Source: FDA, National Drug Code (US) Revision Year: 2017
OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39 cm² system containing 36 mg of oxybutynin. OXYTROL has a nominal in vivo delivery rate of 3.9 mg oxybutynin per day through skin of average permeability (inter-individual variation in skin permeability is approximately 20%).
Oxybutynin is an antispasmodic, anticholinergic agent. Oxybutynin is administered as a racemate of R- and S-isomers. Chemically, oxybutynin is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate. The empirical formula of oxybutynin is C22H31NO3.
Its structural formula is:
Oxybutynin is a white powder with a molecular weight of 357. It is soluble in alcohol, but relatively insoluble in water.
OXYTROL is a matrix-type transdermal system composed of three layers as illustrated in Figure 1. Layer 1 (Backing Film) is a thin flexible polyester/ethylene-vinyl acetate film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 (Adhesive/Drug Layer) is a cast film of acrylic adhesive containing oxybutynin and triacetin, USP. Layer 3 (Release Liner) is two overlapped siliconized polyester strips that are peeled off and discarded by the patient prior to applying the matrix system.
Figure 1. Side and top views of the OXYTROL system (Not to scale):
| Dosage Forms and Strengths |
|---|
|
Transdermal System: 3.9 mg/day. |
| How Supplied |
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Unit Dose: Heat sealed pouch containing 1 OXYTROL (oxybutynin transdermal system). Each 39 cm² system imprinted with “OXYTROL 3.9 mg/day” contains 36 mg of oxybutynin for nominal delivery of 3.9 mg oxybutynin per day when dosed in a twice weekly regimen. NDC 0023-6153-08 Patient Calendar Box of 8 Systems Distributed By: Allergan USA, Inc., Irvine, CA 92612 |
| Drug | Countries | |
|---|---|---|
| OXYTROL | Australia, Canada, New Zealand, United States |
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