Roxanol-T

In the U.S.

• Arymo ER
• AVINza
• Kadian
• Kadian ER
• Morphabond
• Morphabond ER
• MS Contin
• Oramorph SR
• Roxanol
• Roxanol-T

Available Dosage Forms:

• Capsule, Extended Release
• Capsule, Extended Release, 24 HR
• Solution
• Tablet, Extended Release
• Capsule
• Tablet
• Powder for Suspension, Extended Release
• Capsule, Delayed Release
• Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.

Morphine extended-release capsules or tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Roxanol-T. 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.

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Do not take too much of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Applies to morphine: oral capsule, oral capsule delayed release, oral capsule extended release, oral capsule extended release 24 hr, oral powder for suspension extended release, oral solution, oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• epidural suspension extended release
• injection injectable, injection solution

Along with its needed effects, morphine (the active ingredient contained in Roxanol-T) 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 while taking morphine:

• 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 while taking morphine:

• 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 of morphine 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

Applies to morphine: compounding powder, injectable solution, injectable tablet soluble, intravenous solution, oral capsule, oral capsule extended release, oral concentrate, oral liquid, oral solution, oral tablet, oral tablet extended release, rectal suppository, spinal solution

Nervous system

Central nervous system side effects may be either depressant or excitatory. Excitatory symptoms are sometimes ignored as possible side effects of morphine (the active ingredient contained in Roxanol-T) Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.

Patients receiving continuous infusion of morphine sulfate via indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms. Further assessment or intervention should be based on the clinical condition of the individual patient.

Myoclonic spasms may occur in patients receiving high dose morphine, particularly in the setting of renal dysfunction. Hyperalgesia has also been reported with high doses.[Ref]

Very common (10% or more): Drowsiness (28%)
Common (1% to 10%): Dizziness, sedation, fever, anxiety, confusion, tremor, diaphoresis, lethargy, feeling of warmth
Uncommon (0.1% to 1%): Withdrawal symptoms after either abrupt cessation or fast tapering of the drug, headache, chills, flu syndrome, malaise, withdrawal syndrome, pallor, facial flushing, syncope, loss of concentration, insomnia, amnesia, paresthesia, agitation, vertigo, foot drop, ataxia, hypesthesia, slurred speech, hallucinations, euphoria, apathy, seizures, myoclonus
Frequency not reported: Inflammatory masses including granulomas (some of which have resulted in serous neurologic impairment including paralysis) in patients receiving continuous infusion of opioids via indwelling intrathecal catheter[Ref]

Respiratory

Common (1% to 10%): Respiratory depression
Uncommon (0.1% to 1%): Hiccup, rhinitis, atelectasis, asthma, hypoxia, voice alteration, depressed cough reflex, noncardiogenic pulmonary edema, bronchospasm[Ref]

Gastrointestinal

Morphine may cause constriction of the common bile duct and spasm of the sphincter of Oddi, thereby increasing intrabiliary pressure and worsening, rather than relieving, biliary colic.

In addition, morphine (the active ingredient contained in Roxanol-T) may cause intense but uncoordinated duodenal contraction and decreased gastric emptying.[Ref]

Common (1% to 10%): Dry mouth, constipation, nausea, diarrhea, anorexia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Dysphagia, dyspepsia, stomach atony disorder, gastroesophageal reflux, delayed gastric emptying, biliary colic, increased gastroesophageal reflux, intestinal obstruction[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Tachycardia, atrial fibrillation, hypertension, hypotension, palpitations, bradycardia, vasodilation[Ref]

Psychiatric

Uncommon (0.1% to 1%): Abnormal thinking, abnormal dreams, depression, fearfulness, agitation, paranoia, psychosis, hypervigilance, hallucinations, delirium
Frequency not reported: Withdrawal symptoms after abrupt cessation of therapy[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary abnormality, urinary retention, urinary hesitancy[Ref]

The risk of acute urinary retention is very high when morphine is administered by epidural or intrathecal injection. Clinicians should be attentive to the increased risk of urosepsis in this setting, particularly if instrumentation of the urinary tract is necessary.[Ref]

Hematologic

Common (1% to 10%): Anemia, leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia[Ref]

Endocrine

Uncommon (0.1% to 1%): Hyponatremia due to inappropriate ADH secretion, gynecomastia, amenorrhea, reduced libido, reduced potency, prolonged labor[Ref]

Musculoskeletal

Common (1% to 10%): Asthenia, accidental injury
Uncommon (0.1% to 1%): Back pain, bone pain, arthralgia
Frequency not reported: Opioid-induced involuntary muscle hyperactivity with chronic high doses[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Decubitus ulcer, pruritus, skin flush[Ref]

Ocular

Uncommon (0.1% to 1%): Amblyopia, conjunctivitis, miosis, blurred vision, nystagmus, diplopia[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions, anaphylaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Increases in hepatic enzymes[Ref]

Metabolic

Common (1% to 10%): Peripheral edema
Uncommon (0.1% to 1%): Hyponatremia

Some side effects of Roxanol-T may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.