Famotidine 20 mg instructions for use. Famotidine - instructions for use and reviews. International non-proprietary name


film-coated tablets

Owner/Registrar

FP OBOLENSKOE CJSC

International Classification of Diseases (ICD-10)

E16.8 Other specified disorders of the internal secretion of the pancreas J95.4 Mendelssohn's syndrome K21.0 Gastroesophageal reflux with esophagitis K25 Gastric ulcer K26 Duodenal ulcer K27 Peptic ulcer, unspecified K29 ​​Gastritis and duodenitis K30 Dyspepsia

Pharmacological group

Histamine H2 receptor blocker. Antiulcer drug

pharmachologic effect

Blocker of H 2 -histamine receptors of the III generation. Suppresses basal and stimulated by histamine, gastrin and acetylcholine production of hydrochloric acid. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin also decreases. Significantly does not change the concentration of gastrin in plasma. Weakly inhibits the cytochrome P450 oxidase system in the liver. After oral administration, the action begins after 1 hour, reaches a maximum within 3 hours. The duration of action of the drug in a single dose depends on the dose and ranges from 12 to 24 hours.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved within 1-3.5 hours. The bioavailability of famotidine is 40-45%, changes slightly in the presence of food and decreases while taking antacids.

Communication with plasma proteins - 15-20%. Penetrates through the placental barrier and 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 hours, in patients with creatinine clearance below 30 ml / min increases to 10-12 hours.

In patients with severe renal insufficiency (creatinine clearance below 10 ml / min), it increases up to 20 hours.

Treatment and prevention of recurrence of peptic ulcer of the stomach and duodenum;

Treatment and prevention of symptomatic gastric and duodenal ulcers (associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress, postoperative ulcers);

Erosive gastroduodenitis;

Functional dyspepsia associated with increased secretory function of the stomach (including heartburn, sour belching);

Reflux esophagitis;

Zollinger-Ellison syndrome;

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

Prevention of aspiration of gastric juice during general anesthesia (Mendelssohn's syndrome).

Children's age up to 12 years (due to lack of sufficient experience in the use of the drug);

Individual hypersensitivity to the components of the drug.

Carefully: liver failure, liver cirrhosis with a history of portosystemic encephalopathy, renal failure, immunodeficiency, old age.

From the digestive system: dry mouth, nausea, vomiting, abdominal pain, loss of appetite. In some cases, an increase in the activity of transaminases in the blood plasma.

From the nervous system: headache, dizziness, tinnitus, transient mental disorders.

From the side of the cardiovascular system: rarely - arrhythmias.

From the side of the hematopoietic organs: rarely - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the reproductive system: with prolonged use of large doses - hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

From the sense organs: paresis of accommodation, blurred vision, ringing in the ears.

Allergic reactions: urticaria, pruritus, skin rash, bronchospasm are possible.

Others: fever, arthralgia, myalgia.

Overdose

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

Treatment: gastric lavage, symptomatic therapy, hemodialysis.

special instructions

Symptoms of duodenal ulcer may disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or x-ray data. May mask the symptoms associated with gastric carcinoma, therefore, before starting treatment, it is necessary to exclude the presence of a malignant neoplasm. Cancel gradually because of the risk of developing the "rebound" syndrome with abrupt cancellation.

With long-term treatment of debilitated patients, as well as stress, bacterial lesions of the stomach are possible, followed by the spread of infection. H2-histamine receptor blockers should be taken 2 hours after taking itraconazole or ketoconazole to avoid a significant decrease in their absorption. Counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach.

Suppresses the skin reaction to histamine, thus leading to false-negative results (it is recommended to stop using H2-histamine receptor blockers before performing diagnostic skin tests to detect an immediate type of allergic skin reaction).

During treatment, you should avoid eating foods, drinks and other drugs that can cause irritation of the gastric mucosa.

The effectiveness of the drug in inhibiting nocturnal acid secretion in the stomach may
decrease as a result of 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 for the next dose; do not double doses.

Influence on the ability to drive a car and other mechanisms

There are no data on the effect of the drug on the ability to drive vehicles or perform work that requires concentration and increased attention.

