Gelnique

(Oxybutynin Chloride)

The active ingredient in Gelnique is oxybutynin chloride.

Oxybutynin is an antimuscarinic, antispasmodic medicine. Its mechanism of action involves blocking muscarinic receptors in the bladder muscle, which helps relax the muscle and reduces sudden bladder contractions. This leads to fewer episodes of urinary urgency, frequency, and urge incontinence in people with overactive bladder.

Follow all directions given to you by your doctor. Read all documents provided, including the Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Gelnique. The following is a summary of general guidelines for using Gelnique:

• Gelnique is for use on the skin only and should not be taken by mouth or injected.
• The usual dose is the contents of one sachet or one actuation of the metered-dose pump applied once daily to dry, intact skin.
• Recommended application sites are the abdomen, upper arms/shoulders, or thighs, on healthy skin without cuts, burns, or irritation. Rotate application sites and avoid using the same site on consecutive days.
• Apply the full dose onto the skin or into your palm and gently rub it in until the gel dries.
• Wash your hands with soap and water immediately after applying the gel.
• Do not bathe, shower, swim, or exercise to the point of heavy sweating for at least 1 hour after application.
• The gel contains alcohol and is flammable. Avoid open flames or smoking until the gel has fully dried.
• To reduce transfer of oxybutynin to another person, allow the gel to dry and cover the application site with clothing if skin-to-skin contact is likely.
• Do not apply cosmetics, lotions, or other topical gels or creams on the treated area unless your healthcare provider says it is acceptable.
• If you miss a dose, apply it as soon as you remember on the same day. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not apply extra gel to make up for a missed dose.

Some mild or common possible side effects of Gelnique include:

• Dry mouth.
• Urinary tract infection.
• Application site reactions such as itching, rash, redness, or irritation.
• Upper respiratory tract infection or cold-like symptoms.
• Dizziness or lightheadedness.
• Fatigue or drowsiness.
• Headache.
• Constipation.

Some individuals may experience serious side effects while using Gelnique. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Little or no urination, a weak urine stream, or painful urination may signal urinary retention or urinary tract problems.
• Severe constipation, abdominal pain, or symptoms of blocked bowels.
• Confusion, hallucinations, severe dizziness, or sudden changes in thinking or behavior.
• Signs of a serious allergic reaction or angioedema, such as hives, swelling of the face, lips, tongue, or throat, trouble breathing, or chest tightness.
• Very hot, dry skin, feeling extremely hot, reduced sweating, or signs of heat stroke, especially in hot weather or with vigorous exercise.
• Persistent or severe application site reactions such as intense rash, blistering, or hives.

These are not all of the possible adverse effects of Gelnique. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report side effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Gelnique, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of urinary retention or significant urinary blockage.
• Stomach or intestinal problems such as gastric retention, intestinal blockage, intestinal atony, ulcerative colitis, or severe constipation.
• Gastroesophageal reflux disease (GERD), esophagitis, or if you use medicines that can irritate the esophagus.
• Narrow-angle glaucoma, especially if it is poorly controlled.
• Myasthenia gravis or other conditions involving generalized muscle weakness.
• Kidney disease or reduced kidney function.
• Any history of severe allergic reaction or angioedema to oxybutynin or similar anticholinergic medicines.
• Parkinson’s disease or other neurologic conditions that may be affected by anticholinergic drugs.

Gelnique should not be used in the following situations:

• Urinary retention.
• Gastric retention or severe stomach problems that slow or block stomach emptying.
• Uncontrolled narrow-angle glaucoma.
• Known serious hypersensitivity reaction to oxybutynin or any component of the product.

Gelnique is used as a daily, long-term treatment for an overactive bladder. Some people may notice an improvement in urgency, frequency, or incontinence episodes within the first few days to weeks of treatment, but full benefit may take several weeks of consistent use.

When Gelnique is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other anticholinergic or antimuscarinic medicines may increase the risk of anticholinergic side effects such as dry mouth, constipation, blurred vision, somnolence, and urinary retention.
• Strong cytochrome P450 (CYP3A4) inhibitors such as certain antimycotics (for example, ketoconazole, itraconazole, or miconazole) or macrolide antibiotics (for example, erythromycin or clarithromycin) may increase oxybutynin levels and the risk of side effects.

Gelnique is supplied as a 10% oxybutynin chloride gel for transdermal use, and each unit dose (sachet or pump actuation) delivers 100 mg of oxybutynin chloride in 1 gram of gel.

The usual adult dose is the contents of one sachet or one pump actuation applied once daily to recommended skin sites. Your healthcare provider may adjust your regimen based on your response and tolerance.

Store at room temperature and keep out of reach of children.

Gelnique (oxybutynin chloride gel) was originally developed and distributed in the United States by Watson Pharma, Inc., and later associated with Allergan and related companies.

Gelnique, as a brand, has been discontinued in the United States, but oxybutynin gel formulations may be available as generic products or under other brand names, depending on the country and regulatory approvals.

Gelnique is generally used as an ongoing treatment for an overactive bladder. You should not stop using it without talking to your healthcare provider.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Gelnique is found in breast milk during lactation. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.