GELNIQUE- oxybutynin gel
Watson Pharma, Inc.
1 INDICATIONS AND USAGE
GELNIQUE 3% (oxybutynin) gel 3% is a muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
The recommended dosage is three pumps of GELNIQUE 3% (84 mg/day) applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs. Apply immediately after actuating the dose. Application sites may be rotated to reduce the potential for local site reactions [see Adverse Reactions (6.1)]. GELNIQUE 3% is for topical application only and should not be ingested.
Wash hands immediately after product application. 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 Warnings and Precautions (5.3)].
3 DOSAGE FORMS AND STRENGTHS
GELNIQUE 3% is a homogeneous, colorless to slightly colored gel 3%.
DESCRIPTION
Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE 3% is a topical, homogeneous, very lightly to moderately opalescent, translucent colorless to slightly colored gel, without particles. The product is a hydroalcoholic gel containing 30 mg oxybutynin per gram of gel. GELNIQUE 3% is available in a 0.92 gram (1 mL) unit dose that contains 28 mg oxybutynin. Oxybutynin is delivered as a racemate of R- and S-isomers. Chemically, oxybutynin base is d, l (racemic) 4-(Diethylamino)-2-butynyl (�)-α-phenylcyclohexaneglycolate.
Oxybutynin is a white powder with a molecular weight of 357.
Inactive ingredients in GELNIQUE 3% are diethylene glycol monoethyl ether, NF; alcohol, USP; hydroxypropyl cellulose, NF; propylene glycol, NF; butylated hydroxytoluene, NF; HCl 0.1 M, NF; and purified water, USP.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Oxybutynin is a racemic (50:50) mixture of R- and S- isomers. Antimuscarinic activity resides predominantly with the R-isomer.
Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.