With kidney failure

With caution in renal failure.

In violation of the functions of the liver

With caution in liver failure.

Elderly

With caution in old age.

Use during pregnancy and lactation

Use during pregnancy is possible only if the potential benefit to the mother outweighs the risk to the fetus.

Penetrates into breast milk. During lactation, discontinue the use of the drug or stop breastfeeding.

drug interaction

Due to an increase in the pH of the contents of the stomach, while taking it, the absorption of ketoconazole and itraconazole may decrease.

With simultaneous use with antacids, sucralfate, the intensity of famotidine absorption decreases, so the interval between taking these drugs should be at least 1-2 hours.

It inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, lidocaine, phenytoin, theophylline, indirect anticoagulants, glipizide, buformin, metronidazole, caffeine, slow calcium channel blockers, tricyclic antidepressants. Increases the absorption of amoxicillin and clavulanic acid.

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

Inside, without chewing, drinking plenty of water.

At peptic ulcer of the stomach and duodenum in the acute phase, symptomatic ulcers, erosive gastroduodenitis usually prescribed 20 mg 2 times a day or 40 mg 1 time per day at night. If necessary, the daily dose can be increased to 80-160 mg. The course of treatment is 4-8 weeks.

At dyspepsia associated with increased secretory function of the stomach, appoint 20 mg 1-2 times a day.

For prevention of recurrence of peptic ulcer of the stomach and duodenum: 20 mg once at bedtime.

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

At 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 may be increased to 160 mg every 6 hours.

For prevention of aspiration of gastric juice during general anesthesia appoint 40 mg in the evening and / or in the morning before surgery.

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

For prevention of recurrent bleeding from the upper gastrointestinal tract- 20 mg 2 times a day for 3-4 weeks.

Storage conditions and shelf life

List B. In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life - 2 years.

Blocker of histamine H 2 receptors. Antiulcer drug

Active substance

Famotidine (famotidine)

Release form, composition and packaging

7 pcs. - cellular contour packings (1) - packs of cardboard.
7 pcs. - cellular contour packings (2) - packs of cardboard.
7 pcs. - cellular contour packings (3) - packs of cardboard.
7 pcs. - cellular contour packings (4) - packs of cardboard.
7 pcs. - cellular contour packings (10) - packs of cardboard.
10 pieces. - cellular contour packings (1) - packs of cardboard.
10 pieces. - cellular contour packings (2) - packs of cardboard.
10 pieces. - cellular contour packings (3) - packs of cardboard.
10 pieces. - cellular contour packings (4) - packs of cardboard.
10 pieces. - cellular contour packings (10) - packs of cardboard.
14 pcs. - cellular contour packings (1) - packs of cardboard.
14 pcs. - cellular contour packings (2) - packs of cardboard.
14 pcs. - cellular contour packings (3) - packs of cardboard.
14 pcs. - cellular contour packings (4) - packs of cardboard.
14 pcs. - cellular contour packings (10) - packs of cardboard.
20 pcs. - cellular contour packings (1) - packs of cardboard.
20 pcs. - cellular contour packings (2) - packs of cardboard.
20 pcs. - cellular contour packings (3) - packs of cardboard.
20 pcs. - cellular contour packings (4) - packs of cardboard.
20 pcs. - cellular contour packings (10) - packs of cardboard.

pharmachologic effect

Blocker of H 2 -histamine receptors of the III generation. Suppresses basal and stimulated by histamine, gastrin and acetylcholine production of hydrochloric acid. Simultaneously with a decrease in the production of hydrochloric acid and an increase in pH, the activity of pepsin also decreases. Does not significantly change the concentration of gastrin in. Weakly inhibits the cytochrome P450 oxidase system in the liver. After oral administration, the action begins after 1 hour, reaches a maximum within 3 hours. The duration of action of the drug in a single dose depends on the dose and ranges from 12 to 24 hours.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved within 1-3.5 hours. The bioavailability of famotidine is 40-45%, changes slightly in the presence of food and decreases during administration.

Communication with plasma proteins - 15-20%. Penetrates through the placental barrier and 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 hours, in patients with creatinine clearance below 30 ml / min increases to 10-12 hours.

