Levorphanol Tartrate

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Levorphanol has a risk for abuse and addiction, which can lead to overdose and death. Levorphanol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of levorphanol that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

Ask your doctor or pharmacist if you should have medication available to treat opioid overdose (such as naloxone, nalmefene). Teach your family or household members about the signs of an opioid overdose and how to treat it.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take levorphanol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, dry mouth, flushing, or vision problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as confusion, depression, abnormal thoughts), trouble urinating, fast/slow/irregular heartbeat, severe stomach/abdominal pain, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss), trouble swallowing.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, severe drowsiness/difficulty waking up, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine), cimetidine, MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), naltrexone, samidorphan.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Before taking levorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), heart problems (such as irregular heartbeat), low blood pressure, certain bowel diseases (such as paralytic ileus, toxic megacolon), breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, emphysema, low oxygen/high carbon dioxide in the blood, sleep apnea), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), kidney disease, liver disease, adrenal gland problem (such as Addison's disease), difficulty urinating (such as due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breastfeeding.

Read the Medication Guide provided by your pharmacist before you start taking levorphanol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually every 6 to 8 hours as needed. If you have nausea, you may take this drug with food, although this may cause your body to absorb less of the drug and get less benefit from it. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition, age, and response to treatment. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using levorphanol safely with other drugs.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a mental/mood disorder or a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your pain does not get better or if it gets worse, or if you have any new pain.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone or nalmefene if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow breathing, slow heartbeat, weak muscles, extreme drowsiness, coma.