Oxybutynin Chloride

Oxybutynin Chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin Chloride Extended Release Tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Oxybutynin exerts direct antispasmodic effect on the smooth muscle by inhibiting the muscarinic action of acetylcholine. It exhibits moderate anticholinergic effect, but has potent antispasmodic effects on urinary smooth muscle.

The recommended starting dose of Uricon is 5 mg once daily, with or without food. Dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.

Administration

May be taken with or without food.

Anticholinergic agents, cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g., Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), have not been performed. No specific drug-drug interaction studies have been performed with Oxybutynin.

Oxybutynin Chloride is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow angle glaucoma and in patients who are at risk for these conditions. It is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

The incidence of dry mouth may occur which is dose-related. Abdominal pain, dry nasal and sinus mucous membranes, back pain, hypertension, palpitation, vasodilatation, flatulence, gastro-esophageal reflux, insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin, rash, impaired urination (hesitancy), urinary retention, etc. may be reported.

Oxybutynin Chloride should not be given to pregnant women unless, the probable clinical benefits outweigh the possible hazards, caution should be exercised when it is administered to a nursing woman.

Oxybutynin Chloride should be used with caution in patients with hepatic or renal impairment, clinically significant bladder outflow obstruction because of the risk of urinary retention, gastrointestinal obstructive disorders because of the risk of gastric retention, conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis, gastro-esophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Anticholinergic effects including CNS excitation (e.g. restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention may occur after overdose. Treatment should be symptomatic and supportive. Activated charcoal may be administered.

Anticholinergics (antimuscarinics)/ Anti-spasmodics.

Store at 15-30° C.