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PRIMSOL® Solution (trimethoprim hydrochloride) 50 mg/5 mL

For Uncomplicated Urinary Tract Infections...

The SOLUTION Without the Sulfa

SCROLL DOWN FOR IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION:

CONTRAINDICATIONS:
Primsol (trimethoprim hydrochloride) is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.

SCROLL DOWN FOR IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION:

CONTRAINDICATIONS:
Primsol (trimethoprim hydrochloride) is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.

WARNINGS:
Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses 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.

PRECAUTIONS:
Trimethoprim should be given with caution to patients with possible folate deficiency. Folates may be administered concomitantly without interfering with the antibacterial action of trimethoprim. Trimethoprim should be given with caution to patients with impaired renal or hepatic function. A complete blood count should be obtained if there are any clinical signs of a blood disorder. Primsol may need to be discontinued if there is a significant reduction in count.

ADVERSE REACTIONS:
The most commonly reported adverse reactions in clinical trials were: diarrhea, vomiting, skin rash, and abdominal pain.

DRUG INTERACTIONS:
Primsol may inhibit the hepatic metabolism of phenytoin. When administering these drugs concurrently be alert for possible excessive phenytoin effect.

INDICATION FOR USE:
Primsol is indicated for the treatment of initial episodes of uncomplicated urinary tract infections in adults due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species and coagulase-negative Staphylococcus species, including S. Saprophyticus.

Before prescribing Primsol, please read the Full Prescribing Information.

To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch