OXYBUTYNIN CHLORIDE tablet, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)

Boleh didapati daripada:

Major Pharmaceuticals

INN (Nama Antarabangsa):

OXYBUTYNIN CHLORIDE

Komposisi:

OXYBUTYNIN CHLORIDE 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are 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). Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are 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. Pregnancy Category B. There are no adequate and well-controlled studies using oxybutynin chloride in pregnant women. Oxybutynin chloride s

Ringkasan produk:

Oxybutynin chloride extended-release tablets USP, 5 mg are supplied as purple, round, biconvex, coated tablets debossed with “A31” on one side and plain on the other side. They are available as follows: Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6570-04 Carton of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6570-06 Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6570-61 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity. Keep out of the reach of children.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYBUTYNIN CHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS.
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
Oxybutynin chloride extended-release tablets must be swallowed whole
with the aid of liquids, and must
not be chewed, divided, or crushed. Oxybutynin chloride
extended-release tablets may be administered
with or without food. (2)
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DOSAGE FORMS AND STRENGTHS
Extended-release tablets 5 mg, 10 mg and 15 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Oxybutynin chloride extended-release tablets are a muscarinic
antagonist indicated for the treatment
of overactive bladder with symptoms of urge urinary incontinence,
urgency, and frequency. (1)
Oxybutynin chloride extended-release tablets are 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)
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)
Urinary retention (4)
Gastric retention (4)
Uncontrolled narrow angle glaucoma (4)
Known hypersensitivity to oxybutynin chloride, oxybutynin or any
component of oxybutynin chloride
extended-release tablets. (4)
Angioedema: Angioedema has been reported with oxybutynin. If symptoms
of angioedema occur,
discontinue oxybutynin chloride immediately and initiate appropriate
therapy. (5.1)
Central Nervous System (CNS) effe