2  DOSAGE AND ADMINISTRATION
The contents of one sachet or one actuation of the metered-dose pump of GELNIQUE should be applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated. Application of GELNIQUE should not be made to the same site on consecutive days [see Clinical Pharmacology (12.3)].

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

3  DOSAGE FORMS AND STRENGTHS
Gel: 10%

4  CONTRAINDICATIONS
The use of GELNIQUE is contraindicated in the following conditions:

Urinary retention

Gastric retention

Uncontrolled narrow-angle glaucoma

 Known serious hypersensitivity reaction to GELNIQUE, oxybutynin, or to any of the components of GELNIQUE [see Warnings and Precautions (5.3, 5.4)].

5  WARNINGS AND PRECAUTIONS

5.1 Urinary Retention
Administer GELNIQUE with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

5.2 Use in Patients with Gastrointestinal Disorders
Administer GELNIQUE with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

GELNIQUE, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony. GELNIQUE should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

5.3 Angioedema
 Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, oxybutynin-containing product should be discontinued and appropriate therapy promptly provided.

5.4 Skin Hypersensitivity
In a controlled clinical trial of skin sensitization, 1 of 200 patients (0.5%) demonstrated skin hypersensitivity to GELNIQUE. Patients who develop skin hypersensitivity to GELNIQUE should discontinue drug treatment.

5.5 Skin Transference
Transfer of oxybutynin to another person can occur when vigorous skin-to-skin contact is made with the application site. To minimize the potential transfer of oxybutynin from GELNIQUE-treated skin to another person, patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see Clinical Pharmacology (12.3)]. Patients should wash their hands immediately after application of GELNIQUE.

5.6 Flammable Gel
GELNIQUE is an alcohol-based gel and is therefore flammable. Avoid open fire or smoking until gel has dried.

5.7 Myasthenia Gravis
Administer GELNIQUE with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.

6  ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

6.1 Clinical Studies Experience