OXYBUTYNIN CHLORIDE EXTENDED RELEASE- oxybutynin chloride tablet, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

AvPAK

INN (nume internaţional):

OXYBUTYNIN CHLORIDE

Compoziție:

OXYBUTYNIN CHLORIDE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 angiodema. Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-releas

Rezumat produs:

Oxybutynin chloride extended-release tablets 5 mg are round, biconvex, white coated tablets imprinted in black ink with "270" on one side and "KU" on the other side. They are supplied as follows: NDC 50268-627-15 (10 Tablets per card, 5 cards per carton) Oxybutynin chloride extended-release tablets 10 mg are round, biconvex, white coated tablets imprinted in black ink with "271" on one side and "KU" on the other side. They are supplied as follows: NDC 50268-628-15 (10 Tablets per card, 5 cards per carton) Oxybutynin chloride extended-release tablets 15 mg are round, biconvex, white coated tablets imprinted in black ink with "272" on one side and "KU" on the other side. They are supplied as follows: NDC 50268-629-13 (10 Tablets per card, 3 cards per carton) Dispensed in Unit Dose package. For Institutional Use Only. 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

OXYBUTYNIN CHLORIDE EXTENDED RELEASE- OXYBUTYNIN CHLORIDE TABLET,
EXTENDED RELEASE
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS USP
RX ONLY
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