SULFAMETHOXAZOLE AND TRIMETHOPRIM- sulfamethoxazole and trimethoprim tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

KAISER FOUNDATION HOSPITALS

INN (الاسم الدولي):

SULFAMETHOXAZOLE

تركيب:

SULFAMETHOXAZOLE 400 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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. Ac

ملخص المنتج:

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: Bottles of 6:                   NDC 0179-0138-06 Bottles of 10:                 NDC 0179-0138-10 Bottles of 14:                 NDC 0179-0138-14 Bottles of 20:                 NDC 0179-0138-20 Bottles of 28:                 NDC 0179-0138-28 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: Boxes of 30 Unit Dose Tablets:                   NDC 0179-0206-70 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
KAISER FOUNDATION HOSPITALS
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH TABLETS,
USP
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
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
1
10
11
3
3
14
18
4
3
4
4
4
4
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