Drug Information for GELNIQUE (oxybutynin chloride) 10% gel (Watson Pharmaceuticals, Inc.): PATIENT COUNSELING INFORMATION

  • [see FDA-approved Patient Labeling (17.3)]

  • 17.1 Instructions for Use

  • GELNIQUE is for topical application only and should not be ingested.

    GELNIQUE should not be applied to recently shaved skin surfaces. Patients should wash hands immediately after product application. Application sites should not be subject to showering or water immersion for 1 hour after product application. Application sites should be covered with clothing if close skin-to-skin contact at the application site is anticipated.

    Alcohol based gels are flammable. Avoid open fire or smoking until the gel has dried.

  • 17.2 Important Anticholinergic Adverse Reactions

  • Patients should be informed that anticholinergic (antimuscarinic) agents, such as GELNIQUE, may produce clinically significant adverse reactions related to anticholinergic pharmacological activity including constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur when anticholinergics such as GELNIQUE are used in a hot environment. Because anticholinergic (antimuscarinic) agents, such as GELNIQUE, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until GELNIQUE’s effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic (antimuscarinic) agents such as GELNIQUE.

  • 17.3  FDA-Approved Patient Labeling

  • Information for the Patient

    GELNIQUE(oxybutynin chloride) 10% gel

    (For Topical Use Only)

    Read this information carefully before you begin treatment. Read the information whenever you refill a prescription as there may be something new. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about GELNIQUE, ask your doctor. Only your doctor can determine if GELNIQUE is right for you.

    What is GELNIQUE?

    GELNIQUE is a clear and colorless topical gel approved for the treatment of overactive bladder 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 control urination (passing water). Overactive bladder can make you urinate more often (increased frequency) or make you feel the need to urinate suddenly (urgency). Overactive bladder can also lead to accidental urine loss (leaking or wetting oneself).

    The active ingredient in GELNIQUE, oxybutynin, is formulated into a topical gel for daily application. GELNIQUE delivers the medicine slowly and constantly through your skin and into your bloodstream for 24 hours. GELNIQUE contains the same active ingredient as oxybutynin tablets, patches and syrup.

    Who should not use GELNIQUE?

    Do not use GELNIQUE if you have the following medical conditions:

    • Urinary retention. Your bladder does not empty or does not empty completely when you urinate.

    • Gastric retention. Your stomach empties slowly or incompletely after a meal.

    • Uncontrolled narrow-angle glaucoma (high pressure in your eye). Tell your doctor if you have glaucoma or a family history of glaucoma.

    • Allergy to oxybutynin or the inactive ingredients in GELNIQUE. If you need to know the inactive ingredients, ask your doctor or pharmacist. If you have allergies to topical medical products, tell your doctor.

    If you have certain other medical conditions, use GELNIQUE with caution. Tell your doctor about all your medical conditions, especially if you have any of the following:

    • Pregnancy or breastfeeding

    • Liver disease

    • Kidney disease

    • Difficulty in emptying bladder completely

    • Constipation or difficulty in emptying bowels

    • Ulcerative colitis (inflamed bowels)

    • Gastric reflux disease or esophagitis (inflamed esophagus, the tube between your mouth and stomach)

    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and supplements. Some of them may cause problems if you administer GELNIQUE. Also, GELNIQUE may affect how some medicines are absorbed from the stomach.

    What should I avoid while using GELNIQUE?

    Do not apply GELNIQUE to areas of the skin that have been treated with oils, lotions, or powders as that could affect the amount of oxybutynin absorbed through the skin. However, GELNIQUE may be used with sunscreen.

    GELNIQUE is a gel which contains alcohol. Gels with alcohol are flammable. Avoid fire, flame or smoking until the gel has dried.

    What are the possible side effects of GELNIQUE?

    You may have skin changes at the site of application, such as itching, rash, or redness. If uncomfortable irritation or excessive itchiness continues, tell your doctor.

    Oxybutynin may cause sleepiness or blurred vision, so be careful when driving or operating machinery. Drinking alcoholic beverages may increase these effects.

    Since oxybutynin treatment may decrease sweating, you may overheat or have fever or heat stroke if you are in warm or hot temperatures.

    The most common side effect of GELNIQUE is dry mouth. Other possible side effects include application site skin changes (such as itching, rash, or redness), headache, constipation, and dizziness. If you take other medicines that cause dry mouth, constipation, or sleepiness, GELNIQUE can increase those effects.

    Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GELNIQUE. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    How should I use GELNIQUE?

    GELNIQUE is for application to the skin only. GELNIQUE SHOULD NOT BE TAKEN BY MOUTH.

    Important: Avoid contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not approved for the application of GELNIQUE.

    • Step 1. The approved application sites for GELNIQUE are the shaded areas shown in Figure A. These are the abdomen (stomach area), upper arms/shoulder, and thigh.Select an approved site for the application of GELNIQUE.Changing the approved application sites with each dose is recommended and may help you to find the most comfortable areas for applying GELNIQUE.The approved application sites are shown below. Do not apply GELNIQUE in an area that is not approved.Figure A:

    • Step 2. Wash your hands with soap and water before applying GELNIQUE.

    • Step 3. Wash the area where GELNIQUE will be applied with mild soap and water. Allow the area to dry completely.

    • Step 4. Tear the packet of GELNIQUE open at the indentation just before use. See Figure B.Figure B:Squeeze the entire contents of the packet into the palm of your hand or squeeze directly onto the application site. See Figure C.Squeeze from the bottom of the packet toward the open end. Repeat until the packet is empty. The amount of gel in each packet will be about the size of a nickel on your skin.Figure C:

    • Step 5. Gently rub GELNIQUE into your skin until it dries. Do not continue rubbing after GELNIQUE has dried. If applying GELNIQUE to the stomach, care should be taken to avoid the area around the navel (belly-button). See Figure D.Figure D:

    • Step 6. Carefully throw away the open packet of GELNIQUE so that children and pets are not exposed to it.

    • Step 7. After applying GELNIQUE, immediately wash your hands thoroughly with soap and water. Avoid bathing, swimming, showering, exercising or immersing the application site in water for one hour after application.The application site may be covered with clothing once GELNIQUE has dried.

    What should I do if someone else is exposed to GELNIQUE?

    If someone else is exposed to GELNIQUE by direct contact with the gel or at the application site of GELNIQUE, that person should wash the area of contact with soap and water as soon as possible.

    What should I do if I get GELNIQUE in my eyes?

    If you get GELNIQUE in your eyes, rinse your eyes right away with warm, clean water to flush out any GELNIQUE. Seek medical attention if needed.

    General advice about GELNIQUE

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not give GELNIQUE to other people, even if they have the same symptoms you have. It may harm them.

    This leaflet summarizes the most important information about GELNIQUE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about GELNIQUE that is written for health professionals. You can get more information about GELNIQUE from the product information department at 1-800-272-5525 or by selecting patient information at the GELNIQUE Website located at www.GELNIQUE.com.

    Store at room temperature, 25°C (77°F). Temporary storage between 15 - 30°C (59 - 86°F) is also permitted. Keep GELNIQUE and all medications in a safe, secure place and out of the reach of children.

    Address medical inquiries to:Watson Pharma, Inc.Medical CommunicationsP. O. Box 1953Morristown, NJ 07962-1953800-272-5525

    Watson Pharmaceuticals, Inc.Corona, CA 92880 USA

    ©2008 Watson Pharmaceuticals, Inc., Corona, CA 92880

  • Drug Information Provided by National Library of Medicine (NLM).