Quamatel, 20mg vials, 5pcs

Composition

1 bottle contains:

Active ingredient:  

famotidine 20 mg;

Auxiliary substances:  

aspartic acid; 

mannitol;

sodium chloride;

water for injection.

Pharmacological action

Kvamatel is a histamine H2-receptor blocker. Reduces basal and stimulated gastrin, pentagastrin, betazol, caffeine, histamine, acetylcholine and physiological vagal reflex secretion of hydrochloric acid.

This increases the pH and reduces the activity of pepsin. Virtually no effect on fasting and post-meal gastrin levels. It does not affect gastric motility, exocrine activity of the pancreas, blood circulation in the portal system, hormone levels, and does not have an antiandrogenic effect.

Famotidine has little effect on microsomal liver enzymes. After taking the drug inside, the effect occurs in 1 hour, the maximum effect is 3 hours after ingestion, the duration of the effect varies between 12-24 hours, depending on the dose. The drug in the form of lyophilizate for the preparation of a solution for intravenous use after use in a single dose of 20 or 40 mg in the evening suppresses basal and nocturnal secretion for 10-12 hours

. Pharmacokinetics in special clinical cases With creatinine clearance. Pharmacokinetics The pharmacokinetics are linear. Absorption After oral use, it is not completely absorbed from the gastrointestinal tract. Cmax is reached in 1-3 hours and is 0.07-0.1 mg/l. Bioavailability – 40-45%, increases with simultaneous food intake and decreases with simultaneous use of antacids.

The distribution of binding to plasma proteins is 10-20%. Penetrates through the placental barrier and through the BBB. It is excreted in breast milk. Metabolism 30-35% of the drug is metabolized in the liver to form S-oxide. Elimination T1 / 2 is 2.3-3.5 h. After oral use,30-35% of famotidine, and after intravenous use,65-70% of famotidine is excreted unchanged in the urine.

Indications

• Peptic ulcer of duodenum 12 and stomach in the acute phase, prevention of relapses.
• Treatment and prevention of symptomatic gastric and duodenal ulcers (associated with nonsteroidal anti-inflammatory drugs (NSAIDs), stress ulcers, and postoperative ulcers).
• Erosive gastroduodenitis.
• Functional dyspepsia associated with increased secretory function of the stomach.
• Reflux-esophagitis.
• Zollinger-Ellison syndrome.
• Prevention of recurrent bleeding from the upper gastrointestinal tract.
• Prevention of gastric juice aspiration under general anesthesia (Mendelssohn syndrome).

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to famotidine and other H2-histamine receptor blockers, pregnancy, lactation, childhood.

With caution: hepatic or renal failure, cirrhosis of the liver with a history of portosystemic encephalopathy.

Side effects

From the digestive system: dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, decreased appetite; increased activity of liver transaminases, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

Allergic reactions: urticaria, skin rash, pruritus, bronchospasm, angioedema, anaphylactic shock.

From the hematopoietic system: very rarely – agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, hypo-or aplasia of the bone marrow. Musculoskeletal disorders: arthralgia, muscle spasms.

Dermatological reactions: alopecia, acne vulgaris, dry skin, toxic epidermal necrolysis.

From the central nervous system: headache, dizziness, drowsiness, hallucinations, confusion, fatigue, depression, agitation, anxiety.

Sensory disorders: decreased visual acuity, tinnitus. From the cardiovascular system: arrhythmia, bradycardia, AV block, decreased blood pressure.

On the part of the reproductive system: with prolonged use in high doses-hyperprolactinemia, gynecomastia, amenorrhea, decreased libido. Other: fever.

Interaction

Antacids and sucralfate used simultaneously with Quamatel slow the absorption of famotidine.

Due to an increase in the pH of the stomach contents, Kvamatel, when used simultaneously, reduces the absorption of ketoconazole and itraconazole; increases the absorption of amoxicillin and clavulanic acid.

Concomitant use of Kvamatel and drugs that inhibit bone marrow hematopoiesis increases the risk of developing neutropenia.

How to take, course of use and dosage

Kvamatel is used intravenously, jet or drip only in severe cases or if it is impossible to take the drug inside.

It is intended for hospital use only. At the first opportunity, you should switch to oral famotidine. The average dose is 20 mg 2 times a day (every 12 hours). A single dose should not exceed 20 mg.

In Zollinger-Ellison syndrome, the initial dose is 20 mg every 6 hours, then the dose of the drug is adjusted depending on the secretion of hydrochloric acid and the clinical condition of the patient.

To prevent aspiration of gastric contents before general anesthesia,20 mg of the drug is administered intravenously on the eve of surgery or at least 2 hours before the operation.

In patients with impaired renal function (creatinine clearance less than 30 ml / min), or with a serum creatinine level of more than 3 mg / dl, the daily dose of the drug (both for oral use and for intravenous use) is reduced to 20 mg or the interval between individual doses of the drug is increased to 36-48 hours.

If liver function is impaired, the drug is prescribed with caution, in reduced doses.

Rules for the preparation and use of solutions for injection

To prepare the solution, the contents of one ampoule with the Active ingredient should be previously diluted in 5-10 ml of saline solution (ampoule with solvent). The prepared solution remains stable at room temperature for 24 hours. The drug is administered for at least 2 minutes. With intravenous drip use, the duration of the infusion should be 15-30 minutes. The solution should be prepared immediately before use.

Overdose

Symptoms: tachycardia, motor agitation, vomiting, tremor, decreased blood pressure, collapse.

Treatment: gastric lavage, symptomatic and supportive therapy; hemodialysis.

Special instructions

The use of Kvamatel can mask the symptoms of gastric cancer, so before starting treatment with famotidine, it is necessary to exclude the presence of a malignant neoplasm.

In patients with impaired liver function, Kvamatel should be administered with caution and at lower doses. If treatment is abruptly discontinued, famotidine can cause withdrawal symptoms, so treatment is stopped, gradually reducing its dose.

Long-term treatment of debilitated patients or patients under stress may cause bacterial lesions of the stomach with further spread of infection. Kvamatel should be taken 2 hours after taking itraconazole or ketoconazole to avoid a significant decrease in their absorption. You should also observe a 1-2-hour break between taking Kvamatel and antacids.

Influence on the ability to drive motor vehicles and manage mechanisms

While taking Kvamatel, patients should exercise caution when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. Histamine H2-receptor blockers (including Kvamatel) They can inhibit the acid-stimulating effect of pentagastrin and histamine, so you should stop prescribing Kvamatel 24 hours before the test.

During treatment, you should avoid consuming food, beverages, and other medications that may cause irritation of the stomach lining. Histamine H2 receptor blockers can inhibit the skin response to histamine, thus leading to false negative results.

Therefore, before performing diagnostic skin tests to detect an immediate type of allergic skin reaction, Kvamatel should be discontinued.

Form of production

Lyophilized powder for preparation of solution for injection

Storage conditions

In a dark place, at a temperature of 25 °C.

Shelf

life is 3 years.

Active ingredient

Famotidine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection