Project Description
Famo
international nonproprietary name
Famotidine
Ref
BP-0050
Pharmacotherapeutic group
Anti-ulcerous preparations – H2–anti-histamine preparations
Composition of the preparation
1 tablet contains 20 mg of famotidine.
Pharmacological action
Pharmacodynamics Famotidine is a H2–histamine receptors blocker of the III generation. It suppresses the hydrochloric acid production both basal and the histamine, gastrin and acethylcholine stimulated. Simultaneously with the hydrochloric acid production reducing and pH increasing it decreases the pepsin activity. The preparation action duration when it is taken once depends on the dose and varies from 12 to 24 hours. Pharmacokinetics The preparation is not absorbed completely in the gastro-intestinal tract, the bioavailability is 40 – 45%, increasing under food influence and decreasing when antacids are applied. The blood maximal concentration is achieved in 1 – 3 hours. The period of half elimination is 2.5 – 3 hours. 30 – 35% of the preparation is metabolized in the liver and is excreted by the kidneys. 25 – 30% of the dose taken per os is eliminated unchanged. The period of half elimination in patients with severe renal insufficiency (creatinine clearance is less than 10 ml/min) increases to 20 hours (the dose correction is necessary).
Indications
Stomach and duodenum ulcerous diseases (treatment and exacerbations prevention), symptomatic ulcers, erosive esophagitis, reflux-esophagitis, Zollinger – Allison’s syndrome, prevention of gastro-intestinal tract erosive and ulcerous changes on the background of NSAIDs intake and the stomach contents aspiration under general anesthesia.
Special indication
Not established
Special warning
Not established
Dosage and method of administration
The dosage regime is determined individually. In case of the stomach and duodenum ulcerous diseases 40 mg of famo is taken once a day before sleep or 20 mg – two times a day. For preventing the ulcerous disease exacerbation 20 mg of the preparation is taken once a day. In case of reflux-esophagitis famo is prescribed in the dose 20 mg 1 – 2 times a day for 6 – 12 weeks. In case of Zollinger – Allison’s syndrome 20 – 40 mg of the preparation is taken 4 times a day.
Overdosage
Treatment: No specific antidote is known. The stomach washing, symptomatic or supportive therapy are recommended.
Safety measures
The preparation should be prescribed with caution to persons with the liver and kidneys functions disturbances. Before prescribing famotidine it is necessary to exclude the possibility of esophageal, gastric or duodenal tumors.
Side effects
Xerostomia, constipation, diarrhea, stomach pains, nausea or vomiting, sleepiness, dizziness, headache, hyporexia, murmurs in the ears, sexual function reduction, increased sweating, muscular or articular pains. When these symptoms resist for a long time the patient should address his doctor.
Contraindications
Famotidine is contraindicated to persons with hypersensitivity to any of preparation components or to other preparations of the same group such as cimetidine, ranitidine, nizatidine as well as in pregnancy and lactation. The preparation is not recommended to children.
Interactions with other medicinal preparations
Famotidine should not be taken simultaneously with ketoconazole, intraconazole (anti-fungal preparations). The preparations mentioned may be taken in two hours after famo has been received. In those cases when the preparation is taken in combination with antacids the interval between the antacide and famo intakes should be not less than 1 – 2 hours (antacids may condition the famotidine absorption changing). The preparation does not change the liver microsomal enzymes activity.
The form of release
20 mg tablets. Preparation “Famo” is produced in cooperation with the firm “CTS Chemical Industries Ltd.”, Israel.