Mastodon

Famotidine (Tablets, Lyophilisate) Instructions for Use

ATC Code

A02BA03 (Famotidine)

Active Substance

Famotidine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H2-receptor blocker. Antiulcer drug

Pharmacotherapeutic Group

H2 histamine receptor blocker

Pharmacological Action

Famotidine is a competitive histamine antagonist.

By acting on the histamine H2-receptors of parietal cells, it significantly reduces the secretion of hydrochloric acid induced by various stimuli. Basal secretion of hydrochloric acid is also reduced. Stimulated secretion of pepsinogen is inhibited to a lesser extent. It causes a dose-dependent suppression of hydrochloric acid production and a decrease in pepsin activity. It does not significantly alter the plasma gastrin level.

The duration of the drug’s action after 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, Cmax in blood plasma is reached within 1-3.5 hours.

Plasma protein binding is 15-20%. It penetrates the placental barrier and is excreted in breast milk.

30-35% of famotidine is metabolized in the liver (forming S-oxide).

Elimination occurs mainly through the kidneys: 27-40% of the drug is excreted unchanged in the urine. T1/2 is 2.5-4 hours; in patients with CrCl below 30 ml/min, it increases to 10-12 hours.

Indications

  • Gastric and duodenal ulcer, prevention of recurrence;
  • Erosive gastroduodenitis;
  • Functional dyspepsia associated with increased secretory function;
  • Symptomatic and stress ulcers of the gastrointestinal tract;
  • Reflux esophagitis;
  • Prevention of recurrence associated with long-term use of NSAIDs;
  • Zollinger-Ellison syndrome;
  • Systemic mastocytosis;
  • Multiple endocrine adenomatosis;
  • Prevention of recurrent bleeding in the postoperative period;
  • Prevention of gastric juice aspiration in patients undergoing surgery under general anesthesia (Mendelson’s syndrome);
  • Prevention of aspiration pneumonitis;
  • Dyspepsia with epigastric or retrosternal pain occurring at night or associated with food intake.

ICD codes

ICD-10 code Indication
C96.2 Malignant mast cell tumor
D44.8 Lesion of more than one endocrine gland (multiple endocrine adenomatosis)
E16.4 Disorder of gastrin secretion (hypergastrinemia, Zollinger-Ellison syndrome)
J95.4 Mendelson's syndrome
K21.0 Gastro-esophageal reflux disease with esophagitis
K25 Gastric ulcer
K26 Duodenal ulcer
K27 Peptic ulcer
K29 Gastritis and duodenitis
K30 Functional dyspepsia (digestive disorder)
Y45 Analgesics, antipyretics and anti-inflammatory drugs
ICD-11 code Indication
02 Neoplasms
2A21.Z Mastocytosis, unspecified
2F7A.Z Neoplasms of uncertain behavior of endocrine glands, unspecified
2F9A Neoplasms of endocrine glands of unknown nature
5A43.Z Gastrin secretion disorder, unspecified
CA72 Mendelson's syndrome
DA22.Z Gastro-esophageal reflux disease, unspecified
DA24.Z Unspecified esophagitis
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA61 Peptic ulcer of unspecified site
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, without chewing, with a sufficient amount of water.

Adults

For gastric and duodenal ulcer in the acute phase, symptomatic ulcers, erosive gastroduodenitis, 20 mg 2 times/day or 40 mg once/day at night is usually prescribed. If necessary, the daily dose can be increased to 80-160 mg. The course of treatment is 4-8 weeks.

For dyspepsia associated with increased gastric secretory function, 20 mg 1-2 times/day is prescribed.

For prevention of peptic ulcer recurrence, 20 mg once/day before bedtime is prescribed.

For reflux esophagitis – 20-40 mg 2 times/day for 6-12 weeks.

For Zollinger-Ellison syndrome, the drug dose and duration of the treatment course are set individually. The initial dose is usually 20 mg every 6 hours and can be increased to 160 mg every 6 hours.

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

Famotidine tablets should be swallowed without chewing, with a sufficient amount of water.

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

Children over 3 years old

For gastric and duodenal ulcer in the acute phase, reflux esophagitis, Famotidine is prescribed to children weighing more than 10 kg at a dose of 2 mg/kg/day, divided into 2 doses, or 20 mg 2 times/day, but not more than 40 mg/day.

Lyophilisate

Individual, depending on the indications.

Orally for treatment, 10-20 mg 2 times/day or 40 mg once/day is used. If necessary, the daily dose can be increased to 80-160 mg. For prevention – 20 mg once/day before bedtime.

For IV administration, a single dose is 20 mg, the interval between administrations is 12 hours.

If CrCl is less than 30 ml/min or serum creatinine concentration is more than 3 mg/dl, the dose is recommended to be reduced to 20 mg/day.

