Famotidine lyophilizate solution 20mg, vials 5pcs + solvent 5pcs

Composition

Lyophilizate – 1 fl. :

• Active ingredient: Famotidine-20.0 mg;
• Excipients: Aspartic acid-8.8 mg; Mannitol-44.0 mg.

Lyophilizate for the preparation of a solution for intravenous use,20 mg

Pharmacological action

Pharmaco-therapeutic group

Agent that reduces the secretion of gastric glands-H < SUB>2</SUB>-histamine receptor blocker < / SUB>

Pharmacological action

Histamine_H2-receptor blocker of the third generation. Inhibits the production of hydrochloric acid, both basal and stimulated by histamine, gastrin and, to a lesser extent, acetylcholine. Simultaneously with a decrease in hydrochloric acid production and an increase in pH, pepsin activity decreases. The duration of action with a single dose depends on the dose and ranges from 12 to 24 hours.

Indications

Treatment and prevention of relapses of gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome, diseases and conditions accompanied by increased secretion of gastric juice, prevention of erosive and ulcerative lesions of the gastrointestinal tract against the background of NSAIDs; bleeding from the upper gastrointestinal tract (for intravenous use, as part of complex treatment).

Use during pregnancy and lactation

It is contraindicated for use during pregnancy and lactation.

Famotidine is excreted in breast milk.

Contraindications

Pregnancy, lactation, hypersensitivity to famotidine.

Side effects

From the digestive system:  there may be a lack of appetite, dry mouth, taste disorders, nausea, vomiting, bloating, diarrhea or constipation; in some cases, the development of cholestatic jaundice, an increase in the level of transaminases in blood plasma.

From the central nervous system:  possible headaches, increased fatigue, tinnitus, transient mental disorders.

From the cardiovascular system:  rarely-arrhythmias.

From the hematopoietic system:  very rarely – agranulocytosis, pancytopenia, leukopenia, thrombocytopenia.

Musculoskeletal disorders:  possible muscle pain, joint pain.

Allergic reactions:  possible skin pruritus, bronchospasm, fever.

Dermatological reactions:  possible alopecia, acne vulgaris, dry skin.

Local reactions:  irritation at the injection site.

Interaction

When used concomitantly with anticoagulants, the possibility of an increase in prothrombin time and the development of bleeding is not excluded.

When used concomitantly with antacids containing magnesium hydroxide and aluminum hydroxide, it is possible to reduce the absorption of famotidine.

When used concomitantly with itraconazole, it is possible to reduce the concentration of itraconazole in blood plasma and reduce its effectiveness.

When used concomitantly with nifedipine, a case of a decrease in cardiac minute volume and cardiac output has been described, apparently due to an increase in the negative inotropic effect of nifedipine.

When used concomitantly with norfloxacin, the concentration of norfloxacin in the blood plasma decreases; with probenecid, the concentration of famotidine in the blood plasma increases.

When used concomitantly, a case of an increase in the concentration of phenytoin in blood plasma with a risk of toxic effects is described.

When used concomitantly, the bioavailability of cefpodoxime decreases, apparently due to a decrease in its solubility in the stomach contents with an increase in the pH of gastric juice under the influence of famotidine.

When used concomitantly with cyclosporine, a slight increase in the concentration of cyclosporine in blood plasma is possible.

How to take, course of use and dosage

Individual, depending on the indications.

Inside for the purpose of treatment, apply 10-20 mg 2 times/day or 40 mg 1 time/day. If necessary, the daily dose can be increased to 80-160 mg. For the purpose of prevention-20 mg 1 time/day before bedtime.

With intravenous use, a single dose is 20 mg, the interval between injections is 12 hours.

If the creatinine clearance is less than 30 ml / min or if the serum creatinine concentration is more than 3 mg / dl, the dose should be reduced to 20 mg / day.

Special instructions

Use with caution in patients with impaired renal and hepatic function.

Before starting treatment, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum.

It does not change the activity of microsomal liver enzymes.

The interval between antacids and famotidine should be observed for at least 1-2 hours.

Clinical experience with famotidine in children is limited.

Use in patients with impaired renal function

Use with caution in patients with impaired renal function.

Use in patients with liver function disorders

Use with caution in patients with impaired liver function.

Use in children

Clinical experience with famotidine in children is limited.

Active ingredient

Famotidine

Conditions of release from pharmacies

By prescription

Dosage form

lyophilizate for solution preparation