KVAMATEL

Active material: Famotidin
When ATH: A02BA03
CCF: Gistaminovыh blocker H₂-receptors. Anti-ulcer drug
ICD-10 codes (testimony): E16.8, J95.4, K21.0, K25, K25.0, K26, K26.0, K27, K29, K30
At KFU: 11.01.01
Manufacturer: GEDEON RICHTER Ltd. (Hungary)

Pharmaceutical form, composition and packaging

Pills, coated Pink colour, convex, labeled “F20” on one side.

Excipients: Colloidal anhydrous silica, magnesium stearate, povidone K90, sodium carboxymethyl starch type A, talc, corn starch, lactose monohydrate.

The composition of the shell: iron oxide red (C.I.77491), Colloidal anhydrous silica, Titanium dioxide, macrogol 6000, sepifilm 003 (gipromelloza, macrogol stearate).

14 PC. – blisters (2) – cardboard boxes.

Pills, coated dark pink, convex, labeled “F40” on one side.

Excipients: Colloidal anhydrous silica, magnesium stearate, povidone K90, sodium carboxymethyl starch type A, talc, corn starch, lactose monohydrate.

The composition of the shell: iron oxide red (C.I.77491), Colloidal anhydrous silica, Titanium dioxide, macrogol 6000, sepifilm 003 (gipromelloza, macrogol stearate).

14 PC. – blisters (1) – cardboard boxes.

Valium for drug of a solution for / in white or nearly white; enclosed solvent transparent, colorless, without smell.

Excipients: aspartic acid, mannitol.

Solvent: rr sodium chloride 0.9% – 5 ml.

72.8 mg of freeze-dried product – colorless glass vials (5) together with the solvent (amp. – 5 PC.) – contoured plastic packaging (1) – packs cardboard.

Pharmacological action

Gistaminovыh blocker H₂-receptors. It reduces basal and stimulated gastrin, pentagastrin, ʙetazolom, caffeine, gistaminom, acetylcholine and vagal reflex physiological secretion of hydrochloric acid. This increases the pH and reduces the activity of pepsin. Virtually no effect on fasting gastrin levels and postprandial. No effect on gastric motility, exocrine activity of the pancreas, blood flow in the portal system, hormone levels, It has no antiandrogenic action.

Increases defense mechanisms of the gastric mucosa by increasing the formation of gastric mucosa and its content of glycoproteins, as well as stimulating the secretion of bicarbonate and endogenous prostaglandin synthesis, and promotes healing of mucosal damage, incl. scarring of stress ulcers and stopping gastrointestinal bleeding.

The low degree inhibits cytochrome P450 oxidase system of the liver.

After taking the drug inside the action comes through 1 no , maximum action occurs through 3 h after administration, duration of effect varies 12-24 hours depending on the dose.

After the on / in the maximum effect occurs during the first 30 m. The drug is in the form of a lyophilisate for solution for i / v administration after administration of a single dose 20 or 40 mg in the evening inhibits basal and nocturnal secretion for 10-12 no.

Pharmacokinetics

The pharmacokinetics is linear.

Absorption

Once inside absorbed from the gastrointestinal tract is not fully. C_max achieved through 1-3 h and is 0.07-0.1 mg / l. Bioavailability – 40-45 %, increases while eating, and decreases while taking antacids.

Distribution

Associated with the plasma protein by 10-20%. It penetrates through the placental barrier and the GEB. Provided with breast milk.

Metabolism

30-35% The drug is metabolized in the liver to form S-oxide.

Deduction

T_1/2 is 2.3-3.5 no. Once inside 30-35% famotidina, and after the on / in the 65-70% famotidine is excreted in the urine in unchanged form.

Pharmacokinetics in special clinical situations

If CC<10 ml/min T_1/2 can reach 20 no.

Testimony

- Duodenal ulcer and stomach in the acute phase, relapse prevention;

- Symptomatic treatment and prevention of ulcers of the stomach and duodenum (associated with taking NSAIDs, stress, postoperative ulcers);

- Erosive gastro;

- Funktsionalynaya dyspepsia, associated with increased gastric secretion;

- Reflux esophagitis;

- Zollinger-Ellison;

- Prevention of recurrence of bleeding from the upper gastrointestinal tract;

- Prevention of gastric aspiration during general anesthesia (Mendelson's syndrome).

Dosage regimen

Orally

At gastric ulcer and duodenal ulcer in the acute phase Kvamatel^® administered at a dose of 40 mg 1 time / day before bedtime or 20 mg 2 times / day, in the morning and in the evening. If necessary, the daily dose can be increased to 80-160 mg. Duration of treatment averages 4-8 weeks.

With the aim of prevention of relapse of gastric ulcer and duodenal ulcer Kvamatel^® administered at a dose of 20 mg 1 time / day before bedtime.

At reflux esophagitis the drug is prescribed in a dose 20 mg 2 times / day (in the morning and in the evening) during 6 weeks; if necessary – 20-40 mg 2 times / day for 12 weeks.