Adverse Reactions

From the digestive system dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, loss of appetite; increased activity of liver enzymes, hepatitis, acute pancreatitis.

From the CNS headache, dizziness, insomnia, anxiety, tinnitus; increased fatigue, drowsiness, depression, nervousness, psychosis; blurred vision, accommodation paresis; confusion, hallucinations, hyperthermia.

From the cardiovascular system bradycardia, arrhythmia, vasculitis, decreased BP, AV block.

Dermatological reactions dry skin, alopecia, acne vulgaris, skin rash, itching, bronchospasm, angioedema, anaphylactic shock, other manifestations of hypersensitivity.

From the hematopoietic system leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypoplasia, bone marrow aplasia.

From the reproductive system with long-term use of high doses – hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

Other fever, muscle pain, joint pain, increased blood urea level.

Contraindications

  • Pregnancy;
  • Lactation period;
  • Children under 3 years of age weighing less than 20 kg (for this dosage form);
  • Hypersensitivity to famotidine and other histamine H2-receptor blockers.

With caution: hepatic and/or renal failure, liver cirrhosis with portosystemic encephalopathy (in history), immunodeficiency, children’s age.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is contraindicated.

Use in Hepatic Impairment

With caution: hepatic failure, liver cirrhosis with portosystemic encephalopathy (in history).

Use in Renal Impairment

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

Pediatric Use

Children over 3 years old

For gastric and duodenal ulcer in the acute phase, reflux esophagitis, Famotidine is prescribed to children weighing more than 10 kg at a dose 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 of age weighing less than 20 kg (for this dosage form);

Special Precautions

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

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

Famotidine should be discontinued gradually due to the risk of developing a “rebound” syndrome upon abrupt withdrawal.

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

Famotidine (histamine H2-receptor blocker) should be taken 2 hours after taking itraconazole or ketoconazole to avoid a significant reduction in their absorption.

It counteracts the effect of pentagastrin and histamine on gastric acid-forming function, so it is not recommended to use Famotidine for 24 hours preceding the test.

Famotidine suppresses the skin reaction to histamine, thus leading to false-negative results (before performing diagnostic skin tests to detect an immediate-type allergic skin reaction, it is recommended to discontinue the use of Famotidine).

During treatment, consumption of food, beverages, and other medications that may cause irritation of the gastric mucosa should be avoided.

The effectiveness of Famotidine in inhibiting nocturnal acid secretion in the stomach may be reduced as a result of smoking.

Patients with burns may require an increase in the drug dose due to increased clearance.

If a dose is missed, it should be taken as soon as possible; do not take if it is time for the next dose; do not double the dose. If there is no improvement, a doctor’s consultation is necessary.

Overdose

Symptoms: vomiting, motor agitation, tremor, decreased BP, tachycardia, collapse.

Treatment: in case of oral intake, induction of vomiting and/or gastric lavage is indicated. Symptomatic and supportive therapy: for convulsions – IV diazepam; for bradycardia – atropine; for ventricular arrhythmias – lidocaine. Hemodialysis is effective.

Drug Interactions

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 antacids containing magnesium and aluminum, sucralfate, the intensity of famotidine absorption decreases, so the interval between taking these drugs should be at least 1-2 hours.

Due to an increase in the pH of gastric contents upon simultaneous administration, the absorption of ketoconazole and itraconazole may decrease.

Drugs that suppress the bone marrow increase the risk of neutropenia.

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

Storage Conditions

List B. Keep out of reach of children, in a dry, light-protected place at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Labeled By

CHEMOPHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 20, 30, or 10980 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale brown in color, round, biconvex.

1 tab.
Famotidine 20 mg

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

Coating composition: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide brown.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (1098) – cardboard boxes.

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Labeled By

CHEMOPHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 40 mg: 20, 30, or 7800 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brown with a slightly pinkish tint, round, biconvex.

1 tab.
Famotidine 40 mg

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

Coating composition: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide brown.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (780) – cardboard boxes.

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Manufactured By

Chemopharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 40 mg: 20, 30, or 7800 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brown with a slightly pinkish tint, round, biconvex.

1 tab.
Famotidine 40 mg

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

Coating composition: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide brown.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (780) – cardboard boxes.

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Manufactured By

Chemopharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 20, 30, or 10980 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale brown in color, round, biconvex.

1 tab.
Famotidine 20 mg

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

Coating composition: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide brown.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (1098) – cardboard boxes.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

Bottle OTC Icon Famotidine Sugar-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 70, 80, 100, 140 or 200 pcs.
Sugar-coated tablets, 40 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, 56, 60, 70, 100 or 140 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Famotidine 20 mg
-"- 40 mg

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (1) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilisate for preparation of solution for intravenous administration 20 mg: vial 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration as a porous mass of white or almost white color, clumping is allowed; solvent: transparent colorless solution.

