Nov 16, 2011 amikacin sulfate should be preserved in a tight container. Using the bestdose clinical softwareexamples with aminoglycosides. The invention discloses a kind of amikacin sulfate injection and preparation method thereof. Item amikacin sulfate injection usp 500mg2ml 250mgml and. The dosage form is supplied as a sterile, colorless to light straw colored. Found 3 results for amikacin sulfate injection sort by. Amikacin sulfate injection is an aminoglycoside antibiotic indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter mimaherellea. Cn103181890a amikacin sulphate injection and preparation. Dglucopyranosyl16n 34aminol2hydroxybutyryl2deoxylstreptamine sulfate 1.
Liquid chromatographic determination of amikacin sulphate. In this rphplc method shimadzu lc 20 ad of pda detector was used with lc solutions software. It is used either by injection into a vein or muscle. Amikacin sulfate should be preserved in a tight container. Side effects of amikacin sulfate injection amikacin sulfate. Assay of amikacin in the skin by highperformance liquid chromatography. Sigmaaldrich offers a number of amikacin disulfate salt products. Amikacin sulphate injection is contraindicated in patients with known allergy to amikacin or any component of the formulation. Amikacin sulfate injection is indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter mimaherellea species. Most infections typically respond in 24 to 48 hours.
Amikacin sulfate injection, usp safety data sheet sds may, 2016 sds no sds 077 sds version no 1. Amikacin sulfate injection, usp is indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiella species, enterobacter species, serratia species, and acinetobacter species. Journal of pharmaceutical science and bioscience research 2012. Amikacin sulfate injection 4 ml, each clearance nonreturnable patterson vet generics. Amikacin belongs belongs to the family of medications called antibiotics. Amikacin amikacin sulfate amikin intramuscular inj sol. Amikacin sulfate injection, usp is a semisynthetic aminoglycoside antibiotic derived from kanamycin. The concurrent or serial use of other ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects. Amikacin sulfate injection is an aminoglycoside antibiotic indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter mimaherellea species. The canada vigilance program does not provide medical advice. Cats are more sensitive to vestibular damage due to aminoglycosides. This product is for single use in one patient only.
No antimicrobial preservative is added to the formulation. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Amikacin is a semisynthetic aminoglycoside antibiotic that is derived from kanamycin a. Amikacin sulfate reference guide for safe and effective use from the. This drug is registered for use in humans and animals. This ed material has been downloaded from a licensed data provider and is not for distribution, except. At times the solution may become a very pale yellow.
Development and validation of rphplc method for simultaneous estimation of cefepime hydrochloride and amikacin sulphate in injection dosage form. In the above solutions with amikacin sulfate injection. Drug name active ingredients strength dosage formroute marketing status rld te code application no. Amikacin sulfate injection, usp rx only to reduce the development of drugresistant bacteria and maintain the effectiveness of the amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent infections that are proven or. The amikacin sulphate injection and the preparation method for the same disclosed by the invention are simple in production process and low in cost. Fourier transform of midir spectra were recorded without any sample pretreatment.
Amikacin sulfate injection, usp is supplied as a colorless solution which requires no refrigeration. Arikayce is designed to deliver amikacin directly to the site of infection via inhalation. Free or liposomeencapsulated amikacin is administered to mice iv at a dose of 100. The aim of the study was to develop an easy, sensible and rapid method for the estimation of amikacin in both pure and marketed formulation by pre derivatisation technique using reverse phase c 18 column in hplc. The use of amiglydev in eliminating infections caused by the above. Liposomal encapsulation of amikacin sulphate for optimizing its. Amikacin is a prescription drug and can only be obtained from a veterinarian or by prescription from a veterinarian. The amikacin sulfate injection is indicated in the shortterm treatment of serious bacterial infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, as well as acinetobacter mimaherellea species. Mar 29, 2018 amikacin sulfate injection, usp is indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter mima. Amikacin sulfate amikacin sulfate injection westward pharmaceuticals corp. It is also used for the treatment of multidrugresistant tuberculosis. Monitor renal function, including urine output, specific gravity, urinalysis, bun and creatinine levels, and creatinine clearance.
