FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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)].
History
There is currently no drug history available for this drug.
Other Information
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.
The empirical formula of oxybutynin base is C22H31NO3. Its structural formula is:
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.
Sources
Pre Post 5000 Manufacturers
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Universal
Pre Post 5000 | Actavis Pharma, Inc.
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)].
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