Product Description.:
PAD 0115
tablet , film-coated , white , round round
Debossed
Urispas (flavoxate HCl) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.
Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride.
Urispas is supplied in tablets for oral administration. Each round, white, film-coated Urispas tablet is debossed URISPAS SKF and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, castor oil, cellulose acetate phthalate, magnesium stearate, polyethylene glycol, starch and talc.
INDICATIONS
Urispas (flavoxate HCl) is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Urispas is not indicated for definitive treatment, but is compatible with drugs used for, the treatment of urinary tract infections.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years of age: One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
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.