DITROPAN

What it is

DITROPAN contains oxybutynin hydrochloride. Oxybutynin hydrochloride has anticholinergic properties that may enable it to antagonise the muscarinic receptor expressed in the eccrine sweat glands, acting as an antiperspirant.

Approved indications

— Primary palmar hyperhidrosis.

Dosing overview

The recommended dose per application is 5 pumps of DITROPAN (approximately 500 µL, equivalent to approximately 96 mg of oxybutynin hydrochloride), applying it to the entire palms of both hands once daily before bedtime.

Key safety warnings

Patients should exercise caution while operating machinery with associated risks such as driving a vehicle, due to the anticholinergic effect of oxybutynin hydrochloride, which may lead to eye accommodation disorders (such as visual impairment or blurred vision), dizziness, or sleepiness. Dosage should be avoided in high environmental temperatures and excessive exercise in high temperatures since oxybutynin hydrochloride administered under these conditions can cause heat prostration (fever and heat stroke due to decreased sweating). In an environment where perspiration occurs, the sweating inhibitory action may increase body temperature. Patients should be instructed to take appropriate measures in the event of symptoms indicative of heat illness. The anticholinergic effect of oxybutynin hydrochloride inhibits the contraction and movement of gastrointestinal smooth muscles, potentially leading to gastrointestinal hypomotility. Patients should be instructed to discontinue DITROPAN and seek medical attention if they experience gastrointestinal symptoms. Anticholinergic CNS effects (such as hallucinations, agitation, confusion, sleep disturbance) have been reported with other oxybutynin products. Monitoring is recommended, particularly during the first few months of treatment. If anticholinergic CNS effects develop, consider ceasing treatment.

Contraindications

DITROPAN is contraindicated in patients with angle closure glaucoma (symptoms may worsen due to the anticholinergic effect which increases intraocular pressure); patients with impaired urination due to lower urinary tract obstruction disease such as prostatic hypertrophy (symptoms may worsen due to the anticholinergic effect which inhibits bladder contraction during urination); patients with severe cardiac disease (cardiac workload may increase due to the anticholinergic effect which causes tachycardia and palpitations); patients with intestinal obstruction or paralytic ileus (symptoms may worsen due to the anticholinergic effect which inhibits the contraction and movement of gastrointestinal smooth muscles); patients with myasthenia gravis (symptoms may worsen due to the anticholinergic effect which decreases muscle tone); and patients with a history of hypersensitivity to any of the ingredients of DITROPAN.

PBS listing

A tablet containing oxybutynin hydrochloride 5 mg is listed on the PBS as 2 items with restricted authority required status, with an ex-manufacturer price of A$8.22.

Regulatory history

DITROPAN oxybutynin hydrochloride 5 mg tablets were first listed on the ARTG on 30 May 1994.