SULFAMETHOXAZOLE AND TRIMETHOPRIM DS- sulfamethoxazole and trimethoprim tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Advanced Rx Pharmacy of Tennessee, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

INDICATIONS AND USAGE 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. A

Produkto santrauka:

Sulfamethoxazole and trimethoprim is 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 Children Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim 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: Children 2 months of age or older: Weight Dose – every 12 hours lb kg Tablets 22 10 - 44 20 1 66 30 1½ 88 40 2 or 1 DS tablet 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 to 30 ½ 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 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim single strength tablets every 12 hours for 14 days. Pneumocystis Jirovecii Pneumonia Treatment Adults and Children The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 mg/kg to 100 mg/kg sulfamethoxazole and 15 mg/kg to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days12. The following table is a guideline for the upper limit of this dosage: Weight Dose – every 6 hours lb kg Tablets 18 8 - 35 16 1 53 24 1½ 70 32 2 or 1 DS tablet 88 40 2½ 106 48 3 or 1½ DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2½ DS tablets For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table. Prophylaxis Adults: The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim double strength tablet daily13. Children: For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1,600 mg sulfamethoxazole and 320 mg trimethoprim14. The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose – every 12 hours (m2) Tablets 0.26 - 0.53 ½ 1.06 1 Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim single strength tablets every 12 hours for 5 days.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

SULFAMETHOXAZOLE AND TRIMETHOPRIM DS- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG/160MG TABLETS
DESCRIPTION
Sulfamethoxazole and trimethoprim is a synthetic antibacterial
combination product
available in DS (double strength) tablets, each containing 800 mg
sulfamethoxazole, USP
and 160 mg trimethoprim, USP; in tablets, each containing 400 mg
sulfamethoxazole,
USP and 80 mg trimethoprim, USP 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:
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:
Inactive ingredients: Magnesium stearate, povidone, pregelatinized
starch and sodium
starch glycolate.
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 oxidative metabolites, including the
major metabolites, 1-
and 3-oxides and the 3- and 4-hydroxy derivatives.
The free forms of sulfamethoxazole and trimethoprim are considered to
be the
therapeutically active forms.
In vitro studies suggest that trimethoprim is a substrate of
P-glycoprotein, OCT1 and
OCT2, and that sulfamethox