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:

American Health Packaging

INN（国際名）:

SULFAMETHOXAZOLE

構図:

SULFAMETHOXAZOLE 800 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, 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 the 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 mirabil

製品概要:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets, USP, 800 mg/160 mg , are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-230-01 Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg , are supplied as white, round, bisected tablets debossed “IP” over “271” on one side. They are available as follows: Unit dose packages of 30 (5 x 6) NDC 68084-747-25 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
AMERICAN HEALTH PACKAGING
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH TABLETS,
USP
8274725/0216PS
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,
USP and 160 mg trimethoprim,
USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80
mg trimethoprim, USP for oral
administration.
Sulfamethoxazole, USP is _N_ -(5-methyl-3-isoxazolyl) sulfanilamide;
the molecular formula is C
H
N
O
S. It is almost white, odorless, tasteless compound with a molecular
weight of 253.28 and the
following structural formula:
Trimethoprim, USP 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.
It has 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
1
10
11
3
3
14
18
4
3
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
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