Kwamatel - instructions for use, dose, side effects, contraindications

Famotidine is a potent competitive inhibitor of H₂-gistaminovyh receptors. The main clinically significant pharmacological action of famotidine is the inhibition of gastric secretion. Famotidine reduces both the concentration of hydrochloric acid and the volume of gastric secretion, while the changes in pepsin secretion are proportional to the secreted volume.

In healthy volunteers and patients with hypersecretion famotidine inhibits basal and night secretion of hydrochloric acid and pepsinogen, as well as secretion stimulated by the administration of pentagastrin, betazole, caffeine, insulin and physiological reflex of the vagus nerve.

The duration of inhibition of secretion using doses of 20 mg and 40 mg is from 10 to 12 hours.

Famotidine has virtually no effect on the concentration - gastrin in the serum on an empty stomach or after a meal.

Famotidine has no effect on gastric emptying, exocrine pancreatic function, blood flow in the liver and portal system.

Famotidine does not affect the enzymatic system of cytochrome P450 in the liver.

Anti-androgenic effect of the drug was not noted.

Pharmacokinetics:

The kinetics of famotidine are linear in nature.

Suction. Kwamatel® is for intravenous administration only.

Distribution. Binding to plasma proteins is relatively weak (15-20%).

The half-life is 2.3-3.5 hours. In patients with severe renal failure, the half-life of famotidine may exceed 20 hours.

Biotransformation. Metabolism famotidine occurs in the liver. The only metabolite found in humans is the sulfoxide.

Excretion. Famotidine is excreted by the kidneys (65-70%) and by metabolism (30-35%). Renal clearance is 250-450 ml / min, which indicates a certain degree of tubular excretion of 65-70% of intravenously administered dose is found in urine in unchanged form.A small portion of the administered dose may be excreted in the form of a sulfoxide.

Indications:

Kwamatel® is indicated for the following diseases:

- duodenal ulcer;

- a stomach ulcer without malignancy;

- gastroesophageal reflux disease;

- Other conditions accompanied by hypersecretion (eg, Zollinger-Ellison syndrome);

- prevention of aspiration of acidic gastric contents (Mendelssohn syndrome) during general anesthesia.

Contraindications:

Hypersensitivity to the active substance or any of the excipients, pregnancy, lactation period, children's age.

Carefully:

Hepatic and / or renal insufficiency, cirrhosis with portosystemic encephalopathy (in anamnesis), immunodeficiency.

Pregnancy and lactation:

Famotidine penetrates the placenta. Controlled studies in humans have not been conducted.

Kwamatel® is not recommended for use during pregnancy.

Famotidine is secreted with human breast milk, so breastfeeding should be discontinued during application of Kwamatel®.

Dosing and Administration:

Kwamatel® is for intravenous administration only.

Kwamatel® is recommended for use in hospitalized patients who are unable to take the drug inside. Kwamatel® can be used until oral therapy is made possible. The recommended dose is 20 mg intravenously (iv) twice daily (every 12 hours).

With peptic ulcer of the stomach and duodenum in the acute stage: hypersecretory states: iv slowly, for 2 minutes 20 mg 2 times / day in diluted form; intravenous infusion: slowly, during 15-30 min by 20 mg 2 times / day.

With reflux esophagitis the initial dose is 20 mg 2 times / day iv in slowly.

With Zollinger-Ellison syndrome: the initial dose is 20 mg IV every 6 hours. Next: the dose of the drug depends on the amount of secretion and the clinical state of the patient.

With general anesthesia to prevent aspiration of acidic gastric contents: Kwamatel® is administered at a dose of 20 mg IV in the morning of the day of the operation or at least 2 hours before the commencement of the operation. The initial dose for intravenous administration can not exceed 20 mg. For intravenous injection, the contents of the vial should be dissolved in 5 to 10 ml of a 0.9% solution of sodium chloride (ampoule solvent), and then slowly, enter (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 the introduction. Only transparent colorless solutions can be used.

Application for renal failure: PBecause famotidine excreted mainly by the kidneys, in patients with severe renal insufficiency, precautions should be observed. If the creatinine clearance is less than 30 ml / min, and the serum creatinine concentration exceeds 3 mg / 100 ml, then the daily dose it is necessary to reduce to 20 mg or increase the intervals between administrations to 36-48 hours.

Use in children

Safety and efficacy of the drug in children are not established.

Application in elderly patients

Correction of dose depending on age is not required.

Side effects:

The following undesirable phenomena have been described in very rare or rare cases. However, in many cases, the causal relationship with famotidine therapy has not been established.

Organs and Systems	Rare(≥1/10000 <1/1000)	Very rare (< 1/10000)	Unknown (it is not possible to establish on the basis of availabledata)
Hematological violations		Agranulocytosis Leukopenia Pancytopenia Thrombocytopenia
Immune violations		Anaphylaxis
Disorders of metabolism and nutrition		Anorexia
Mental disorders		Depression Hallucinations Excitation Anxiety Confusion of consciousness
Neurological violations	Headache Dizziness
Disturbances from the organs of hearing and balance			Tinnitus
Cardiac disorders		Arrhythmia Atrioventricular blockade
Respiratory disorders, diseases of the chest and mediastinum		Bronchospasm
Digestive violations	Diarrhea Constipation	Feeling of discomfort in a stomach Nausea Vomiting Dry mouth
Hepatobiliary violations		Cholestatic jaundice
Diseases of the skin and subcutaneous tissue		Acne Alopecia Angioedema Dryness of the skin Toxic epidermal necrolysis Hives Itching
Musculoskeletal disorders, connective tissue diseases		Arthralgia Muscle spasms
Reproductive disorders, diseases of mammary glands		Gynecomastia *
Systemic disorders and complications at the site of administration		Increased fatigue Fever
The abnormalities detected in laboratory examination		Activity decline "hepatic" enzymes

* Gynecomastia is very rare and with reversal of treatment is reversible.

Overdose:

Patients with the syndrome of pathological hypersecretion used doses up to 800 mg per day for a period of more than one year, which was not accompanied by the occurrence of serious adverse events.

Treatment of overdose: symptomatic and supportive therapy; monitoring of the patient's condition.

Interaction:

Compatible with 0.18% and 0.9% sodium chloride solution, 4 and 5% dextrose solution, 4.2% sodium bicarbonate solution. Increases the absorption of amoxicillin and clavulanic acid.

Antacids and sucralfate slow the absorption of famotidine.

Reduces the absorption of itraconazole and ketoconazole.

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

Special instructions:

Before beginning therapy with famotidine or, if this is not possible, before the transition to oral treatment, it is necessary to exclude the presence of malignant neoplasm of the stomach. For hepatic insufficiency, Kwamatel® should be used with caution in a reduced dose.

Since in the case of blockers H₂-gistamine receptors, cross-reactivity has been described, the use of Kwamatel® in patients who have a history of hypersensitivity to other H blockers₂-gistaminovyh receptors, requires caution.

Effect on the ability to drive transp. cf. and fur:

Patients should be careful when driving vehicles and working with machinery, as dizziness may occur during treatment and fatigue can be observed.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration, 20 mg.

Packaging:

72.80 mg of lyophilizate (corresponding to 20 mg of active ingredient) in a colorless glass vial (I of hydrolytic class) with a rubber stopper closed by an aluminum cap with a plastic lid.

For 5 ml of solvent (0.9% solution of sodium chloride) in a colorless glass ampoule (I hydrolytic class) with a point for the fault. A label is applied to the vial and ampoule.

5 bottles and 5 ampoules in contour plastic packaging.

On 1 contour plastic packing in a cardboard pack with the instruction on application.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light. Keep out of the reach of children.

Shelf life:

Lyophilizate: 2 years.

Solvents: 5 years.

Do not use at the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012002 / 02

Date of registration:02.05.2011

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp26.12.2017

Illustrated instructions

Instructions

Kwamatel® (Quamatel®)