gentamicin sulfate injection How Supplied/Storage and Handling | Pfizer Medical Information - US

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HOW SUPPLIED

Gentamicin Sulfate Injection, USP containing gentamicin 40 mg/mL is supplied as follows:

Unit of Sale	Concentration
NDC 0409-1207-03 Tray containing 25 single-dose vials	80 mg/2 mL (40 mg/mL)

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

gentamicin sulfate injection Quick Finder

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WARNINGS

Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.

As with other aminoglycosides, Gentamicin Sulfate Injection, USP is potentially nephrotoxic....

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INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are...

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DOSAGE AND ADMINISTRATION

Gentamicin Sulfate Injection, USP may be given intramuscularly or by intravenous infusion. The patient's pretreatment body weight should be...

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CONTRAINDICATIONS

Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known...

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WARNINGS

(see WARNINGS box).

Aminoglycosides can cause fetal harm when administered to a pregnant woman....

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ADVERSE REACTIONS

Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum...

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OVERDOSAGE

In the event of overdosage or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, and is especially important if renal function is, or becomes compromised. The rate of removal of...

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DESCRIPTION

Gentamicin Sulfate Injection, USP is a sterile, nonpyrogenic solution of gentamicin sulfate in water for injection. It is administered by the intramuscular or intravenous route.

Each milliliter (mL)...

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CLINICAL PHARMACOLOGY

After intramuscular administration of gentamicin sulfate, peak serum concentrations usually occur between 30 to 60 minutes and serum levels are measurable for 6 to 8 hours. When gentamicin is...

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HOW SUPPLIED

Gentamicin Sulfate Injection, USP containing gentamicin 40 mg/mL is supplied as follows:

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Injection, USP

80 mg/2 mL

(40 mg/mL as Gentamicin)

...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.