Kvamatel lyophilisate for preparation of injection solution 20mg, No. 5

KvamatelЃ is indicated for the following diseases:

• duodenal ulcer

• stomach ulcer without malignancy;

• gastroesophageal reflux disease;

• other conditions accompanied by hypersecretion (for example, Zollinger-Ellison syndrome);

• prevention of aspiration of acidic gastric contents (Mendelssohn's syndrome) during general anesthesia.

KvamatelЃ is intended for intravenous administration only.

KvamatelЃ is recommended for use in hospitalized patients who cannot take the drug orally. KvamatelЃ can be used until oral therapy becomes possible.

The recommended dose is 20 mg intravenously (IV) twice a day (every 12 hours).

In case of gastric ulcer and duodenal ulcer in the stage of exacerbation, hypersecretory states: IV slowly, for 2 minutes, 20 mg 2 times / day in diluted form; IV infusion: slowly, over 15-30 minutes, 20 mg 2 times / day.

With reflux esophagitis, the initial dose is 20 mg 2 times / day IV slowly.

With Zollinger-Ellison syndrome: The initial dose is 20 mg IV every 6 hours. Further: the dose of the drug depends on the volume of secretion and the clinical condition of the patient.

Under general anesthesia to prevent aspiration of acidic gastric contents: KvamatelЃ is administered at a dose of 20 mg IV in the morning of the day of surgery or at least 2 hours before the start of surgery. The initial dose for intravenous administration may not exceed 20 mg.

For intravenous injection, the contents of the vial should be dissolved in 5-10 ml of 0.9% sodium chloride solution (solvent ampoule), and then slowly injected (for at least 2 minutes).

When infusing the drug, the solution should be injected over 15-30 minutes.

Solutions should be prepared immediately prior to administration. Only clear, colorless solutions can be used. Application for renal failure.

Since famotidine is excreted primarily by the kidneys, precautions must be taken in patients with severe renal impairment.

If creatinine clearance is less than 30 ml / min, and serum creatinine concentration exceeds 3 mg / 100 ml, then the daily dose should be reduced to 20 mg or the intervals between injections should be increased to 36-48 hours.

Use in children: The
safety and efficacy of the drug in children have not been established.

Use in elderly patients:
No dose adjustment depending on age is required.

Lyophilisate:

each bottle contains:

Active ingredient: famotidine 20 mg.

Excipients: aspartic acid - 8.8 mg, mannitol - 44.0 mg.

Solvent:

0.9% sodium chloride solution: each ampoule contains: sodium chloride - 45.0 mg, water for injection - up to 5.0 ml.

• Hypersensitivity to the active substance or any of the excipients,

• pregnancy,

• lactation period,

• childhood.

With care
Hepatic and / or renal failure, liver cirrhosis with portosystemic encephalopathy (in history), immunodeficiency.

TRADING NAME KVAMATELЃ

COMPOSITION:

Lyophilisate:

each bottle contains:

Active ingredient: famotidine 20 mg.

Excipients: aspartic acid - 8.8 mg, mannitol - 44.0 mg.

Solvent:

0.9% sodium chloride solution: each ampoule contains: sodium chloride - 45.0 mg, water for injection - up to 5.0 ml.

DESCRIPTION:

Lyophilisate: white or off-white powder.
Solvent: A clear, colorless, odorless solution.

Pharmacotherapeutic group:

an agent that lowers the secretion of gastric glands - a H2-histamine receptor blocker.

ATX code: A02BA03.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics
Famotidine is a potent competitive inhibitor of H2-histamine receptors.
The main clinically significant pharmacological action of famotidine is inhibition of gastric secretion. Famotidine reduces both the concentration of hydrochloric acid and the volume of gastric secretion, while changes in pepsin secretion are proportional to the secreted volume.
In healthy volunteers and patients with hypersecretion, famotidine inhibits the basal and nocturnal secretion of hydrochloric acid and pepsinogen, as well as the secretion stimulated by the administration of pentagastrin, betazol, caffeine, insulin and the physiological reflex of the vagus nerve.
The duration of inhibition of secretion when using doses of 20 mg and 40 mg is from 10 to 12 hours.
Famotidine has virtually no effect on fasting or postprandial serum gastrin concentration.
Famotidine has no effect on gastric emptying, exocrine pancreatic function, blood flow in the liver and portal system.
Famotidine has no effect on the cytochrome P450 enzyme system in the liver.
The antiandrogenic effect of the drug was not observed.

