Rms

Morphine is a prescription medication used to treat moderate to severe pain. It is useful for both temporary pain and around-the-clock, long-term pain.

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

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. Morphine passes into human breast milk and may harm your baby.

WARNING: RISK OF MEDICATION ERRORS

Morphine sulfate oral solution is available in the 100 mg per 5 mL (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 morphine sulfate oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

Morphine sulfate extended-release tablets contain morphine, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit.  Assess each patient’s risk for opioid abuse or addiction prior to prescribing morphine sulfate extended-release tablets.  The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving morphine sulfate extended-release tablets for signs of misuse, abuse, and addiction during treatment.

Life-Threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of morphine sulfate extended-release tablets, even when the drug has been used as recommended and not misused or abused.  Proper dosing and titration are essential and morphine sulfate extended-release tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.  Monitor for respiratory depression, especially during initiation of morphine sulfate extended-release tablets or following a dose increase.  Instruct patients to swallow morphine sulfate extended-release tablets whole.  Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of morphine.

Accidental Exposure-Accidental ingestion of morphine sulfate extended-release tablets, especially in children, can result in a fatal overdose of morphine.

WARNING: Avinza Capsules

AVINZA capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. AVINZA CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. PATIENTS MUST NOT CONSUME ALCOHOLIC BEVERAGES WHILE ON AVINZA THERAPY. ADDITIONALLY, PATIENTS MUST NOT USE PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS CONTAINING ALCOHOL WHILE ON AVINZA THERAPY. CONSUMPTION OF ALCOHOL WHILE TAKING AVINZA MAY RESULT IN THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

• It is used to ease pain.

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 RMS (morphine suppositories) 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.

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.

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.