OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

OXYBUTYNIN CHLORIDE

Composition:

OXYBUTYNIN CHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 extended-release tablets are 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. There are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant

Product summary:

Oxybutynin Chloride Extended-Release Tablets, USP are available containing 5 mg, 10 mg or 15 mg of oxybutynin chloride, USP. The 5 mg tablets are light green, film-coated, round, unscored tablets with M over O 5 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6605-01 bottles of 100 tablets NDC 0378-6605-05 bottles of 500 tablets The 10 mg tablets are peach, film-coated, round, unscored tablets with M over O 10 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6610-01 bottles of 100 tablets NDC 0378-6610-05 bottles of 500 tablets The 15 mg tablets are white, film-coated, round, unscored tablets with M over O 15 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6615-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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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
The most common (incidence ≥ 5%) adverse reactions were dry mouth,
constipation, diarrhea, headache, somnolence, and
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 extended-release
tablets, oxybutynin or any component of
oxybutynin chloride extended-release tablets. (4)
Angioedema: Angioedema has been reported wit