In patients with severe (creatinine clearance below 10 ml / min), it increases up to 20 hours.

Indications

- treatment and prevention of recurrence of peptic ulcer of the stomach and duodenum;

- treatment and prevention of symptomatic and duodenal ulcers (associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress, postoperative ulcers);

- erosive gastroduodenitis;

- functional dyspepsia associated with increased secretory function of the stomach (including heartburn, sour belching);

- reflux esophagitis;

- Zollinger-Ellison syndrome;

- prevention of recurrence of bleeding from the upper gastrointestinal tract (GIT);

- prevention of aspiration of gastric juice during general anesthesia (Mendelssohn's syndrome).

Contraindications

- children's age up to 12 years (due to lack of sufficient experience in the use of the drug);

- individual hypersensitivity to the components of the drug.

Carefully: liver failure, liver cirrhosis with a history of portosystemic encephalopathy, renal failure, immunodeficiency, old age.

Dosage

Inside, without chewing, drinking plenty of water.

At peptic ulcer of the stomach and duodenum in the acute phase, symptomatic ulcers, erosive gastroduodenitis usually prescribed 20 mg 2 times a day or 40 mg 1 time per day at night. If necessary, the daily dose can be increased to 80-160 mg. The course of treatment is 4-8 weeks.

At dyspepsia associated with increased secretory function of the stomach, appoint 20 mg 1-2 times a day.

For prevention of recurrence of peptic ulcer of the stomach and duodenum: 20 mg once at bedtime.

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

At 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 may be increased to 160 mg every 6 hours.

For prevention of aspiration of gastric juice during general anesthesia appoint 40 mg in the evening and / or in the morning before surgery.

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

For prevention of recurrent bleeding from the upper gastrointestinal tract- 20 mg 2 times a day for 3-4 weeks.

Side effects

From the digestive system: dry mouth, nausea, vomiting, abdominal pain, loss of appetite. In some cases, an increase in the activity of transaminases in the blood plasma.

From the nervous system: headache, dizziness, tinnitus, transient mental disorders.

From the side of the cardiovascular system: rarely - arrhythmias.

From the side of the hematopoietic organs: rarely - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the reproductive system: with prolonged use of large doses - hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

From the sense organs: paresis of accommodation, blurred vision, ringing in the ears.

Allergic reactions: urticaria, pruritus, skin rash, bronchospasm are possible.

Others: fever, arthralgia, myalgia.

Overdose

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

Treatment: gastric lavage, symptomatic therapy, hemodialysis.

drug interaction

Due to an increase in the pH of the contents of the stomach, while taking itraconazole, absorption may also decrease.

With simultaneous use with antacids, sucralfate, the intensity of famotidine absorption decreases, so the interval between taking these drugs should be at least 1-2 hours.

It inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, indirect anticoagulants, glipizide, buformin, metronidazole, caffeine, slow calcium channel blockers, tricyclic antidepressants. Increases the absorption of amoxicillin and clavulanic acid.

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

special instructions

Symptoms of duodenal ulcer may disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or x-ray data. May mask the symptoms associated with gastric carcinoma, therefore, before starting treatment, it is necessary to exclude the presence of a malignant neoplasm. Cancel gradually because of the risk of developing the "rebound" syndrome with abrupt cancellation.

With long-term treatment of debilitated patients, as well as stress, bacterial lesions of the stomach are possible, followed by the spread of infection. H2-histamine receptor blockers should be taken 2 hours after taking itraconazole or ketoconazole to avoid a significant decrease in their absorption. Counteracts the influence of pentagastrin and histamine on the acid-forming function of the stomach.

Suppresses the skin reaction to histamine, thus leading to false-negative results (it is recommended to stop using H2-histamine receptor blockers before performing diagnostic skin tests to detect an immediate type of allergic skin reaction).

During treatment, you should avoid eating foods, drinks and other drugs that can cause irritation of the gastric mucosa.

The effectiveness of the drug in inhibiting nocturnal acid secretion in the stomach may
decrease as a result of 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 for the next dose; do not double doses.

Influence on the ability to drive a car and other mechanisms

For impaired liver function

With caution in liver failure.

