SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Sun Pharmaceutical Industries, Inc.

INN（国際名）:

Sulfamethoxazole

構図:

Sulfamethoxazole 400 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
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 tablets are 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_ -(5-methyl-3-isoxazolyl) sulfanilamide; the
molecular formula is
C
H
N O S. 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 C
H
N O . It is a white to light yellow, odorless, bitter compound with a
molecular weight of 290.3 and the following structural formula:
INACTIVE INGREDIENTS: Docusate sodium 85%, sodium benzoate 15%, sodium
starch
glycolate, magnesium stearate and pregelatinized starch.
1
10
11
3
3
14
18
4
3
CLINICAL PHARMACOLOGY
Sulfamethoxazole and trimethoprim tablets are 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 N -
acetyl-, N -hydroxy-, 5-methylhydroxy-, N -acetyl-5-methylhydroxy-
sulfamethoxazole
metabolites, and an N-glucuronide conjugate. The formulation of N
-hydroxy metabolite
is mediated _via_ CYP2C9.
Trimethoprim is metabolized _in vitro_ to 11 different metabolites, of
which, five