SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

RedPharm Drug, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, 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. 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 sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim 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 influenzaewhen a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia. Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli. Sulfamethoxazole and trimethoprim is contraindicated in patients with a known hypersensitivity to trimethoprim or sulfonamides, in patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency. Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole and trimethoprim is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.

Resumen del producto:

Sulfamethoxazole and trimethoprim tablets, USP are supplied as follows: Sulfamethoxazole 400 mg and trimethoprim 80 mg tablets, white, round, scored, debossed MP 81 Bottles of 100 NDC 53489-145-01 Bottles of 500 NDC 53489-145-05 Sulfamethoxazole 800 mg and trimethoprim 160 mg tablets, double strength, white, oval shaped, scored, debossed MP 85 Bottles of 100 NDC 53489-146-01 Bottles of 500 NDC 53489-146-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
sulfamethoxazole and trimethoprim tablets and other antibacterial
drugs,
sulfamethoxazole and trimethoprim tablets should be used only to treat
or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
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 N1-(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.
CLINICAL PHARMACOLOGY
Sulfamethoxazole and trimethoprim 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 metabolized in humans to at least 5 metabolites:
the N4-acetyl-, N4-
hydroxy-, 5-methylhydroxy-, N4-acetyl- 5-methylhydroxy-
sulfamethoxazole
metabolites, and an N-glucuronide conjugate. The formulation of
N4-hydroxy metabolite
is mediated via CYP2C9.
Trimethoprim is metabolized in vitro to 11 different metabolites, of
which, five are
glutathione adducts and six are o