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Boxed Warning

Levorphanol Tartrate Tablets 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 Levorphanol Tartrate Tablets, and monitor all patients regularly for the development of these behaviors and conditions Click Here for full Boxed Warning

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  4. A Sentynl Patient Services Representative will call you back within 24 hours.

October 2019: New safety information is provided in the revised Prescribing Information and Medication Guide.

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IMPORTANT SAFETY INFORMATION

Levorphanol Tartrate Tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine when other pain treatments, such as non-opioid pain medicines, do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Levorphanol Tartrate Tablets:

  • Get emergency medical help right away if you:
    • Take too much Levorphanol Tartrate Tablets (overdose). When you first start taking Levorphanol Tartrate Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
    • Have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • Taking Levorphanol Tartrate Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your Levorphanol Tartrate Tablets. They could die from taking it. Selling or giving away Levorphanol Tartrate Tablets is against the law.
  • Store Levorphanol Tartrate Tablets securely, out of sight and reach of children and in a location not accessible by others, including visitors to the home.

Do not take Levorphanol Tartrate Tablets if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.
  • Previously had an allergic reaction to levorphanol.

Before taking Levorphanol Tartrate Tablets, tell your healthcare provider if you have a history of:

  • Head injury, seizures.
  • Problems urinating.
  • Abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • Liver, kidney or thyroid problems.
  • Pancreas or gallbladder problems.

Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of Levorphanol Tartrate Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. Levorphanol Tartrate Tablets pass into breast milk and may harm your baby.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Levorphanol Tartrate Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Levorphanol Tartrate Tablets:

  • Do not change your dose. Take Levorphanol Tartrate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 6 to 8 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Levorphanol Tartrate Tablets regularly, do not stop taking them without talking to your healthcare provider. It is important to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. Abruptly discontinuing Levorphanol Tartrate Tablets may lead to serious withdrawal symptoms, uncontrolled pain, and suicide.
  • Store Levorphanol Tartrate Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Leaving Levorphanol Tartrate Tablets unsecured can pose a deadly risk to others in the home.
  • Dispose of expired, unwanted, or unused Levorphanol Tartrate Tablets by promptly flushing down the toilet if a drug take-back option is not readily available. Visit https://www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Levorphanol Tartrate Tablets, DO NOT:

  • Drive or operate heavy machinery until you know how Levorphanol Tartrate Tablets affects you. Levorphanol Tartrate Tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Levorphanol Tartrate Tablets may cause you to overdose and die.

Levorphanol Tartrate Tablets can cause:

Levorphanol Tartrate Tablets:

This information is not intended to replace discussions with your doctor. For additional information, please see Full Prescribing Information, Boxed Warning, the Medication Guide and talk to your doctor. Levorphanol is available by prescription only.

Please report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch, or call 1-800-FDA-1088, or to Sentynl Therapeutics, Inc. at 1-888-507-5206. Updated October 2019.