Amikacin description

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Amikacin
AMIKACIN SULFATE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Description

Amikacin Sulfate Injection USP is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. D-Streptamine,O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-, sulfate (1:2) (salt).

The dosage form is supplied as a sterile, colorless to light straw-colored solution for intramuscular or intravenous use. The 500 mg per 2 mL vial and the 1 gram per 4 mL vial each contain, per mL, 250 mg amikacin USP (as the sulfate), 2.5% sodium citrate dihydrate, 0.66% sodium metabisulfite, and water for injection, q.s. pH is adjusted with sulfuric acid and/or, if necessary, sodium hydroxide. The pH is 3.5 to 5.5.[1]

References

  1. "AMIKACIN SULFATE INJECTION [TEVA PARENTERAL MEDICINES, INC.]".

Adapted from the FDA Package Insert.