Amikacin sulfate injection, usp sagent pharmaceuticals. Retrieve technical documents for our entire portfolio of instruments, assays and test kitsall with a single pointofaccess. 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 is used for short term treatment of serious infections caused by. If any of the side effects gets serious, or if you notice any side effects not. The product catalog provides you with a full listing of tevas brand and generic product lines.
The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Highlights of prescribing information these highlights do not. Product name dbl amikacin 500mg2ml solution for injection 2. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and nonqwave myocardial infarction, when concurrently administered with aspirin. Draw the amikacin into the 5 ml syringe using the 1inch 22 or 23 gauge needle. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The recommended dosage is oncedaily oral inhalation of the contents of one 590 mg8. Amikacin injection manufacturers, suppliers and exporters. Amikacin dosing, indications, interactions, adverse. Percocetoxycodone and acetaminophen tablets, uspcii rx.
Alprostadil is an endogenous substance known as prostaglandin e 1 pge 1. 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. Some of the areas are public while some are restricted and require for you to first register for a siemens healthineers online services account. If you have any further questions, ask your doctor or pharmacist. Amikacin sulfate injection, usp fresenius kabi usa. Sterile vancomycin hydrochloride, usp is a lyophilized powder, for preparing intravenous iv infusions. Amikacin dosing, indications, interactions, adverse effects. Indications 1, 2 amikacin must be reserved for treating infections due to microorganisms that are resistant to other aminoglycosides. The mean sd mcs predicted c max and auc 24 values and cfr are provided in table 2 and centered on tbwbased and dwbased doses and a fixed dosing approach.
Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Adjust the dose based on the patients inr and the condition being treated. Oct, 2015 similarly, the amikacin cl was correlated to age and serum creatinine but not to tbw or dw. Amikacin investigated as a drug, natural product, and reproductive effector. Find out what health conditions may be a health risk when taken with amikacin injection. This medication is given by injection into a vein or muscle as directed by your doctor.
Consistent with this observation, the amikacin c max and auc 24 were better correlated to amikacin dose in milligrams r 2 amikacin sulfate injection, usp 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 suspected to be caused by bacteria. Information on submitting spl files using elist may be found in the guidance for industry titled spl standard for content of labeling technical qs and as at. The document library provides customers with a single pointofaccess to technical documents for our entire portfolio of instruments, assays and test kits. Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.
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. Dec 17, 2018 ndc 0641616610 rx only amikacin sulfate injection, usp equivalent to amikacin 1 gram4 ml 250 mgml for intramuscular or intravenous use 10 x 4 ml vials each ml contains 250 mg amikacin as sulfate, 0. Amikacin liposome inhalation suspension for treatmentrefractory lung disease caused by mycobacterium avium complex convert. Evidence of ototoxicity dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss or nephrotoxicity requires discontinuation of the drug or dosage. Treatment with amikacin for 14 days has not been established as being safe. It may be supplied in packs containing 5 x 500 mg2 ml vials. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Amikacin normon is indicated for the shortterm treatment of severe. For obese patients total body weight 20% over ideal body weight, dosage requirement may best be. It is usually given every 8 hours or as directed by your doctor. Women of childbearing potential should use adequate contraception and. Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Arikayce also known as liposomal amikacin for inhalation, or lai is an approved treatment for adults developed by insmed to treat lung infections caused by mycobacterium avium complex mac, a type of nontuberculous mycobacteria ntm, which have not responded to standard treatments.
Amikacin 250 mg injection is used to treat a variety of bacterial infections of the lungs, skin, abdomen, and blood caused by li, streptococci, enterococci, etc. Refer to impaired renal function of dosage description. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram. The length of your treatment depends on the type of infection you have. This is a guideline only, for more detailed inform ation please refer to. Ndc 0641616610 rx only amikacin sulfate injection, usp equivalent to amikacin 1 gram4 ml 250 mgml for intramuscular or intravenous use 10 x 4 ml vials each ml contains 250 mg amikacin as sulfate, 0. 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. Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels and prolonged peak concentrations above 35 micrograms per ml. Highlights of prescribing information these highlights do not include all the information needed to use zerbaxasafely and effectively. Clinical trial arikayce amikacin liposome inhalation. Arikayce consists of liposomes that contain amikacin, an antibiotic. Amikacin sulphate is an aminoglycoside antibiotic with activity against a broad spectrum of gramnegative organisms such as pseudomonas species, escherichia coli, klebsiellaenterobacterserratia and salmonella species author.