Use in the elderly

With caution in old age.

Terms of dispensing from pharmacies

Over the counter.

Terms and conditions of storage

List B. In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life - 2 years.



General characteristics. Compound:

Active ingredient: famotidine - 0.0200 g or 0.0400 g;

excipients: lactose monohydrate, potato starch, croscarmellose sodium (primellose), colloidal silicon dioxide (aerosil), magnesium stearate; shell composition: hypromellose, macrogol (polyethylene glycol), titanium dioxide E 171, for a dosage of 40 mg iron dye yellow oxide E172.

DESCRIPTION. Tablets, film-coated, white or white with a grayish tint (for a dosage of 20 mg) or yellow (for a dosage of 40 mg), round, biconvex. On a cross section, the color of the tablet core is white or white with a yellow tint.


Pharmacological properties:

Pharmacodynamics. H2 - histamine receptor blocker III generation. Suppresses basal and stimulated by histamine, gastrin and acetylcholine production of hydrochloric acid. Reduces the activity of pepsin. It enhances the protective mechanisms of the gastric mucosa and promotes the healing of its damage associated with exposure to hydrochloric acid (including the cessation of gastrointestinal and scarring of stress ulcers) by increasing the formation of gastric mucus, the content of glycoproteins in it, stimulating the secretion of bicarbonate by the gastric mucosa, endogenous synthesis in her prostaglandins and the rate of regeneration. Significantly does not change the concentration of gastrin in plasma. Weakly inhibits the cytochrome P450 oxidase system in the liver. After oral administration, the action begins after 1 hour, reaches a maximum within 3 hours. The duration of action of the drug in a single dose depends on the dose and ranges from 12 to 24 hours.

Pharmacokinetics. After oral administration, it is rapidly absorbed from the gastrointestinal tract. After oral administration, the maximum plasma concentration is reached within 1-3.5 hours. Bioavailability - 40-45%, increases when taken with food and decreases when taking antacids. Communication with plasma proteins - 15-20%. About 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. The half-life is 2.5-4 hours; in patients with creatinine clearance below 30 ml / min, it increases to 10-12 hours. In patients with severe renal insufficiency (creatinine clearance below 10 ml / min), it increases up to 20 hours. Penetrates through the placental barrier and excreted in breast milk.

Indications for use:

Peptic ulcer of the duodenum and stomach in the acute phase, prevention of relapses.

Treatment and prevention of symptomatic gastric and duodenal ulcers (associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress, postoperative ulcers).

Dosage and administration:

inside. With peptic ulcer of the stomach and 12 duodenal ulcer in the acute phase, symptomatic ulcers, erosive gastroduodenitis, 20 mg 2 times a day or 40 mg 1 time per day at night are usually prescribed. 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, 20 mg is prescribed 1-2 times a day. In order to prevent recurrence of peptic ulcer, 20 mg is prescribed once a day at bedtime. With reflux esophagitis - 20-40 mg twice a 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 may be increased to 160 mg every 6 hours. For the prevention of aspiration of gastric juice during general anesthesia, 40 mg is prescribed in the evening and / or in the morning before surgery. Tablets should be swallowed without chewing, drinking plenty of water. In renal failure, if creatinine clearance is less than 30 ml / min or serum creatinine is more than 3 mg / 100 ml, the daily dose of the drug should be reduced to 20 mg.

Application Features:

Before starting treatment, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum. Famotidine, like all H2-histamine blockers, is undesirable to abruptly cancel (rebound syndrome). With long-term treatment in debilitated patients, under conditions of stress, bacterial lesions of the stomach are possible, followed by the spread of infection. H2-histamine receptor blockers can counteract the effect of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within the 24 hours preceding the test, the use of H2-histamine receptor blockers is not recommended. H2-histamine receptor blockers can suppress the skin reaction to histamine, thus leading to false negative results (it is recommended to stop using H2-histamine receptor blockers before performing diagnostic skin tests to detect an immediate type of allergic skin reaction). During treatment, you should avoid eating foods, drinks and other drugs that can cause irritation of the gastric mucosa. Influence on the ability to drive a car and other mechanisms. During the period of treatment, care should be taken when driving vehicles and other activities that require an increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the digestive system: dry mouth, abdominal pain, loss of appetite, increased activity of "liver" transaminases, acute. From the nervous system: confusion. From the side of the cardiovascular system: lowering blood pressure, atrioventricular blockade,. Allergic reactions:, bronchospasm, angioedema,. From the side of the hematopoietic organs: rarely -,; in isolated cases - pancytopenia, hypoplasia, bone marrow aplasia. On the part of the reproductive system: with prolonged use of large doses - decreased libido, impotence. From the senses: paresis of accommodation, blurred vision, ringing in the ears. Other: rarely - fever,.

