DITROPAN XL- oxybutynin chloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

oxybutynin chloride (UNII: L9F3D9RENQ) (oxybutynin - UNII:K9P6MC7092)

Available from:

Physicians Total Care, Inc.

INN (International Name):

oxybutynin chloride

Composition:

oxybutynin chloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DITROPAN XL® (oxybutynin chloride) is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DITROPAN XL® is also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). DITROPAN XL® (oxybutynin chloride) is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. DITROPAN XL® is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

Product summary:

DITROPAN XL® (oxybutynin chloride) Extended Release Tablets are available in three dosage strengths, 10 mg (pink), and 15 mg (gray) and are imprinted with "10 XL", or "15 XL". DITROPAN XL® Extended Release Tablets are supplied in Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Authorization status:

New Drug Application

Summary of Product characteristics

DITROPAN XL- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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DITROPAN XL
(OXYBUTYNIN CHLORIDE)
EXTENDED RELEASE TABLETS
DESCRIPTION
DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic
agent. Each DITROPAN
XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of
oxybutynin chloride USP, formulated
as a once-a-day controlled-release tablet for oral administration.
Oxybutynin chloride is administered as
a racemate of R- and S-enantiomers.
Chemically, oxybutynin chloride is d,l (racemic)
4-diethylamino-2-butynyl phenylcyclohexylglycolate
hydrochloride. The empirical formula of oxybutynin chloride is C
H NO •HCl.
Its structural formula is:
Oxybutynin chloride is a white crystalline solid with a molecular
weight of 393.9. It is readily soluble
in water and acids, but relatively insoluble in alkalis.
DITROPAN XL also contains the following inert ingredients: cellulose
acetate, hypromellose,
lactose, magnesium stearate, polyethylene glycol, polyethylene oxide,
synthetic iron oxides, titanium
dioxide, polysorbate 80, sodium chloride, and butylated
hydroxytoluene.
SYSTEM COMPONENTS AND PERFORMANCE
DITROPAN XL uses osmotic pressure to deliver oxybutynin chloride at a
controlled rate over
approximately 24 hours. The system, which resembles a conventional
tablet in appearance, comprises an
osmotically active bilayer core surrounded by a semipermeable
membrane. The bilayer core is
composed of a drug layer containing the drug and excipients, and a
push layer containing osmotically
active components. There is a precision-laser drilled orifice in the
semipermeable membrane on the
drug-layer side of the tablet. In an aqueous environment, such as the
gastrointestinal tract, water
permeates through the membrane into the tablet core, causing the drug
to go into suspension and the
push layer to expand. This expansion pushes the suspended drug out
through the orifice. The
semipermeable membrane controls the rate at which water permeates into
the tablet core, which in turn
con