SULFAMETHOX-TMP DS- sulfamethoxazole, trimethoprim tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

PharmPak, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 sing

Dettagli prodotto:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets USP, 800 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Bottles of 6:                   NDC 54348-625-06 Bottles of 10:                   NDC 54348-625-10 Bottles of 14:                   NDC 54348-625-14 Bottles of 20:                   NDC 54348-625-20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

SULFAMETHOX-TMP DS- SULFAMETHOXAZOLE, TRIMETHOPRIM TABLET
PHARMPAK, INC.
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH 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 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 an 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:
1
10
11
3
3
14
18
4
3
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 metabolite
is mediated _via _CYP2C9.
Trimethoprim is metabolized _in vitro _to 11 different metabolites, of
which, five are
glutathione adducts and