Interaction with other drugs:

Due to an increase in the pH of the contents of the stomach, while taking it, the absorption of ketoconazole and itraconazole may decrease. With simultaneous use with antacids, sucralfate, the intensity of famotidine absorption decreases, so the interval between taking these drugs should be at least 1-2 hours. It inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, lidocaine, phenytoin, theophylline, indirect anticoagulants, glipizide, buformin, metronidazole, caffeine, slow calcium channel blockers, tricyclic antidepressants. Increases the absorption of amoxicillin and clavulanic acid. Medicines that depress the bone marrow increase the risk of developing neutropenia.

Contraindications:

Pregnancy, lactation, childhood, hypersensitivity to the components of the drug.

Overdose:

Symptoms: vomiting, motor agitation, lowering blood pressure, .

Storage conditions:

In a dry, dark place, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Leave conditions:

On prescription

Package:

Film-coated tablets, 20 mg and 40 mg. 10 tablets in a blister pack. 1, 2 or 3 blister packs together with instructions for use in a cardboard pack.


Famotidine - a drug (tablets), belongs to the category of drugs used for conditions associated with acid disorders. The instructions for use highlight the following features:

  • Sold by prescription only
  • During pregnancy: with caution
  • When breastfeeding: contraindicated
  • In childhood: contraindicated
  • With impaired liver function: with caution
  • In case of impaired renal function: with caution
  • In old age: with caution

Package

Compound

Additional elements are: starch, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, talc, as well as titanium dioxide, hydroxypropyl methylcellulose, iron oxide, macrogol 600.

Release form

Pills.

pharmachologic effect

Blocker of histamine H 2 receptors. It has an anti-ulcer effect.

Pharmacodynamics and pharmacokinetics

The active ingredient inhibits the production of basal hydrochloric acid in the stomach, as well as HCl stimulated by acetylcholine, histamine and gastrin. Reduces the activity of pepsin, increases the pH of gastric juice, reduces the production of HCl.

By increasing the level of glycoproteins, increasing the formation of gastric mucus, stimulating the synthesis of prostaglandins, the secretion of bicarbonate, the protective and wound-healing effect of the drug is achieved.

The drug helps to stop gastric bleeding, promotes healing of lesions on the gastric mucosa, and scars stress ulcers.

The drug has a weak effect on the oxidase system of the cytochrome P450 enzyme in the hepatic system (suppressive effect).

The medicine begins its action in an hour, lasts 12-24 hours. With intravenous administration of solutions with the active substance famotidine, the effect is recorded after half an hour. A single dose leads to suppression of secretion for 10-12 hours.

Indications for use Famotidine

What are the pills for?

The drug is prescribed for hyperacidity of gastric juice, ulcerative lesions of the digestive system, stress ulcers, symptomatic ulcers, Zollinger-Ellison syndrome, NSAID gastropathy, erosive variant of reflux esophagitis, heartburn, for the prevention of recurrent bleeding after surgical interventions on the digestive system, polyendocrine adenomatosis, with systemic mastocytosis.

What other indications are there for the use of Famotidine? The drug is prescribed to prevent aspiration of gastric juice in patients who are given general anesthesia. The drug is effective in dyspeptic disorders. The drug is prescribed for the prevention of aspiration pneumonitis.

Contraindications

Famotidine is not prescribed for breastfeeding, intolerance to components, during pregnancy.

With cirrhosis of the liver with concomitant portosystemic encephalopathy, with pathology of the kidneys, the hepatic system, in pediatrics, it is prescribed with caution.

