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Amikacin sulfate 500 mg 50s lyophilized powder for injection




The instruction for use of medicine for experts of AMIKACIN SULPHATE (Amikacini sulfas) the Trade name of Amikacin sulfate the International unlicensed name Amikacin Dosage Form Powder for preparation of solution for injections in bottles of 0.5 g Structure Active agent – amikacin sulfate (in terms of amikacin) – 0.50 g the Description Powder or porous mass of color, white or white with a yellowish shade, is hygroscopic. Pharmacotherapeutic group Antimicrobial drugs for system use. Other aminoglycosides. J01GB06 code the Pharmacological Pharmacokinetics At properties intramuscular administration of amikacin of sulfate is quickly soaked up by automatic telephone exchange, the maximum concentration in blood is found in 1 hour after introduction, therapeutic concentration of drug remain till 10-12 o’clock. At intravenous drop administration the concentration of amikacin of sulfate in blood exceeds observed at intramuscular introduction, the peak of concentration is created in blood in 30 min., dynamics of decrease in content of drug is similar to that at intramuscular introduction, therapeutic concentration of drug is maintained within 10-12 hours. The antibiotic gets into tissues of lungs, a liver, a myocardium, spleens, a bone tissue, in pleural and peritoneal exudates, synovial fluid and bile. Selectively collects in a bast layer of kidneys. Amikacin sulfate gets through a blood-brain barrier and it is found in liquor. At inflammation of meningeal covers the penetration of amikacin into cerebrospinal fluid increases. The antibiotic gets through a placenta and it is found in blood of a fruit and in amniotic liquid. Amikacin sulfate is removed in pharmacological active form by kidneys by glomerular filtration, creating high concentration in urine. At patients with disturbance of secretory function of kidneys the concentration of amikacin of sulfate in blood increases with significant increase in duration of circulation of an antibiotic in an organism. The Amikacin pharmacodynamics sulfate – antibacterial agent from group of aminoglycosides III of generation. Amikacin sulfate possesses a wide range of antimicrobic action. The mechanism of action is connected with disturbance of synthesis of protein ribosomes. Has bactericidal effect. It is active concerning the majority of gram-positive and gram-negative microorganisms: Staphylococcus, including penitsillino- and metitsillinoustoychivy strains, Escherichia coli, Proteus spp., Providencia, microorganisms of the group Serratia, Klebsiella, Enterobacter, Citrobacter, Salmonella, Shigella, Pseudomonas aeruginosa, including gentamitsino-, tobramitsino- and sizomitsinoustoychivy strains. Amikacin sulfate is moderately active concerning streptococci, enterococci, pneumococci. It is inactive concerning asporous gram-negative anaerobe bacterias and protozoa. Indications – sepsis, meningitis, peritonitis, a septic endocarditis – pneumonia, a pleura empyema, lung abscess – pyelonephritis, an urethritis, cystitis – the infected burns the Route of administration and doses Intramusculary or intravenously (by drop infusion). To adults and teenagers with normal function of kidneys – 15 mg/kg/days (on 5 mg/kg each 8 h or on 7.5 mg/kg each 12 h). The premature newborn an initial dose – 10 mg/kg, then on 7.5 mg/kg each 18-24 h, newborn an initial dose – 10 mg/kg, then on 7.5 mg/kg each 12 h within 7-10 days. The maximum daily dose – 1.5 g, the general course dose – no more than 15 g. In the absence of effect within 5 days pass to treatment with other drugs. Treatment duration – 7-10 days. Patients with a renal failure need reduction of a dose or increase in intervals between introductions without change of a single dose. The interval is calculated by a formula: concentration of creatinine in blood serum x 9. The first dose the patient with a renal failure makes 7.5 mg/kg, for calculation of the subsequent doses use a formula: Cl of creatinine (ml/min.) x an initial dose (mg) / Cl of creatinine is normal (ml/min.). Side effects – a hearing disorder and balances – nephrotoxicity – a headache, nausea, vomiting – anemia, a leukopenia, thrombocytopenia, a granulocytopenia – increase in activity of hepatic transaminases – a skin itching, urticaria – respiratory depression, spasms, parasthesias. Contraindications – hypersensitivity – neuritis of an acoustical nerve – disturbance of a vestibular mechanism – an azotemia (residual nitrogen of 150 mg of %) – a myasthenia, uraemia – pregnancy and a lactation. Medicinal interactions Streptomycin, Kanamycinum, Monomycinum, gentamycin, Tobramycinum, Viomycinum, polymyxin B and also diuretics (furosemide, Acidum etacrynicum) increase risk from – / nephrotoxicity (it is impossible to appoint at the same time or consistently). Pharmaceutical it is incompatible with other medicines (it is impossible to enter in one syringe). Special instructions Due to high from – nefro-, neurotoxicity drug is used in extreme cases! Before use of drug it is necessary to define sensitivity of microorganisms to an antibiotic. During treatment it is necessary to control the maintenance of an antibiotic in blood plasma (concentration should not exceed 30 mkg/ml). Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Driving or potentially dangerous mechanisms with care, in connection with possible disturbance of balance. Overdose Symptoms: strengthening of side effects Treatment: peritoneal dialysis or hemodialysis, simpomatichesky therapy. A form of release and packing Powder for preparation of solution for injections of 0.5 g in bottles on 10 ml. On 50 bottles in a box cardboard together with the instruction for medical use. To Store storage conditions in the dry, protected from light place at a temperature from + 15 to + 25 0C. To store out of children’s reach! An expiration date 2 years After an expiration date should not be applied. Prescription status According to the prescription the Synthesis Joint-stock Kurgan Company Producer of medications and products of joint stock company, Russian Federation, 640008, Kurgan, Konstitutsii Avenue, 7.

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