1 vial
Famotidine 20 mg

Excipients: mannitol – 44 mg, aspartic acid – 8.8 mg.

Solvent (in 1 ml): sodium chloride – 9 mg, water for injection – up to 1 ml.

20 mg – vials of colorless glass (5) in a set with solvent (amp. 5 ml 5 pcs.) – cardboard packs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Forms

Bottle OTC Icon Famotidine Film-coated tablets, 20 mg: 10, 20, or 30 pcs.
Film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or white with a grayish tint, round, biconvex; on the cross-section, the color of the tablet core is white or almost white with a yellowish tint.

1 tab.
Famotidine 20 mg

Excipients: lactose monohydrate, potato starch, croscarmellose sodium (primellose), colloidal silicon dioxide (aerosil), magnesium stearate.

Shell composition hypromellose, macrogol (polyethylene glycol), titanium dioxide (E171).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets yellow, round, biconvex; on the cross-section, the color of the tablet core is white or almost white with a yellowish tint.

1 tab.
Famotidine 40 mg

Excipients: lactose monohydrate, potato starch, croscarmellose sodium (primellose), colloidal silicon dioxide (aerosil), magnesium stearate.

Shell composition hypromellose, macrogol (polyethylene glycol), titanium dioxide (E171), yellow iron oxide dye (E172).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Kursk Biopharmaceutical Plant – Firm "Biok", FKP (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilisate for preparation of solution for intravenous administration 20 mg: vial or amp. 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration as a porous mass of white or almost white color, clumping is allowed; solvent – transparent, colorless solution.

1 vial
Famotidine 20 mg

Excipients: aspartic acid – 8.8 mg, mannitol – 44 mg.

Solvent (0.9% sodium chloride solution) sodium chloride – 45 mg, water for injection – 5 ml.

20 mg – vials (5) – contour cell packaging (1) – in a set with solvent (amp. 5 pcs.) – contour cell packaging (1) – cardboard packs.
20 mg – ampoules (5) – contour cell packaging (1) – in a set with solvent (amp. 5 pcs.) – contour cell packaging (1) – cardboard packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilisate for preparation of solution for intravenous administration 20 mg: vial in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration from white to white with a yellowish tint.

1 vial
Famotidine 20 mg

Excipients: aspartic acid – 8.8 mg, mannitol – 44 mg, sodium hydroxide – to pH 5.0-5.5.

Solvent sodium chloride solution 0.9%

Vial – cardboard pack.
Vial (10) – cardboard pack.
Vials in a set with solvent (amp. 5 ml – 2 pcs.) – contour cell packaging – cardboard packs.
Vials in a set with solvent (amp. 10 ml – 1 pc.) – contour cell packaging – cardboard packs.
Vials (5) in a set with solvent (amp. 5 ml – 10 pcs.) – contour cell packaging – cardboard packs.
Vials (5) in a set with solvent (amp. 10 ml – 5 pcs.) – contour cell packaging – cardboard packs.
Vials (10) in a set with solvent (amp. 5 ml – 20 pcs.) – contour cell packaging – cardboard packs.
Vials (10) in a set with solvent (amp. 10 ml – 10 pcs.) – contour cell packaging – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Chemopharm, LLC (Russia)

Contact Information

CHEMOPHARM A.D. (Serbia)

Dosage Forms

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 20 or 30 pcs.
Film-coated tablets, 40 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale brown, round, biconvex.

1 tab.
Famotidine 20 mg

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

Shell composition hypromellose, macrogol 6000, titanium dioxide (E171), talc, brown iron oxide dye.

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

Film-coated tablets brown with a slightly pinkish tint, round, biconvex.

1 tab.
Famotidine 40 mg

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

Shell composition hypromellose, macrogol 6000, titanium dioxide (E171), talc, brown iron oxide dye.

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

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Makiz-Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or white with a grayish tint, round, biconvex; on the cross-section, two layers are visible – an inner layer of white or almost white color.

1 tab.
Famotidine 20 mg

Excipients: potato starch, magnesium stearate, colloidal silicon dioxide (aerosil), talc, ludipress, lactose-tabletose 80, microcrystalline cellulose, titanium dioxide, hypromellose, polyethylene glycol.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Makiz-Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 40 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; on the cross-section, two layers are visible – an inner layer of white or almost white color.

1 tab.
Famotidine 40 mg

Excipients: potato starch, magnesium stearate, colloidal silicon dioxide (aerosil), talc, ludipress, lactose-tabletose 80, microcrystalline cellulose, titanium dioxide, hypromellose, polyethylene glycol, tropaeolin O.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: from 10 to 540 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round biconvex; on the cross-section, two layers are visible – a core and a film coating.

1 tab.
Famotidine 20 mg

Excipients: lactose monohydrate (milk sugar) – 100 mg, microcrystalline cellulose (MCC 101) – 53.92 mg, potato starch – 16.82 mg, povidone K25 – 6.36 mg, magnesium stearate – 1.9 mg.