Side effects

Digestive tract: epigastric pain, dry mouth, nausea, loss of appetite, vomiting, elevated liver enzymes, acute pancreatitis, mixed hepatitis, hepatocellular hepatitis, cholestatic hepatitis.

Sense organs: ringing in the ears, paresis of accommodation, blurred vision.

Genitourinary system: decreased libido, amenorrhea, gynecomastia, hyperprolactinemia.

Agranulocytosis, allergic reactions, tremor, drop in blood pressure, dizziness, asystole, AV blockade, bradycardia, anaphylactic shock, bronchospasm, myalgia, arthralgia, hallucinations may develop.

Famotidine, instructions for use (Method and dosage)

Instructions for use Famotidine tablets

Taken inside.

With ulcerative lesions of the digestive system: 0.02 grams twice a day or 0.04 grams at bedtime. In some cases, the amount of the drug is increased to 80-160 mg. The duration of therapy is 4-8 weeks.

In order to prevent recurrence of ulcerative lesions, it is prescribed 1 time per day, 0.02 grams at night.

The initial dose for Zollinger-Ellison syndrome is 20-40 mg 4 times a day, it is possible to increase the dose to 24-48 mg.

Prevention of aspiration of stomach contents: 0.04 grams; before surgery, take 2 hours before surgery. With reflux esophagitis: twice a day, 0.02 grams.

Preparations with a solution of famotidine

Intravenously injected slowly over 2 minutes: 20 mg every 12 hours. For the prevention of aspiration pneumonitis: intramuscularly 0.02 grams before surgery, or in the morning on the day of surgery.

Powder for injection is dissolved in sodium chloride 0.9% 5-10 ml.

Overdose

Manifested by tremor, collapse, motor excitation, drop in blood pressure, vomiting.

Requires hemodialysis, symptomatic therapy.

Interaction

Famotidine inhibits the metabolism of diazepam, aminophenazone, phenazone, lidocaine, caffeine, tricyclic antidepressants, phenytoin, indirect anticoagulants, aminophylline, metronidazole, metoprolol, buformin, glipizide, theophylline, metoprolol, clavulanic acid in the liver.

When taking drugs that depress the bone marrow increases the risk of developing neutropenia. Famotidine reduces the absorption of ketoconazole, itraconazole.

Sucralfate and antacids slow down the rate of absorption. Famotidine is compatible with sodium chloride solution, dextrose. The drug increases the absorption of clavulonic acid, amoxicillin.

Terms of sale

Need a prescription.

Storage conditions

In a dark, dry place inaccessible to children at a temperature of 15-25 degrees Celsius.

Best before date

No more than three years.

special instructions

Famotidine may mask symptoms suggestive of carcinoma in the stomach. It is recommended to exclude malignant neoplasms of the digestive tract before prescribing the drug.

The drug must be discontinued gradually to prevent rebound syndrome. With stress, long-term therapy, the development of a bacterial infection in the stomach is possible, and further spread of microbes is not excluded.

Famotidine must be taken two hours after the use of ketoconazole, itraconazole to prevent their hyperabsorption.

When conducting skin reactions to histamine, it is important to consider that a histamine receptor blocker can suppress the reaction and lead to a false negative result.

Treatment involves the exclusion from the diet of foods that irritate the gastric mucosa.

Famotidine's analogs

Analogues are drugs: Gastromax, Gastrotide, Kvamatel, Ulfamid, Famodingexal, Famozol, Famosan.

Reviews about Famotidine

An inexpensive and effective medicine used for problems with the gastrointestinal tract. Helps with ulcers, gastritis.

In negative reviews of Famotidine, there are complaints about side effects and contraindications.

Famotidine price, where to buy

The price of Famotidine in 20 mg tablets ranges from 32 to 55 rubles per pack of 20 pieces.

Europharm* 4% discount with promo code medside11

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P N014077/01 Tradename: famotidine

International non-proprietary name:

famotidine

Dosage form:

film-coated tablets.

