SULFAMETHOXAZOLE AND TRIMETHOPRIM- sulfamethoxazole and trimethoprim tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

REMEDYREPACK INC.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 single effective antibacterial agent rather than the combination. Acute Otitis Med

Tuoteyhteenveto:

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 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 USP, 400 mg/80 mg, are supplied as white, round, bisected tablets debossed “IP” over “271” on one side. They are available as follows: 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
REMEDYREPACK 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 gl