SULFAMETHOXAZOLE AND TRIMETHOPRIM - sulfamethoxazole and trimethoprim tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aurobindo Pharma Limited

INN (Rahvusvaheline Nimetus):

SULFAMETHOXAZOLE

Koostis:

SULFAMETHOXAZOLE 400 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SULFAMETHOXAZOLE AND TRIMETHOPRIM - SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
AUROBINDO PHARMA LIMITED
----------
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 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 a white to off-white, practically odorless, crystalline powder,
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 or cream-colored crystals or crystalline powder
with a molecular weight of
290.3 and the following structural formula:
INACTIVE INGREDIENTS:Docusate sodium, magnesium stearate,
pregelatinized starch, sodium benzoate,
and sodium starch glycolate.
CLINICAL PHARMACOLOGY
1
10
11
3
3
14
18
4
3
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. The metabolism of
sulfamethoxazole occurs
predominately by N -acetylation, although the glucuronide conjugate
has been identified. The principal
metabolites of trimethoprim are the 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.
Approximately 70% of sulfamethoxazole and 44% of