SULFAMETHOXAZOLE AND TRIMETHOPRIM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Available from:

Mylan Institutional LLC

INN (International Name):

SULFAMETHOXAZOLE

Composition:

SULFAMETHOXAZOLE 80 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sulfamethoxazole and trimethoprim injection is indicated in the treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older. Sulfamethoxazole and trimethoprim injection is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older. Sulfamethoxazole and trimethoprim injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris when oral administration of sulfamethoxazole and trimethoprim injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract. To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethox

Product summary:

Sulfamethoxazole and trimethoprim injection, USP is supplied as follows: 5 mL Single-Dose Vials, containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water. 30 mL Multiple-Dose Vials, each 5 mL containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water. After initial entry into vial, the remaining contents must be used within 48 hours. Store at 20° to 25°C [68° to 77°F]. [See USP Controlled Room Temperature]. DO NOT REFRIGERATE.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM INJECTION
MYLAN INSTITUTIONAL LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SULFAMETHOXAZOLE
AND TRIMETHOPRIM INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION.
SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1981
RECENT MAJOR CHANGES
Indications and Usage (1.3) 7/2020
Warnings and Precautions, Hypersensitivity and Other Serious or Fatal
Reactions (5.2) 5/2021
Warnings and Precautions, Potential Risk in the Treatment of
_Pneumocystis jirovecii _Pneumonia in Patients
with Acquired Immunodeficiency Syndrome (AIDS) (5.16) 5/2021
Warnings and Precautions, Monitoring of Laboratory Tests (5.18) 5/2021
INDICATIONS AND USAGE
Sulfamethoxazole and trimethoprim injection is a combination of
sulfamethoxazole, a sulfonamide
antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor
antibacterial, indicated in adults and
pediatric patients two months of age and older for treatment of
infections caused by designated,
susceptible bacteria.
•
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of sulfamethoxazole
and trimethoprim injection and other antibacterial drugs,
sulfamethoxazole and trimethoprim injection
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
susceptible bacteria. (1.4)
DOSAGE AND ADMINISTRATION
DOSAGE GUIDELINES FOR ADULTS AND PEDIATRIC PATIENTS
(TWO MONTHS OF AGE AND OLDER)
INFECTION
TOTAL DAILY DOSE (BASED ON
TRIMETHOPRIM CONTENT)
FREQUENCY
DURATION
_Pneumocystis jirovecii_
Pneumonia
15 to 20 mg/kg (in 3 or 4 equally
divided doses)
Every 6 to 8 hours
14 days
Severe Urinary Tract
Infections
8 to 10 mg/kg (in 2 to 4 equally
divided doses)
Every 6, 8 or 12 hours
14 days
Shigellosis
8 to 10 mg/kg (in 2 to 4 equally
divided doses)
Every 6, 8 or 12 hours
5 days
•