Universal reference book for medicines
Name of the drug: FAMOTYDIN (FAMOTIDIN)

Active ingredient: famotidine

Type: The blocker of histamine H 2 -receptors.
Antiulcer drug
Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
The tablets covered with a film membrane of
pale brown color, round, biconcave.

1 tab.

famotidine 20 mg

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

Composition of the membrane: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron dye oxide brown.

10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
The tablets covered with a film membrane of brown color with slightly pinkish shade, round, biconcave.

1 tab.

famotidine 40 mg

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

Composition of the membrane: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron dye oxide brown.

10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Famotidine is a competitive antagonist of histamine.
Acting on histamine H 2 -receptors of parietal cells, significantly reduces the secretion of hydrochloric acid caused by various stimuli. The basal secretion of hydrochloric acid also decreases. To a lesser degree, the induced secretion of pepsinogen is inhibited. Causes dose-dependent suppression of production of hydrochloric acid and a decrease in the activity of pepsin. It does not significantly alter the level of gastrin in the plasma.
The duration of the drug in a single dose depends on the dose and is from 12 to 24 hours.

PHARMACOKINETICS

After oral administration, it is rapidly absorbed from the digestive tract.
After ingestion C max in blood plasma is achieved within 1 to 3.5 hours.
Binding to plasma proteins is 15-20%.
It penetrates through the placental barrier and is excreted in breast milk.
30-35% of famotidine is metabolized in the liver (with the formation of S-oxide).

Elimination, mainly, occurs through the kidneys: 27-40% of the drug is excreted in the urine unchanged.
T 1/2 - 2.5-4 h, in patients with QC below 30 ml / min increases to 10-12 hours.
INDICATIONS

- Stomach ulcer and duodenal ulcer, prevention of relapses;

- erosive gastroduodenitis;

- functional dyspepsia associated with an increased secretory function;

- symptomatic and stressful gastrointestinal ulcers;

- reflux esophagitis;

- prevention of relapses associated with prolonged intake of NSAIDs;

- Zollinger-Ellison syndrome;

- systemic mastocytosis;

- polyendocrine adenomatosis;

- prevention of bleeding recurrences in the postoperative period;

- prevention of aspiration of gastric juice in patients undergoing general anesthetic surgery (Mendelssohn syndrome);

- prevention of aspiration pneumonitis;

- dyspepsia with epigastric or chest pain, arising at night or associated with food intake.

DOSING MODE

Inside, not liquid, squeezed enough water.

Adults:

With gastric ulcer and duodenal ulcer in the phase of exacerbation, symptomatic ulcers, erosive gastroduodenitis usually prescribed 20 mg 2 times / day or 40 mg 1 time / day for the night.
If necessary, the daily dose can be increased to 80-160 mg. The course of treatment is 4-8 weeks.
With dyspepsia associated with increased secretory function of the stomach, appoint 20 mg 1-2 times / day.

In order to prevent recurrences of peptic ulcer , 20 mg 1 time / day before bedtime is prescribed.

When refpux-esophagitis - 20-40 mg 2 times / day for 6-12 weeks.

With Zollinger-Ellison syndrome, the dose of the drug and the duration of the course of treatment are set individually.
The initial dose is usually 20 mg every 6 hours and can be increased to 160 mg every 6 hours.
To prevent the aspiration of gastric juice with general anesthesia appoint 40 mg in the evening and / or in the morning before the operation.

Famotidine tablets should be swallowed without chewing, with plenty of water.

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

Children over 3 years:

With gastric ulcer and duodenal ulcer in the phase of exacerbation, reflux-esophagitis Famotidine is prescribed for children with a body weight of more than 10 kgat a rate of 2 mg / kg / day, divided into 2 doses or 20 mg 2 times / day, but not more than 40 mg / day.

SIDE EFFECT

On the part of the digestive system: dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, impaired appetite;
increased activity of hepatic enzymes, hepatitis, acute pancreatitis.
From the side of the central nervous system: headache, dizziness, insomnia, anxiety, tinnitus;
increased fatigue, drowsiness, depression, nervousness, psychosis;blurred vision, paresis of accommodation; confusion, hallucinations, hyperthermia.
From the cardiovascular system: bradycardia, arrhythmia, vasculitis, lowering of blood pressure, AV blockade.

Dermatological reactions: dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm,

antineurotic edema, anaphylactic shock, other manifestations of hypersensitivity.

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.

On the part of the reproductive system: with prolonged intake of large doses of hyperprolactinaemia, gynecomastia, amenorrhea,

decreased libido, impotence.

Other: fever, muscle pain, joint pain, increased urea levels in the blood.

CONTRAINDICATIONS

- Pregnancy;

- lactation period;

- Children under 3 years of age with a body weight of less than 20 kg (for this dosage form);

- Hypersensitivity to famotidine and other blockers of histamine H 2 -receptors.

With caution: hepatic and / or renal failure, cirrhosis with portosystemic encephalopathy (in the anamnesis), immunodeficiency, children's age.

PREGNANCY AND LACTATION

During pregnancy and lactation, the use of the drug is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

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

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: hepatic insufficiency, cirrhosis of the liver with portosystemic encephalopathy (in the anamnesis).

APPLICATION FOR CHILDREN

Children over 3 years:

With gastric ulcer and duodenal ulcer in the phase of exacerbation, reflux-esophagitis Famotidine is prescribed for children with a body weight of more than 10 kgat a rate of 2 mg / kg / day, divided into 2 doses or 20 mg 2 times / day, but not more than 40 mg / day.

Contraindicated: children under 3 years old with a body weight of less than 20 kg (for this dosage form);

SPECIAL INSTRUCTIONS

Before the beginning of treatment it is necessary to exclude the possibility of having a malignant disease of the esophagus, stomach or duodenum, since Famotidine can mask symptoms.

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

They abolish famotidine 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.

Famotidine (a blocker of histamine H 2 -receptors) should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

It counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach, therefore it is not recommended to apply famotidine for 24 hours prior to the test.

Famotidine suppresses skin reaction to histamine, thus leading to false negative results (it is recommended to stop using Famotidine before conducting diagnostic skin tests to detect an allergic skin reaction of immediate type).

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

The efficacy of famotidine 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 if it is time to take the next dose; do not double the dose. If there is no improvement, consult a doctor.
OVERDOSE

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

Treatment: when taken orally, induction of vomiting or / and gastric lavage is indicated.
Symptomatic and maintenance therapy: with convulsions - in / in diazepam;with bradycardia, atropine; when ventricular arrhythmias - lidocaine. Hemodialysis is effective.
DRUG INTERACTION

Increases the absorption of amoxicillin and clavulanic acid.

Compatible with 0.18 and 0.9% sodium chloride solution, 4% and 5% dextrose solution, 4.2% sodium bicarbonate solution.

With simultaneous use with antacid agents containing magnesium and aluminum, sucralfate decreases the intensity of absorption of famotidine, therefore, a break between taking these drugs should be at least 1-2 hours.

Due to the increase in the pH of the contents of the stomach with simultaneous intake may decrease absorption of ketoconazole and itraconazole.

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

Inhibits the metabolism in the liver of diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, indirect anticoagulants.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Keep out of reach of children, dry, protected from light at a temperature of 15 ° to 25 ° C.
Shelf life - 3 years.
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