OXYBUTYNIN CHLORIDE tablet, film coated, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Oxybutynin Chloride (UNII: L9F3D9RENQ) (Oxybutynin - UNII:K9P6MC7092)

זמין מ:

Aphena Pharma Solutions - Tennessee, Inc.

INN (שם בינלאומי):

Oxybutynin Chloride

הרכב:

Oxybutynin Chloride 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oxybutynin chloride extended-release tablets are a once-daily extended-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are 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). Oxybutynin chloride extended-release tablets are 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. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

leaflet_short:

Oxybutynin Chloride Extended-Release Tablets USP 5 mg are round, biconvex, white coated tablets imprinted in black ink with 270 on one side and K and U on the other side. They are supplied as follows: Oxybutynin Chloride Extended-Release Tablets USP 10 mg are round, biconvex, white coated tablets imprinted in black ink with 271 on one side and K and U on the other side. They are supplied as follows: Oxybutynin Chloride Extended-Release Tablets USP 15 mg are round, biconvex, white coated tablets imprinted in black ink with 272 on one side and K and U on the other side. They are supplied as follows: 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
OXYBUTYNIN CHLORIDE
EXTENDED-RELEASE TABLETS USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Oxybutynin chloride extended-release tablets are an antispasmodic,
anticholinergic agent. Each
Oxybutynin chloride extended-release tablet contains 5 mg, 10 mg, or
15 mg of oxybutynin chloride
USP, formulated as a once-a-day extended-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.
Oxybutynin chloride extended-release tablets also contain the
following inert ingredients: anhydrous
lactose, lactose monohydrate, mannitol, anhydrous dextrose, tartaric
acid, colloidal silicon dioxide,
magnesium stearate, cellulose acetate, polyethylene glycol, titanium
dioxide, triacetin, black iron oxide,
propylene glycol, hypromellose.
SYSTEM COMPONENTS AND PERFORMANCE
Oxybutynin chloride extended-release tablets 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 core surrounded by a
semipermeable membrane. The
unitary tablet core is composed of the drug and excipients (including
the osmotically active
components). There is a precision-laser drilled orifice in the
semipermeable membrane on the 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 osmotic components to
expand. This expansion pushes the drug