COMPOUND
Each 20 mg film-coated tablet contains the active ingredient famotidine 20 mg.
Excipients: corn starch - 16.0 mg, microcrystalline cellulose - 78.35 mg, silicon dioxide - 1.4 mg, talc - 5.625 mg, magnesium stearate - 1.125 mg, croscarmellose sodium - 2.5 mg.
Shell: hypromellose - 2.5 mg, titanium dioxide - 1.53 mg, lactose monohydrate - 1.313 mg, macrogol-4000 - 0.5 mg, triacetin - 0.375 mg, iron dye yellow oxide - 0.021 mg, iron dye red oxide [E172] - 0.006 mg, iron dye black oxide [E172] - 0.005 mg.
1 film-coated tablet 40 mg contains the active ingredient famotidine 40 mg.
Excipients: corn starch - 32.0 mg, microcrystalline cellulose - 156.7 mg, silicon dioxide - 2.8 mg, talc - 11.25 mg, magnesium stearate - 2.25 mg, croscarmellose sodium - 5.0 mg.
Shell: hypromellose - 5.0 mg, titanium dioxide - 2.61 mg, lactose monohydrate - 2.625 mg, macrogol-4000 - 1.0 mg, triacetin - 0.75 mg, iron dye yellow oxide [E172] - 0.375 mg, iron dye oxide red [E172] - 0.125 mg, iron dye black oxide [E172] - 0.015 mg.

DESCRIPTION:
Film-coated tablets 20 mg: round, biconvex film-coated tablets, pale pink with a grayish tint, white on a break.
Film-coated tablets 40 mg: round, biconvex film-coated tablets, pale brown with a slightly pinkish tint, white on the break.

Pharmacotherapeutic group
Gastric glands secretion lowering agent - H 2 -histamine receptor blocker

ATX code:[A02BA03].

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics. Famotidine is a competitive histamine antagonist. 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 extent, the induced secretion of pepsinogen is inhibited. It causes a dose-dependent suppression of hydrochloric acid production and a decrease in pepsin activity. Significantly does not change the level of gastrin in plasma. The duration of action of the drug in a single dose depends on the dose and ranges from 12 to 24 hours.
Pharmacokinetics. After oral administration, it is rapidly absorbed from the gastrointestinal tract. After oral administration, the maximum plasma concentration is reached within 1-3.5 hours. Plasma protein binding 15-20%. 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. The half-life is 2.5-4 hours, in patients with creatinine clearance below 30 ml / min it increases to 10-12 hours. Penetrates through the placental barrier and excreted in breast milk.

INDICATIONS FOR USE
- Peptic ulcer of the stomach and duodenum, prevention of recurrence;
- Erosive gastroduodenitis;
- Functional dyspepsia associated with increased secretory function;
- Symptomatic and stress ulcers of the gastrointestinal tract;
- Reflux esophagitis;
- prevention of relapses associated with long-term use of non-steroidal anti-inflammatory drugs;
- Zollinger-Ellison syndrome;
- Systemic mastocytosis;
- Polyendocrine adenomatosis,
- Prevention of recurrence of bleeding in the postoperative period.
- Prevention of aspiration of gastric juice in patients undergoing operations under general anesthesia (Mendelssohn's syndrome);
- Prevention of aspiration pneumonitis;
- Dyspepsia with epigastric or retrosternal pain occurring at night or associated with eating.

CONTRAINDICATIONS
Pregnancy, lactation, hypersensitivity to famotidine and other blockers of H 2 -histamine receptors, children's age.
Carefully: hepatic and / or renal failure, cirrhosis of the liver with portosystemic encephalopathy (history), immunodeficiency.

USE IN PREGNANCY AND LACTATION
During pregnancy and lactation - the use of the drug is contraindicated.

METHOD OF APPLICATION AND DOSES
Inside, without chewing, drinking plenty of water.
Adults:
With peptic ulcer of the stomach and duodenum in the acute phase, symptomatic ulcers, erosive gastroduodenitis usually prescribed 20 mg 2 times a day or 40 mg 1 time per day at 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 a day.
To prevent recurrence of peptic ulcer appoint 20 mg 1 time per day at bedtime.
For reflux esophagitis 20–40 mg twice daily for 6–12 weeks.
With Zollinger-Ashison 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 may be increased to 160 mg every 6 hours.
For the prevention of aspiration of gastric juice during general anesthesia appoint 40 mg in the evening and / or in the morning before surgery. Famotidine tablets should be swallowed without chewing, pouring enough water.
With kidney failure if the creatinine clearance 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.

