Kvamatel - histamine H 2 receptor blocker; anti-ulcer agent.
Release form and composition
Quamatel Dosage Forms:
- Film coated tablets of 20 and 40 mg - 14 pcs. in blisters, in a cardboard box 2 blisters (20 mg tablets) or 1 (40 mg tablets);
- The lyophilisate from which the solution is prepared for intravenous (IV) administration — at 72.8 mg in colorless glass vials, in a carton pack of 5 bottles complete with 5 ampoules of solvent.
The active ingredient of the drug - famotidine: in 1 tablet - 20 or 40 mg, in 1 vial of lyophilisate (72.8 mg) - 20 mg.
Tablet auxiliaries: sodium carboxymethyl starch (type A), povidone K90, talc, magnesium stearate, corn starch, lactose monohydrate, colloidal silicon dioxide.
The composition of the shell: titanium dioxide, colloidal silicon dioxide, macrogol 6000, ferric oxide red and 003 sepifilm, consisting of macrogol-40 OE stearate (E431), microcrystalline cellulose (E460) and hypromellose (E464).
Additional components of the lyophilisate: aspartic acid and mannitol.
The solvent attached to the lyophilisate is a 0.9% solution of sodium chloride (sodium chloride - 45 mg and water for injection - up to 5 ml).
Indications for use
- Zollinger-Ellison Syndrome;
- Reflux esophagitis;
- Erosive gastroduodenitis;
- Exacerbation of duodenal ulcer and stomach ulcer, prevention of relapse;
- Functional dyspepsia due to increased gastric secretion;
- Treatment and prevention of symptomatic ulcers of the stomach and duodenum, including postoperative, stressful and nonsteroidal anti-inflammatory drugs caused by taking;
- Prevention of recurrent bleeding from the upper gastrointestinal tract;
- Prevention of gastric juice aspiration during general anesthesia (Mendelssohn's syndrome).
- Breastfeeding period;
- Hypersensitivity to quamatel;
- Hypersensitivity to other blockers of histamine H2 receptors.
Patients with a history of liver cirrhosis with portosystemic encephalopathy, as well as patients with renal and / or liver failure should be under constant observation during the treatment period.
Dosing and Administration
Quamatel tablets should be taken orally.
- Exacerbation of duodenal ulcer and stomach ulcer - 20 mg twice a day or 40 mg once before bedtime. If necessary, increase the daily dose to 80-160 mg. Treatment can last from 4 to 8 weeks;
- Prevention of acute peptic ulcer - 20 mg daily before bedtime;
- Reflux esophagitis - 20 mg twice a day, in case of insufficiency of the effect, a single dose is increased to 40 mg;
- Zollinger-Ellison syndrome - 20-40 mg every 6 hours, if necessary, increase the dose. The maximum permissible daily dose is 480 mg;
- Prevention of gastric juice aspiration during general anesthesia - 40 mg on the eve of the planned surgical intervention or on the morning of the operation.
A solution is prepared from the lyophilisate for intravenous administration — slow jet or drip. Kvamatel is prescribed only to hospitalized patients who cannot take pills orally. At the earliest opportunity they are transferred to peroral form of the drug.
Immediately before administration, the lyophilisate is diluted with the supplied solvent. The duration of the injection: with a jet injection - not less than 2 minutes, with drip - 15-30 minutes.
The recommended daily dose is 40 mg - 20 mg twice a day (with an interval of 12 hours).
In Zollinger-Ellison syndrome, at the beginning of treatment, 20 mg is prescribed every 6 hours, then the dose is determined depending on the patient’s clinical condition and the amount of secretion.
To prevent aspiration of gastric contents during general anesthesia, Kvamatel is administered in a dose of 20 mg in the morning on the day of surgery (no later than 2 hours before surgery).
In patients with renal insufficiency (with creatinine clearance less than 30 ml / minute or blood creatinine more than 3 mg / 100 ml), the daily dose, either by ingestion or intravenous administration, is reduced to 20 mg or the interval between doses / injections is increased to 36 -48 hours.
Dose reduction is also required in patients with hepatic insufficiency.
- Digestive system: loss of appetite, abdominal pain, nausea, vomiting, dry mouth, constipation or diarrhea, flatulence, increased transaminase liver, acute pancreatitis, cholestatic, hepatocellular or mixed hepatitis;
- Central nervous system: fatigue, drowsiness, dizziness, hallucinations, headache, confusion, agitation, depression, anxiety;
- Hematopoietic system: very rarely - leukopenia, pancytopenia, thrombocytopenia, agranulocytosis, bone marrow hypo- or aplasia;
- Cardiovascular system: AV blockade, bradycardia, arrhythmia, lowering blood pressure (BP);
- Musculoskeletal system: muscle spasms, arthralgia;
- Sense organs: tinnitus, reduced visual acuity;
- Dermatological reactions: dry skin, common acne, alopecia, toxic epidermal necrolysis;
- Allergic reactions: skin rash, urticaria, pruritus, angioedema, bronchospasm, anaphylactic shock;
- The reproductive system: with prolonged use in high doses - amenorrhea, gynecomastia, hyperprolactinemia, decreased libido;
- Other: fever.
Overdose symptoms: vomiting, tremor, lowering blood pressure, motor agitation, tachycardia, collapse. Treatment involves gastric lavage, hemodialysis, the appointment of symptomatic and supportive therapy.
Kvamatel can mask the clinical signs of gastric cancer, so before its appointment should be excluded the presence of malignant tumors.
The drug is canceled by gradually reducing the dose, since with an abrupt cessation of treatment may develop withdrawal syndrome.
Patients driving vehicles and employed in potentially hazardous industries are advised to take extra care during therapy.
With long-term treatment of Kvamatel for weakened patients and patients under stress, there is a risk of bacterial lesions of the stomach with a further spread of infection.
During the period of therapy, it is not recommended to use food, drinks and other medicines that may cause irritation of the gastric mucosa.
In the case of concomitant administration of antacids, itraconazole or ketoconazole, it is necessary to withstand 1-2-hour intervals between doses of drugs.
Kvamatel can inhibit the acid-stimulating effect of histamine and pentagastrin, as well as inhibit the skin reaction to histamine, with the result that false-negative results can be obtained. Therefore, 24 hours before the test or diagnostic skin tests to detect an allergic reaction of the immediate type, the drug should be canceled.
Famotidine reduces the absorption of itraconazole and ketoconazole, increases the absorption of clavulanic acid and amoxicillin.
Famotidine absorption is slowed down by antacids and sucralfate.
With simultaneous use of Kvamatel with drugs that suppress bone marrow hematopoiesis, the risk of developing neutropenia increases.
Terms and conditions of storage
Store in a dark place, out of reach of children: tablets at temperatures up to 30 ºС, lyophilisate - 15-25 ºС.
The shelf life of the lyophilisate is 3 years, the solvent attached to it, and also the tablets are 5 years.