Pharmacokinetics.
Famotidine kinetics is linear.
Suction. KvamatelЃ is intended for intravenous administration only.
Distribution. Plasma protein binding is relatively weak (15-20%).
The half-life is 2.3 - 3.5 hours. In patients with severe renal impairment, the half-life of famotidine may exceed 20 hours.
Biotransformation. Famotidine metabolism occurs in the liver. The only metabolite found in humans is sulfoxide.
Excretion.Famotidine is excreted by the kidneys (65 - 70%) and by metabolism (30 - 35%). Renal clearance is 250-450 ml / min, indicating some degree of tubular excretion. 65 - 70% of the intravenously administered dose is found unchanged in the urine. A small portion of the administered dose may be excreted in the form of sulfoxide.

INDICATIONS FOR USE

KvamatelЃ is indicated for the following diseases:

• duodenal ulcer

• stomach ulcer without malignancy;

• gastroesophageal reflux disease;

• other conditions accompanied by hypersecretion (for example, Zollinger-Ellison syndrome);

• prevention of aspiration of acidic gastric contents (Mendelssohn's syndrome) during general anesthesia.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or any of the excipients,

• pregnancy,

• lactation period,

• childhood.

With care
Hepatic and / or renal failure, liver cirrhosis with portosystemic encephalopathy (in history), immunodeficiency.

Application during pregnancy and lactation

Famotidine crosses the placenta.
No controlled studies have been conducted in humans.
KvamatelЃ is not recommended for use during pregnancy.
Famotidine is secreted in human breast milk; in this regard, breastfeeding should be discontinued while using KvamatelЃ.

DOSAGE AND APPLICATION

KvamatelЃ is intended for intravenous administration only.

KvamatelЃ is recommended for use in hospitalized patients who cannot take the drug orally. KvamatelЃ can be used until oral therapy becomes possible.

The recommended dose is 20 mg intravenously (IV) twice a day (every 12 hours).

In case of gastric ulcer and duodenal ulcer in the stage of exacerbation, hypersecretory states: IV slowly, for 2 minutes, 20 mg 2 times / day in diluted form; IV infusion: slowly, over 15-30 minutes, 20 mg 2 times / day.

With reflux esophagitis, the initial dose is 20 mg 2 times / day IV slowly.

With Zollinger-Ellison syndrome: The initial dose is 20 mg IV every 6 hours. Further: the dose of the drug depends on the volume of secretion and the clinical condition of the patient.

Under general anesthesia to prevent aspiration of acidic gastric contents: KvamatelЃ is administered at a dose of 20 mg IV in the morning of the day of surgery or at least 2 hours before the start of surgery. The initial dose for intravenous administration may not exceed 20 mg.

For intravenous injection, the contents of the vial should be dissolved in 5-10 ml of 0.9% sodium chloride solution (solvent ampoule), and then slowly injected (for at least 2 minutes).

When infusing the drug, the solution should be injected over 15-30 minutes.

Solutions should be prepared immediately prior to administration. Only clear, colorless solutions can be used. Application for renal failure.

Since famotidine is excreted primarily by the kidneys, precautions must be taken in patients with severe renal impairment.

If creatinine clearance is less than 30 ml / min, and serum creatinine concentration exceeds 3 mg / 100 ml, then the daily dose should be reduced to 20 mg or the intervals between injections should be increased to 36-48 hours.

Use in children: The
safety and efficacy of the drug in children have not been established.

Use in elderly patients:
No dose adjustment depending on age is required.

OVERDOSE

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

Overdose treatment: symptomatic and supportive therapy; monitoring the patient's condition.

Interaction with other medicinal products

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 down the absorption of famotidine.
Reduces the absorption of itraconazole and ketoconazole.
Medicines that suppress the bone marrow increase the risk of neutropenia.

SPECIAL INSTRUCTIONS

Before starting therapy with famotidine or, if this is not possible, before switching to oral treatment, it is necessary to exclude the presence of a malignant neoplasm of the stomach.
In case of liver failure, KvamatelЃ should be used with caution in a reduced dose.
Since cross-reactivity has been described in the case of the use of H2-histamine receptor blockers, the use of KvamatelЃ in patients with a history of hypersensitivity to other H2-histamine receptor blockers requires caution.

Influence on the ability to drive vehicles and work with equipment

Patients should be careful when driving and working with equipment, since dizziness and increased fatigue may occur during treatment.

RELEASE FORM

72.80 mg of lyophilisate (corresponds to 20 mg of active substance) in a colorless glass bottle (hydrolytic class I) with a rubber stopper closed with an aluminum cap.
5 ml of solvent (0.9% sodium chloride solution) in a colorless glass ampoule (hydrolytic class I) with a break point. A label is attached to the bottle and ampoule.
5 vials and 5 ampoules in a contour plastic package.
1 contour plastic package in a cardboard box with instructions for use.

STORAGE CONDITIONS

At a temperature not exceeding 25 ? —, in a dark place.
Keep out of the reach of children.

SHELF LIFE

Lyophilisate: 3 years.
Solvent: 5 years.
Should not be used after the expiration date.

TERMS OF RELEASE FROM PHARMACIES

On prescription.