TRIMETHOPRIM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

TRIMETHOPRIM

Composition:

TRIMETHOPRIM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 results of these tests. Trimethoprim is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIMETHOPRIM - TRIMETHOPRIM TABLET
LUPIN PHARMACEUTICALS,INC.
----------
TRIMETHOPRIM TABLETS, USP
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, 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.
14
18
4
3
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