Levorphanol is an opioid medicine that is used to treat moderate to severe pain.

Levorphanol may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use levorphanol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of levorphanol.

Your dose needs may be different if you recently used opioid medicine and your body is tolerant to it (ask your doctor if you're not sure).

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Do not stop using levorphanol suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a levorphanol pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Usual Adult Dose for Pain:

As First Opioid Analgesic:
Initial dose: 1 to 2 mg orally every 6 to 8 hours as needed for pain
-May increase dose up to 3 mg orally every 6 to 8 hours as needed; if around the clock dosing is used, allow 72 hours for patient to reach a new steady-state before dose adjustment
Maximum doses: Higher doses may be appropriate in opioid tolerant patients

CONVERSION from other Opioids:
-Due to inter-patient variability, a conservative approach is advised
-Levorphanol is 4 to 8 times as potent as morphine and has a longer half-life
-May consider initiating levorphanol at 1/15 to 1/12 the total daily dose of oral morphine and adjust to clinical response
-Allow 72 hours for patient to reach a new steady-state before dose adjustment

Comments:
-Doses should be adjusted according to the severity of the pain, age, weight, and physical status, underlying disease, and use of concomitant medications.
-Monitor closely for respiratory depression especially on initiation and with each dose increase.
-Because of the risks of addiction, abuse, and misuse, even at recommended doses, this drug should be reserved for use in patients for whom alternative treatment options have not or are not expected to be tolerated or have not or are not expected to provide adequate analgesia.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

You should not use levorphanol if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing stops during sleep);

• a head injury, or seizures;

• drug or alcohol addiction;

• liver or kidney disease;

• urination problems; or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Levorphanol is not approved for use by anyone younger than 18 years old.

Since levorphanol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Flush any levorphanol tablets that are outdated or no longer needed down the toilet so that others will not take them. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how levorphanol will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Levorphanol may cause serious side effects. Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;

• a slow heart rate or weak pulse;

• a light-headed feeling, like you might pass out;

• mood changes, unusual thoughts or behavior;

• severe stomach pain, severe constipation;

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or

• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of levorphanol may include:

• nausea, vomiting, stomach pain;

• constipation;

• dizziness, drowsiness;

• tiredness; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect levorphanol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to levorphanol.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking levorphanol.

This prescription is not refillable. If you are taking levorphanol to control your pain on a long term basis, be sure to schedule appointments with your doctor so that you do not run out of medication. If you continue to have pain after you finish your levorphanol prescription, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.