Amikacin fda prescribing information, side effects and uses. Amikacin injection is a clear, colourless to pale yellow solution for injection which comes in glass containers called vials. Common name amikacin intended use the tdxtdxflx amikacin assay is a reagent system for the quantitative measurement of amikacin, an aminoglycoside antibiotic drug, in serum or plasma. Reference is also made to the complete response letter issued by this office on july 23, 2014, and to your amendments dated may 15, july 1, november, and november 16, 2015. The main goal is to improve or maintain lung function. Urinary tract infections other than pseudomonal infections 500 mgday in two equally divided doses is.
Venofer is indicated for the treatment of iron deficiency anemia in patients. We do not recommend the use of amikacin as part of an. Jan 01, 2020 arikayce is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unitdose glass vial containing amikacin 590 mg8. Many gram negative organisms resistant to gentamicin and tobramycin in vitro are sensitive to amikacin. In normal adult volunteers, average peak serum concentrations of about 12, 16 and 21 mcgml are obtained 1 hour after intramuscular administration of 250 mg 3. Full text get a printable copy pdf file of the complete article 872k, or click on a page image below to browse page by page. Information for the user amikacin 250 mgml injection read all of this leaflet carefully before you start using this medicine. Amikacin can be given by inhalation to decrease the amount of bacteria pseudomonas aeruginosa in the lungs. Jan 08, 2020 arikayce also known as liposomal amikacin for inhalation, or lai is an approved treatment for adults developed by insmed to treat lung infections caused by mycobacterium avium complex mac, a type of nontuberculous mycobacteria ntm, which have not responded to standard treatments. If you need help accessing information in different file formats. Act, for amikacin sulfate injection usp, 50 mgml 100 mg2 ml vial. It is used either by injection into a vein or muscle amikacin, like other aminoglycoside antibiotics, can cause hearing loss, balance.
Dglucopyranosyl16n 34aminol2hydroxybutyryl2deoxylstreptamine sulfate 1. Broad spectrum antibiotic amikacin sulfate injection, usp. Arikayce is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unitdose glass vial containing amikacin 590 mg8. Arikayce liposomal amikacin for inhalation bronchiectasis. Amikacin 250 mg injection uses, dosage, side effects. The inhaled form of amikacin is available as a 500mg2ml solution kept in a vial that can be stored at room temperature. These amikacin injection manufacturing companies are offering high. See actual entry in rtecs for complete information.
The patients pretreatment bodyweight should be obtained for calculation of correct dosage. Both monitoring of blood levels and limiting duration of therapy may prevent amikacin ototoxicity. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Amikacin was administered intramuscularly andor intravenously at a dose of 7. It contains the equivalent of not less than 674 mcg and not more than 786 mcg amikacin per mg, calculated on the dried basis. However, the cfr was consistently higher with a fixeddose approach. Mims, mircomedex, and the australian injectable drugs handbook. Amikacin is rapidly absorbed after intramuscular administration. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Be sure to hold the handset level throughout the treatment. Jul 01, 2018 amikacin is rapidly absorbed after intramuscular administration. Overexposure may cause damage to hearing, nervous system and kidneys.
Amikacin intended use the tdxtdxflx amikacin assay is a reagent system for the quantitative measurement of amikacin, an aminoglycoside antibiotic drug, in serum or plasma. Amikacin sulfate amikacin sulfate dose, indications. The dosage form is supplied as a sterile, colorless to light straw colored. Amikacin sulphate injection may be given intramuscularly or intravenously. Amikacin sulfate injection is potentially nephrotoxic, ototoxic and neurotoxic.
