Famotidine, 20 mg 20 pcs

Pharmacotherapeutic group

Gastric gland secretion reducing agent – H2-histamine receptor blocker

ATX code: A02BA03

Pharmacodynamics:

A 3rd generation H2-histamine receptor blocker. Suppresses basal and histamine-stimulated gastrin and acetylcholine production of hydrochloric acid. Reduces the activity of pepsin.

It enhances the protective mechanisms of the mucous membrane of the stomach by increasing the formation of gastric mucus increasing the content of glycoproteins in it stimulation of the secretion of hydrocarbonate endogenous synthesis of prostaglandins. Increases the regeneration rate of gastric mucosa and promotes healing of its damage (including cessation of gastrointestinal bleeding and scarring of stress ulcers). It does not significantly change the level of gastrin in plasma. It weakly inhibits cytochrome P450 oxidase system in the liver. After oral administration the action begins after 1 hour and reaches a maximum within 3 hours. The duration of action of the drug after a single dose depends on the dose and varies from 12 to 24 hours.

Pharmacokinetics:

After oral administration the drug is quickly absorbed from the gastrointestinal tract. After ingestion, the maximum plasma concentration is reached within 1-35 hours. Bioavailability is 40-45% increased with food and decreased with antacids. Binding to plasma proteins is 15-20%. 30-35% of famotidine is metabolized in the liver (with the formation of S-oxide). Elimination occurs mainly through the kidneys: 27-40% of the drug is excreted unchanged in the urine. The elimination half-life is 25-4 hours. Period of half-life increases up to 10-12 hours in patients with creatinine clearance less than 30 ml/min, up to 20 hours in patients with severe renal insufficiency (creatinine clearance less than 10 ml/min). It penetrates through the placental barrier and is excreted with breast milk.

Indications

Treatment and prevention of peptic ulcers of the stomach and duodenum.

The treatment and prevention of symptomatic peptic ulcers of the stomach and duodenum (associated with taking nonsteroidal anti-inflammatory drugs stress ulcers after surgery).

Erosive gastroduodenitis.

Functional dyspepsia associated with increased secretory function of the stomach.

Reflux esophagitis.

Zollinger-Ellison syndrome.

Prevention of recurrent bleeding from the upper gastrointestinal tract. Prevention of aspiration of gastric juice during general anesthesia (Mendelsohn syndrome).

Active ingredient

Composition

active ingredient: famotidine 20 mg;

excipients: lactose (milk sugar), potato starch, povidone low molecular weight (polyvinylpyrrolidone low molecular weight medical), calcium stearate monohydrate (calcium stearic acid 1-water), stearic acid, Hypromellose (hydroxypropyl methylcellulose), povidone medium molecular (polyvinylpyrrolidone medium molecular medical grade), titanium dioxide (titanium dioxide), polysorbate 80 (tween-80), tropeolin O.

How to take, the dosage

The tablets should be swallowed without chewing and with plenty of water.

In peptic ulcer and 12 duodenal ulcer in acute phase symptomatic erosive gastroduodenitis usually prescribed by 20 mg 2 times daily or by 40 mg once daily at bedtime. If necessary, daily dose may be increased to 80-160 mg. The course of treatment is 4 to 8 weeks.

In case of dyspepsia associated with increased secretory function of the stomach, 20 mg 1 to 2 times a day is prescribed.

In order to prevent recurrence of peptic ulcer 20 mg 1 time a day before sleep.

In reflux esophagitis, 20-40 mg 2 times a day for 6-12 weeks.

In Zollinger-Ellison syndrome, the dose of the drug and the duration of treatment are set individually. The initial dose is usually 20 mg every 6 hours and may be increased to 60 mg every 6 hours.

To prevent aspiration of gastric juice during general anesthesia, 40 mg is prescribed in the evening and/or in the morning before surgery.

In case of renal insufficiency if creatinine clearance is less than 30 ml/min or serum creatinine more than 3 mg/100 ml the daily dose of the drug should be reduced to 20 mg.

Interaction

Due to an increase in the pH of the stomach contents, concomitant use may decrease absorption of ketoconazole.

In concomitant use with the antacids sucralfate decreases the intensity of absorption of famotidine, so a break between the intake of these drugs should be at least 1-2 hours.

Inhibits metabolism in the liver of phenazone aminophenazone diazepam hexobarbital propranolol metoprolol lidocaine phenytoin theophylline indirect anticoagulants glipizide buformin metronidazole caffeine “slow” calcium channel blockers. Increases absorption of amoxicillin and clavulanic acid.

Medications that depress bone marrow increase the risk of neutropenia.

Special Instructions

Famotidine as well as all H2-histamine blockers should not be abruptly withdrawn (“ricochet” syndrome is characteristic).

Before starting treatment, the possibility of malignancy of the esophagus or duodenum should be excluded.

In long-term treatment in debilitated patients bacterial lesions of the stomach with subsequent spread of infection are possible.

With caution it is used in patients with liver dysfunction.

H2-histamine receptor blockers may counteract the effects of pentagastrin and histamine on gastric acid-producing function; therefore, the use of H2-histamine receptor blockers is not recommended during the 24 hours prior to the test.

Histamine receptor blockers may suppress the skin reaction to histamine, resulting in false negatives (prior to diagnostic skin testing for immediate allergic skin reactions, the use of H2-histamine receptor blockers is recommended to be discontinued).

At the time of treatment, beverages and medications that irritate the gastric mucosa should be avoided.

Contraindications

Hypersensitivity to the components of the drug.

Side effects

Digestive system: dry mouth decreased appetite nausea vomiting abdominal pain increased activity of “liver” transaminases constipation diarrhea jaundice hepatocellular cholestatic or mixed hepatitis acute pancreatitis.

Hematopoietic organs: neutropenia leukopenia thrombocytopenia hemolytic anemia agranulocytosis pancytopenia.

Allergic reactions: urticaria skin rash pruritus bronchospasm angioedema erythema multiforme exfoliative dermatitis Stevens-Johnson syndrome toxic epidermal necrolysis anaphylactic shock.

Cardiovascular system disorders: decreased arterial pressure bradycardia atrioventricular block arrhythmia vasculitis.

Nervous system disorders: headache asthenia somnolence insomnia fatigue anxiety depression nervousness psychosis dizziness confusion hallucinations hyperthermia.

Sensory organs: tinnitus.

Urogenital system: with prolonged use of large doses – decrease in potency and libido.

Musculoskeletal system: arthralgia myalgia.

Others: dry skin alopecia gynecomastia.

Overdose

Symptoms: vomiting motor agitation tremor decreased blood pressure tachycardia collapse.

Treatment: gastric lavage symptomatic therapy hemodialysis.

Similarities