Amikacin Sulfate 1 g/4mL
Amikacin Sulfate · INJECTION, SOLUTION · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Amikacin Sulfate is a prescription antibiotic injection used to treat serious bacterial infections. It is given as an intramuscular injection and works by killing bacteria that cause infections in the body.
Key Facts
- Brand Name
- Amikacin Sulfate
- Generic Name
- Amikacin Sulfate
- NDC Code (Product)
23155-786- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Strength
- 1 g/4mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA204040
- Marketing Start
- 12/15/2020
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Heritage Pharmaceuticals, Inc.
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Teva Pharmaceuticals USA
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Teva Pharmaceuticals USA
CGMP Deviations
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Teva Pharmaceuticals USA
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli , species of indole-positive and indole-negative Proteus , Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species. Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including Amikacin Sulfate Injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Bacteriologic studies should be performed to identi…
Dosage & Administration
DOSAGE AND ADMINISTRATION The patient’s pretreatment body weight should be obtained for calculation of correct dosage. Amikacin Sulfate Injection may be given intramuscularly or intravenously. The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy. Whenever possible, amikacin concentrations in serum should be measured to assure adequate but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30 to 90 minutes after injection) above 35 micrograms per mL and trough concentrations (just prior to the next dose) above 10 micrograms per mL should be avoided. Dosage should be adjusted as indicated. Intramuscular Administration for Patients with Normal Renal Function The recommended dosage for adults, children and older infants (see WARNINGS box) with normal renal function is 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided int…
Warnings
WARNINGS See WARNINGS box above. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to the fetus or newborns have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Reproduction studies of amikacin have been performed in rats and mice and revealed no evidence of impaired fertility or harm to the fetus due to amikacin. There are no well controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in t…
Contraindications
CONTRAINDICATIONS A history of hypersensitivity to amikacin is a contraindication for its use. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other aminoglycoside because of the known cross-sensitivities of patients to drugs in this class.
Adverse Reactions
ADVERSE REACTIONS All aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see WARNINGS box). They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended. Neurotoxicity-Ototoxicity Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected. Neurotoxicity-Neuromuscular Blockade Acute muscular paralysis and apnea can occur following treatment with aminoglycoside drugs. Nephrotoxicity Elevation of serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, and oliguria have been reported. Renal function changes are usually reversible when the drug is discontinued. As would be expected with any aminoglycoside, reports of toxic nephropathy and acute renal failure have been received during postmarketing surveillance. Other In addition to those descr…
Frequently Asked Questions
What is Amikacin Sulfate used for?
Amikacin Sulfate is a prescription antibiotic injection used to treat serious bacterial infections. It is given as an intramuscular injection and works by killing bacteria that cause infections in the body.
Is Amikacin Sulfate a controlled substance?
Amikacin Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Amikacin Sulfate?
The generic name for Amikacin Sulfate is Amikacin Sulfate. There are 1 other brand versions of Amikacin Sulfate.
What is the NDC code for Amikacin Sulfate 1 g/4mL?
The NDC (National Drug Code) for Amikacin Sulfate 1 g/4mL is 23155-786, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
Other Amikacin Sulfate Dosages
- Amikacin Sulfate500 mg/2mL23155-785
- Amikacin Sulfate250 mg/mL0641-6167
- Amikacin Sulfate250 mg/mL0641-6166
- Amikacin Sulfate250 mg/mL23155-290
- Amikacin Sulfate250 mg/mL67184-0569
- Amikacin Sulfate250 mg/mL83301-0022
- Amikacin Sulfate250 mg/mL83301-0023
- Amikacin Sulfate250 mg/mL63323-815
- Amikacin Sulfate250 mg/mL67184-0570
Other Amikacin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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