Cholinergic Muscarinic Antagonist

Oxytrol

Approved 26 Feb 2003TransdermalFilm, extended release

Indications

OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 )

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, or to any of the components of OXYTROL [ see Warnings and Precautions (5.5) ] . Urinary retention ( 4 ) Gastric retention ( 4 ) Uncontrolled narrow-angle glaucoma ( 4 ) Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL ( 4 )

Warnings and precautions

Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1 ) Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis.

( 5.2 ) Central Nervous System Effects: Somnolence has been reported with products containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. ( 5.3 ) Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue OXYTROL and initiate appropriate therapy. ( 5.4 ) Skin Hypersensitivity: Discontinue OXYTROL in patients with skin hypersensitivity.

( 5.5 ) Myasthenia gravis: Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ( 5.6 )

5.1Urinary Retention Administer

Indications

Contraindications

Warnings and precautions

( 5.5 ) Myasthenia gravis: Avoid use in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ( 5.6 )

5.1Urinary Retention Administer

Adverse reactions

The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-678-1605 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 drug and may not reflect the rates observed in clinical practice. The safety of OXYTROL was evaluated in a total of 417 patients who participated in two clinical efficacy and safety studies and an open-label extension.

Additional safety information was collected in earlier phase trials. In the two pivotal studies, a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively. No deaths were reported during treatment. No serious adverse events related to treatment were reported.

Adverse reactions reported in the pivotal trials are summarized in Tables 1 and 2 below. Table 1: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 1). Adverse Reaction Placebo (N = 132) OXYTROL (3.9 mg/day) (N = 125) N % N % Application site pruritus 8 6.1% 21 16.8% Dry mouth 11 8.3% 12 9.6% Application site erythema 3 2.3% 7 5.6% Application site vesicles 0 0.0% 4 3.2% Diarrhea 3 2.3% 4 3.2% Dysuria 0 0.0% 3 2.4% Table 2: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 2).

Adverse Reaction Placebo (N = 117) OXYTROL (3.9 mg/day) (N = 121) N % N % Application site pruritus 5 4.3% 17 14.0% Application site erythema 2 1.7% 10 8.3% Dry mouth 2 1.7% 5 4.1% Constipation 0 0.0% 4 3.3% Application site rash 1 0.9% 4 3.3% Application site macules 0 0.0% 3 2.5% Abnormal vision 0 0.0% 3 2.5% Most adverse reactions were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2.

Adverse reactions that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these discontinuations were due to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth. In the open-label extension, the most common treatment-related adverse reactions were: application site pruritus, application site erythema, and dry mouth.

6.2Postmarketing 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 to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous System Disorders: Memory impairment, dizziness, somnolence, confusion Psychiatric Disorders: Delirium, hallucinations

Oxytrol

Indications

Contraindications

Warnings and precautions

5.1Urinary Retention Administer

Two medicines in one question?

Oxytrol

Indications

Contraindications

Warnings and precautions

5.1Urinary Retention Administer

Two medicines in one question?

5.2Risks in Patients with Gastrointestinal Disorders Administer

5.3Central Nervous System Effects

5.4Angioedema

5.5Skin Hypersensitivity

5.6Exacerbation of Symptoms of Myasthenia Gravis

Interactions

7.1Other Anticholinergics

7.2Cytochrome P450 Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information

At a glance