ng Respiratory Depression
5.3 Accidental Exposure
5.4 Interaction with Alcohol
5.5 Elderly, Cachectic, and Debilitated Patients
5.6 Use in Patients with Chronic Pulmonary Disease
5.7 Interactions with CNS Depressants and Illicit Drugs
5.8 Use in Patients with Hepatic Impairment
5.9 Hypotensive Effect
5.10 Use in Patients with Head Injury or Increased Intracranial Pressure
5.11 Use in Patients with Gastrointestinal Conditions
5.12 Use in Patients with Convulsive or Seizure Disorders
5.13 Avoidance of Withdrawal
5.14 Driving and Operating Machinery
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 Alcohol
7.2 CNS Depressants
7.3 Mixed Agonist/Antagonist Opioid Analgesics
7.4 Cimetidine
7.5 Anticholinergics
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Neonatal Opioid Withdrawal Syndrome
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
Abuse Potential
OPANA ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA ER for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of OPANA ER, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and OPANA ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER t |
