Bactrim

INDICATIONS

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 are 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.

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.

Also available:

SEPTRA I.V. Infusion: 5 mL vials, containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL), tray of 10;

10 mL multiple dose vials containing 160 mg trimethoprim (16 mg/mL) and 800 mg sulfamethoxazole (80 mg/mL), tray of 10;

20 mL multiple dose vials containing 320 mg trimethoprim (16 mg/mL) and 1600 mg sulfamethoxazole (80 mg/mL), tray of 10.

Rx Only

Prescribing Information as of August 2005.

FDA rev date: 7/28/2005

Bactrim reference

http://www.rxlist.com Search drug information A-Z drug select left column, description, clinical pharmacology, indication and dosage, side effect.....

http://www.rxlist.com/cgi/generic/trisulf_ids.htm bactrim

http://www.fda.gov/cder/foi/label/2003/17377slr057_Bactrim_lbl.pdf