PRIMSOL- trimethoprim hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIMETHOPRIM HYDROCHLORIDE (UNII: 9XE000OU9B) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Available from:

FSC Laboratories, Inc

INN (International Name):

TRIMETHOPRIM HYDROCHLORIDE

Composition:

TRIMETHOPRIM 50 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRIMSOL Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. For the treatment of acute otitis media due to susceptible strains of Streptococcus pneumoniae and Haemophilus influenzae. NOTE: Moraxella catarrhalis isolates were found consistently resistant to trimethoprim in vitro. Therefore, when infection with Moraxella catarrhalis is suspected, the use of alternative antimicrobial agents should be considered. PRIMSOL is not indicated for prophylactic or prolonged administration in otitis media at any age. 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

Product summary:

PRIMSOL (trimethoprim hydrochloride oral solution) is a dye-free, alcohol-free, bubble gum flavored, oral solution containing trimethoprim hydrochloride equivalent to 50 mg of trimethoprim in each 5 mL. NDC 13551-501-01: 20 mL (3/4 ounce) NDC 13551-501-05: 473 mL (1 Pint) Store between 15-25°C (59-77°F). Dispense in tight, light-resistant glass or PET plastic containers as defined in USP. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

PRIMSOL- TRIMETHOPRIM HYDROCHLORIDE SOLUTION
FSC LABORATORIES, INC
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PRIMS OL SOLUTION
(TRIMETHOPRIM HYDROCHLORIDE ORAL SOLUTION)
DYE-FREE, ALCOHOL-FREE, FLAVORED SOLUTION,
50 MG TRIMETHOPRIM PER 5 ML
DESCRIPTION
PRIMSOL (trimethoprim hydrochloride oral solution) is a solution of
the synthetic antibacterial
trimethoprim in water prepared with the aid of hydrochloric acid. Each
5 mL for oral administration
contains trimethoprim hydrochloride equivalent to 50 mg trimethoprim
and the inactive ingredients
bubble gum flavor, fructose, glycerin, methylparaben, monoammonium
glycyrrhizinate, povidone,
propylparaben, propylene glycol, saccharin sodium, sodium benzoate,
sorbitol, water and hydrochloric
acid and/or sodium hydroxide to adjust pH to a range of 3.0 - 5.0.
Trimethoprim is 2,4-diamino-5-(3,4,5-
trimethoxybenzyl) pyrimidine. Trimethoprim is a white to
cream-colored, odorless, bitter compound
with a molecular formula of C
H N O and a molecular weight of 290.32 and the following
structural formula:
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 plasma concentrations of approximately 1 mcg/mL occur 1 to 4
hours after oral
administration of a single 100 mg dose. A single 200 mg dose will
result in plasma concentrations
approximately twice as high. The mean half-life of trimethoprim is
approximately 9 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 s