Composition
Active ingredient: each film-coated tablet contains 20 mg or 40 mg of famotidine. Auxiliary substances: colloidal silicon dioxide; magnesium stearate; povidone K 90; sodium carboxymethyl starch. type A; talc; corn starch;lactose monohydrate. Shell composition: Â red iron oxide, colloidal silicon dioxide, titanium dioxide, macrogol 6000; sepifilm 003 (macrogol-40 OE stearate (or mono and diester of stearic acid and PEG -40 OK) (E 431) + microcrystalline cellulose (E 460) + hypromellose (E 464)).
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.
Indications
- Peptic ulcer disease duodenum and stomach in the acute phase, relapse prevention;
- treatment and prevention of symptomatic ulcers of the stomach and duodenum (associated with taking NSAIDs, stress, postoperative);
- erosive gastroduodenitis;
- functional dyspepsia, associated with increased secretory function of the stomach;
- reflux esophagitis;
- zollingerellison syndrome;
- prevention of recurrent bleeding from upper gastrointestinal tract;
- prevention of aspiration of gastric juice during the General anaesthesia (Mendelson’s syndrome).
Contraindications
- Pregnancy;
- lactation (breast-feeding);
- childhood;
- hypersensitivity to the components of the drug;
- hypersensitivity to other histamine H2-receptor blockers.
With caution: Â the drug should be prescribed for renal and hepatic insufficiency, cirrhosis of the liver with a history of portosystemic encephalopathy.
Side effects
From the digestive system: Â dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, decreased appetite; increased activity of liver transaminases, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From the hematopoietic system: Â very rarely – agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, hypo-or aplasia of the bone marrow.
Allergic reactions: Â urticaria, skin rash, pruritus, bronchospasm, angioedema, anaphylactic shock.
From the cardiovascular system: Â arrhythmia, bradycardia, AV block, decreased blood pressure.
From the central nervous system: Â headache, dizziness, drowsiness, hallucinations, confusion, fatigue, depression, agitation, anxiety.
From the side of the senses: Â decreased visual acuity, tinnitus.
From the side of the reproductive system: Â with prolonged use in high doses – hyperprolactinemia, gynecomastia, amenorrhea, decreased libido.
Musculoskeletal disorders: Â arthralgia, muscle spasms.
Dermatological reactions: Â alopecia, acne vulgaris, dry skin, toxic epidermal necrolysis.
Other services: Â fever.
Interaction
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.
Antacids and sucralfate used simultaneously with Quamatel slow the absorption of famotidine.
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
With peptic ulcer of the stomach and duodenum in the acute phase Kvamatel is prescribed at a dose of 40 mg 1 time a day before bedtime or 20 mg 2 times a day, in the morning and in the evening. If necessary, the daily dose can be increased to 80-160 mg. The average duration of treatment is 4-8 weeks.
In order to prevent exacerbations of peptic ulcer of the stomach and duodenum, Kvamatel is prescribed at a dose of 20 mg 1 time a day before bedtime.
For reflux esophagitis, the drug is prescribed at a dose of 20 mg 2 times a day (morning and evening) for 6 weeks; if necessary,40 mg 2 times a day.
In Zollinger-Ellison syndrome, the initial dose is 20-40 mg every 6 hours; if necessary, the daily dose can be increased to 240-480 mg. The duration of use of the drug depends on the clinical condition of the patient.
In order to prevent aspiration of gastric contents during general anesthesia, Kvamatel is prescribed at a dose of 40 mg on the eve of surgery and/or in the morning on the day of surgery.
Overdose
Symptoms: Â vomiting, motor agitation, tremor, decreased blood pressure, tachycardia, collapse.
Treatment: Â gastric lavage, symptomatic and supportive care; 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.
If treatment is abruptly discontinued, famotidine can cause withdrawal symptoms, so treatment is stopped, gradually reducing its dose.
In patients with impaired liver function, Kvamatel should be administered with caution and at lower doses.
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.
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.
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.
During treatment, you should avoid consuming food, beverages, and other medications that may cause irritation of the stomach lining.
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.
Storage conditions
In a dark place, at a temperature of 25 °C.
Shelf life
5 years
Active ingredient
Famotidine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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