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. 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. If any of the side effects gets serious, or if you notice any side effects not. Amikacin sulfate injection, usp is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Amikacin liposome inhalation suspension for treatmentrefractory lung disease caused by mycobacterium avium complex convert. Mims, mircomedex, and the australian injectable drugs handbook. Date of revision of package insert daymonthyear author. Common commercial concentrations of amikacin are 50 mgml and 250 mgml. 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. Find here directory of amikin injection manufacturers, amikacin injection suppliers and exporters. 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. Then, breathe normally through the mouthpiece until the treatment is complete about 14 to 20 minutes.
Amikacin dosing, indications, interactions, adverse. Arikayce is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unitdose glass vial containing amikacin 590 mg8. Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Broad spectrum antibiotic amikacin sulfate injection, usp. Oct, 2015 similarly, the amikacin cl was correlated to age and serum creatinine but not to tbw or dw. Indications 1, 2 amikacin must be reserved for treating infections due to microorganisms that are resistant to other aminoglycosides.
Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram. Hence, it should be used with extreme caution in elderly patients as well as in patients with kidney. Both monitoring of blood levels and limiting duration of therapy may prevent amikacin ototoxicity. Product name dbl amikacin 500mg2ml solution for injection 2.
The dosage form is supplied as a sterile, colorless to light straw colored. The document library provides customers with a single pointofaccess to technical documents for our entire portfolio of instruments, assays and test kits. Retrieve technical documents for our entire portfolio of instruments, assays and test kitsall with a single pointofaccess. 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.
For obese patients total body weight 20% over ideal body weight, dosage requirement may best be. Some of the areas are public while some are restricted and require for you to first register for a siemens healthineers online services account. However, the cfr was consistently higher with a fixeddose approach. 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. This medicine is known to cause serious kidney problems and hearing problems, especially in the elderly population. Amikacin sulfate injection, uspfor intramuscular or. Intended use the qms amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. 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. Information for the user amikacin 250 mgml injection read all of this leaflet carefully before you start using this medicine. 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.
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. Amikacin sulfate amikin discontinued is an antibiotic injection prescribed to treat bacterial meningitis, infected burns, cystic fibrosis, and severe uti infections. Amikacin sulfate injection usp, 250 mgml 500 mg2 ml and. We do not recommend the use of amikacin as part of an. 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. Amikacin normon is indicated for the shortterm treatment of severe. Venofer iron sucrose injection, usp is an established and effective treatment for chronic kidney disease ckd patients experiencing iron deficiency anemia. 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. Patients are calculated based on an estimated annual cumulative dose. The dosage form is supplied as a sterile, colorless.
It is also used for the treatment of multidrugresistant tuberculosis. 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. 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. Refer to impaired renal function of dosage description. It contains the equivalent of not less than 674 mcg and not more than 786 mcg amikacin per mg, calculated on the dried basis. Amikacin injection manufacturers, suppliers and exporters. 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. Amikacin is used for short term treatment of serious infections caused by. Amikacin dosing, indications, interactions, adverse effects. It acts by inhibiting protein synthesis of susceptible bacteria. Amikacin was administered intramuscularly andor intravenously at a dose of 7. Percocet can be abused and is subject to misuse, addiction, and criminal diversion see warnings. Adjust the dose based on the patients inr and the condition being treated. Amikacin sulfate injection is potentially nephrotoxic, ototoxic and neurotoxic.
Amikacin sulfate injection, usp sagent pharmaceuticals. Amikacin 250 mg injection uses, dosage, side effects. Urinary tract infections other than pseudomonal infections 500 mgday in two equally divided doses is. 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. If you need help accessing information in different file formats. These amikacin injection manufacturing companies are offering high. 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. The recommended dosage is oncedaily oral inhalation of the contents of one 590 mg8. Coumadin has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Be sure to hold the handset level throughout the treatment.
