Gelnique

DRUG DESCRIPTION

Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydro alcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE (oxybutynin chloride 10 % gel) is available in a 1 gram (1.14 mL) unit dose that contains 100 mg oxybutynin chloride. Oxybutynin is delivered as a racemate of R- and S-isomers. Chemically, oxybutynin chloride is d, 1 (racemic) 4-(Diethylamino)-2-butynyl (±)-a-phenylcyclohexaneglycolatehydrochloride.

The empirical formula of oxybutynin is C22H31NO3·HCl. Its structural formula is:

GELNIQUE</b><br />
  (oxybutynin chloride) Structural Formula Illustration

Oxybutynin chloride is a white powder with a molecular weight of 393.95.

Inactive ingredients in GELNIQUE (oxybutynin chloride 10 % gel) are alcohol, USP; glycerin, USP; hydroxypropyl cellulose, NF; sodium hydroxide, NF; and purified water, USP.

What are the possible side effects of oxybutynin topical (Gelnique)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin topical and call your doctor at once if you have any of these serious side effects:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain, burning, or other difficulty when urinating; or
  • severe itching, redness, pain, rash, or other irritation where the medication was applied.

Less serious...

Read All Potential Side Effects and See Pictures of Gelnique »

What are the precautions when taking oxybutynin chloride 10 % gel (Gelnique)?

Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chickenpox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...

Read All Potential Precautions of Gelnique »


Gelnique Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Your risk of infection may be higher while you are taking this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe muscle spasms, fast/irregular heartbeat, muscle weakness, confusion, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes, vision changes, swollen glands, unusual lumps, night sweats.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of chickenpox/shingles, uncontrolled high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney problems (for arthritis or psoriasis patients only).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, any recent/current infections, seizures, untreated mineral imbalance (e.g., low magnesium or high potassium), blood disorders, diabetes, a certain gut problem (malabsorption), high blood fats (cholesterol or triglycerides).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug may reduce the magnesium levels in your blood. Ask your doctor about adding magnesium to your diet. Your doctor may prescribe a magnesium supplement.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or nasal flu vaccine.

Avoid contact with people who have the flu or other contagious illness.

This drug may increase your risk for developing skin cancer. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may cause swelling and growth of the gums (gingival hyperplasia). Brush your teeth and floss daily to minimize this problem. See your dentist regularly.

The elderly may be at greater risk for the effects on blood pressure and kidneys while using this drug.

This medication should be used only when clearly needed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other more serious problems have also been reported, including death of the unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Gelnique Patient Information Including Side Effects

Brand Names: Gelnique

Generic Name: oxybutynin (topical) (Pronunciation: OX i BUE ti nin)

  • What is oxybutynin topical (Gelnique)?
  • What are the possible side effects of oxybutynin topical (Gelnique)?
  • What is the most important information I should know about oxybutynin topical (Gelnique)?
  • What should I discuss with my healthcare provider before using oxybutynin topical (Gelnique)?
  • How should I use oxybutynin topical (Gelnique)?
  • What happens if I miss a dose (Gelnique)?
  • What happens if I overdose (Gelnique)?
  • What should I avoid while using oxybutynin topical (Gelnique)?
  • What other drugs will affect oxybutynin topical (Gelnique)?
  • Where can I get more information?

What is oxybutynin topical (Gelnique)?

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

Oxybutynin topical (for the skin) is used to treat symptoms of overactive bladder, such as frequent or urgent urination and incontinence (urine leakage).

Oxybutynin topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of oxybutynin topical (Gelnique)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin topical and call your doctor at once if you have any of these serious side effects:

  • fever with hot, dry skin;
  • uneven heart rate;
  • pain, burning, or other difficulty when urinating; or
  • severe itching, redness, pain, rash, or other irritation where the medication was applied.

Less serious side effects may include:

  • mild skin irritation where the gel was applied;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • dizziness, drowsiness, tired feeling;
  • headache;
  • blurred vision;
  • dry mouth;
  • constipation;
  • stuffy nose, sore throat; or
  • nausea, vomiting, stomach cramps, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oxybutynin topical (Gelnique)?

Do not use this medication if you are allergic to oxybutynin, or if you have uncontrolled narrow-angle glaucoma, a blockage in your digestive tract, if you have decreased urination, or if you are unable to urinate.

Before using oxybutynin topical, tell your doctor if you have urination problems, glaucoma, liver or kidney disease, myasthenia gravis, severe constipation, ulcerative colitis or other intestinal disorder, gastroesophageal reflux disease (GERD), or slow digestion.

Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.

It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people.

Oxybutynin gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Oxybutynin can cause blurred vision, drowsiness, or dizziness. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol. It can increase some of the side effects of oxybutynin.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using oxybutynin topical.

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