SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RedPharm Drug, Inc.

INN (International Name):

TRIMETHOPRIM

구성:

TRIMETHOPRIM 160 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP 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 M

제품 요약:

Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg are white to off-white circular, beveled edge uncoated tablets, debossed with “H 48” on one side and deep break line on the other side. Bottles of 20 NDC 65862-419-20 Bottles of 100 NDC 65862-419-01 Bottles of 500 NDC 65862-419-05 Bottles of 1000 NDC 65862-419-99 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg are white to off-white oval, beveled edge uncoated tablets, debossed with “H 49” on one side and deep break line on other side. Bottles of 20 NDC 65862-420-20 Bottles of 100 NDC 65862-420-01 Bottles of 500 NDC 65862-420-05 Bottles of 1000 NDC 65862-420-99 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
REDPHARM DRUG, INC.
----------
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
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
sulfamethoxazole is not a substrate of P-glycoprotein.
Approximately 70% of sulfamethoxazole and 44% of trimethoprim are
bound to plasma proteins. The
presence of 10 mg percent sulfamethoxazole in plasma decreases the
protein binding of trimethoprim by
an insignificant degree; trimethoprim does not influence the protein
binding of sulfamethoxazole.
Peak blood levels for the individual components occur 1 to 4 hours
after oral administration. The mean
serum half-lives of sulfamethoxazole and trimethoprim are 10 and 8 to
10 hours, respectively.
However, patients with severely impaired renal function exhibit an
increase in the