Peptic ulcer of the stomach and duodenum. Prevention of duodenal ulcer recurrence. Zollinger-Ellison syndrome. Esophagitis caused by gastroesophageal reflux.
Composition:
1 tabl powl. contains 20 mg or 40 mg famotidine.
Action:
The antiulcer drug binds in a specific and reversible manner to histamine H receptors2, competitively preventing the action of histamine and inhibiting the basic and stimulated secretion of hydrochloric acid and pepsin; as a result, the volume and acidity of gastric juice are reduced. The effect of a single dose is maintained for 12 hours. After oral administration of Famotidine, 40% - 45% of the dose is absorbed. The maximum concentration occurs after 1-3.5 h. In 16% it is bound to plasma proteins. It penetrates the blood-brain barrier and through the placenta as well as into breast milk; it is metabolised in the liver. It is excreted in 20% - 40% unchanged in urine, the rest is excreted in faeces. A small amount of Famotidine appears in the urine as an inactive metabolite. T0,5 is 3 hours, in patients with renal failure can be significantly prolonged.
Contraindications:
Hypersensitivity to the components of the preparation. Known hypersensitivity to other H receptor antagonists2because when using H receptor antagonists2 cross-hypersensitivity has been reported.
Precautions:
Before starting treatment in patients with gastric ulcer, its cancerous character should be excluded (the resolution of symptoms associated with gastric ulcer during treatment with the preparation does not preclude their neoplastic nature). Caution should be exercised in patients with impaired renal function; where the creatinine clearance is less than 10 ml / min, a reduction in the daily dose should be considered. There is a possibility of cross-sensitivity with other histamine H-receptor inhibitors2. In the case of long-term treatment with high doses of famotidine, it is recommended to control the number of blood cells and liver function. In long-term peptic ulcer disease, sudden discontinuation of famotidine should be avoided after resolution of symptoms. Elderly patients have experienced no increased incidence or type of famotidine related adverse events; there is no need to change the dose only because of the age of the patient. The safety and efficacy of famotidine in children has not been established.
Pregnancy and lactation:
There are no data on the safety of the medicine in pregnant women, therefore the preparation can only be used if absolutely necessary. Before deciding whether to use the product during pregnancy, the potential benefit-risk balance of famotidine should be considered. Breastfeeding women should discontinue famotidine or breastfeeding, since famotidine is excreted in human milk.
Side effects:
Common: headache, dizziness, diarrhea, constipation. Uncommon: anorexia, dysgeusia, dry mouth, nausea and / or vomiting, abdominal pain or bloating, flatulence, rash, pruritus, urticaria, fatigue. Very rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, pancytopenia, hypersensitivity reactions (anaphylaxis, angioneurotic edema, bronchospasm, orbital edema), reversible psychiatric disorders (including depression, anxiety disorders, agitation, confusion, confusion and hallucinations), insomnia, reduction of libido, epileptic seizures, tonic-clonic seizures (especially in patients with impaired renal function), paresthesia, drowsiness, atrioventricular block when administered intravenously to H-receptor antagonists2, interstitial pneumonia (sometimes fatal), impaired liver enzymes, hepatitis, cholestatic jaundice, alopecia, Stevens-Johnson syndrome / toxic epidermal necrolysis (sometimes fatal), joint pain, muscle spasms, impotence, tightness in the chest . Cases of gynecomastia have been reported rarely, however, in controlled clinical trials, the incidence was not greater than in the placebo group.
Dosage:
Orally.Peptic ulcer of the stomach and duodenum: 40 mg at bedtime for 4-8 weeksPrevention of duodenal ulcer recurrence: 20 mg at bedtime for several months.Esophagitis caused by gastro-oesophageal reflux: 20 or 40 mg (depending on the severity of the disease) 2 times a day for 6-12 weeksZollinger-Ellison syndrome: initially 20 mg every 6 hours; the starting dose is greater when other histamine H inhibitors are used2 before starting famotidine; the dose should be increased gradually until the optimal effect of the drug; The highest doses used in patients in severe cases were up to 160 mg administered every 6 hours. In patients with creatinine clearance <10 ml / min, or with serum creatinine> 265 μmol / l, famotidine 20 mg / day is recommended. daily or 20 mg to 40 mg every 36 or 48 h, respectively. If the creatinine clearance is <30 ml / min, the dose should be carefully selected. The drug works most effectively if taken in the evening before bedtime. When using famotidine twice a day, take one dose in the morning and the other in the evening, before going to bed.
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