At Zollinger-Ellison syndrome starting dose is 20-40 mg every 6 no; if necessary, the daily dose can be increased to 240-480 mg. The duration of the drug depends on the clinical condition of the patient.

With the aim of prevention of aspiration of gastric contents during general anesthesia Kvamatel^® administered at a dose of 40 mg before the operation and / or the morning of surgery.

For i / v administration

Kvamatel^® use / in, bolus or infusion only in severe cases, or if you can not receive the drug inside.

It is intended only for use in hospital. As soon as possible should go to oral famotidine. The average dose is at 20 mg 2 times / day (every 12 no). A single dose should not exceed 20 mg.

At Zollinger-Ellison syndrome starting dose is 20 mg every 6 no, subsequently the dose is adjusted depending on the secretion of hydrochloric acid and the clinical condition of the patient.

To prevention of aspiration of gastric contents prior to general anesthesia administered to / in 20 mg before surgery, or at least 2 hours before the operation.

Patients with impaired renal function (CC less than 30 ml / min), or serum creatinine more 3 mg / dL, daily dose (for oral, and for the on / in the) is reduced to 20 mg or increase the interval between the application of a single dose of the drug to 36-48 no.

At abnormal liver function the drug is prescribed with caution, in small doses.

Terms of preparation and administration of injectable solutions

To prepare the solution the contents of one ampoule of active ingredient to be pre-diluted in 5-10 ml saline (vial of solvent). The prepared solution is stable at room temperature for 24 no. The drug is administered for at least 2 m. The on / in drip duration of infusion should be 15-30 m. Shelf life of the infusion solution, prepared using a solution with dextrose, potassium chloride or sodium lactate, is 4 no; using ISODEX – 5 no, Ringer, Ringer's lactate or salsola A – 8 no. The solution should be prepared immediately before administration.

Side effect

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

From the hematopoietic system: rarely – agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, Hypo- or bone marrow aplasia.

Allergic reactions: hives, skin rash, itch, bronchospasm, angioedema, anaphylactic shock.

Cardio-vascular system: arrhythmia, bradycardia, AV блокада, decrease in blood pressure, fatigue.

CNS: headache, dizziness, drowsiness, hallucinations, confusion, reduced visual acuity, noise in ears.

On the part of the reproductive system: long-term use in high doses – hyperprolactinemia, gynecomastia, amenorrhea, decreased libido.

On the part of the musculoskeletal system: myalgia, muscle spasms, arthralgia.

Dermatological reactions: alopecia, acne vulgaris, xerosis.

Other: fever.

The most likely to develop headaches, dizziness, diarrhea, constipation. The rest of the side effects are very rare (connection with famotidine significantly not installed).

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

- Children's age;

- Hypersensitivity to famotidine and other ingredients.

FROM caution It should be prescribed the drug for kidney and liver failure, liver cirrhosis with portosystemic encephalopathy history, allergic reactions, caused by other histamine H₂-receptors, history (the possibility of cross-allergic reactions).

Pregnancy and lactation

The drug is contraindicated during pregnancy. If necessary, use of the drug in breast-feeding should be discontinued.

Cautions

Application kvamatel^® may mask symptoms of gastric carcinoma, so before, you start treatment famotidine, to rule out malignancy.

In a dramatic famotidine treatment may cause withdrawal symptoms, therefore, treatment should be stopped, gradually reducing the dose.

Patients with impaired hepatic function Kvamatel^® should be used with caution and at lower doses.

With long-term treatment of debilitated patients, or patients under stress are possible bacterial lesions of the stomach with a further spread of infection.

Kvamatel^® should take over 2 hours after administration of ketoconazole or itraconazole avoid significant decrease their absorption. Also to be observed 1-2 hour break between taking kvamatel^® and antacids.

Histamine H₂-receptors (incl. Kvamatel^®) kislotostimuliruyuschee can inhibit the action of histamine and pentagastrin, so for 24 hours before the test should abandon destination kvamatel^®.

Histamine H₂-receptors can inhibit the skin reaction to histamine, thus leading to false negative results. Therefore, before the diagnostic skin tests to identify allergic skin reactions of immediate type Kvamatel^® should be abolished.

During treatment should avoid eating food, beverages and other drugs, which can cause irritation of the gastric mucosa.

Effects on ability to drive vehicles and management mechanisms

During dosing Kvamatel^® Caution should be exercised when engaging in potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Symptoms: vomiting, motor stimulation, tremor, decrease in blood pressure, tachycardia, collapse.

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

Drug Interactions

By increasing the pH of the stomach contents Kvamatel^® while the application reduces the absorption of ketoconazole and itraconazole; increases the absorption of amoxicillin and clavulanic acid.

Antacids and sucralfate, applied simultaneously with kvamatel^®, slow down the absorption of famotidine.

At simultaneous reception kvamatel^® and preparations, oppressing bone marrow, increased risk of neutropenia.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in the dark, inaccessible to children at temperature from 15 ° to 25 ° C. Shelf life Tablets – 5 years, lyophilisate – 3 year, Solvent – 5 years.