Shell composition: hypromellose – 7.5 mg, titanium dioxide – 2.03 mg, quinoline yellow dye – 0.19 mg, polysorbate-80 – 1.28 mg.

From 10 to 30 pcs. – contour cell packaging (from 1 to 18 pcs.) – cardboard packs.
From 10 to 180 pcs. – jars with first opening control (1) – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 40 mg: from 10 to 540 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round biconvex; on the cross-section, two layers are visible – a core and a film coating.

1 tab.
Famotidine 40 mg

Excipients: lactose monohydrate (milk sugar) – 100 mg, microcrystalline cellulose (MCC 101) – 53.9 mg, potato starch – 16 mg, povidone K25 – 7 mg, magnesium stearate – 2.1 mg.

Shell composition: hypromellose – 7.5 mg, titanium dioxide – 2.22 mg, polysorbate-80 – 1.28 mg.

From 10 to 30 pcs. – contour cell packaging (from 1 to 18 pcs.) – cardboard packs.
From 10 to 180 pcs. – jars with first opening control (1) – cardboard packs.

Marketing Authorization Holder

Pharmalab, LLC (Russia)

Manufactured By

Ferment Firm, LLC (Russia)

Labeled By

OHFK, JSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilizate for preparation of solution for intravenous administration 20 mg: vial in set with solvent 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intravenous administration as a white or white with a yellowish tint lyophilized powder.

1 vial
Famotidine 20 mg

Excipients: aspartic acid – 20 mg, mannitol – 44 mg.

20 mg – vials (5) in a set with solvent 5 amp. – contour cell packaging (1) – cardboard packs.
20 mg – vials (5) in a set with solvent 5 amp. – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Pharmpotrebsoyuz, LLC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilisate for preparation of solution for intravenous administration 20 mg: vial or amp. 5 pcs. in set with or without solvent, amp. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration white or white with a yellowish tint.

1 vial
Famotidine 20 mg

Excipients: aspartic acid – 8.8 mg, mannitol – 44 mg.

Solvent: 0.9% sodium chloride solution – 5 ml (ampoules).

10 ml vials (5) – contour cell packs (1) – cardboard cartons.
15 ml vials (5) – contour cell packs (1) – cardboard cartons.
5 ml ampoules (5) – contour cell packs (1) – cardboard cartons.
5 ml ampoules (5) – contour cell packs (2) – cardboard cartons.
10 ml vials (5) – contour cell packs (1) in a set with solvent (amp. 5 ml 5 pcs.) – contour cell packs (1) – cardboard cartons.
15 ml vials (5) – contour cell packs (1) in a set with solvent (amp. 5 ml 5 pcs.) – contour cell packs (1) – cardboard cartons.
5 ml ampoules (5) – contour cell packs (1) in a set with solvent (amp. 5 ml 5 pcs.) – contour cell packs (1) – cardboard cartons.

Marketing Authorization Holder

Pharmsintez OJSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 10, 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Famotidine 20 mg

10 pcs. – contour cell packs (1) – cardboard cartons.
10 pcs. – contour cell packs (2) – cardboard cartons.
10 pcs. – contour cell packs (3) – cardboard cartons.
10 pcs. – contour cell packs (5) – cardboard cartons.

Marketing Authorization Holder

Pharmsintez OJSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 40 mg: 10, 20, 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Famotidine 40 mg

10 pcs. – contour cell packs (1) – cardboard cartons.
10 pcs. – contour cell packs (2) – cardboard cartons.
10 pcs. – contour cell packs (3) – cardboard cartons.
10 pcs. – contour cell packs (5) – cardboard cartons.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Film-coated tablets, 20 mg: 20, 30, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Famotidine 20 mg

10 pcs. – contour cell packs (2) – cardboard cartons
10 pcs. – contour cell packs (3) – cardboard cartons
20 pcs. – contour cell packs (2) – cardboard cartons
20 pcs. – contour cell packs (3) – cardboard cartons.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Bottle Rx Icon Famotidine Lyophilisate for preparation of solution for intravenous administration 20 mg: amp. 5 pcs. in set with or without solvent, or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration in the form of a lyophilized powder or a porous, compacted mass of white or almost white color, with a characteristic odor.

1 amp.
Famotidine 20 mg

Excipients: aspartic acid – 8.8 mg, mannitol – 44 mg.

Solvent: 0.9% sodium chloride solution (amp. 5 ml).

20 mg – vials (5) – contour cell packs (1) – cardboard cartons.
20 mg – vials (5) in a set with solvent (amp. 5 pcs.) – contour cell packs (1) – cardboard cartons.
20 mg – vials (10) – contour cell packs (1) – cardboard cartons.

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