OXYBUTYNIN CHLORIDE tablet extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

INN (Nome Internazionale):

OXYBUTYNIN CHLORIDE

Composizione:

OXYBUTYNIN CHLORIDE 10 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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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 (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, 10 mg and 15 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 patient