FAMOTIDINE

Active material: Famotidin
When ATH: A02BA03
CCF: Gistaminovыh blocker H₂-receptors. Anti-ulcer drug
When CSF: 11.01.01
Manufacturer: HEMOFARM A.D. (Serbia)

DOSAGE FORM, STRUCTURE AND PACKAGING

Pills, Film-coated pale brown, round, lenticular.

Excipients: corn starch, microcrystalline cellulose, silicon dioxide, talc, magnesium stearate, sodium croscarmellose.

The composition of the shell: gipromelloza, macrogol 6000, Titanium dioxide (E171), talc, red iron oxide Brown.

10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

Pills, Film-coated brown with a slightly pinkish tint, round, lenticular.

Excipients: corn starch, microcrystalline cellulose, silicon dioxide, talc, magnesium stearate, sodium croscarmellose.

The composition of the shell: gipromelloza, macrogol 6000, Titanium dioxide (E171), talc, red iron oxide Brown.

10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Gistaminovыh blocker H₂-III generation receptors. Suppresses the production of hydrochloric acid, as 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 after a single dose depends on the dose and ranges from 12 to 24 no.

Pharmacokinetics

Quickly after ingestion, but not completely, absorbed from the gastrointestinal tract. C_max plasma levels achieved after 2 no. Bioavailability is 40-45% and changes slightly in the presence of food.

T_1/2 from plasma is about 3 h and increases in patients with impaired renal function. Protein binding is 15-20%. A small part of the active substance is metabolized in the liver to form famotidine S-oxide. Most of it is excreted unchanged in urine.

Testimony

Treatment and prevention of relapses of gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison, Diseases and conditions, accompanied by increased secretion of gastric juice, prevention of erosive and ulcerative lesions of the gastrointestinal tract while taking NSAIDs; bleeding from the upper gastrointestinal tract (for / in the, as part of complex treatment).

Dosage regimen

Individual, depending on the evidence.

Used internally for treatment purposes: 10-20 mg 2 times / day, or 40 mg 1 time / day. If necessary, the daily dose may be increased to 80-160 mg. With the aim of preventing – by 20 mg 1 time / day before bedtime.

When administered intravenously, a single dose is 20 mg, the interval between wvedeniami – 12 no.

At least QC 30 ml/min or with a serum creatinine concentration of more than 3 mg/dl dose is recommended to be reduced to 20 mg / day.

Side effect

From the digestive system: possible lack of appetite, dry mouth, taste disorders, nausea, vomiting, abdominal distention, diarrhea or constipation; in some cases – development of cholestatic jaundice, increased levels of transaminases in blood plasma.

CNS: possible headache, fatigue, noise in ears, transient mental disorders.

Cardio-vascular system: rarely – Arrhythmia.

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

On the part of the musculoskeletal system: possible muscle pain, joint pain.

Allergic reactions: possible itching, bronchospasm, fever.

Dermatological reactions: possible alopecia, acne vulgaris, xerosis.

Local reactions: irritation at the injection site.

Contraindications

Pregnancy, lactation, hypersensitivity to famotidine.

Pregnancy and lactation

Contraindicated during pregnancy and lactation.

Famotidine is excreted in breast milk.

Cautions

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.

Does not change the activity of microsomal liver enzymes.

The interval between taking antacids and famotidine should be at least 1-2 no.

Clinical experience with famotidine in children is limited..

Drug Interactions

When used simultaneously with anticoagulants, the possibility of an increase in prothrombin time and the development of bleeding cannot be excluded..

In an application with antacids, containing magnesium hydroxide and aluminum hydroxide, Possible decreased absorption of famotidine.

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

When used simultaneously with nifedipine, a case of a decrease in cardiac output and cardiac output has been described., apparently, due to increased negative inotropic effect of nifedipine.

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

With simultaneous use, a case of increased concentrations of phenytoin in the blood plasma with a risk of toxic effects has been described..

With simultaneous use, 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 simultaneously with cyclosporine, a slight increase in the concentration of cyclosporine in the blood plasma is possible..