Uripan XR . (Tablets)
Each Uripan extended release tablet contains
10mg Oxybutynin hydrochloride.
-Oxybutynin hydrochloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle.
-In addition to its smooth muscle relaxing effects, oxybutynin hydrochloride exerts an analgesic and a local anesthetic effect.
-Oxybutynin hydrochloride exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but 4 to 10 times the antispasmodic activity.
-No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia.
-Oxybutynin hydrochloride relaxes bladder smooth muscle.
-Oxybutynin hydrochloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.
Urinary frequency, urgency and incontinence, neurogenic bladder instability and nocturnal enuresis associated with overactive bladder.
-Uripan XR must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
-Uripan XR may be administered with or without food.
-Uripan XR should be taken at a consistent time each day.
-In adults, the usual starting dose is 10 mg once daily at a consistent time each day.
-Dose may be adjusted 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.
-Patients already taking immediate-release oxybutynin hydrochloride tablets may be switched to the equivalent total daily dose of Uripan XR.
-The missed dose should be taken as soon as possible, if it is almost time for the next dose, the missed dose should not be taken. Instead, the next scheduled dose should be taken.
-Doses should not be doubled.
Pediatric patients aged 6 years of age and older:-
-The recommended starting dose of Uripan XR is 5mg once daily at approximately the same time each day.
-Dosage may be adjusted to achieve a balance of efficacy and tolerability up to a maximum 20 mg/day.
Uripan XR is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow angle glaucoma and in patients who are at risk for these conditions.
- Uripan XR is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other component of the product.
URIPAN XR should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis.
- URIPAN XR may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia gravis, and prostatic hypertrophy.
- Patients should be informed that, when administered in the presence of high environmental temperature, anticholinergics such as Uripan XR can cause heat prostration.
- Because anticholinergic agents such as Uripan XR may produce drwosiness or blurred vision, patients should be advised to exercise caution.
- Urinary Retention
URIPAN XR should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
- Gastrointestinal Disorders
URIPAN XR should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
- Administration of URIPAN XR to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.
- URIPAN XR, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, and intestinal atony.
- URIPAN XR should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
-Most adverse effects reported with Oxybutynin are due to its anticholinergic activity.
-These effects include dry mouth, asthenia, dry nasal and sinus mucous membranes, palpitation, peripheral edema, dry eyes.
-Other adverse events that have been reported include: - tachycardia, hallucinations, cyclopegia, mydriasis, impotence, vasodilation, rash, decreased gastrointestinal motility, flatulence, urinary retention, convulsions and decreased sweating.
Box of 2 strips each containing 10 extended release tablets.