Composition, form of production and packaging
The tablets covered with a film cover of pink color, convex, with engraving "F20" on one side; On a break of white or almost white color.
famotidine 20 mg
Auxiliary substances: silicon dioxide colloid - 1 mg, magnesium stearate - 2 mg, povidone K90 - 4 mg, sodium carboxymethyl starch (type A) - 6 mg, talc - 6 mg, corn starch - 56 mg, lactose monohydrate - 105 mg.
The composition of the film shell: iron oxide red is 0.012 mg, silicon dioxide colloid is 0.088 mg, titanium dioxide is 0.288 mg, macrogol is 6000 0.499 mg, sepilated 003 is 6.613 mg (macrogol-40 stearate (type I) 8-12% cellulose microcrystalline - 35-45%, hypromellose - 45-55%).
14 pcs. - blisters (2) - packs of cardboard.
The tablets covered with a film shell of dark pink color, convex, with engraving "F40" on one side; On a break of white or almost white color.
famotidine 40 mg
Auxiliary substances: silicon dioxide colloid - 1 mg, magnesium stearate - 2 mg, povidone K90 - 4 mg, sodium carboxymethyl starch (type A) - 6 mg, talc - 6 mg, corn starch - 51 mg, lactose monohydrate - 90 mg.
The composition of the film shell: iron oxide red - 0.024 mg, silicon dioxide colloid - 0.088 mg, titanium dioxide - 0.276 mg, macrogol 6000 - 0.499 mg, sepiliphilm 003 - 6.613 mg (macrogol-40 stearate (type I) - 8-12% cellulose microcrystalline - 35-45%, hypromellose - 45-55%).
14 pcs. - blisters (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white or almost white; The applied solvent is clear, colorless, odorless.
1 f. (72.8 mg of lyophilizate)
famotidine 20 mg
Excipients: aspartic acid - 8.8 mg, mannitol - 44 mg.
Solvent (0.9% sodium chloride solution): sodium chloride - 45 mg, water d / and - 5 ml.
72.8 mg - bottles of colorless glass (5) complete with a solvent (amp 5 pcs.) - packaging contour plastic (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
The blocker of histamine H 2 -receptors. Reduces the 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 does not affect fasting gastrin levels after eating. Does not affect gastric motility, exocrine pancreatic activity, blood circulation in the portal system, hormone levels, does not have an antiandrogenic effect.
Famotidine has little effect on microsomal enzymes of the liver.
After taking the drug inside the action occurs after 1 hour, the maximum of the action - 3 hours after the administration, the duration of the effect varies within 12-24 hours, depending on the dose.
The drug in the form of lyophilizate for the preparation of a solution for intravenous administration after administration in a single dose of 20 or 40 mg in the evening inhibits basal and night secretion for 10-12 hours.
Pharmacokinetics is linear.
After oral administration, it is not absorbed completely from the digestive tract. C max is achieved in 1-3 hours and is 0.07-0.1 mg / l. Bioavailability - 40-45%, increases with simultaneous intake of food and decreases with simultaneous administration of antacids.
Binding to plasma proteins is 10-20%. Penetrates through the placental barrier and through the BBB. Excreted in breast milk.
30-35% of the drug is metabolized in the liver to form an S-oxide.
T 1/2 is 2.3-3.5 h. After oral administration, 30-35% of famotidine, and after intravenous administration of 65-70% of famotidine is excreted unchanged in urine.
Pharmacokinetics in special clinical cases
At a CC <10 ml / min T 1/2 can reach 20 hours.
- peptic ulcer of the duodenum and stomach in the phase of exacerbation, prevention of relapses;
- treatment and prevention of symptomatic gastric and duodenal ulcers (associated with the administration of NSAIDs, stressful, postoperative ulcers);
- erosive gastroduodenitis;
- functional dyspepsia associated with increased secretory function of the stomach;
- reflux esophagitis;
- Zollinger-Ellison syndrome;
- prevention of recurrence of bleeding from the upper gastrointestinal tract;
- prevention of aspiration of gastric juice in general anesthesia (Mendelssohn syndrome).
For oral administration
In peptic ulcer of the stomach and duodenum in the phase of exacerbation, Kwamatel В® is prescribed in a dose of 40 mg 1 time / day at bedtime or 20 mg 2 times / day, morning and evening. If necessary, the daily dose can be increased to 80-160 mg. The duration of treatment is an average of 4-8 weeks.
In order to prevent exacerbations of peptic ulcer of the stomach and duodenum Kwamatel В® is prescribed in a dose of 20 mg 1 time / day before bedtime.
With reflux esophagitis the drug is prescribed in a dose of 20 mg 2 times / day (morning and evening) for 6 weeks; if necessary, 40 mg twice a day.
With 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 the drug depends on the clinical condition of the patient.
