Septra (Trimethoprim / Sulfamethoxazole) - Indications and Dosage

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SEPTRA and other antibacterial drugs, SEPTRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Urinary Tract Infections:

For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media:

For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, SEPTRA offers some advantage over the use of other antimicrobial agents. To date, there is limited data on the safety of repeated use of SEPTRA in pediatric patients under two years of age. SEPTRA is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults:

For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, SEPTRA offers some advantage over the use of a single antimicrobial agent.

Travelers’ Diarrhea in Adults:

For the treatment of travelers’ diarrhea due to susceptible strains of enterotoxigenic E. coli.

Shigellosis:

For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis Carinii Pneumonia:

For the treatment of documented Pneumocystis carinii pneumonia. For prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.

DOSAGE AND ADMINISTRATION

Contraindicated in pediatric patients less than 2 months of age.

Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients and Acute Otitis Media in Pediatric Patients:

Adults: The usual adult dosage in the treatment of urinary tract infections is one SEPTRA DS (double strength) tablet, two SEPTRA tablets, or four teaspoonfuls (20 mL) SEPTRA Suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

Pediatric Patients: The recommended dose for pediatric patients with urinary tract infections or acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg sulfamethoxazole per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:

Pediatric Patients: Two Months of Age or Older

Weight		Dose – Every 12 Hours
lb	kg	Teaspoonfuls	Tablets
22	10	1 (5 mL)
44	20	2 (10 mL)	1
66	30	3 (15 mL)	11⁄2
88	40	4 (20 mL)	2 (or 1 DS Tablet)

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

Creatinine	Recommended
Clearance	Dosage
(mL/min)	Regimen
Above 30	Use Standard Regimen
15-30	1⁄2 the Usual Regimen
Below 15	Use Not Recommended

Acute Exacerbations of Chronic Bronchitis in Adults:

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is one SEPTRA DS (double strength) tablet, two SEPTRA tablets, or four teaspoonfuls (20 mL) SEPTRA Suspension every 12 hours for 14 days.

Travelers’ Diarrhea in Adults:

For the treatment of travelers’ diarrhea, the usual adult dosage is one SEPTRA DS (double strength) tablet, two SEPTRA tablets, or four teaspoonfuls (20 mL) of SEPTRA Suspension every 12 hours for 5 days.

Pneumocystis Carinii Pneumonia:

Treatment:

Adults and Pediatric Patients: The recommended dosage for treatment of patients with documented Pneumocystis carinii pneumonia is 15 to 20 mg/kg trimethoprim and 75 to 100 mg/kg sulfamethoxazole per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. The following table is a guideline for the upper limit of this dosage:

Weight Dose – Every 6 Hours
lb	kg	Teaspoonfuls	Tablets
18	8	1 (5 mL)
35	16	2 (10 mL)	1
53	24	3 (15 mL)	1 1⁄2
70	32	4 (20 mL)	2 (or 1 DS Tablet)
88	40	5 (25 mL)	2 1⁄2
106	48	6 (30 mL)	3 (or 1 1⁄2 DS Tablets)
141	64	8 (40 mL)	4 (or 2 DS Tablets)
176	80	10 (50 mL)	5 (or 2 1⁄2 DS Tablets)

For the lower limit dose (15 mg/kg trimethoprim and 75 mg/kg sulfamethoxazole per 24 hours) administer 75% of the dose in the above table.

Prophylaxis:

Adults: The recommended dosage for prophylaxis in adults is one SEPTRA DS (double strength) tablet daily.

Pediatric Patients: For pediatric patients, the recommended dose is 150 mg/m²/day trimethoprim with 750 mg/m²/day sulfamethoxazole given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 320 mg trimethoprim and 1,600 mg sulfamethoxazole. The following table is a guideline for the attainment of this dosage in pediatric patients:

Body Surface Area	Dose–every 12 hours
(m2)	Teaspoonfuls	Tablets
0.26	1⁄2 (2.5 mL)
0.53	1 (5 mL)	1⁄2
1.06	2 (10 mL)	1

HOW SUPPLIED

TABLETS (pink, scored, round-shaped) containing 80 mg trimethoprim and 400 mg sulfamethoxazole: Bottles of 100 (NDC 61570-052-01). Imprint on tablets “M052”.

DS (DOUBLE STRENGTH) TABLETS (pink, scored, oval-shaped) containing 160 mg trimethoprim and 800 mg sulfamethoxazole: Bottles of 20 (NDC 61570-053-20), 100 (NDC 61570-053-01), 250 (NDC 61570-053-52) and 500 (NDC 61570- 053-05). Imprint on tablets“M053”.

ORAL SUSPENSIONS (pink, cherry-flavored) containing 40 mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5 mL): Bottle of 1 pint (473 mL) (NDC 61570-050-16) and 100 mL–package of 6 (NDC 61570-050-11); and (purple, grape-flavored) containing 40 mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5 mL): Bottle of 1 pint (473 mL) (NDC 61570-051-16).

Tablets should be stored at 15° to 25°C (59° to 77°F) in a dry place and protected from light.

Suspensions should be stored at 15° to 25°C (59° to 77°F) and protected from light.