Roxanol

Roxanol is a prescription medication used to treat moderate to severe pain. Roxanol belongs to a group of drugs called opioid narcotics. Opioid narcotics bind to receptors throughout the body which works to relieve moderate to severe pain. 

Roxanol comes in an oral solution and the dose will be individualized.

Common side effects of Roxanol include constipation, nausea, itchiness, and sleepiness. Do not drink alcohol or any foods or medications containing alcohol while taking Roxanol as alcohol increases the risk that you will experience breathing problems or other serious, life-threatening side effects.

Roxanol is a prescription medication used to treat moderate to severe pain. This medication is indicated for the relief of acute and chronic pain in opioid-tolerant patients.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

This medication may cause serious side effects. See "Drug Precautions".

Common side effects include:

• dizziness
• drowsiness
• nausea
• vomiting
• constipation
• diarrhea
• loss of appetite
• weight loss
• dry mouth
• sweating
• weakness
• headache
• agitation
• nervousness
• mood changes
• confusion
• small pupils (black circles in the middle of the eyes
• flu symptoms
• difficulty urinating or pain when urinating

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face
• tongue or throat
• extreme drowsiness, or you are feeling faint

These are not all the possible side effects of Roxanol. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. 

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 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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Roxanol there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication, tell your doctor if you:

• have severe asthma, trouble breathing, or other lung problems.
• have a bowel blockage or have narrowing of the stomach or intestines.
• have a history of head injury, seizures.
• have liver, kidney, thyroid, pancreas, or gallbladder problems.
• have problems urinating.
• are pregnant or planning to become pregnant. 
• are breastfeeding. 
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
• have a history of abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding. Roxanol passes into human breast milk and may harm your baby.

Follow the directions on your prescription label carefully. Take this medication as prescribed by your healthcare provider. Do not change your dose.

Oral (by mouth) Roxanol in a solution (liquid) to take by mouth.

• The liquid is usually taken every 4 hours as needed for pain.

If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.

Do not stop taking Roxanol without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking Roxanol, you may experience withdrawal symptoms such as restlessness; teary eyes; runny nose; yawning; irritability; anxiety; sweating; difficulty falling asleep or staying asleep; chills; back, muscle. or joint pain; nausea; vomiting; loss of appetite; diarrhea; stomach cramps; weakness; fast heartbeat; or fast breathing.

If you take too much Roxanol, call your local Poison Control Center or seek emergency medical attention right away.

Keep this and all medications out of the reach of children.

Roxanol is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away morphine may harm others, and is against the law.

WARNING: RISK OF MEDICATION ERRORS

Roxanol oral solution is available in the 20 mg/mL concentration and is indicated for use in opioid-tolerant patients only. 

Take care when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. 

Keep Roxanol oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.