PRIMSOL- trimethoprim hydrochloride solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Allegis Holdings, LLC

INN (Rahvusvaheline Nimetus):

TRIMETHOPRIM HYDROCHLORIDE

Koostis:

TRIMETHOPRIM 50 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 s

Toote kokkuvõte:

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 71297-500-20: 20 mL (2/3 ounce) NDC 71297-500-16: 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.

Volitamisolek:

New Drug Application

Toote omadused

PRIMSOL- TRIMETHOPRIM HYDROCHLORIDE SOLUTION
ALLEGIS HOLDINGS, LLC
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PRIMSOL 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
ADMINISTRATI