Quamatel, lyophilizate 20 mg 5 pcs

Quamatel is a blocker of histamine H2-receptors. It reduces basal and stimulated by gastrin, pentagastrin, betazol, caffeine, histamine, acetylcholine and physiological vagus reflex secretion of hydrochloric acid.

The pH increases and pepsin activity decreases. Virtually no effect on gastrin levels on an empty stomach and after meals. It does not affect gastric motility, exocrine activity of the pancreas, blood flow in the portal system, hormone levels, and has no antiandrogenic effect.

Famotidine has little effect on microsomal liver enzymes. After oral intake the action comes within 1 hour, maximum of action – 3 hours after intake, the duration of effect varies within 12-24 hours, depending on the dose. The drug in the form of lyophilisate for preparation of a solution for intravenous injection after administration of 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 In CC. Pharmacokinetics Pharmacokinetics is linear. Absorption After oral administration is not completely absorbed from the gastrointestinal tract. Cmax is reached after 1-3 hours and is 0.07-0.1 mg/L. Bioavailability is 40-45%; it increases with simultaneous food intake and decreases with simultaneous use of antacids.

Distribution Binding to plasma proteins is 10-20%. It penetrates through the placental barrier and through the HEB. It is excreted with breast milk. Metabolism 30-35% of the drug is metabolized in the liver to form S-oxide. Excretion T1/2 is 2.3-3.5 hours. After oral administration 30-35% of famotidine, and after intravenous administration 65-70% of famotidine is excreted unchanged in the urine.

Indications

Active ingredient

Composition

1 vial contains:

The active ingredient:

Famotidine 20 mg;

Supplementary substances:

Asparagic acid;

Mannitol;

sodium chloride;

water for injection.

How to take, the dosage

Quamatel is administered by IV, jet or drip only in severe cases or when it is not possible to take the drug orally.

It is intended for inpatient use only. At the first opportunity, switch to oral administration of 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 starting dose is 20 mg every 6 hours; thereafter the dose is adjusted depending on hydrochloric acid secretion and on the clinical condition of the patient.

In order to prevent aspiration of gastric contents prior to general anesthesia, 20 mg of the drug is administered by IV dose the day before surgery or at least 2 hours prior to surgery.

In patients with impaired renal function (CKG less than 30 ml/min), or with serum creatinine levels greater than 3 mg/dL, the daily dose of the drug (for both oral and intravenous administration) is reduced to 20 mg or the interval between doses of the drug is increased to 36-48 hours.

In patients with hepatic impairment the drug is indicated with caution and in reduced doses.

Regulations for preparation and administration of solutions for injection

In order to prepare the solution, the contents of one ampoule with the active substance must be diluted in 5-10 ml of physiological solution (ampoule with solvent) beforehand. The prepared solution is stable at room temperature for 24 hours. The drug is administered for at least 2 min. When administered by intravenous drip infusion the duration of infusion should be 15-30 minutes. The solution should be prepared immediately before administration.

Interaction

Antacids and sucralfate used concomitantly with Quamatel slow down absorption of famotidine.

Due to increase in the pH of the stomach contents, Quamatel concomitantly reduces absorption of ketoconazole and itraconazole; increases absorption of amoxicillin and clavulanic acid.

In concomitant use of Quamatel and drugs that inhibit bone marrow hematopoiesis, the risk of neutropenia increases.

Special Instructions

The use of Quamatel may mask the symptoms of gastric cancer, so the presence of a malignant neoplasm should be excluded before starting treatment with famotidine.

Patients with impaired liver function should be prescribed Quamatel with caution and in lower doses. If treatment is stopped abruptly, famotidine may cause withdrawal syndrome, so the treatment is stopped by gradually reducing its dose.

In prolonged treatment of weakened patients or patients under stress, bacterial lesions of the stomach with further spread of infection are possible. Quamatel should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid significant reduction of their absorption. Also a 1-2 hour break between taking Quamatel and antacids should be observed.

Impact on driving and operating machinery

Patients should be careful while taking Quamatel when driving vehicles and engaging in potentially dangerous activities that require high concentration and quick psychomotor reactions. Blockers of histamine H2-receptors (including Kvamatel) may inhibit the acid-stimulating effect of pentagastrin and histamine; therefore, 24 hours before the test, Kvamatel should not be prescribed.

During treatment, food, beverages and other drugs that may cause irritation of the gastric mucosa should be avoided. Histamine H2-receptor blockers may suppress the cutaneous response to histamine, thus leading to false-negative results.

Therefore, Quamatel should be discontinued before diagnostic skin tests are performed to detect an immediate allergic skin reaction.

Contraindications

WARNING
Hepatic or renal insufficiency, cirrhosis with a history of portosystemic encephalopathy.

Side effects

Digestive system disorders: dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, decreased appetite; increased liver transaminase activity, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

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

Hematopoietic system: very rarely – agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, hypo- or aplasia of bone marrow. Musculoskeletal system: arthralgia, muscle cramps.

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

CNS disorders: headache, dizziness, somnolence, hallucinations, confusion, increased fatigue, depression, agitation, anxiety.

Sensory organs: decreased visual acuity, tinnitus. Cardiovascular system: arrhythmia, bradycardia, AV-blockade, BP decrease.

As to the sexual system: in case of long-term use in high doses – hyperprolactinemia, gynecomastia, amenorrhea, decreased libido. Other: fever.

Overdose

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

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

Pregnancy use

The drug is contraindicated for use during pregnancy.

Breastfeeding should be stopped if the drug has to be used during lactation.

Similarities