Famosan - instructions for use, doses, side effects, contraindications

Excipients: microcrystalline cellulose (granulated), lactose (granulated), corn starch, magnesium stearate, silicon dioxide colloid, hypromellose 5, titanium dioxide, macrogol 6000, iron dye oxide red (at a dosage of 20 mg), iron oxide pigment oxide yellow (at a dosage of 40 mg ), simethicone emulsion 23%.

Description:

20 mg: round, biconcave tablets, covered with a film coat of brownish color.

40 mg: round, biconvex tablets, covered with a film coating of a brownish yellow color.

Pharmacotherapeutic group:glands of the stomach secretion lowering agent - H2-histamine receptor blocker

ATX: & nbsp

A.02.B.A.03 Famotidine

Pharmacodynamics:

Block H₂-gystamine receptors of the third generation. It causes inhibition of basal and hydrochloric acid (HCl) production stimulated by histamine, gastrin and acetylcholine. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin decreases. Strengthens the protective mechanisms of the mucous membrane of the stomach by increasing the formation of gastric mucus and the content of glycoproteins in it, as well as stimulating the secretion of bicarbonate and endogenous synthesis of prostaglandins in it, inhibiting the degranulation of mast cells, reducing the content of histamine in the periulcerous zone,stimulates the healing of ulcers (including cicatrization of stress ulcers), increasing the number of DNA-synthesizing cells of the epithelium and contributing to the cessation of gastrointestinal bleeding. Therapeutic doses do not affect the main level of gastrin in the blood plasma. Weakly suppresses the oxidase system of cytochrome P₄₅₀ in the liver.

When administered internally, the action of famotidine begins within 1 hour, reaches a maximum within 3 hours and continues, depending on the dose, from 12 to 24 hours. A single dose of 20 mg suppresses the secretion for 10-12 hours.

Pharmacokinetics:

At intake absorption - incomplete; bioavailability is 40-45%, increases with admission with food and decreases with antacids. The connection with plasma proteins is 15-20%. Maximum plasma concentration after oral administration is achieved in 1-3 hours. Penetrates into the cerebrospinal fluid, through the placental barrier and into breast milk. The half-life (T_1/2) - 2,5-3,5 hours.

In patients with severe renal failure (creatinine clearance (CC) - below 10 ml / min) T_1/2 increases to 20 hours (dose adjustment required). 30-35% of the drug is metabolized in the liver with education Soxide. Famotidine refers to weak bases and is a hydrophilic medicinal substance that is practically incapable of penetrating into tissues (heart, bronchi, central nervous system, etc.) and cause side effects peculiar to H₂-histamine receptors of the first generation.

It is excreted by the kidneys through glomerular filtration and tubular secretion. 25-30% of the dose taken internally is found in the urine in unchanged form.

Indications:

- Treatment and prevention of relapses of peptic ulcer of stomach and duodenum.

- Treatment and prevention of symptomatic gastric and duodenal ulcers (NSAIDs-gastropathy, stressful, postoperative ulcers).

- Erosive gastroduodenitis.

- Functional dyspepsia associated with increased secretory function of the stomach.

- Reflux esophagitis.

- Zollinger-Ellison syndrome, systemic mastocytosis, polyendocrine adenomatosis.

- Prevention of recurrence of bleeding from the upper gastrointestinal tract (GIT).

- Prevention of aspiration of gastric juice in general anesthesia (Mendelssohn syndrome).

Contraindications:

Hypersensitivity to famotidine and other components of the drug.

Children's age (for this dosage form).

Hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:

Hepatic and / or renal failure, cirrhosis with portosystemic encephalopathy (in the anamnesis), immunodeficiency, pregnancy, lactation.

Pregnancy and lactation:

The use of famotidine in pregnancy, especially in the first trimester, and during lactation is possible only in cases where the expected benefit to the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

Inside, not liquid, squeezed a little water.

With exacerbations of peptic ulcer of stomach and duodenum - 40 mg once a day at bedtime or 20 mg twice a day. If necessary, the daily dose can be increased to 80-160 mg. The duration of treatment is 4-8 weeks.

For prevention of exacerbations of peptic ulcer - 20 mg once a day before bedtime.

With Zollinger-Ellison syndrome - in an initial dose of 20-40 mg 4 times a day; if necessary, the daily dose can be increased to 240-480 mg. Treatment continues for as long as necessary (severe forms of the syndrome - up to 160 mg every 6 hours).

With reflux esophagitis the initial dose - 20 mg 2 times / day to 6 weeks (if necessary, 20-40 mg twice a day to 12 weeks).

To prevent aspiration of gastric contents - 40 mg on the eve of surgery or on the morning of the day of surgery for 2 hours before the operation.

With other indications most often a dose of 20 mg 2 times / day or 20-40 mg once a day before bedtime.

Patients with a creatinine clearance (CC) below 10 ml / min 20 mg at bedtime. The time interval between doses can be increased to 36-48 hours.

Side effects:

From the 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.

On the part of the organs of hematopoiesis: neutropenia, leukopenia, thrombocytopenia, hemolytic anemia, agranulocytosis, pancytopenia.

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

From the side of the cardiovascular system: decrease in blood pressure (BP), bradycardia, atrio-ventricular (AV) blockade, arrhythmia, vasculitis.

From the nervous system: headache, asthenia, drowsiness, insomnia, fatigue, anxiety, depression, nervousness, psychosis, dizziness, confusion, hallucinations, hyperthermia.

From the sense organs: tinnitus.

From the genitourinary system: at long reception of greater or big doses - depression of a potency and a libido.

From the side of the musculoskeletal system: arthralgia, myalgia.

Other: dry skin, alopecia, gynecomastia.

Overdose:

Symptoms: vomiting, motor excitation, tremor, lowering blood pressure, tachycardia, collapse.

Treatment: when taken orally, induction of emesis or / and gastric lavage is indicated. Symptomatic and maintenance therapy: with convulsions - intravenously (intravenously) diazepam; bradycardia - atropine; ventricular arrhythmias - lidocaine. Hemodialysis is effective.

Interaction:

Increases the absorption of amoxicillin and clavulanic acid.

Antacids and sucralfate slow absorption.

Reduces the absorption of itraconazole and ketoconazole.

Drugs that depress the bone marrow increase the risk of developing neutropenia.

Special instructions:

Symptoms of duodenal ulcer can disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or X-ray data.

May mask symptoms associated with carcinoma of the stomach, so before starting treatment, you must exclude the presence of malignant neoplasm.

They are being canceled gradually because of the risk of developing the "rebound" syndrome with a sharp cancellation.

With long-term treatment in weakened patients, as well as under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

Blockers H₂-gistaminovyh receptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

Counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, use blockers H₂-gistaminovyh receptors is not recommended.

Blockers H₂-gistaminovyh receptors can suppress the skin reaction to histamine, leading to false-negative results (before conducting diagnostic skin tests for detecting an allergic skin reaction of immediate type, use of blockers H₂-gistaminovyh receptors it is recommended to stop).

During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.

The effectiveness of the drug in inhibiting night secretion of acid in the stomach can be reduced by smoking.

Patients with burns may need to increase the dose of the drug due to increased clearance.

If a dose is missed, it must be taken as soon as possible; Do not take the missed dose if it's time to take the next dose; do not double the dose.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Tablets, film-coated, 20 mg and 40 mg.

Packaging:

10 tablets in a blister pack.

1 blister for tablets of 40 mg or 2 blisters for tablets of 20 mg in a cardboard pack together with instructions for use.

Storage conditions:

In dry, dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life:4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013718 / 01

Date of registration:12.12.2008

Expiration Date:Unlimited

The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic

Manufacturer: & nbsp

PRO.MED.CS Praha, a.s. Czech Republic

Representation: & nbspPRO.MED.CS Prague as. PRO.MED.CS Prague as. Czech Republic

Information update date: & nbsp06.01.2017

Illustrated instructions

Instructions

Famosan® (Famosan®)