BACTRIM DS- sulfamethoxazole and trimethoprim tablet BACTRIM- sulfamethoxazole and trimethoprim tablet

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:

Sun Pharmaceutical Industries, Inc

INN (International Name):

sulfamethoxazole

Composition:

sulfamethoxazole 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (sulfamethoxazole and trimethoprim) tablets 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 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

Product summary:

BACTRIM™ TABLETS are supplied as follows: BACTRIM™ DS (double strength) TABLETS (white, oval shaped, scored) containing 160 mg trimethoprim and 800 mg sulfamethoxazole – bottles of 100 (NDC 49708-146-01). Imprint on tablets (debossed): (front) BACTRIM DS BACTRIM™ TABLETS (white, round, scored) containing 80 mg trimethoprim and 400 mg sulfamethoxazole – bottles of 100 (NDC 49708-145-01). Imprint on tablets (debossed): (front) BACTRIM Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

New Drug Application

Summary of Product characteristics

BACTRIM DS - TABLET
BACTRIM - TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC * HUMAN PRESCRIPTION DRUG LABEL
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets
and other antibacterial drugs, Bactrim (sulfamethoxazole and
trimethoprim) tablets should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
INDEX * 1. DESCRIPTION * 2. CLINICAL PHARMACOLOGY * 3. INDICATIONS AND USAGE * 4. CONTRAINDICATIONS * 5. WARNINGS * 6. PRECAUTIONS * 7. ADVERSE REACTIONS * 8. OVERDOSAGE * 9. DOSAGE AND ADMINISTRATION * 10. HOW SUPPLIED * 11. REFERENCES * 12. DISTRIBUTED BY * 13. PRINCIPAL DISPLAY PANEL - MG/MG TABLET BOTTLE LABEL * 14. PRINCIPAL DISPLAY PANEL - MG/MG TABLET BOTTLE LABEL *
1. DESCRIPTION
BACTRIM (sulfamethoxazole and trimethoprim) is a synthetic
antibacterial combination product available in DS (double strength)
tablets, each containing 800 mg sulfamethoxazole and 160 mg
trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and
80 mg trimethoprim for oral administration.
Sulfamethoxazole is N 1-(5-methyl-3-isoxazolyl)sulfanilamide; the
molecular formula is C10H11N3O3S. It is an almost white, odorless,
tasteless compound with a molecular weight of 253.28 and the following
structural formula:
[Chemical Structure]
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the
molecular formula is C14H18N4O3. It is a white to light yellow,
odorless, bitter compound with a molecular weight of 290.3 and the
following structural formula:
[Chemical Structure]
Inactive ingredients: Docusate sodium 85%, sodium benzoate 15%, sodium
starch glycolate, magnesium stearate and pregelatinized starch. *
2. CLINICAL PHARMACOLOGY
BACTRIM is rapidly absorbed following oral administration. Both
sulfamethoxazole and trimethoprim exist in the blood as unbound,
protein-bound and metabolized forms; sulfamethoxazole also exists as
the conjugated form. Sulfamethoxazole is metaboliz