TRIMETHOPRIM tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Доступно од:

Novel Laboratories, Inc.

INN (Међународно име):

TRIMETHOPRIM

Састав:

TRIMETHOPRIM 100 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, 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. For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli , Proteus mirabilis , Klebsiella pneumoniae , Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus . Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the

Резиме производа:

Trimethoprim tablets, USP, 100 mg: White, round, convex tablet, debossed "N", bisect, "L" on one side and debossed "330" on the other, in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Storage recommendation:  PROTECT FROM MOISTURE AND LIGHT.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

TRIMETHOPRIM- TRIMETHOPRIM TABLET
NOVEL LABORATORIES, INC.
----------
TRIMETHOPRIM TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of trimethoprim
tablets, USP and other antibacterial drugs, trimethoprim tablets, USP
should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Trimethoprim is a synthetic antibacterial available in tablet form for
oral administration. Each scored
white tablet contains 100 mg trimethoprim.
Trimethoprim is
5-[(3,4,5-trimethoxyphenyl)methyl]-2,4-pyrimidinediamine. It is a
white to light yellow,
odorless, bitter compound with a molecular weight of 290.32 and the
molecular formula C
H N O .
The structural formula is:
INACTIVE INGREDIENTS
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate, and purified water.
CLINICAL PHARMACOLOGY
Trimethoprim is rapidly absorbed following oral administration. It
exists in the blood as unbound,
protein-bound, and metabolized forms. Ten to twenty percent of
trimethoprim is metabolized, primarily
in the liver; the remainder is excreted unchanged in the urine. The
principal metabolites of trimethoprim
are the 1- and 3-oxides and the 3'- and 4'-hydroxy derivatives. The
free form is considered to be the
therapeutically active form. Approximately 44% of trimethoprim is
bound to plasma proteins.
Mean peak serum concentrations of approximately 1.0 mcg/mL occur 1 to
4 hours after oral
administration of a single 100 mg dose. A single 200 mg dose will
result in serum levels approximately
twice as high. The half-life of trimethoprim ranges from 8 to 10
hours. However, patients with
severely impaired renal function exhibit an increase in the half-life
of trimethoprim, which requires
either dosage regimen adjustment or not using the drug in such
patients (see DOSAGE AND
14
18
4
3
ADMINISTRATION). During a 13 week study of trimethoprim administered
at a daily dosag