Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store oxymorphone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions (5.1, 5.3), Drug Abuse and Dependence (9.2)]. Inform patients that leaving oxymorphone hydrochloride tablets unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused oxymorphone hydrochloride tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse
Inform patients that the use of oxymorphone hydrochloride tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share oxymorphone hydrochloride tablets with others and to take steps to protect oxymorphone hydrochloride tablets from theft or misuse.
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxymorphone hydrochloride tablets or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.3)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3)].
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if oxymorphone hydrochloride tablet is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.5), Drug Interactions (7)].
Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions
Inform patients that anaphylaxis, angioedema, and other hypersensitivity reactions have been reported with ingredients contained in oxymorphone hydrochloride tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Warnings and Precautions (5.7), Adverse Reactions (6)].
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications. [see Drug Interactions (7)]
Inform patients to avoid taking oxymorphone hydrochloride tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking oxymorphone hydrochloride tablets [see Drug Interactions (7)].
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.8)].
Important Administration Instructions
Instruct patients how to properly take oxymorphone hydrochloride tablets exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression).
- Advise patients not to adjust the dose of oxymorphone hydrochloride tablets without consulting with a physician or other healthcare professional.
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue oxymorphone hydrochloride tablets without first discussing a tapering plan with the prescriber [see Dosage and Administration (2.8)].
Inform patients that oxymorphone hydrochloride tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.9)].
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of oxymorphone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].
Inform female patients of reproductive potential that oxymorphone hydrochloride tablets can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1), Warnings and Precautions (5.4)].
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see Use in Specific Populations (8.2)].
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2)].
Driving or Operating Heavy Machinery
Inform patients that oxymorphone hydrochloride tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.14)].
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6)].
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854