SIDE EFFECT
- Dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, loss of appetite;
- Increased activity of "liver" enzymes, hepatitis, acute pancreatitis;
- Headache, dizziness, insomnia, anxiety, tinnitus;
- Increased fatigue, drowsiness, depression, nervousness, psychosis;
- Fuzziness of visual perception, paresis of accommodation;
- Confusion of consciousness, hallucinations, hyperthermia;
- fever;
- bradycardia, arrhythmia, vasculitis, lowering blood pressure, antrioventricular blockade;
- Muscle pain, joint pain;
- Dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitization;
- An increase in the level of urea in the blood, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.
- With prolonged use of large doses - hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

OVERDOSE
Symptoms: vomiting, motor excitation, tremor, decrease in blood pressure, tachycardia, collapse.
Treatment: when taken orally, induction of vomiting and/or gastric lavage is indicated. Symptomatic and supportive therapy: for convulsions - intravenous diazepam; with bradycardia - atropine; with ventricular arrhythmias - lidocaine. Hemodialysis is effective.

INTERACTION WITH OTHER DRUGS
Increases the absorption of amoxicillin and clavulanic acid.
Compatible with 0.18 and 0.9% NaCl solution, 4 and 5% dextrose solution, 4.2% sodium bicarbonate solution.
With simultaneous use with antacids containing magnesium and aluminum, sucralfate reduces the intensity of absorption of famotidine, so the interval between taking these drugs should be at least 1-2 hours.
Due to an increase in the pH of the contents of the stomach, while taking it, the absorption of ketoconazole and itraconazole may decrease.
Medicines that depress the bone marrow increase the risk of developing neutropenia.
It inhibits the metabolism in the liver of diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, indirect anticoagulants.

SPECIAL INSTRUCTIONS
Before starting treatment, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum, since famotidine may mask symptoms.
Symptoms of duodenal ulcer may disappear within 1-2 weeks, therapy should be continued until scarring is confirmed by endoscopic or x-ray data.
Discontinue Famotidine gradually due to the risk of rebound syndrome with abrupt withdrawal.
With prolonged treatment in debilitated patients, as well as stress, bacterial lesions of the stomach are possible, followed by the spread of infection. Famotidine (a blocker of H 2 -histamine receptors) should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant decrease in their absorption.
It counteracts the effect of pentagastrin and histamine on the acid-forming function of the stomach, therefore, it is not recommended to use Famotidine within 24 hours prior to the test.
Famotidine suppresses the skin reaction to histamine, thus leading to false negative results (it is recommended to stop using Famotidine before performing diagnostic skin tests to detect an immediate type of allergic skin reaction).
During treatment, you should avoid eating food, drinks, and other drugs that can cause irritation of the gastric mucosa.
The effectiveness of famotidine in inhibiting nocturnal gastric acid secretion may 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 for the next dose; do not double doses. If there is no improvement, a doctor's consultation is necessary.

RELEASE FORM
Film-coated tablets 20 mg and 40 mg.
10 film-coated tablets in a PVC/AL blister. 2 or 3 blisters with instructions for use in a cardboard box.

STORAGE CONDITIONS
List B.
In a dry, dark place at a temperature of 15 to 25 ° C.
Keep out of the reach of children.

BEST BEFORE DATE
3 years.
Do not use after the expiry date stated on the packaging.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
On prescription.

Manufacturer
1. Manufacturer
Hemofarm A.D., Serbia
26300 Vrsac, Beogradsky way bb, Serbia
Representative office in the Russian Federation / organization that accepts claims from consumers:
107023, Moscow, st. Elektrozavodskaya, 27, building 2.
In the case of packaging at Hemofarm Ltd. Russia:
Produced by: Hemofarm A.D., Vrsac, Serbia
Packed:

Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv shosse, 62.

OR
2. Manufacturer
Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv shosse, 62.
Organization accepting complaints from consumers:
Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv shosse, 62.