Amoxicillin FT powder for oral suspension 250mg/5ml in 33.3g vial #1

Name:
Amoxicillin FT Dosage form and description powder for suspension for oral use.
Description:
of the dosage form Powder of white or almost white color with a fruity odor. When added to the contents of the vial of carbon dioxide-free water (freshly boiled and cooled), a pink suspension with white inclusions with a characteristic strawberry odor is obtained. The composition of 5 ml of the suspension contains as an active substance 0.125 g (125 mg), or 0.250 g (250 mg), amoxicillin trihydrate in terms of amoxicillin. Excipients: xanthan gum, anhydrous colloidal silicon dioxide, calcium stearate, sodium benzoate, sodium citrate, aspartame, dye carmoisine, flavoring additive “Aromatic” Vanillin AP220, flavoring additive “Aromatic” Strawberry AP1943, granulated sugar Pharmacotherapeutic group Beta-lactam antibiotic-penicillin. ATC code: J01C A04 bacteria. Has a wide spectrum of action. Active against a large number of both gram-negative and gram-positive microorganisms. Escherichia coli, Proteus mirabilis, Salmonella, Shigella, Campylobacter, Haemophilus influenzae, Bordetella pertussis, Leptospira, Chlamydia are sensitive to the drug. Active against streptococci of groups A, B, C, G, H, I, M, Streptococcus pneumoniae, staphylococci that do not produce penicillinase, Neisseria; Erysipelothrix rhusiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, Streptobaccili, Spirillium minus, Pastereulla multocida, Listeria, Spirochaeta (Leptospira, Treponema, Borrelia, etc.) ). Pharmacokinetics Absorption When administered orally, amoxicillin is almost completely absorbed from the gastrointestinal tract. Eating does not affect absorption. The maximum plasma concentration is reached 1-2 hours after ingestion. Distribution Amoxicillin penetrates well into tissues and body fluids, including sputum. With normal liver function, a high concentration of amoxicillin is observed in bile. Withdrawal Amoxicillin is excreted mainly by the kidneys, about 50% – unchanged. The half-life is 1-2 hours. Indications for use Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug, including: – infectious diseases of the upper respiratory tract and ENT organs; – infectious diseases of the lower respiratory tract (acute and chronic bronchitis, pneumonia, lung abscesses, initial stages or incubation period of whooping cough); – infectious diseases of the genitourinary system (acute and chronic pyelonephritis, pyelitis, prostatitis, epididymitis, cystitis, urethritis, asymptomatic bacteriuria during pregnancy); – gonorrhea; – gynecological infections (septic abortion, adnexitis, endometritis); – typhoid and paratyphoid, incl. complicated by septicemia (in combination with aminoglycosides); – salmonellosis; – shigellosis; – infectious diseases of the biliary tract (cholangitis, cholecystitis) in the absence of cholestasis; – infectious diseases of the skin and soft tissues; – leptospirosis; – acute and latent listeriosis. The drug is also used for short-term (24-48 hours) prevention of infectious complications during minor surgical interventions. The drug is also used in the treatment of infective endocarditis (in combination with aminoglycosides), meningitis, septicemia in the case when parenteral antimicrobial therapy is not required. Method of administration and dosesFrom Amoxicillin-Pharma, which is in the form of a powder, it is necessary to prepare a ready-to-use suspension before using the drug. To do this, first shake the powder in the vial, then add boiled drinking water cooled to room temperature to the “60 ml” mark (when using 20.0 g of powder), to the “100 ml” mark (when using 33.3 g of powder) and intensively shake up. After the resulting foam settles, add an additional volume of suspension with water to 60 ml, up to 100 ml, shake thoroughly. The suspension is ready for use. Before each use, the bottle is vigorously shaken and left to stand until the resulting foam settles. The dosage regimen is set individually, depending on the sensitivity of microorganisms and the localization of the infectious process. Adults on average appoint 1.5-2 g / day. If necessary, the dose of the drug can be increased to 6 g / day. The multiplicity of reception is 2 times / day. In acute infectious diseases of the gastrointestinal tract (paratyphoid, typhoid fever) and biliary tract, as well as in gynecological infectious diseases for adults, the drug is prescribed 1.5-2 g 3 times / day or 1-1.5 g 4 times / day. With leptospirosis, adults are prescribed 500-750 mg 4 times / day for 6-12 days. With salmonella carriage in adults – 1.5-2 g 3 times / day for 2-4 weeks. For the prevention of endocarditis during minor surgical interventions, adults are administered 3-4 g 1 hour before the procedure. If necessary, a second dose is prescribed after 8-9 hours. In children, the dose of the drug should be halved. Treatment with Amoxicillin-Pharma should be continued for 2-5 days after the symptoms disappear. Streptococcal infections should be treated for at least 10 days to prevent complications. In patients with impaired renal function with CC below 30 ml / min, the dose of the drug is reduced and / or the interval between doses is increased. With CC 15-40 ml / min, the interval between doses of the