Roxanol

Morphine is an opioid pain medication. An opioid is sometimes called a narcotic.

Morphine is used to treat moderate to severe pain. Short-acting morphine is taken as needed for pain. Extended-release morphine is for use when around-the-clock pain relief is needed.

Morphine is not for treating pain just after surgery unless you were already taking morphine before the surgery.

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

You may not be able to take this medicine unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Morphine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are using morphine. Dangerous side effects or death can occur when alcohol is combined with morphine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take morphine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop using morphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using morphine.

THE MAJOR HAZARDS OF MORPHINE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRA-TORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION, RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are suffering severe pain. In such individuals, lower doses are available. Some adverse reactions may be alleviated in the ambulatory patient if he lies down.

Other adverse reactions include the following

Central Nervous System: Euphoria, dysphoria, weakness, headache, insomnia, agitation, disorientation, and visual disturbances.

Gastrointestinal: Dry mouth, anorexia, constipation, and biliary tract spasm.

Cardiovascular: Flushing of the face, bradycardia, palpitation, faintness and syncope.

Allergic: Pruritus, urticaria, other skin rashes, edema, and, rarely hemorrhagic urticaria.

Treatment of the most frequent adverse reactions

Ample intake of water or other liquids should be encouraged. Concomitant administration of a stool softener and a peristaltic stimulant with the narcotic analgesic can be an effective preventive measure for those patients in need of therapeutics. If elimination does not occur for two days, an enema should be administered to prevent impaction.

In the event diarrhea occurs, seepage around fecal impaction is a possible cause to consider before antidiarrheal measures are employed.

Phenothiazines and antihistamines can be effective treatments of nausea of the medullary and vestibular sources respectively. However, these drugs may potentiate the side effects of the narcotic or the antinauseant.

Once pain control is achieved, undesirable sedation can be minimized by titrating the dosage to a level that just maintains a tolerable pain or pain free state.

Drug Abuse And Dependence

Morphine Sulfate, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substance Act. As with other narcotics, some patients may develop a physical and psychological dependence on morphine. They may increase dosage without consulting a physician and subsequently may develop a physical dependence on the drug. In such cases, abrupt discontinuance may precipitate typical withdrawal symptoms, including convulsions. Therefore the drug should be withdrawn gradually from any patient known to be taking excessive dosages over a long period of time.

In treating the terminally ill patient the benefit of pain relief may outweigh the possibility of drug dependence. The chance of drug dependence is substantially reduced when the patient is placed on scheduled narcotic programs instead of a “pain to relief-of-pain” cycle typical of a PRN regimen.

Read the entire FDA prescribing information for Roxanol (Morphine Sulfate)

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.

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.

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• blurred vision
• bulging soft spot on the head of an infant
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in the ability to see colors, especially blue or yellow
• chest pain or discomfort
• confusion
• cough
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• headache
• hives, itching, or skin rash
• increased sweating
• loss of appetite
• nausea or vomiting
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe constipation
• severe vomiting
• shakiness in the legs, arms, hands, or feet
• slow heartbeat
• sweating or chills

• Black, tarry stools
• cold, clammy skin
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of consciousness
• low blood pressure or pulse
• painful urination
• pale or blue lips, fingernails, or skin
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

• Constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme drowsiness
• fever
• increased blood pressure
• increased thirst
• lower back or side pain
• muscle cramps or spasms
• muscle pain or stiffness
• no muscle tone or movement
• severe sleepiness
• swelling of the face, fingers, or lower legs
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cramps
• difficulty having a bowel movement (stool)
• drowsiness
• false or unusual sense of well-being
• relaxed and calm feeling
• sleepiness or unusual drowsiness
• weight loss

• Absent, missed, or irregular menstrual periods
• agitation
• bad, unusual, or unpleasant (after) taste
• change in vision
• depression
• dry mouth
• face is warm or hot to touch
• floating feeling
• halos around lights
• heartburn or indigestion
• loss in sexual ability, desire, drive, or performance
• muscle stiffness or tightness
• night blindness
• overbright appearance of lights
• problems with muscle control
• redness of the skin
• skin rash
• stomach discomfort or upset
• trouble sleeping
• uncontrolled eye movements

• Abnormal dreams
• change in walking and balance
• change or problem with discharge of semen
• clumsiness or unsteadiness
• confusion as to time, place, or person
• delusions
• dementia
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• holding false beliefs that cannot be changed by fact
• problems with memory
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• unusual excitement, nervousness, or restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Dry mouth.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Headache.
• Anxiety.
• Feeling tired or weak.
• Belly pain.
• Sweating a lot.
• Loose stools (diarrhea).
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.