To prevent aspiration of gastric contents during general anesthesia, Kwamatel В® is prescribed at a dose of 40 mg on the eve of surgery and / or on the morning of the day of surgery.
For intravenous administration
Kwamatel В® is applied iv, jet or drip only in severe cases or when it is not possible 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 / day (every 12 hours). Single dose should not exceed 20 mg.
With 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 state of the patient.
To prevent aspiration of gastric contents before the general anesthesia is administered iv 20 mg of the drug on the eve of the operation or at least 2 hours prior to the commencement of the operation.
Patients with impaired renal function (QC less than 30 ml / min) , or with a serum creatinine level of more than 3 mg / dl, daily dose of the drug (for ingestion and intravenous administration) is reduced to 20 mg or increase the interval between the use of individual doses of the drug to 36-48 hours.
If the liver function is impaired, the drug is administered with caution, in reduced doses.
Rules for the preparation and administration of injection solutions
To prepare the solution, the contents of one ampoule with the active substance should be previously diluted in 5-10 ml of physiological solution (ampoule with a solvent). The prepared solution remains stable at room temperature for 24 hours. The drug is administered for at least 2 minutes. With IV injection, the duration of infusion should be 15-30 minutes. The solution should be prepared immediately before administration.
On the part of the digestive system: dry mouth, nausea, vomiting, abdominal pain, flatulence, constipation, diarrhea, decreased appetite; increased liver transaminase activity, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.
From the hemopoietic system: very rarely - agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, hypo- or aplasia of the bone marrow.
Allergic reactions: urticaria, skin rash, itching, bronchospasm, angioedema, anaphylactic shock.
From the cardiovascular system: arrhythmia, bradycardia, AV-blockade, lowering blood pressure.
From the side of the central nervous system: headache, dizziness, drowsiness, hallucinations, confusion, increased fatigue, depression, agitation, anxiety.
From the senses: a decrease in visual acuity, tinnitus.
On the part of the reproductive system: with prolonged use in high doses - hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido.
From the musculoskeletal system: arthralgia, muscle spasms.
Dermatological reactions: alopecia, acne vulgaris, dry skin, toxic epidermal necrolysis.
- the period of lactation (breastfeeding);
- hypersensitivity to the components of the drug;
- Hypersensitivity to other blockers of histamine H 2 -receptors.
With caution should prescribe the drug in renal and hepatic insufficiency, with cirrhosis of the liver with portosystemic encephalopathy in the anamnesis.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy. If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal function (QC less than 30 ml / min) , or with a serum creatinine level of more than 3 mg / dl, daily dose of the drug (for ingestion and for intravenous administration) is reduced to 20 mg or increase the interval between the use of individual doses of the drug to 36-48 hours.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
If the liver function is impaired, the drug is administered with caution, in reduced doses.
The use of Kwamatel can mask the symptoms of stomach cancer, so before starting treatment with famotidine, it is necessary to exclude the presence of malignant neoplasm.
With a sharp discontinuation of treatment, famotidine can cause withdrawal syndrome, so treatment is stopped, gradually reducing its dose.
Patients with violations of liver function Kwamatel В® should be administered with caution and in lower doses.
With prolonged treatment of weakened patients or patients under stress, bacterial lesions of the stomach with further spread of infection are possible.
Kwamatel В® should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption. Also, you should observe a 1-2 hour break between taking Kwamatel and antacids.
The blockers of histamine H 2 receptors (including Kwamatel В® ) can inhibit the acid-stimulating effect of pentagastrin and histamine, therefore, the appointment of Kwamatel should be abandoned 24 hours before the test.
The blockers of histamine H 2 -receptors can suppress the skin reaction to histamine, thus leading to false negative results. Therefore, before carrying out diagnostic skin tests to detect an allergic skin reaction immediate type Kwamatel В® should be discarded.
During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.
Impact on the ability to drive vehicles and manage mechanisms
During the period of taking Kwamatel В®, patients should be careful when driving vehicles and engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
Symptoms: vomiting, motor excitation, tremor, lowering blood pressure, tachycardia, collapse.
Treatment: gastric lavage, symptomatic and maintenance therapy; hemodialysis.
Due to the increase in the pH of the contents of the stomach, Kwamatel В®, when used at the same time, reduces the absorption of ketoconazole and itraconazole;increases the absorption of amoxicillin and clavulanic acid.
Antacids and sucralfate, used simultaneously with Kwamatel, slow the absorption of famotidine.
With the simultaneous administration of Kwamatel and drugs that inhibit bone marrow hematopoiesis, the risk of developing neutropenia increases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children.
Tablets should be stored in a dark place at a temperature of no higher than 30 В° C. Shelf life - 5 years.
The lyophilizate should be stored in a dark place at a temperature of 15 В° to 25 В° C. Shelf life - 3 years, solvent - 5 years.