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Uroxate

Content
Each Uroxate Tablet contains 100 mg Flavoxate hydrochloride.

Description
Uroxate is a white round and slightly biconvex film-coated tablet embossed with "SPS" on one side and plain on the other.

Properties
Flavoxate hydrochloride is a non-specific, direct acting smooth muscle relaxant. It counteracts smooth muscle spasm of the urinary tract and has been reported to produce an increase in urinary bladder capacity in patients with evidence of bladder spasticity.

Pharmacokinetics
There are very limited published reports on the pharmacokinetic data on flavoxate. In a single study of 11 normal male subjects, the time to onset of action is 55 minutes after oral administration. Peak plasma concentration was observed at 112 minutes and 57% of the flavoxate hydrochloride was excreted via the kidneys within 24 hours in this particular study. It has also been reported that 10-30% of a 100 mg dose is excreted in urine within 6 hours after oral administration.

Indications
Uroxate Tablet is used as an antispasmodic to provide symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence that may occur in patients with cystitis, prostatitis, urethritis, urethrocystitis and urethrotrigonitis.

Contraindications
Uroxate Tablet is contraindicated in patients with pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal haemorrhage. or obstructive uropathies of the lower urinary tract.

Drug Interactions
Flavoxate hydrochloride has antimuscarinic effects, concomitant use of two or three such drugs potentiate the side effects such as dry mouth, urine retention and constipation. Concomitant use with other antimuscarinic drug may also lead to confusion in the elderly.

Side-effects
The incidence of adverse effects of Uroxate Tablet compared with other antispasmodic is low with the following having been reported:-
GI Tract - nausea, vomiting, dry mouth, diarrhoea;
CNS - vertigo, headache, drowsiness, mental confusion especially in the elderly, fatigue, nervousness and hyperpyrexia;
Haematologic - reversible leukopenia and eosinophilia;

Cardiovascular - tachycardia and palpitation;

Allergic - urticaria and other dermatoses;
Ophthalmic - increase ocular tension, blurred vision, disturbance in eye accommodation;

Renal - dysuria.

Precautions and Warnings
Patients should be warned that if drowsiness and blurred vision occur, they should not drive, operate machinery or participate in activities where alertness is required. Uroxate Tablet should be given cautiously in patients with suspected glaucoma.

Use in pregnancy - The safety of flavoxate hydrochloride in pregnant women has not been established. As such Uroxate Tablet should be given to pregnant women only under compelling reasons, and when in the opinion of the doctors, the potential benefits justify the potential risks to the mother and foetus.

Nursing mothers - Since it is not known whether flavoxate hydrochloride is excreted in human milk, Uroxate Tablet should be administered to nursing mothers with caution.

Paediatric Use - The safety and efficacy of flavoxate hydrochloride in children below the age of 12 years have not been established. As such Uroxate Tablet is not recommended for use in infants and children in this age group.

Dosage
Adults and children over 12 years old: one or two 100 mg tablets to be taken three or four times daily. The dose may be reduced with improvement in symptoms.

Overdosage and Treatment
Symptoms of overdosage developing soon after ingestion of the drug include: tachycardia, palpitation, dry mouth, blurred vision, speech disturbance, drowsiness, difficulty in swallowing, restlessness, diarrhoea or constipation, dry hot skin and fever.

Treatment - Gastric lavage and other measures to limit intestinal absorption should be initiated without delay. Administration of parasympathetic drugs should also be considered.

Pack sizes
Box of 10 x 10 tablets.

Bottle of 500 tablets.
Store in a cool dry place, below 30C
Protect from light.
Keep all medicines out of the reach of children.

 

Shelf life

Refer to outer Box

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