene glycol); lecithin (soy); pink coloring pigment (contains titanium dioxide E 171, aluminum varnish based on carmoisine E 122, aluminum varnish based on indigo carmine E 132)). Pharmacotherapeutic group H2-histamine receptor blocker. ATX code: A02BA03. Pharmacological properties Pharmacodynamics Blocker of H2-histamine receptors of the III generation. Suppresses basal and stimulated by histamine, gastrin and acetylcholine production of hydrochloric acid. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin also decreases. Increases the resistance of the gastric mucosa by increasing the formation of gastric mucus, secretion of bicarbonate, synthesis of glycoproteins and prostaglandins, promotes healing of its damage (including scarring of stress ulcers). Virtually no effect on the activity of cytochrome P450 in the liver. After oral administration, the action begins after 1 hour, reaches a maximum within 3 hours and lasts from 12 hours to 24 hours. A single dose (10 mg and 20 mg) inhibits secretion for 10-12 hours. Pharmacokinetics Absorption: famotidine is absorbed quickly. Systemic bioavailability is about 40-45% of the accepted oral dose. The degree of absorption increases with food intake and decreases against the background of antacids. The maximum concentration of famotidine in plasma is proportional to the dose and is reached within 1-3.5 hours after ingestion. Distribution: Plasma protein binding approximately 16%. The volume of distribution is 1.2 l/kg. Famotidine crosses the blood-brain and placental barriers. Metabolism: metabolized in the liver with the formation of sulfoxide. Elimination: half-life 2.5-3.5 hours. Excretion from the body is carried out through the kidneys through canal excretion. 25-30% of the dose taken orally is excreted in the urine unchanged. In the presence of severe renal insufficiency, the half-life may increase by 20 hours. Indications for use: gastric and duodenal ulcers (benign); prevention of duodenal ulcer; Zollinger-Ellison syndrome; gastroesophageal reflux disease (reflux esophagitis); prevention of reflux esophagitis. Contraindications Hypersensitivity to famotidine or any component of the drug. Hypersensitivity to other blockers of H2-histamine receptors in history (due to the presence of cross-sensitivity to this class of compounds). Pregnancy, lactation, liver failure, childhood. With caution – cirrhosis of the liver with a history of portosystemic encephalopathy, renal failure. Method of administration and doses Peptic ulcer of the stomach and duodenum: once 40 mg in the evening before bedtime for 4-8 weeks. Prophylactic treatment to prevent recurrence of ulcers: 20 mg once a day at bedtime for 4-6 weeks. Zollinger-Elisson syndrome: 20 mg every 6 hours. Some patients may require a higher starting dose. Doses should be adjusted to individual tolerance and treatment should be continued for as long as there is a clinical need. Some adult patients with severe Zollinger-Ellison syndrome may require doses up to 160 mg every 6 hours. The duration of the course is determined by the attending physician. Gastroesophageal reflux: 20 mg in the morning and evening before bedtime or 40 mg once in the evening before bedtime for 6-12 weeks. After achieving a therapeutic effect – take 20 mg once a day at bedtime. In gastroesophageal reflux disease associated with the presence of esophageal erosion or ulcers, the recommended dose is 40 mg 2 times a day for 6-12 weeks. Patients with renal insufficiency: in patients with severe renal insufficiency (creatinine clearance < 10 ml / min), the half-life is increased to 20 hours. In these cases, it is recommended to reduce the daily dose to 20 mg, although the relationship between severity, frequency of adverse reactions and increased plasma scores. Use in Elderly Patients: There are no special requirements for use in elderly patients. Children: efficacy and safety in children have not been established. Side effects The drug is well tolerated and rarely gives adverse reactions. The frequency of adverse reactions is determined: very frequent (≥ 1/10); frequent (≥ 1/100 - < 1/10); infrequent (≥ 1/1000 - < 1/100); rare (≥ 1/10000 - < 1/1000); very rare (< 1/10000); with unknown frequency (cannot be estimated based on available data). Nervous system disorders: common: headache, dizziness; infrequent: taste disturbance; very rare: convulsions, grand mal seizures (especially in patients with impaired renal function), paresthesia, drowsiness. Respiratory, thoracic and mediastinal disorders: very rare: interstitial pneumonia, sometimes fatal. Gastrointestinal disorders: common: constipation, diarrhea; infrequent: dry mouth, nausea and / or vomiting, abdominal discomfort, flatulence. Metabolic and nutritional disorders: infrequent: anorexia. On the part of the hepatobiliary system: very rare: increased levels of "liver" enzymes, hepatitis, cholestatic jaundice. Skin and subcutaneous tissue disorders: infrequent: rash, itching, urticaria; very rare: hair loss, Stevens-Johnson syndrome/toxic epidermal necrolysis. Immune system disorders: very rare: hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm). Musculoskeletal and connective tissue disorders: very rare: arthralgia, muscle twitching. General disorders and disorders at the