OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Patriot Pharmaceuticals, LLC

INN (Alþjóðlegt nafn):

oxybutynin chloride

Samsetning:

oxybutynin chloride 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Oxybutynin Chloride is 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. Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin Chloride Extended Release Tablets in pregnant wom

Vörulýsing:

Oxybutynin Chloride 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. Oxybutynin Chloride 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.

Leyfisstaða:

New Drug Application

Vara einkenni

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
PATRIOT PHARMACEUTICALS, LLC
----------
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 (OXYBUTYNIN CHLORIDE) FOR
ORAL USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Oxybutynin Chloride is 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)
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)
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 oxybutynin chloride or any component of
Oxybutynin Chloride Extended Release Tablets
(4)
WARNINGS AND PRECAUTIONS
Angioedema: Angioedema has been reported with oxybutynin. If symptoms
of angioedema occur, discontinue
Oxybutynin Chloride Extended Release Tablets immediately and initiate
appropriate therapy. (5.1)
Central Nervous System (CNS) effects: CNS effects have been reported
with oxybutynin. If patien