TRIMETHOPRIM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

TRIMETHOPRIM

Composition:

TRIMETHOPRIM 100 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

TRIMETHOPRIM- TRIMETHOPRIM TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
TRIMETHOPRIM TABLETS, USP
2158
RX ONLY
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, dibasic calcium phosphate dihydrate,
magnesium stearate, microcrystalline
cellulose, pregelatinized starch, and sodium starch glycolate.
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
ADMINISTRATION). During a 13 week study of trimethoprim administered
at a da