Primsol
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Questions & Answers
Side Effects & Adverse Reactions
Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.
The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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. Therapy may be initiated prior to obtaining the results of these tests.
History
There is currently no drug history available for this drug.
Other Information
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 C14H18N4O3 and a molecular weight of 290.32 and the following structural formula:
Sources
Primsol Manufacturers
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Fsc Laboratories, Inc
![Primsol (Trimethoprim Hydrochloride) Solution [Fsc Laboratories, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Primsol | Fsc Laboratories, Inc
Acute Otitis Media in Pediatric PatientsThe recommended dose for pediatric patients with acute otitis media is 10 mg/kg trimethoprim per 24 hours, given in divided doses every 12 hours for 10 days. The following table is a guideline for the attainment of this dosage:
Pediatric patients 6 months of age or older Weight Dose (every 12 hours) lb kg tsp mL 11 5 ½ 2.5 22 10 1 5 33 15 1½ 7.5 44 20 2 10 55 25 2½ 12.5 66 30 3 15 77 35 3½ 17.5 ≥88 ≥40 4 20 Uncomplicated Urinary Tract InfectionsThe usual oral adult dosage is 100 mg (10 mL) every 12 hours or 200 mg (20 mL) every 24 hours, each for 10 days.
Patients with Impaired Renal FunctionThe use of trimethoprim in patients with a creatinine clearance of less than 15 mL/min is not recommended. Patients with a creatinine clearance of 15 to 30 mL/min should receive half the dose recommended for patients of the same age with normal renal function.
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