CEFAZOLIN injection powder for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)

Available from:

Apotex Corporation

INN (International Name):

CEFAZOLIN SODIUM

Composition:

CEFAZOLIN 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFAZOLIN FOR INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFAZOLIN FOR
INJECTION, USP.
CEFAZOLIN FOR INJECTION, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1973
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF CEFAZOLIN FOR INJECTION
AND OTHER ANTIBACTERIAL DRUGS, CEFAZOLIN FOR INJECTION SHOULD BE USED
ONLY TO TREAT OR PREVENT INFECTIONS THAT
ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Cefazolin for Injection, USP is a cephalosporin antibacterial
indicated in the treatment of the following infections caused by
susceptible isolates of the designated microorganisms:
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DOSAGE AND ADMINISTRATION
For intravenous use. (2)
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RECOMMENDED DOSING SCHEDULE IN ADULT PATIENTS WITH CRCL GREATER THAN
OR EQUAL TO 55 ML/MIN. (2.1)
TYPE OF INFECTION
DO SE
FREQUENCY
Moderate to severe infections
500 mg to 1 gram
every 6 to 8 hours
Mild infections caused by susceptible gram-positive cocci
250 mg to 500 mg
every 8 hours
Acute, uncomplicated urinary tract infections
1 gram
every 12 hours
Pneumococcal pneumonia
500 mg
every 12 hours
Severe, life-threatening infections (e.g., endocarditis, septicemia)
1 gram to 1.5
grams
every 6 hours
Severe, life-threatening infections (e.g., endocarditis, septicemia)
1 gram to 1.5
grams
every 6 hours
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Respiratory tract infections. (1.1)
Urinary tract infections. (1.2)
Skin and skin structure infections. (1.3)
Biliary tract infections. (1.4)
Bone and joint infections. (1.5)
Genital infections. (1.6)
Septicemia. (1.7)
Endocarditis. (1.8)
Perioperative prophylaxis. (1.9)
In rare instances, doses of up to 12 grams of cefazolin per day have
been used.
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1g per piggyback bottle. (3)
Hypersen