SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
05-05-2011

有効成分:

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

から入手可能:

MedVantx, Inc.

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 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 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. Acute Otitis M

製品概要:

Sulfamethoxazole and Trimethoprim Tablets are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets 800 mg/160 mg are available as: White, oval, bisected tablets debossed “IP” bisect “272” on one side. Bottles of 10 – NDC 53746-272-11 Bottles of 24 – NDC 53746-272-24 Bottles of 100 – NDC 53746-272-01 Bottles of 250 – NDC 53746-272-02 Bottles of 500 – NDC 53746-272-05 Sulfamethoxazole and Trimethoprim Tablets 400 mg/80 mg are available as: White, round, bisected tablets debossed “IP” over “271” on one side. Bottles of 50 – NDC 53746-271-50 Bottles of 100 – NDC 53746-271-01 Bottles of 500 – NDC 53746-271-05 Bottles of 1000 – NDC 53746-271-10 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
MEDVANTX, INC.
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH TABLETS
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 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.
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. 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.
1
10
11
3
3
14
18
4
3
4
Approximately 70% of sulfamethoxazole and 44% of trimet
                                
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