Composition
1 film-coated tablet 40 mg, contains:  Active substance: camotidine 40 mg. Auxiliary substances: 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: polymer — 5.0 mg, titanium dioxide — of 2.61 mg, lactose monohydrate — 2,625 mg, macrogol-4000 — 1.0 mg, triacetin — 0.75 mg, dye iron oxide yellow [E 172] — 0.375 mg, dye iron oxide red [E 172] 0,125 mg, dye iron oxide black [E 172] — 0,015 mg.
Pharmacological action of
Famotidine inhibits the release (secretion) of hydrochloric acid. In addition, this drug reduces the activity of the protein – splitting enzyme pepsin. According to reviews, Famotidine begins to have a therapeutic effect after 45-60 minutes after taking the initial dose. The duration of action of the drug is determined by the dose taken and ranges from 12 hours to a day.
Indications
Famotidine is recommended for use in inpatient patients who are unable to take the drug orally. Parenteral use of famotidine can be used until oral therapy becomes possible.
– Peptic ulcer of the duodenum;
– ulcer of the stomach without malignancy (good clinical effect in response to the appointment of famotidine does not allow to exclude the presence of malignancy ulcers);
– gastroesophageal reflux disease;
– other conditions associated with hypersecretion of gastric juice (for example, the syndrome of zollingerellison);
– prevention of Mendelson’s syndrome (aspiration of acidic gastric contents) under General anaesthesia.
Contraindications
-Hypersensitivity to famotidine or other components of the drug;
– pregnancy and lactation;
– age up to 18 years.
With caution:
Hepatic and / or renal insufficiency, cirrhosis of the liver with encephalopathy (in the anamnesis), immunodeficiency.
History of allergy to other H2-histamine blockers (possible cross-hypersensitivity).
Side effects
The frequency of side effects after the use of the drug is classified according to WHO recommendations: rare (≥1/10000 and <1/1000), very rare (
From the gastrointestinal tract: rarely-diarrhea, constipation; very rarely-abdominal discomfort, nausea, vomiting, dry mouth, anorexia, various taste disorders.
Liver and biliary tract disorders: Â very rarely – cholestatic jaundice.
From the central nervous system: rarely-headache, very rarely-dizziness, convulsive epileptiform seizures.
From the side of the psyche: Â very rarely-depression, hallucinations, agitation, anxiety, confusion, insomnia; drowsiness.
Musculoskeletal disorders: Â very rarely – arthralgia, myalgia. muscle spasms.
From the blood and lymphatic system: very rarely – agranulocytosis, leukopenia, pancytopenia, thrombocytopenia.
From the skin and subcutaneous tissues: very rarely – acne, alopecia, dry skin, toxic epidermal necrolysis.
From the side of the organ of hearing and vestibular apparatus: Â frequency unknown-tinnitus.
From the genitals and breast: very rarely – gynecomastia (when treatment is stopped, it is reversible), decreased libido, impotence.
From the immune system: Â very rarely – anaphylaxis, urticaria, skin rash, hyperemia of the sclera and skin, angioedema, edema of the periorbital areas of the eyes, face.
From the cardiovascular system: Â very rarely – arrhythmia, atrioventricular block, palpitations.
Respiratory, thoracic and mediastinal disorders: Â very rarely – bronchospasm.
General disorders and disorders at the injection site: Â very rarely – increased fatigue, asthenia, fever.
Laboratory and instrumental data: Â very rarely – increased activity of “liver” enzymes.
Interaction
Compatible with 0.9% sodium chloride solution,5% dextrose solution,4.2% sodium bicarbonate solution.
Increases the absorption of amoxicillin and clavulanic acid.
Antacids and sucralfate slow the absorption of famotidine after oral use.
Reduces the absorption of itraconazole and ketoconazole.
Medications that depress bone marrow increase the risk of developing neutropenia.
How to take, course of use and dosage
The drug is intended for intravenous use only!
The initial dose for intravenous use should not exceed 20 mg 2 times a day (every 12 hours).
The contents of the vial should be dissolved in 5-10 ml of 0.9% sodium chloride solution (ampoule of solvent), and then slowly introduced (for at least 2 minutes). When the drug is infused, the solution should be administered for 15-30 minutes.
Solutions should be prepared immediately before use. Only clear, colorless solutions can be used.
Hypersecretory conditions, stomach and duodenal ulcer in the acute stage:
– slowly bolus, for 2 minutes,20 mg 2 times a day;
– drip, for 15-30 minutes,20 mg 2 times a day.
Reflux esophagitis
– 20 mg 2 times a day intravenously slowly.
Zollinger-Ellison syndrome
The initial dose is 20 mg intravenously every 6 hours. If necessary, the dose of the drug is increased depending on the volume of acid production and the patient’s clinical condition.
To prevent aspiration of acidic gastric contents during general anesthesia
-20 mg in the morning on the day of surgery or at least 2 hours before its start.
Kidney failure
Since famotidine is mainly excreted unchanged by the kidneys, precautions should be taken in patients with severe renal insufficiency. If the creatinine clearance is less than 30 ml / min and the serum creatinine concentration exceeds 3 mg / 100 ml, then the dose should be reduced to 10 mg or the intervals between the usual dose should be increased to 36-48 hours.
Children
The safety and efficacy of the drug in children have not been fully established.
Older age (over 65 years)
No age-dependent dose adjustment is required.
Overdose
In patients with pathological hypersecretion syndrome, doses of up to 800 mg per day were prescribed for a period of more than one year, which was not accompanied by the occurrence of serious adverse events.
Treatment: symptomatic and supportive therapy; monitoring of the patient’s condition.
Special instructions
Before starting therapy, or if this is not possible, before switching to oral treatment, it is necessary to exclude the presence of gastric malignancy.
In patients with renal and/or hepatic insufficiency, famotidine should be used with caution at a reduced dose.
Since cross-allergy has been described in the use of H2-histamine receptor blockers, the use of famotidine in patients with a history of hypersensitivity to other H2-histamine receptor blockers requires caution.
Influence on the ability to drive vehicles and mechanisms:
Patients should be careful when performing work that requires rapid psychomotor reactions (including when driving vehicles and working with equipment), as dizziness and increased fatigue may occur during treatment.
Storage conditions
Keep out of the reach of children in a dark place, at a temperature not exceeding 25 °C.
Shelf
life is 3 years. Do not use the product after the expiration date indicated on the package.
Active ingredient
Famotidine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as directed by your doctor
Indications
Reflux esophagitis, Gastritis, Gastric ulcer and duodenal ulcer, Heartburn, Gastroduodenitis
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Side effects of Famotidine, pills 40mg, 30pcs.
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