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:

Janssen Pharmaceuticals, 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 muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DITROPAN XL ® is also indicated for 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 ® is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. DITROPAN XL ® is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. Risk Summary There are no adequate data on DITROPAN XL ® use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscar

Product summary:

DITROPAN XL ® extended-release tablets are available in two dosage strengths, 5 mg (pale yellow) and 10 mg (pink) and are imprinted on one side with "5 XL" or "10 XL" with black ink. DITROPAN XL ® extended-release tablets are supplied in bottles of 100 tablets. Storage 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. Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

DITROPAN XL- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DITROPAN XL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DITROPAN XL
.
DITROPAN XL (OXYBUTYNIN CHLORIDE) EXTENDED RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
DITROPAN XL
(oxybutynin chloride) is a muscarinic antagonist indicated for the
treatment of
overactive bladder with symptoms of urge urinary incontinence,
urgency, and frequency. ( 1)
DITROPAN XL
is also indicated for the treatment of pediatric patients aged 6 years
and older with
symptoms of detrusor overactivity associated with a neurological
condition (e.g., spina bifida). ( 1)
DOSAGE AND ADMINISTRATION
DITROPAN XL
must be swallowed whole with the aid of liquids, and must not be
chewed, divided, or
crushed. DITROPAN XL
may be administered with or without food. ( 2)
ADULTS: Start with 5 mg or 10 mg, once daily at approximately the same
time every day. Dose should
not exceed 30 mg per day. ( 2.1)
PEDIATRIC PATIENTS (6 YEARS OF AGE OR OLDER): Start with 5 mg, once
daily at approximately the
same time every day. Dose should not exceed 20 mg per day. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Extended release tablets 5 mg and 10 mg ( 3)
CONTRAINDICATIONS
Urinary retention ( 4)
Gastric Retention ( 4)
Uncontrolled narrow angle glaucoma ( 4)
Known hypersensitivity to DITROPAN XL
, oxybutynin or any component of DITROPAN XL
( 4)
WARNINGS AND PRECAUTIONS
Angioedema: Angioedema has been reported with oxybutynin. If symptoms
of angioedema occur,
discontinue DITROPAN XL
immediately and initiate appropriate therapy. ( 5.1)
Central Nervous System (CNS) effects: CNS effects have been reported
with oxybutynin. If patient
experiences anticholinergic CNS effects, consider dose adjustment or
discontinuation of DITROPAN XL
. ( 5.2)
Use with caution due to aggravation of symptoms:
Pre-existing dementia in patients treated with cholinest