Patients and Caregivers

Medicines From Purdue

Purdue is a pioneer in healthcare, with a patient-first approach in developing medicines. We combine medical science with compassionate care in every phase of drug research and manufacturing.

For each prescription medication listed below, you can readily access the MEDICATION GUIDE and FULL PRESCRIBING INFORMATION when you click on the links below the product name.

Information About Safe Disposal of Opioids

Public Health Initiative Products

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Zurnai (nalmefene injection)

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Prescription Opioids

Prescription opioid medicines are controlled substances. It is VERY IMPORTANT to read the Medication Guide that comes with your prescription medicine.

What is the Medication Guide?

  • The Medication Guide is an FDA-approved document written in non-medical language so that the general public can more easily understand the information and the important warnings
  • The Medication Guide is a 1-page, 1-sided document that explains how to safely use, store, and dispose of your used or unused prescription medicine
  • The Medication Guide will include important information specific to the medicine you were prescribed
  • This document is given to you when you receive your prescription from the pharmacy
  • Your healthcare team (your doctor, nurse, physician assistant, and/or pharmacist) needs you to follow all of the instructions in the Medication Guide. Staying informed about your medicine can help with a treatment plan that’s appropriate for you

Where can I find the Medication Guide for my Purdue medicine?

Click on the Medication Guide links under the prescription medications below. You can also ask your pharmacist, doctor, nurse, or physician assistant for the Medication Guide. If you have any questions about your prescription or the Medication Guide, ask your healthcare provider.

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Butrans® (buprenorphine) Transdermal System CIII

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTRANS

Addiction, Abuse, and Misuse
Because the use of BUTRANS 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 BUTRANS, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of BUTRANS are essential. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

Accidental Exposure
Accidental exposure of even one dose of BUTRANS, especially in children, can result in a fatal overdose of buprenorphine [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 BUTRANS 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)].

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Hysingla® ER (hydrocodone bitartrate) extended-release tablets CII

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYSINGLA ER

Addiction, Abuse, and Misuse
Because the use of HYSINGLA ER 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 HYSINGLA ER, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of HYSINGLA ER are essential. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)].

Accidental Ingestion
Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [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 HYSINGLA ER 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 HYSINGLA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Regularly evaluate patients receiving HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6), Drug Interactions (7), and Clinical Pharmacology (12.3)].

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OxyContin® (oxycodone HCl) extended-release tablets CII

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)].

How to Report a Side Effect

If you or someone you know has a side effect from a Purdue medicine, you can report it to Purdue or the FDA.

Responsible Use of Opioids

The pain medications from Purdue are prescription opioids (narcotic drugs, such as oxycodone or morphine). There are many ways you can help to improve the responsible use of opioids and reduce prescription drug abuse.

To Ask a Question

If you have a question about a Purdue product and would like to speak with a Medical Information professional, please call 888‑726‑7535 and select option 1.

To Report a Product Quality Complaint

If you have a question about a Purdue product and would like to speak with a Medical Information professional, please call 888‑726‑7535 and select option 3.

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