Amikacin sulfate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Amikacin sulfate is an antibiotic that is FDA approved for the treatment of 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, Acinetobacter (Mima-Herellea) species, Staphylococcus and Gram-positive organisms, such as streptococcus. Clinical studies have proven efficacy in:
- Bacterial Septicemia (including neonatal sepsis)
- Severe respiratory tract infections
- Bone infections
- Joint infections
- Central nervous system infections (including meningitis)
- Skin and soft tissue infections
- Intra-abdominal infections (including peritonitis).
- Burns
- Post-operative infections (including post-vascular surgery)
- Serious complicated and recurrent urinary tract infections. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Amikacin sulfate FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amikacin sulfate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amikacin sulfate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Amikacin sulfate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amikacin sulfate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amikacin sulfate in pediatric patients.
Contraindications
There is limited information regarding Amikacin sulfate Contraindications in the drug label.
Warnings
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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There is limited information regarding Amikacin sulfate Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Amikacin sulfate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Amikacin sulfate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Amikacin sulfate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Amikacin sulfate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amikacin sulfate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Amikacin sulfate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Amikacin sulfate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Amikacin sulfate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Amikacin sulfate in geriatric settings.
Gender
There is no FDA guidance on the use of Amikacin sulfate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Amikacin sulfate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Amikacin sulfate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Amikacin sulfate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Amikacin sulfate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Amikacin sulfate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Amikacin sulfate Administration in the drug label.
Monitoring
There is limited information regarding Amikacin sulfate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Amikacin sulfate and IV administrations.
Overdosage
There is limited information regarding Amikacin sulfate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Amikacin sulfate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Amikacin sulfate Mechanism of Action in the drug label.
Structure
There is limited information regarding Amikacin sulfate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Amikacin sulfate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Amikacin sulfate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Amikacin sulfate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Amikacin sulfate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Amikacin sulfate How Supplied in the drug label.
Storage
There is limited information regarding Amikacin sulfate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Amikacin sulfate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Amikacin sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Amikacin sulfate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Amikacin sulfate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.