URIPAX F.C. Tablet

Symptomatic relief of dysuria, vesical suprapubic pain, nocturia, frequency and incontinence associated with cystitis, prostatitis, urethritis and urethrotrigonitis. Relief of vesico-urethral spasm due to catheterization cystoscopy or indwelling catheters, and sequelae of surgical intervention of the lower urinary tract.

Dosage and Administration

Adults: 1 tablet 3 times a day.

In patients who have any of the following obstructive conditions:

pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal haemorrhage and obstructive uropathies of the lower urinary tract.

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.

1. Anticholinergic or medications with anticholinergic effect:

Concurrent use may intensify the anticholinergic effects of flavoxate.

2. Central nervous system depression-producing medications:

Concurrent use may potentiate the CNS depressant effects of either these medications or flavoxate.

See the package insert about the details below:

Pregnancy

This drug should be used during pregnancy only if clearly needed.

Lactation

Caution should be exercised when flavoxate is administered to a nursing woman.

1. Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.

2. Patients should be informed that if drowsiness and blurred vision occurs, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

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

2. By counteracting smooth muscle spasms of the urinary tract, it relieves the pain and discomfort accompanying a variety of urological disorder, e.g. frequency, dysuria, urgency, nocturia and incontinence.

3. Its pharmacological effects are considered to be due to a direct action on the smooth muscle of the urinary tract, rather than to indirect blocking of autonomic nervous system receptors, as elicited by anticholinergic medications. Inhibition of phosphodiesterase by the drug itself or a metabolite is regarded to codetermine its mechanism of action.

4. Flavoxate hydrochloride exerts a direct spasmolytic (papaverine-like) action on smooth muscle. In vitro, the spasmolytic effect has been demonstrated on the small intestine, gallbladder, uterus, seminal vesicle, and colon of various animals. Flavoxate hydrochloride has been reported to produce an increase in urinary bladder capacity in patients with evidence of bladder spasticity, possibly as a result of the action of the drug on the detrusor muscle.

5. Based on animal studies, Flavoxate hydrochloride appears to be well absorbed from the GI tract. In rats, peak plasma flavoxate concentration was achieved approximately 2 hours following oral administration of the drug. In one study in healthy males, the onset of action was 55 minutes and peak effect occurred at 112 minutes. It is not known whether the drug is distributed into milk. The manufacturer reports that 57% of a dose of flavoxate hydrochloride is excreted in urine within 24 hours after oral administration.