Venofer iron sucrose injection, usp is an established and effective treatment for chronic kidney disease ckd patients experiencing iron deficiency anemia. Manually determine the antibiotic susceptibility of microorganisms using antimicrobial susceptibility testing ast methods in conjunction with reliable, easytouse thermo scientific oxoid amikacin antimicrobial susceptibility disks. Material is a clear, colorless to strawcolored, odorless liquid. Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. In this group, the initial volume of distribution and volume of distribution at steady state was 0. Hence, it should be used with extreme caution in elderly patients as well as in patients with kidney. Nov 16, 2011 common commercial concentrations of amikacin are 50 mgml and 250 mgml. Amikacin s structure has been altered to reduce enzymatic deactivation, thus reducing bacterial resistance. Amikacin sulphate is an aminoglycoside antibiotic with. Use of ideal body weight ibw for determining the mgkgdose appears to be more accurate than dosing on the basis of total body weight tbw.
Intended use the qms amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. Common commercial concentrations of amikacin are 50 mgml and 250 mgml. Percocet contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. When amikacin is injected intravenously, it is usually infused injected slowly over a period of 30 to 60 minutes. Avoid concurrent or sequential use of neurotoxic andor nephrotoxic drugs including other aminoglycosides eg, amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin cumulative listing of drugs to avoid from all aminoglycoside package inserts include amphotericin b, bacitracin, cephaloridine, cisplatin, colistin, polymyxin b. Amikacin sulfate injection usp, 250 mgml 500 mg2 ml and. The dosage and administration of coumadin must be individualized for each patient according to the patients international normalized ratio inr response to the drug.
Each 2 ml vial contains amikacin sulfate equivalent to amikacin activity 500 mg 500,000. Close clinical observation and evaluation of the potential ototoxicity and nephrotoxicity in renal impairment, serum amikacin concentrations should be monitored if possible, or dose to be reduced. Package insert instructions must be followed accordingly. Only select registry of toxic effects of chemical substances rtecs data is presented here. It is also used for the treatment of multidrugresistant tuberculosis. The measurements obtained are used in the diagnosis and.
Read all of this leaflet carefully before you start using this medicine. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Amikacin is an antibiotic used for a number of bacterial infections. Webmd provides common contraindications for amikacin injection. This medicine is known to cause serious kidney problems and hearing problems, especially in the elderly population. This insert supersedes all previous insertsmanual inserts. To reduce the development of drugresistant bacteria and maintain the. It is used either by injection into a vein or muscle. Patients are calculated based on an estimated annual cumulative dose.
The measurements obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy. Package insert template for carboplatin solution for injection brand or product name product name solution for injection 10mgml name and strength of active substances carboplatin 10mgml product description visual description of the appearance of the product eg colour etc eg clear colourless liquid pharmacodynamics. This includes joint infections, intraabdominal infections, meningitis, pneumonia, sepsis, and urinary tract infections. Qualitative and quantitative composition amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Amikacin sulfate amikin discontinued is an antibiotic injection prescribed to treat bacterial meningitis, infected burns, cystic fibrosis, and severe uti infections. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may. Then, breathe normally through the mouthpiece until the treatment is complete about 14 to 20 minutes. The document library provides customers with a single pointofaccess to technical documents for our entire portfolio of medical devices, assays, test kits and healthcare it offerings. Amikacin sulfate injection, uspfor intramuscular or. Material safety data sheet amikacin sulfate injection, usp 3.
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. Increased nephrotoxicity has been reported following concomitant parenteral administration of. Amikacin normon belongs to a group of antibiotic medicines in the aminoglycoside group. Inhaled amikacin the toronto adult cystic fibrosis. Percocet can be abused and is subject to misuse, addiction, and criminal diversion see warnings. Coumadin has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Date of revision of package insert daymonthyear author. It acts by inhibiting protein synthesis of susceptible bacteria. Amikacin sulfate injection, usp is a semisynthetic aminoglycoside antibiotic derived from kanamycin.
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