OXYBUTYNIN CHLORIDE tablet, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Advagen Pharma Limited

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-asso

उत्पाद समीक्षा:

Oxybutynin chloride extended-release tablets, USP are available in three dosage strengths, 5 mg (light pink to pink), 10 mg (light pink to pink) and 15 mg (white to off-white) and imprinted on one side with ‘Λ13’ or ‘Λ14’ or ‘Λ15’ with black ink respectively. Oxybutynin chloride extended-release tablets, USP are supplied in bottles as: 5 mg          100 count bottle                  NDC 72888-030-01 10 mg        100 count bottle                  NDC 72888-031-01 15 mg        100 count bottle                  NDC 72888-032-01 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
ADVAGEN PHARMA LIMITED
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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: CNS e