Oxytrol

What is Oxytrol?

• Oxybutynin (Oxytrol) is a muscarinic antagonist used for treatment of urinary incontinence and overactive bladder syndrome.

What are the uses of this medicine?

• Oxytrol is a transdermal system (skin patch) for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. It delivers the active ingredient, oxybutynin, directly into your bloodstream through your skin.
• Overactive bladder makes it hard to urinate (passing water). Overactive bladder can make you urinate more often (increased frequency) or make you feel the need to urinate often (urgency). Overactive bladder can also lead to accidental urine loss (leaking or wetting oneself).

How does this medicine work?

• Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma
• Known serious hypersensitivity reaction to Oxytrol, oxybutynin, or to any of the components of Oxytrol

What drug interactions can this medicine cause?

• No specific drug-drug interaction studies have been performed with Oxytrol.
• Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects.

Is this medicine FDA approved?

• Initial U.S. Approval: 1975

How should this medicine be used?

Recommended Dosage:

• Oxytrol 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days).

Administration

• Use Oxytrol exactly as your doctor tells you to use it.
• Put on a new patch of Oxytrol 2 times a week (every 3 to 4 days) according to your doctor’s instructions.
• Choose a new skin site for each new patch application. You should not use the same skin site within 7 days.
• Wear the patch all the time until it is time to apply a new one.
• Wear only 1 patch of Oxytrol at a time.
• Try to change the patch on the same 2 days each week.
• Your package of Oxytrol has a calendar checklist printed on the back to help you remember your schedule. Mark the schedule you plan to follow. Always change Oxytrol on the 2 days of the week you mark on the calendar.
• Contact with water when you are bathing, swimming, showering or exercising will not change the way that Oxytrol works.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Transdermal system: 3.9 mg/day

This medicine is available in fallowing brand namesː

• Oxytrol

What side effects can this medication cause?

The most common side effects of this medicine include:

• skin reactions where the patch is placed and dry mouth
• Since oxybutynin treatment may decrease sweating, you may overheat or have fever or heat stroke if you are in warm or hot temperatures.

Oxytrol may cause serious side effects, including:

• inability to empty your bladder (urinary retention)
• increased risk of stomach problems in certain patients
• central nervous system effects
• swelling (angioedema)
• skin hypersensitivity
• worsening of myasthenia gravis

What special precautions should I follow?

• You should not drink alcohol while using Oxytrol. It can increase your chance of getting serious side effects.
• Oxytrol can cause dizziness or blurred vision. Do not drive or operate machinery, or do other dangerous activities until you know how Oxytrol affects you.
• Do not put Oxytrol on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin. Do not expose the patch to sunlight. Wear your patch under clothing.
• Avoid rubbing the patch area during bathing, swimming, showering or exercising.
• Administer Oxytrol with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
• Administer Oxytrol with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
• Products containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, somnolence, confusion and hallucinations. Advise patients not to drive or operate heavy machinery until they know how Oxytrol affects them.
• Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue Oxytrol and initiate appropriate therapy.
• Patients who develop skin hypersensitivity to Oxytrol should discontinue drug treatment.
• Avoid use of Oxytrol in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. If experiencing exacerbation of symptoms of myasthenia gravis, oxybutynin-containing product should be discontinued and appropriate therapy promptly provided.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• CNS excitation
• flushing
• fever
• dehydration
• cardiac arrhythmia
• vomiting
• urinary retention

Management of overdosage:

• In the event of overdosage, observe the patient and give appropriate supportive treatment.

Can this medicine be used in pregnancy?

• There are no studies with topical or oral oxybutynin use in pregnant women to inform a drug associated risk for birth defects or miscarriage.

Can this medicine be used in children?

• The safety and efficacy of Oxytrol in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: oxybutynin
• Inactive Ingredients: Flexible polyester/ethylene-vinyl acetate film, acrylic adhesive, triacetin, siliconized polyester film.

Who manufactures and distributes this medicine?

Packager: Allergan, Inc.

What should I know about storage and disposal of this medication?

• Store Oxytrol at 68°F to 77°F (20°C to 25°C).
• Do not store Oxytrol outside the sealed pouch.
• Keep Oxytrol patches in a dry place.
• Keep Oxytrol and all medicines out of the reach of children.

• Dailymed label info on Oxytrol
• FDA Oxytrol

Oxytrol Resources
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