OXYBUTYNIN CHLORIDE EXTENDED RELEASE- oxybutynin chloride tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

McKesson Corporation dba SKY Packaging

INN (Mezinárodní Name):

OXYBUTYNIN CHLORIDE

Složení:

OXYBUTYNIN CHLORIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. Animal Data Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin chloride extended-release tablets are administered to a nursing woman. The safety and efficacy of Oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of Oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. Urodynamic results were consistent with clinical results. Administration of Oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O , and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%. The pharmacokinetics of Oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology ( 12.3)] . Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6. The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of Oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with renal impairment. There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with hepatic impairment.

Přehled produktů:

Oxybutynin chloride extended-release tablets, USP 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: Boxes of 3x10 UD 30, NDC 63739-548-33 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

OXYBUTYNIN CHLORIDE EXTENDED RELEASE- OXYBUTYNIN CHLORIDE TABLET,
EXTENDED RELEASE
MCKESSON CORPORATION DBA SKY PACKAGING
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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
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