OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

KAISER FOUNDATION HOSPITALS

INN (International Nazwa):

OXYBUTYNIN CHLORIDE

Skład:

OXYBUTYNIN CHLORIDE 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. Pregnancy Category B. There are no adequate and well-controlled studies using oxybutynin chloride extended-relea

Podsumowanie produktu:

Oxybutynin chloride extended-release tablets, 10 mg – Each light pink, film-coated, round convex tablet is debossed with "G 342" on one side and plain on the other side. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity. Dispense in a tightly-closed, light-resistant container (USP).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
KAISER FOUNDATION HOSPITALS
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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
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)
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 extended-release
tablets, oxybutynin 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: