| Composition |
| Each 5 mL of Oxybutynin Syrup contains 5 mg of oxybutynin chloride. |
| Side effect |
| Diarrhea, hypotension, Headache, Nasopharyngitis, Nasal Congestion, Retrograde Ejaculation. |
| Pharmacodynamics properties |
| Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions. |
| Therapeutic indications |
| This drug is indicated for the relief of symptoms of bladder instability associated with voiding in patients with neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria). |
| Contraindication |
• Urinary retention, gastric retention
• Uncontrolled narrow-angle glaucoma
• Hypersensitivity to the drug substance or other components of the product. |
| Warnings and precautions |
| This drug should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis, and patients with clinically significant bladder outflow obstruction. It should be administered with caution to patients with gastrointestinal obstructive disorders. |
| Drug interactions |
| The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness) may increase the frequency and/or severity of such effects. |
| DOSAGE & ADMINISTRATION |
Adults
The usual dose is one teaspoon (5 mg/5 mL) of syrup two to three times a day. The maximum recommended dose is one teaspoon (5 mg/5 mL) of syrup four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly.
Pediatric patients over 5 years of age
The usual dose is one teaspoon (5 mg/5 mL) of syrup two times a day. The maximum recommended dose is one teaspoon (5 mg/5mL) of syrup three times a day. |
| Overdose |
Prandosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
The dose-limiting adverse event was postural hypotension.
Should overdose of Prandosin lead to hypotension, support of the cardiovascular system has to be provided. |
