OXYTROL Transdermal system (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Allergan, Inc.

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1. Indications and Usage

OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.

2. Dosage and Administration

OXYTROL 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days). A new application site should be selected with each new system to avoid re-application ...

3. Dosage Forms and Strengths

Transdermal System: 3.9 mg/day.

4. Contraindications

The use of OXYTROL is contraindicated in the following conditions: Urinary retention Gastric retention Uncontrolled narrow-angle glaucoma Known serious hypersensitivity reaction to OXYTROL, oxybutynin, ...

5. Warnings and Precautions

5.1 Urinary Retention Administer OXYTROL with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention <em>[see Contraindications (4)]</em>. ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of OXYTROL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

No specific drug-drug interaction studies have been performed with OXYTROL. 7.1 Other Anticholinergics The concomitant use of OXYTROL with other anticholinergic drugs, or with other agents that produce ...

8.1. Pregnancy

Risk Summary There are no studies with topical or oral oxybutynin use in pregnant women to inform a drug associated risk for birth defects or miscarriage. No adverse developmental outcomes were observed ...

8.2. Lactation

Risk Summary There is no information on the presence of oxybutynin in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding ...

8.4. Pediatric Use

The safety and efficacy of OXYTROL in pediatric patients have not been established.

8.5. Geriatric Use

Forty-nine percent of OXYTROL-treated patients in the clinical studies were at least 65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger ...

10. Overdosage

The plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s). Patients should be monitored until symptoms resolve. Overdosage with oxybutynin has been associated ...

11. Description

OXYTROL (oxybutynin transdermal system) is designed to deliver oxybutynin over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39 cm² system containing 36 mg of oxybutynin. ...

12.1. Mechanism of Action

The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting ...

12.3. Pharmacokinetics

Absorption Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum. The average daily dose of oxybutynin absorbed from the 39 cm² ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at dosages of oxybutynin chloride of 20, 80 and 160 mg/kg showed no evidence of carcinogenicity. These doses are approximately 6, 25 and 50 times the maximum exposure in humans ...

14. Clinical Studies

The efficacy and safety of OXYTROL were evaluated in patients with urge urinary incontinence in two controlled studies and one open-label extension. Study 1 was a placebo controlled study, comparing the ...

16.1. How Supplied

<u>Unit Dose:</u> Heat sealed pouch containing 1 OXYTROL (oxybutynin transdermal system). Each 39 cm² system imprinted with OXYTROL 3.9 mg/day contains 36 mg of oxybutynin for nominal delivery of 3.9 mg ...

16.2. Storage and Handling

Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from moisture and humidity. Do not store outside the sealed pouch. Apply immediately after removal from the protective pouch. ...

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use) Instructions for Use Inform patients that OXYTROL should be applied to dry, intact skin on the abdomen, hip, or buttock ...