Flavoxate HCl

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.

URISPAS® (flavoxate HC1) should be given cautiously in patients with suspected glaucoma.

The oral LD50 for flavoxate HC1 in rats is 4273 mg/kg. The oral LD50 for flavoxate HC1 in mice is 1837 mg/kg. It is not known whether flavoxate HC1 is dialyzable.

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes.

57% of the flavoxate HC1 was excreted in the urine within 24 hours.

Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bacterial or fungal bladder infection. Infections must be treated with an antibiotic.

Flavoxate may also be used for other purposes not listed in this medication guide.

Your pharmacist can provide more information about flavoxate.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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