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Uripax F.C

Each tablet contains: Flavoxate Hydrochloride 200mg

Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
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.

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

Flavoxate is contraindicated 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.

Dosage and Administration
Adults: One tablet three times a day.

Precaution(s) / Warning(s)
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.

3. Reproduction studies have been performed in rats and rabbits at dose up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. 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.

4. 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 flavoxate is administered to a nursing woman.

Side Effect(s) / Adverse Reaction(s)
The following adverse reactions have been observed, but there are not enough data to support on 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.

Drug Interactions:
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.

Symptoms and Treatment for Overdosage, and Antidote(s)
Although no such experience has been reported to date, it is considered likely that the following symptoms may be observed: nausea, vomiting, dryness of the mouth, blurred vision, disturbance in visual accommodation, tachycardia, tachypnea, mental confusion and excitement.

There is no known specific antidote. Recommended treatment for overdose with flavoxate includes:
To decrease absorption Emesis or gastric lavage with 4% tannic acid solution or administration of an aqueous slurry of activated charcoal.

Specific treatment Administration of small doses of short-acting barbiturate (100mg thiopental sodium) or benzodiazepines, or rectal infusion of 100 to 200mL of a 2% solution of chloral hydrate, to control excitement. Artificial hydration. Symptomatic artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

Supportive case Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.

3 years from the date of manufacture.

Storage Condition(s)
Keep in a tight container. Store at temperature below 30C. Protect from light and moisture.

Product Description and Packing(s)
A slight yellow film coated tablet.
Plastic bottle of 500's.
Blister packing of 10's x 10, 10's x 50 and 10's x 100.











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