Adult Dosing

Treatment of overactive bladder

• 1 g once daily applied to dry, intact skin on the abdomen, upper arms/shoulders, or thighs

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

• Hypersensitivity to any of the ingredients of the product
• Urinary retention
• Gastric retention
• Uncontrolled narrow-angle glaucoma

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Discontinue therapy in patients with skin hypersensitivity
• Bladder outflow obstruction because of the risk of urinary retention
• Gastrointestinal obstructive disorders because of the risk of gastric retention

Caution: Use cautiously in:

• Renal impairment
• Hepatic impairment
• Ulcerative colitis
• Intestinal atony
• Gastroesophageal reflux
• Cardiovascular disease
• Prostatic hypertrophy
• Concomitant use with drugs such as bisphosphonates that causes or exacerbates esophagitis
• Concomitant use with other anticholinergic agents
• Myasthenia gravis
• High environmental temperature
• Autonomic neuropathy
• Hypertension
• Hyperthyroidism
• Geriatric patients

Supplemental Patient Information

• Advise patients to cover the application site with clothing to avoid skin-to-skin contact and wash hands immediately after product application
• Advise patients to avoid opening the gel near fire or smoking until the gel has dried
• Advise patients that this product is only for topical application and should not be ingested
• Avoid applying to recently shaved skin surfaces
• Avoid showering or water immersion for 1 hour after topical application
• Advise patients to avoid engaging in potentially dangerous tasks until the product’s effects are determined
• Advise patients to abstain from alcohol during therapy

Gelnique interacts with :

	Aricept
	Aricept ODT
	Donepezil
	Exelon
	Galantamine
	Razadyne
	Razadyne ER
	Rivastigmine

Pregnancy Category:B

Breastfeeding: Safety unknown; Literature unavailable on the use of oxybutynin during breastfeeding. Prolonged use of oxybutynin reduces milk production or milk letdown, but a single dose is unlikely to interfere with breastfeeding. During prolonged use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2010). Unknown whether excreted in human milk. Manufacturer advises caution.

• DERM: Decreased sweating, application site reaction such as pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain
• GI: Dry mouth, constipation, gastroenteritis
• CNS: Dizziness, headache
• GU: UTI
• EENT: Blurred vision
• RESP: URI, nasopharyngitis,
• MISC: Heat prostration, fatigue

• Anticholinergic; competitively antagonizes acetylcholine at postganglionic muscarinic receptors resulting in relaxation of bladder smooth muscle, increases maximum urinary bladder capacity and increases the volume to first detrusor contraction and delays initial desire to void
• Transported across intact skin into the systemic circulation by passive diffusion across the stratum corneum
• Extensively metabolized by liver; CYP450: 3A4 substrate
• Renally excreted: <0.1% (unchanged), <0.1% (metabolite)
• Half-life: 2 hrs

US Trade Name(s)

• Gelnique

US Availability

Gelnique

• GEL: 10%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Urologic

Antispasmodics; Urinary

Obstetrics/Gynecology

Antispasmodics; Urinary

Pricing data from www.DrugStore.com in U.S.A.

• Gelnique 10 % GEL [Box] (WATSON LABS)
  30 % = $175.52
  90 % = $500.23

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.