100 mg 100's: NDC 0007-5290-20
100 mg SUP 100's: NDC 0007-5290-21
Storage: Store between 15° and 30° C (59° and 86° F).
Side Effects
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
Gastrointestinal: Nausea, vomiting, dry mouth.
CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.
Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).
Cardiovascular: Tachycardia and palpitation.
Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.
Renal: Dysuria.
Warnings
Urispas (flavoxate HCl) should be given cautiously in patients with suspected glaucoma.
Precautions
Pregnancy:
Teratogenic Effects - Pregnancy Category B: Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urispas is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness in children below the age of 12 years have not been established.
Contraindications
Urispas (flavoxate HCl) is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
