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Bactrim IV (Trimethoprim and Sulfamethoxazole) - Indications and Dosage

 
 



INDICATIONS

Pneumocystis Carinii Pneumonia: Bactrim IV Infusion is indicated in the treatment of Pneumocystis carinii pneumonia in children and adults.

Shigellosis: Bactrim IV Infusion is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in children and adults.

Urinary Tract Infections: Bactrim IV Infusion is indicated in the treatment of severe or complicated urinary tract infections due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration of Bactrim is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.

Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.

DOSAGE AND ADMINISTRATION

CONTRAINDICATED IN INFANTS LESS THAN 2 MONTHS OF AGE. CAUTION BACTRIM IV INFUSION MUST BE DILUTED IN 5% DEXTROSE IN WATER SOLUTION PRIOR TO ADMINISTRATION. DO NOT MIX BACTRIM IV INFUSION WITH OTHER DRUGS OR SOLUTIONS. RAPID INFUSION OR BOLUS INJECTION MUST BE AVOIDED.

DOSAGE:

CHILDREN AND ADULTS:

Pneumocystis Carinii Pneumonia: Total daily dose is 15 to 20 mg/kg (based on the trimethoprim component) given in 3 or 4 equally divided doses every 6 to 8 hours for up to 14 days. One investigator noted that a total daily dose of 10 to 15 mg/kg was sufficient in 10 adult patients with normal renal function. 6

Severe Urinary Tract Infections and Shigellosis: Total daily dose is 8 to 10 mg/kg (based on the trimethoprim component) given in 2 or 4 equally divided doses every 6, 8 or 12 hours for up to 14 days for severe urinary tract infections and 5 days for shigellosis. The maximum recommended daily dose is 60 mL per day.

For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table:

Creatinine Clearance
(mL/min)
Recommended
Dosage Regimen
Above 30 Usual standard regimen
15-30 1 / 2 the usual regimen
Below 15 Use not recommended

Method of Preparation: Bactrim IV Infusion must be diluted. EACH 5 ML SHOULD BE ADDED TO 125 ML OF 5% DEXTROSE IN WATER. After diluting with 5% dextrose in water the solution should not be refrigerated and should be used within 6 hours. If a dilution of 5 mL per 100 mL of 5% dextrose in water is desired, it should be used within 4 hours. If upon visual inspection there is cloudiness or evidence of crystallization after mixing, the solution should be discarded and a fresh solution prepared.

Multidose Vials: After initial entry into the vial, the remaining contents must be used within 48 hours.

The following infusion systems have been tested and found satisfactory: unit-dose glass containers; unit-dose polyvinyl chloride and polyolefin containers. No other systems have been tested and therefore no others can be recommended.

Dilution: EACH 5 ML OF BACTRIM IV INFUSION SHOULD BE ADDED TO 125 ML OF 5% DEXTROSE IN WATER.

Note:In those instances where fluid restriction is desirable, each 5 mL may be added to 75 mL of 5% dextrose in water. Under these circumstances the solution should be mixed just prior to use and should be administered within 2 hours. If upon visual inspection there is cloudiness or evidence of crystallization after mixing, the solution should be discarded and a fresh solution prepared.

DO NOT MIX BACTRIM IV INFUSION-5% DEXTROSE IN WATER WITH DRUGS OR SOLUTIONS IN THE SAME CONTAINER.

Administration: The solution should be given by intravenous infusion over a period of 60 to 90 minutes. Rapid infusion or bolus injection must be avoided. Bactrim IV Infusion should not be given intramuscularly.

HOW SUPPLIED

10-mL Vials, containing 160 mg trimethoprim (16 mg/mL) and 800 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water. Boxes of 10 (NDC 0004-1955-01).

30-mL Multidose 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. Boxes of 1 (NDC 0004-1958-01).

STORE AT ROOM TEMPERATURE (15°-30°C or 59°-86°F). DO NOT REFRIGERATE.

Bactrim is also available as DS (double strength) Tablets (white, notched, capsule shaped), containing 160 mg trimethoprim and 800 mg sulfamethoxazole bottles of 100 (NDC 0004-0117-01), 250 (NDC 0004-0117-04) and 500 (NDC 0004-0117-14). Imprint on tablets: (front) BACTRIM-DS; (back) ROCHE.

Tablets (light green, scored, capsule shaped), containing 80 mg trimethoprim and 400 mg sulfamethoxazole bottles of 100 (NDC 0004-0050-01). Imprint on tablets: (front) BACTRIM; (back) ROCHE.

Pediatric Suspension (pink, cherry flavored), containing 40 mg trimethoprim and 200 mg sulfamethoxazole per teaspoonful (5 mL) bottles of 16 o (1 pint) (NDC 0004-1033-28).

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