injection site: infrequent: fatigue; very rare: a feeling of discomfort and "tightness" in the chest. Psychiatric disorders: very rare: reversible psychiatric disorders, including depression, anxiety disorders, agitation, disorientation, confusion and hallucinations, decreased libido, insomnia. Blood and lymphatic system disorders: very rare: pancytopenia, leukopenia, thrombocytopenia, agranulocytosis, neutropenia. Reproductive system and mammary gland disorders: very rare: impotence. Cardiac disorders: very rare: atrioventricular block with intravenous administration of H2-histamine receptor blockers, prolongation of the QT interval (especially in patients with renal insufficiency). Side effects with an unproven causal relationship: there are reports of rare cases of gynecomastia, however, in placebo-controlled clinical trials, their frequency did not exceed that when taking placebo. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the medicinal product. You can also report adverse drug reactions, including reports of drug inefficiency, to: Republican Unitary Enterprise "Center for Expertise and Testing in Healthcare", per. Comradely, 2a, 220037, Republic of Belarus, e-mail: . By reporting adverse reactions, you help to get more information about the safety of the medicine. Special instructions Symptoms of duodenal ulcer may disappear within 1-2 weeks, but Famotidine therapy should be continued until scarring is confirmed by endoscopic or x-ray data. May mask the symptoms associated with gastric carcinoma, therefore, before starting treatment, it is necessary to exclude the presence of a malignant neoplasm. Cancellation of famotidine is carried out gradually due to the risk of developing the "rebound" syndrome. With long-term treatment in debilitated patients, bacterial lesions of the stomach are possible, followed by the spread of infection. H2-histamine receptor blockers should be taken 2 hours after taking itraconazole or ketoconazole (risk of significantly reducing their absorption). Blockers of H2-histamine receptors can disrupt pentagastrin and histamine tests of the acid-forming function of the stomach (stop taking 24 hours). Famotidine may suppress the skin reaction to histamine, causing false negative skin test results. When performing skin tests, it is recommended to stop taking famotidine. During treatment, you should avoid eating foods, drinks and medicines that can cause irritation of the gastric mucosa. Smoking reduces the effectiveness of famotidine in relation to nocturnal secretion of hydrochloric acid. Patients with burns may need to increase the dose due to increased clearance of famotidine. Famotidine tablets contain lactose. This medicinal product should not be used in patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. If a dose is missed, it must be taken as soon as possible; do not double the dose if it is time for the next dose. If there is no improvement, a doctor's consultation is necessary. Use during pregnancy or lactation is contraindicated. Influence on the ability to drive vehicles and other mechanisms Does not affect the ability to drive vehicles and other mechanisms. Interaction with other drugs There are no data on undesirable and other interactions. It does not affect the cytochrome P450 enzymatic system, therefore it does not affect the effect of drugs (warfarin, theophylline, phenytoin, diazepam, aminopyrine, antipyrine, etc.) that are metabolized through this system. With simultaneous use together with ketoconazole, a decrease in the degree of resorption of the latter is possible, since it is determined by the gastric pH value. Ketoconazole should be used 2 hours before taking famotidine. Co-administration with high doses of antacid drugs reduces the absorption of famotidine and other H2-histamine blockers by 10-33%. AUC and maximum plasma concentration are reduced by approximately 20%, which leads to a decrease in the effectiveness of famotidine. In this regard, it is recommended to take antacid drugs after 1-2 hours after taking famotidine. Changes in the pH of gastric contents may affect the bioavailability of certain drugs, for example: it leads to a decrease in the absorption of atazanavir. Combined use with theophylline increases plasma concentrations of theophylline, which can cause the development of adverse reactions (nausea, vomiting, palpitations, convulsions). Co-administration with probenecid increases the AUC and maximum plasma concentrations of famotidine due to the mechanism of suppression of renal active tubular secretion. Co-administration of probenecid and famotidine should be avoided. OverdoseSymptoms: vomiting, motor agitation, tremor, lowering blood pressure, tachycardia, collapse. Treatment: induction of vomiting or/and gastric lavage. Symptomatic and supportive therapy: for convulsions - intravenous diazepam; bradycardia - atropine; ventricular arrhythmias - lidocaine. Hemodialysis is effective. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 2 blister packs, together with instructions for use, are placed in a cardboard pack (No. 10 × 2). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiry date stated on the packaging. Conditions for dispensing from pharmacies By prescription. Buy Famotidine tablets p/o 20mg No. 10x2