Roxanol concentrate

Pronunciation

Generic Name: morphine (MORE-feen)
Brand Name: Roxanol

Morphine is available in several different concentrations. This concentration (20 mg/mL) should only be used by patients who have already been taking a narcotic pain medicine and are tolerant to its effects. Use of Roxanol concentrate by people who are not used to taking narcotic pain medicines may cause severe and sometimes fatal breathing problems. Be sure you understand how to measure your dose of Roxanol concentrate. Discuss any questions or concerns with your doctor or pharmacist.

Keep Roxanol concentrate out of the reach of children and away from pets. Seek emergency medical attention immediately if accidental ingestion occurs.


Roxanol concentrate is used for:

Treating moderate to severe pain in patients who have already been taking and are tolerant to narcotic (opioid) pain medicines.

Roxanol concentrate is a narcotic pain reliever. It works in the brain and nervous system to decrease pain.

Do NOT use Roxanol concentrate if:

  • you are allergic to any ingredient in Roxanol concentrate
  • you have known or suspected bowel blockage (eg, paralytic ileus)
  • you have severe or persistent diarrhea associated with antibiotic use (pseudomembranous colitis)
  • you have slow or difficult breathing, severe asthma, severe hypercarbia or hypercapnia (high blood levels of carbon dioxide), or you are having an asthma attack
  • you are taking sodium oxybate (GHB) or drink alcohol
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken one within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Roxanol concentrate:

Some medical conditions may interact with Roxanol concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, especially other narcotic pain relievers (eg, codeine, hydromorphone); foods; or other substances
  • if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
  • if you have increased pressure in the head, a recent head injury, or growths in the brain (eg, tumors, lesions)
  • if you have a history of heart problems (eg, cor pulmonale), liver or kidney problems, thyroid problems, stomach or bowel problems (eg, constipation, blockage, inflammation), gallbladder or pancreas problems, prostate problems, trouble urinating, adrenal gland problems (eg, Addison disease), hypoxia (not enough oxygen in your body), hypercapnia or hypercarbia, curvature of the spine, or seizures
  • if you have a history of mental or mood problems (eg, depression), hallucinations, suicidal thoughts or actions, or alcohol or other substance abuse or dependence
  • if you will be having surgery or you are currently having alcohol withdrawal
  • if you have severe drowsiness; low blood volume; stomach pain; very poor health; have had stomach or intestinal surgery; or you are in shock caused by heart problems, blood vessel problems, or severe bleeding

Some MEDICINES MAY INTERACT with Roxanol concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Mixed narcotic agonists/antagonists (eg, buprenorphine, butophanol, pentazocine) or naltrexone because they may decrease Roxanol concentrate's effectiveness and withdrawal symptoms may occur
  • Fluoxetine, rifamycins (eg, rifampin), or risperidone because they may decrease Roxanol concentrate's effectiveness
  • Cimetidine, ketorolac, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as severe drowsiness, slow or difficulty breathing, confusion, and seizures, may be increased
  • Anticholinergics (eg, oxybutynin, scopolamine), antihistamines (eg, diphenhydramine), antinausea medicines (eg, ondansetron), benzodiazepines (eg, lorazepam), MAOIs (eg, phenelzine), other narcotic pain medicines (eg, hydrocodone), phenothiazines (eg, chlorpromazine), quinidine, sleep medicines (eg, zolpidem), or sodium oxybate (GHB) because they may increase the risk of Roxanol concentrate's side effects
  • Skeletal muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased
  • Mexiletine or trovafloxacin because their effectiveness may be decreased by Roxanol concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxanol concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Roxanol concentrate:

Use Roxanol concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Roxanol concentrate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Roxanol concentrate refilled.
  • Take Roxanol concentrate by mouth with or without food.
  • Only use the dropper that comes with Roxanol concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Roxanol concentrate contains a high concentration of morphine. Be sure you understand how much medicine to use for your dose. Use extreme caution when you measure your dose of Roxanol concentrate. Accidental overdose may cause serious and sometimes fatal side effects.
  • If Roxanol concentrate is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Roxanol concentrate properly.
  • If you miss a dose of Roxanol concentrate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Roxanol concentrate.

Important safety information:

  • Roxanol concentrate may cause dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Roxanol concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking Roxanol concentrate.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Roxanol concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Roxanol concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Roxanol concentrate may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you use Roxanol concentrate.
  • The risk of Roxanol concentrate becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Do NOT change your dose or use more often than prescribed without checking with your doctor.
  • Do NOT suddenly stop taking Roxanol concentrate without checking with your doctor. If you have been taking Roxanol concentrate for more than a few weeks and your doctor tells you to stop using Roxanol concentrate, your dose may need to be gradually lowered as directed by your doctor to avoid side effects.
  • Tell your doctor or dentist that you take Roxanol concentrate before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver, kidney, or lung function and complete blood cell counts, may be performed while you use Roxanol concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Roxanol concentrate with caution in the ELDERLY; they may be more sensitive to its effects, especially severe drowsiness, or slow or shallow breathing.
  • Roxanol concentrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Roxanol concentrate while you are pregnant. Roxanol concentrate is found in breast milk. Do not breast-feed while taking Roxanol concentrate.

When used for long periods of time or at high doses, Roxanol concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Roxanol concentrate stops working well. Do not take more than prescribed.

Some people who use Roxanol concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Roxanol concentrate suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Roxanol concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; restless mood; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); confusion; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes (eg, agitation, exaggerated sense of well-being); seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or headache; shortness of breath; slow or shallow breathing; sudden chest pain; swelling of the hands, ankles, or feet; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; confusion; decreased muscle tone; decreased pupil size; loss of consciousness; low body temperature; seizures; severe drowsiness, dizziness, or lightheadedness; severe muscle pain or weakness; shortness of breath; slow heartbeat; slow or shallow breathing.

Proper storage of Roxanol concentrate:

Store Roxanol concentrate between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxanol concentrate out of the reach of children and away from pets.

General information:

  • If you have any questions about Roxanol concentrate, please talk with your doctor, pharmacist, or other health care provider.
  • Roxanol concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Roxanol concentrate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Roxanol concentrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Roxanol concentrate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Roxanol concentrate.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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