Roxanol

Name: Roxanol

Roxanol Drug Class

Roxanol is part of the drug class:

  • Natural opium alkaloids

Roxanol Interactions

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
  • antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
  • antihistamines (found in cold and allergy medications)
  • beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
  • buprenorphine (Butrans, Subutex, in Suboxone)
  • butorphanol (Stadol)
  • cimetidine (Tagamet)
  • diuretics ('water pills')
  • medications for anxiety, seizures, depression, mental illness, or nausea
  • monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
  • muscle relaxants
  • nalbuphine (Nubain)
  • other narcotic pain medications
  • pentazocine (Talwin, in Talacen)
  • quinidine  
  • sedatives, sleeping pills, or tranquilizers

This is not a complete list of Roxanol drug interactions. Ask your doctor or pharmacist for more information.

Roxanol Precautions

Roxanol may be habit-forming. Take this medication as prescribed. Do not take more of it, or take it more often than as directed by your doctor. There is a greater risk that you will overuse Roxanol if you have or have ever had depression or another mental illness, or if you have abused alcohol, used street drugs, or overused prescription medications.

Do not allow anyone else to take your medication. Keep this medication out of the reach of children and in a safe place so that no one else can take it as Roxanol may harm or cause death to other people who take your medication, especially children. 

Roxanol may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Tell your doctor if you have slowed breathing and if you have or have ever had lung disease such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that cause difficulty breathing), or other breathing problems. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications during your treatment with Roxanol may increase the risk that you will experience breathing problems or other serious, life-threatening side effects.

Important information about Roxanol:

  • Get emergency help right away if you take too much Roxanol (overdose). Roxanol overdose can cause life threatening breathing problems that can lead to death.
  • Never give anyone else your Roxanol. They could die from taking it. Store Roxanol away from children and in a safe place to prevent stealing or abuse.
  • Selling or giving away Roxanol is against the law. Roxanol is a federally controlled substance (CII) because it can be abused or lead to dependence.

Do not take Roxanol if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

While taking Roxanol do not:

  • Drive or operate heavy machinery, until you know how Roxanol affects you. morphine can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Roxanol. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Avinza® is taken every 24 hours. Kadian® is taken every 12 or 24 hours at the same time each day. Morphabond™ is taken every 12 hours. Arymo™ ER is taken every 8 or 12 hours.

You may take this medicine with or without food.

Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release capsules and tablets whole. Do not crush, break, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing. Do not receive this medicine through a nasogastric tube.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • For moderate to severe pain:
      • Adults—
        • The total amount of milligrams (mg) per day is determined by your doctor. Your doctor may adjust your dose if needed.
        • Avinza®: The capsule is given every 24 hours.
        • Kadian®: The capsule is given every 12 or 24 hours.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • Adults—
        • The total amount of milligrams (mg) per day is determined by your doctor. Your doctor may adjust your dose if needed.
        • Arymo™ ER: The tablet is given every 8 or 12 hours.
        • Morphine sulfate: The tablet is given every 8 or 12 hours.
        • Morphabond™: The tablet is given every 12 hours.
        • MS Contin®: The tablet is given every 8 or 12 hours.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • For moderate to severe pain:
      • Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For moderate to severe pain:
      • Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Arymo™ ER, Avinza®, Kadian®, Morphabond™, or MS Contin®, skip the missed dose and take your next dose at your usual time the next day. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Morphine can cause serious unwanted effects if taken by adults, children, or pets who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Uses of Roxanol

  • It is used to ease pain.

What do I need to tell my doctor BEFORE I take Roxanol?

  • If you have an allergy to this medicine or any part of Roxanol.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Roxanol (morphine oral concentrate (20 mg/mL)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Feeling confused.
  • Noisy breathing.
  • Seizures.
  • Very hard stools (constipation).
  • Feeling very tired or weak.
  • Feeling very sleepy.
  • Mood changes.
  • Swelling in the arms or legs.
  • Fever or chills.
  • Sore throat.
  • Pain when passing urine.
  • Low mood (depression).
  • A burning, numbness, or tingling feeling that is not normal.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take Roxanol with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid drug like this medicine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Roxanol is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Roxanol or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Roxanol. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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