Injection site reactions may accur with intramuscular injection. Amikacin sulfate as and polyvinyl alcohol pva, molecular weight mw, 25,000 da were procured from sigmaaldrich, spruce street, st. Amikacin sulfate is the sulfate salt of amikacin, a broadspectrum semisynthetic aminoglycoside antibiotic, derived from kanamycin with antimicrobial property. Amikacin sulfate injection is indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter. Following im administration of a single dose of amikacin of 7. Amikacin sulfate injection 4 ml, 10pkg patterson vet generics. Experience with a oncedaily aminoglycoside program administered to 2,184.
Increased nephrotoxicity has been reported following concomitant parenteral administration of. Amikacin is an antibiotic used for a number of bacterial infections. The present invention adds antioxidant, chelating agent, injection water in amikacin sulfate. This medication works by killing bacteria or preventing their growth. Aug 07, 2011 the purpose of this study was to develop a stabilityindicating method for the determination of sb in injection formulation. Nov 09, 2018 amikacin is an antibiotic that fights bacteria. Amikacin solution for injection drug information, side. Amikacin sulfate injection, usp boehringer ingelheim.
Gentamicin sulfate fda prescribing information, side. The quantitative estimation of amikacin amk in amk sulfate injection samples is reported using ftirderivative spectrometric method in a continuous flow system. Dosage with qualifiers, bacterial infection15 mgkgd imiv divided q824 h. Each milliliter ml contains gentamicin sulfate equivalent to 40 mg gentamicin base with sodium metabisulfite 2. The length of your treatment depends on the type of infection you have. Three corporate drive lake zurich, illinois 60047 general phone number. Amikacin sulfate injection is potentially nephrotoxic, ototoxic and neurotoxic. Amikacin sulfate injection is a sterile solution of amikacin sulfate in water for injection, or of amikacin in water for injection prepared with the aid of sulfuric acid. Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. Reagentfree determination of amikacin content in amikacin. Amikacin solution for injection 250mg drug medication dosage information.
C for 45 days revealed low leakage of drug from all liposomal formulations. Amikacin solution for injection 250mg drug medication dosage. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. It is used to kill certain types of bacteria that cause infections in the abdomen, blood, bones, joints, lungs e. Adverse events should also be reported, as appropriate, to the va aders program and fda. Amikacin may also be used for purposes not listed in this medication guide. A stability indicating method for the determination of the. Jul 01, 2018 amikacin sulfate injection usp 250 mgml, 10 x 4 ml vial, carton label text. The primary mechanism of action of arikayce is the disruption and inhibition of protein synthesis in the target bacteria by binding to the 30s ribosomal subunit. Side effects of amikacin sulfate injection amikacin. Cn1052300a a kind of amikacin sulfate injection and. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class. Amikacin is a semisynthetic aminoglycoside antibiotic used in the treatment of.
Amikacin sulfate injection, usp is a semisynthetic aminoglycoside antibiotic. One group was implanted with the fb and left unchallenged with bacteria and untreated as a sterile control group. The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. Mw, 7,00017,000 da was purchased from sigmaaldrich, steinheim, germany.
Gentamicin sulfate injection, usp is a sterile, nonpyrogenic solution of gentamicin sulfate in water for injection. The blood urea nitrogen bun is much less reliable for this purpose. Label amikacin is synthesized by acylation with the l. Amikacin sulfate amikin discontinued is an antibiotic injection prescribed to treat bacterial meningitis, infected burns, cystic fibrosis, and severe uti infections. Amikacin injection comes as a liquid to be injected intravenously into a vein or intramuscularly into a muscle every 8 or 12 hours two or three times a day. Amikacin injection is available in 500 mg2 ml strength. Amikacin fda prescribing information, side effects and uses. Production technology of the present invention is simple, and cost is low, solves the problem that amikacin sulfate injection can not meet terminal sterilization, compensate for the deficiencies in the prior art. Selected from data included with permission and ed by first databank, inc. Amikacin sulfate injection, usp, 250 mgml, is supplied as follows.
Aug 16, 20 we are engaged in offering excellent quality amikacin sulfate injection u. Ndc 0641616710, 2 ml single dose vial packaged in a carton of 10. Pharmacology microbiology amikacin is active, in vitro, against the following organisms. When amikacin is injected intravenously, it is usually infused injected slowly over a period of 30 to 60 minutes. The method was used for the determination of the aminoglycoside antibiotic amikacin sulphate amk in the presence of its synthetic precursor kanamycin sulphate in pure form and in different pharmaceutical. Amikacin sulfate amikacin sulfate dose, indications. It is administered by the intramuscular or intravenous route. According to the preparation method disclosed by the invention, an antioxidant, a complexant and injection water are added in amikacin sulphate. Minimum inhibitory concentrations mcgml disk diffusion zone diameter in mm pathogen. At times the solution may become pale yellow in color. Amikacin sulfate injection, usp rx only to reduce the development of drugresistant bacteria and maintain the effectiveness of the amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent infections that are proven or strongly. Amikacin sulfate injection, uspfor intramuscular or intravenous use. The injection is colorless to light strawcolored and has a ph ranging from 3.
The same liposome formulation has also been tested against murine. Amikacin sulfate injection usp 250 mgml, 10 x 2 ml single dose vial, carton label text. A novel high performance liquid chromatographic hplc method with a precolumn derivatization reaction has been developed and validated. Amikacin irreversibly binds to the bacterial 30s ribosomal subunit, specifically in contact with 16s rrna and s12 protein within the 30s subunit. Semen extender kit with amikacin and potassium penicillin. The product catalog provides you with a full listing of tevas brand and generic product lines.
Store vials at controlled room temperature 1530c, 5986f. Amikacin is used to treat severe or serious bacterial infections. Lipidbased slowrelease formulation of amikacin sulfate. The purpose of this study was to develop a stabilityindicating method for the determination of sb in injection formulation. Inoculation was followed by either no treatment or a local injection of deas, free amikacin sulfate, nondrugcontaining depofoam, or systemic free amikacin sulfate. It is usually given every 8 hours or as directed by your doctor. Sulfate injection usp and other antibacterial drugs, amikacin sulfate injection usp should. Amikacin sulfate 37517285 50 or 250 mgml water for injection 7732185 in accordance with 29 cfr 1910. Amikacin drug information, uses, side effects, chemistry. This medication is given by injection into a vein or muscle as directed by your doctor.
Clinically, gentamicin sulfate is used to treat severe systemic infections due to sensitive gramnegative and other organisms. The method developed was able to separate sb from amikacin sulfate and other excipients of a drug product within 10 min. Amikacin sulfate injection usp is indicated in the shortterm treatment of serious infections due to susceptible. Studies to evaluate a potential interaction between inhaled formulations of mannitol and tobramycin have not been conducted. For the treatment of uterine infections endometritis, metritis and pyometra in mares, when caused by susceptible organisms including escherichia coli, pseudomonas sp and klebsiella sp. Amikacin sulfate injection usp is indicated in the shortterm treatment of serious infections due to susceptible strains of gramnegative bacteria, including pseudomonas species, escherichia coli, species of indolepositive and indolenegative proteus, providencia species, klebsiellaenterobacterserratia species, and acinetobacter mima. In this method gradient elution with a mobile phase of acetonitrile and acetate. It is used either by injection into a vein or muscle amikacin, like other aminoglycoside antibiotics, can cause hearing loss, balance. Gentamicin sulfate injection is a solution containing gentamicin sulfate, a complex aminoglycoside antibiotic substance with three components, sulfates of gentamicin c1, gentamicin c2 and gentamicin c1a. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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