drug should be at least 12 hours. In patients with anuria, the dose of the drug should not exceed 2 g / day. In infectious diseases of the genitourinary tract, dose adjustment is not required. For children, the drug is prescribed in doses at the rate of 30-60 mg / kg / day. Multiplicity of reception – 2 times / day. Age Daily dose up to 1 year 1-6 years 6-10 years 10-14 years 14-18 years 250 mg 500 mg 750 mg 1 g 1.5 g In severe infectious diseases, the dose for children can be increased to 100 mg / kg / day In premature and newborns, the dose of the drug is reduced and / or the interval between doses is increased. Side effects From the gastrointestinal tract and liver: nausea, diarrhea, rarely – increased activity of hepatic transaminases in the blood plasma, glossitis, stomatitis. Perhaps the development of pseudomembranous colitis. From the side of the hematopoietic system: thrombocytopenia, leukopenia, eosinophilia, agranulocytosis. From the nervous system and psyche: headache, fatigue. Patients with epilepsy and/or meningitis and/or decreased renal function have an increased risk of neurotoxic complications (convulsions). Allergic reactions: rarely – urticaria, fever, joint pain, erythema multiforme, exfoliative dermatitis, Quincke’s edema, in extremely rare cases – anaphylactic shock. Other: rarely – interstitial nephritis. Contraindications infectious mononucleosis; hypersensitivity to penicillins. The use of the drug in combination with metronidazole is contraindicated in diseases of the nervous system, hematopoietic disorders, lymphocytic leukemia, infectious mononucleosis, hypersensitivity to nitroimidazole derivatives, in diseases of the digestive tract that occur with prolonged diarrhea or vomiting, in severe liver pathology, do not prescribe to patients under 18 years of age as well as during pregnancy and lactation. Interaction with other drugs When used simultaneously with allopurinol, the risk of skin rash increases. The drug acts only on multiplying microorganisms, so it should not be administered simultaneously with antimicrobial drugs that act bacteriostatically. In the presence of positive tests for the sensitivity of the pathogen, Amoxicillin-Pharma can be used in combination with other bactericidal antibiotics (cephalosporins, aminoglycosides). The simultaneous use of the drug with probenecid leads to an increase in the concentration of amoxicillin in the blood by reducing its excretion by the kidneys. In this case, the penetration of the drug into the tissues may decrease. Simultaneous administration of antacids reduces the absorption of Amoxicillin-Pharma. The drug may reduce the effectiveness of oral contraceptives. Special instructions In patients with hypersensitivity to cephalosporins, the possibility of cross-allergy should be considered. In severe gastrointestinal infections with persistent diarrhea and vomiting, the drug should not be prescribed due to a possible deterioration in absorption. With caution, the drug is prescribed to patients with allergic diathesis, bronchial asthma and hay fever. In patients with cholecystitis and cholangitis, Amoxicillin-Pharma is prescribed only for mild disease and in the absence of cholestasis. Patients with typhoid fever, leptospirosis or syphilis during drug therapy may develop a Jarisch-Herxheimer reaction due to bacterial lysis. With prolonged use of high doses of the drug in patients, liver and kidney function indicators should be monitored, general urine tests should be performed. It is advisable to control the picture of peripheral blood. With long-term treatment, the possibility of developing superinfection with insensitive microorganisms, incl. mushrooms. During therapy, adequate fluid intake and maintenance of sufficient diuresis should be ensured. With the appearance of watery feces with an admixture of mucus and blood, abdominal pain, fever, tenesmus, the development of pseudomembranous colitis should be suspected. In this case, the drug should be discontinued and appropriate treatment prescribed. In this case, drugs that slow down the motility of the gastrointestinal tract are contraindicated. Before starting treatment for gonorrhea in patients with suspected primary syphilis, a dark field smear should be performed. All patients with suspected concomitant syphilis should have a follow-up serological test for at least 4 months. It is possible to obtain false positive results when determining blood glucose. Amoxicillin-Pharma may distort the results of the determination of urobilinogen. When prescribing the drug to patients with diabetes, it should be borne in mind that the composition of the Amoxicillin-Pharma powder for the preparation of the suspension includes refined sugar. Release form 20.0 g, 33.3 g each in plastic bottles with a dosing cup, packed together with a leaflet in cardboard packs. Storage conditions Store in a place protected from light and moisture at a temperature not higher than + 25 ° C. Shelf life 2 years. The shelf life of the prepared suspension is 10 days when stored at a temperature of +2˚С-+8˚С. The expiration date is indicated on the packaging. The drug can not be used after the date indicated on the package. Terms of dispensing from pharmacies The drug is dispensed by prescription. 250mg/5ml in a vial 33.3g №1