OxyContin
OXYCONTIN- oxycodone hydrochloride tablet, film coated, extended release
Purdue Pharma LP
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN
Addiction, Abuse, and Misuse
Because the use of OXYCONTIN exposes patients and other users to
the risks of opioid addiction, abuse, and misuse, which can lead to
overdose and death, assess each patient’s risk prior to prescribing
and reassess all patients regularly for the development of these behaviors
and conditions [see Warnings and Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory
depression may occur with use of OXYCONTIN, especially during initiation
or following a dosage increase. To reduce the risk of respiratory
depression, proper dosing and titration of OXYCONTIN are essential.
Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing,
or dissolving OXYCONTIN tablets can cause rapid release and absorption
of a potentially fatal dose of oxycodone [see Warnings and
Precautions (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of
OXYCONTIN, especially by children, can result in a fatal overdose
of oxycodone [see Warnings and Precautions (5.2)].
Risks From Concomitant Use With Benzodiazepines
Or Other CNS Depressants
Concomitant
use of opioids with benzodiazepines or other central nervous system
(CNS) depressants, including alcohol, may result in profound sedation,
respiratory depression, coma, and death. Reserve concomitant prescribing
of OXYCONTIN and benzodiazepines or other CNS depressants for use
in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].
Neonatal
Opioid Withdrawal Syndrome (NOWS)
If opioid use is required for an extended period of time in a pregnant
woman, advise the patient of the risk of NOWS, which may be life-threatening
if not recognized and treated. Ensure that management by neonatology
experts will be available at delivery [see Warnings and Precautions
(5.4)].
Opioid Analgesic Risk Evaluation and Mitigation
Strategy (REMS)
Healthcare providers
are strongly encouraged to complete a REMS-compliant education program
and to counsel patients and caregivers on serious risks, safe use,
and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)].
Cytochrome
P450 3A4 Interaction
The concomitant
use of OXYCONTIN with all cytochrome P450 3A4 inhibitors may result
in an increase in oxycodone plasma concentrations, which could increase
or prolong adverse drug effects and may cause potentially fatal respiratory
depression. In addition, discontinuation of a concomitantly used cytochrome
P450 3A4 inducer may result in an increase in oxycodone plasma concentration.
Regularly evaluate patients receiving OXYCONTIN and any CYP3A4 inhibitor
or inducer [see Warnings and Precautions (5.6), Drug Interactions (7), Clinical Pharmacology (12.3)].
1 INDICATIONS AND USAGE
OXYCONTIN is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate in:
- Adults; and
- Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
- Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)] , reserve OXYCONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- OXYCONTIN is not indicated as an as-needed (prn) analgesic.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
- OXYCONTIN should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks.
- OXYCONTIN 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Adult patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of OXYCONTIN for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
- Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with OXYCONTIN. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5.2)].
- Instruct patients to swallow OXYCONTIN tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see Warnings and Precautions (5.12)]. Cutting, breaking, crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].
- OXYCONTIN is administered orally every 12 hours.
2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with OXYCONTIN [see Warnings and Precautions (5.2)].
Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see Warnings and Precautions (5.1, 5.2, 5.3)].
Consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.
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