Gelnique

What is Gelnique?

• Gelnique (oxybutynin chloride) is a muscarinic antagonist used to treat overactive bladder.

Oxybutynin

Oxybutynin 3d balls

What are the uses of this medicine?

Gelnique is a prescription medicine used to treat the symptoms of overactive bladder:

• Urge urinary incontinence (a strong need to urinate with leaking or wetting accidents).
• Urgency (a strong need to urinate right away).
• Frequency (need to urinate often).

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 Gelnique, oxybutynin, or to any of the components of Gelnique

What drug interactions can this medicine cause?

• No specific drug-drug interaction studies have been performed with Gelnique.
• The concomitant use of Gelnique with other anticholinergic (antimuscarinic) agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, somnolence and other anticholinergic pharmacological effects.

Is this medicine FDA approved?

• Oxybutynin was approved for medical use in the United States in 1975.

How should this medicine be used?

Recommended dosage:

• Apply contents of one sachet or one actuation of the metered-dose pump of Gelnique once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs.

Administration:

• Gelnique is for skin use only.
• Use Gelnique exactly as your healthcare provider tells you to use it.
• Gelnique should only be applied to dry intact skin on your stomach (abdomen), upper arms, shoulders, or thighs.
• Do not put Gelnique on open sores, recently shaved skin, or skin with rashes.
• You should change your application site every day. Do not use the same site 2 days in a row. Changing application sites every day can help reduce your chance of getting skin irritation.
• Gelnique contains alcohol and is flammable. Avoid fire, flames or smoking until Gelnique has dried.
• After applying Gelnique, wash your hands with soap and water right away.
• Cover the application site with clothing if skin-to-skin contact between another person and the application site is expected.
• If someone else is exposed to Gelnique by direct contact with the gel or at the application site, that person should wash the area of contact with soap and water as soon as possible.
• If you get Gelnique in your eyes, rinse your eyes right away with warm, clean water to flush out any Gelnique.
• Gelnique may be used with sunscreen.

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

This medicine is available in fallowing doasage form:

• As Gel: 10%

This medicine is available in fallowing brand namesː

• Gelnique

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry mouth
• redness, rash, itching, pain at the application site
• dizziness
• headache
• constipation
• itching
• tiredness

• Other side effects that have been seen with drugs containing oxybutynin, like Gelnique, include: dizziness and blurred vision, drowsiness that may be increased with alcohol (beer, wine, or hard liquor), and decreased sweating that may lead to overheating.

Gelnique can cause serious side effects including:

• Allergic reactions, including allergic skin reactions

What special precautions should I follow?

• Gelnique can cause tiredness, drowsiness, dizziness or blurred vision. Do not drive, operate machinery, or do other dangerous activities until you know how Gelnique affects you.
• Do not take a bath, swim, shower, exercise, or get the application site wet for at least 1 hour after you apply your dose.
• Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
• Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis.
• Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue Gelnique and initiate appropriate therapy.
• Hypersensitivity may occur with Gelnique. Discontinue Gelnique in patients with skin hypersensitivity.
• Advise patients to cover the application site with clothing if skin-to-skin contact at the application site is anticipated. Wash hands immediately after product application.
• Gelnique is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried.
• Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• central nervous system excitation
• flushing
• fever
• dehydration
• cardiac arrhythmia
• vomiting
• [[urinary retention

Overdosage of oxybutynin chloride in association with alcohol may lead:

• memory loss
• stupor
• disorientation
• agitation on awakening
• dilated pupils
• dry skin
• cardiac arrhythmia
• retention of urine

Management of overdosage:

• Plasma concentrations of oxybutynin begin to decline 24 hours after Gelnique application.
• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are no studies with topical or oral oxybutynin use in pregnant women to inform any drug-associated risks of adverse development outcomes.
• No adverse developmental outcomes were observed in animal reproduction studies.

Can this medicine be used in children?

• The safety and effectiveness of Gelnique 10% have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: oxybutynin chloride
• Inactive Ingredients: alcohol, USP; glycerin, USP; hydroxypropyl cellulose, NF; sodium hydroxide, NF; and purified water, USP.

Who manufactures and distributes this medicine?

Distributed By: Allergan USA, Inc. Madison, NJ

• Gelnique® is a registered trademark of Allergan Sales, LLC.

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

• Store Gelnique at 68°F to 77°F (20°C to 25°C).
• Safely throw away Gelnique in household trash. Be careful to prevent accidental exposure to children or pets.
• Keep Gelnique metered-dose pump and sachets in a dry place.

• Dailymed label info on Gelnique
• FDA Gelnique

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