Roxanol

DRUG DESCRIPTION

Each mL of Roxanol™ contains:

Morphine Sulfate...................................... 20 mg

Chemically, Morphine Sulfate is, Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-,(5?,6?)-, sul-fate(2:1)(salt), pentahydrate, which can be represented by the following structural formula:

ROXANOL (IMMEDIATE RELEASE) Structural Formula Illustration

Morphine Sulfate acts as a narcotic analgesic.

What are the possible side effects of morphine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

    ...

Read All Potential Side Effects and See Pictures of Roxanol »

What are the precautions when taking morphine sulfate (Roxanol)?

Before taking morphine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain bowel diseases (paralytic ileus, infectious diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow...

Read All Potential Precautions of Roxanol »


Roxanol Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, slow/fast heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking morphine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain bowel diseases (paralytic ileus, infectious diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), certain heart problems (irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), intestinal disorders (such as colitis, blockage).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

This product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.

Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and the effect on a nursing infant is not known. Discuss the risks and benefits with your doctor before breast-feeding.


Roxanol Patient Information Including Side Effects

Brand Names: Avinza, Kadian, Morphine IR, MS Contin, MSIR, Oramorph SR, Roxanol

Generic Name: morphine (Pronunciation: MOR feen)

  • What is morphine (Roxanol)?
  • What are the possible side effects of morphine?
  • What is the most important information I should know about morphine?
  • What should I discuss with my healthcare provider before using morphine?
  • How should I use morphine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using morphine?
  • What other drugs will affect morphine?
  • Where can I get more information?

What is morphine (Roxanol)?

Morphine is in a group of drugs called narcotic pain relievers.

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 other than those listed in this medication guide.

What are the possible side effects of morphine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • constipation;
  • warmth, tingling, or redness under your skin;
  • nausea, vomiting, stomach pain, diarrhea, loss of appetite;
  • dizziness, headache, anxiety;
  • memory problems; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about morphine?

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 it was prescribed for. Morphine should never be given to another person, especially someone who has a history of drug abuse or addiction. 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 more than your prescribed dose of morphine. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop taking morphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Related Drug Centers
  • Avinza
  • Roxanol
  • MS-Contin
  • Kadian


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