struct patients to swallow OPANA ER tablets intact. (2.4)
Do not abruptly discontinue OPANA ER in a physically dependent patient. (2.3, 5.13)
Reduce the dose of OPANA ER in patients with mild hepatic impairment and patients with renal impairment. (2.5, 2.6)
OPANA ER tablets should be taken one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. (2.1, 17)
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
CONTRAINDICATIONS
Significant respiratory depression (4)
Acute or severe bronchial asthma (4)
Known or suspected paralytic ileus (4)
Hypersensitivity to oxymorphone (4)
Moderate or severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
See Boxed WARNINGS
Elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease: Monitor closely because of increased risk of respiratory depression. (5.5, 5.6)
Interaction with CNS depressants: Consider dose reduction of one or both drugs because of additive effects. (5.7, 7.2)
Hypotensive effect: Monitor during dose initiation and titration. (5.9)
Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid use of OPANA ER in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention. (5.10)
Respiratory depression: Increased risk in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve. (5.2)
ADVERSE REACTIONS
Adverse reactions in ≥2% of patients in placebo-controlled trials: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals Inc. at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CNS depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS depressant is contemplated, the dose of one or both agents should be reduced. (7.2)
Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms. (7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
Nursing mothers: Closely monitor infants of nursing women receiving
OPANA ER. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Initial Dosing
2.2 Titration and Maintenance of Therapy
2.3 Discontinuation of OPANA ER
2.4 Administration of OPANA ER
2.5 Patients with Hepatic Impairment
2.6 Patients with Renal Impairment
2.7 Geriatric Patients
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Abuse Potential
5.2 Life Threateni |