In this group, the initial volume of distribution and volume of distribution at steady state was 0. 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. It may be supplied in packs containing 5 x 500 mg2 ml vials. 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. It is usually given every 8 hours or as directed by your doctor. 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. 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. 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. This includes joint infections, intraabdominal infections, meningitis, pneumonia, sepsis, and urinary tract infections. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may. Amikacin sulphate injection may be given intramuscularly or intravenously. Jul 01, 2018 amikacin is rapidly absorbed after intramuscular administration.
Clinical trial arikayce amikacin liposome inhalation. Treatment with amikacin for 14 days has not been established as being safe. This medication is given by injection into a vein or muscle as directed by your doctor. 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. Find out what health conditions may be a health risk when taken with amikacin injection.
Highlights of prescribing information these highlights do not include all the information needed to use zerbaxasafely and effectively. Inhaled amikacin the toronto adult cystic fibrosis. Sterile vancomycin hydrochloride, usp is a lyophilized powder, for preparing intravenous iv infusions. Amikacin injection is a clear, colourless to pale yellow solution for injection which comes in glass containers called vials. Percocetoxycodone and acetaminophen tablets, uspcii rx. Women of childbearing potential should use adequate contraception and. The patients pretreatment bodyweight should be obtained for calculation of correct dosage. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Amikacin normon belongs to a group of antibiotic medicines in the aminoglycoside group. Overexposure may cause damage to hearing, nervous system and kidneys. When amikacin is injected intravenously, it is usually infused injected slowly over a period of 30 to 60 minutes. The dosage and administration of coumadin must be individualized for each patient according to the patients international normalized ratio inr response to the drug.
This is a guideline only, for more detailed inform ation please refer to. 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. It is used either by injection into a vein or muscle. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and nonqwave myocardial infarction, when concurrently administered with aspirin. Arikayce consists of liposomes that contain amikacin, an antibiotic. Read all of this leaflet carefully before you start using this medicine. 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. Amikacin sulphate is an aminoglycoside antibiotic with. The measurements obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy. Only select registry of toxic effects of chemical substances rtecs data is presented here. Amikacin is rapidly absorbed after intramuscular administration. Highlights of prescribing information these highlights do not.
If you have any further questions, ask your doctor or pharmacist. Amikacin sulfate injection, usp fresenius kabi usa. 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. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route. Amikacin is an antibiotic used for a number of bacterial infections. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Amikacin fda prescribing information, side effects and uses. Percocet contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol.
Arikayce liposomal amikacin for inhalation bronchiectasis. Alprostadil is an endogenous substance known as prostaglandin e 1 pge 1. 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. It is used either by injection into a vein or muscle amikacin, like other aminoglycoside antibiotics, can cause hearing loss, balance. Qualitative and quantitative composition amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Act, for amikacin sulfate injection usp, 50 mgml 100 mg2 ml vial. Nov 16, 2011 common commercial concentrations of amikacin are 50 mgml and 250 mgml. The main goal is to improve or maintain lung function. Amikacin investigated as a drug, natural product, and reproductive effector.
Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. Dglucopyranosyl16n 34aminol2hydroxybutyryl2deoxylstreptamine sulfate 1. Package insert instructions must be followed accordingly. 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.
Many gram negative organisms resistant to gentamicin and tobramycin in vitro are sensitive to amikacin. Venofer is indicated for the treatment of iron deficiency anemia in patients. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. The inhaled form of amikacin is available as a 500mg2ml solution kept in a vial that can be stored at room temperature. Material safety data sheet amikacin sulfate injection, usp 3. Amikacin s structure has been altered to reduce enzymatic deactivation, thus reducing bacterial resistance. Amikacin can be given by inhalation to decrease the amount of bacteria pseudomonas aeruginosa in the lungs. The length of your treatment depends on the type of infection you have. Material is a clear, colorless to strawcolored, odorless liquid. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Webmd provides common contraindications for amikacin injection. Evidence of ototoxicity dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss or nephrotoxicity requires discontinuation of the drug or dosage.
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. This insert supersedes all previous insertsmanual inserts. To reduce the development of drugresistant bacteria and maintain the. The measurements obtained are used in the diagnosis and. When the treatment has ended, the nebulizer will beep and the led light will flash red 2 times. Increased nephrotoxicity has been reported following concomitant parenteral administration of.