MORPHINE SULFATE 80MG (EXTENDED RELEASE)
Morphine sulfate is an opioid pain medication. An opioid is sometimes called a narcotic. Morphine is used to treat moderate to severe pain. Short-acting formulations are taken as needed for pain.
The extended-release form of morphine is for around-the-clock treatment of pain. This form of morphine is not for use on an as-needed basis for pain.
Important informationYou should not take morphine if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or a bowel obstruction called paralytic ileus.
Morphine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Before taking this medicine
You should not take this medicine if you have ever had an allergic reaction to morphine or other narcotic medicines, or if you have:
severe asthma or breathing problems; or
a blockage in your stomach or intestines.
Do not use morphine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure morphine is safe for you, tell your doctor if you have ever had:
any type of breathing problem or lung disease;
a head injury, brain tumor, or seizures;
a drug or alcohol addiction, or mental illness;
liver or kidney disease;
problems with your gallbladder, pancreas, or thyroid; or
if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).
Some medicines can interact with morphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
If you use morphine while you are pregnant your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breast-feed while taking morphine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
Dosage and administration
Morphine sulfate tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with morphine sulfate extended-release tablets.
Morphine sulfate extended-release tablets must be taken whole. Crushing, chewing, or dissolving morphine sulfate extended-release tablets will result in uncontrolled delivery of morphine and can lead to overdose or death.
Use Of Morphine Sulfate Tablets As The First Opioid Analgesic
Initiate treatment with morphine sulfate extended-release tablets with 15 mg tablets orally every 8 or 12 hours.
Use Of Morphine Sulfate Tablets In Patients Who Are Not Opioid Tolerant
The starting dose for patients, who are not opioid-tolerant, is morphine sulfate extended-release tablets 15 mg orally every 12 hours. Patients who are opioid-tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
Conversion From Other Oral Morphine To Morphine Sulfate Extended-Release Tablets
Patients receiving other oral morphine formulations may be converted to morphine sulfate extendedrelease tablets by administering one-half of the patient’s 24-hour requirement as morphine sulfate extended-release tablets on an every-12-hour schedule or by administering one-third of the patient’s daily requirement as morphine sulfate extended-release tablets on an every-8-hour schedule.
Conversion From Other Opioids To Morphine Sulfate Tablets
There are no established conversion ratios for conversion from other opioids to morphine sulfate extended-release tablets defined by clinical trials. Discontinue all other around-the-clock opioid drugs when morphine sulfate extended-release tablets therapy is initiated and initiate dosing using morphine sulfate extended-release tablets 15 mg orally every 8 to 12 hours.
It is safer to underestimate a patient’s 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements and manage an adverse reaction. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
Conversion From Parenteral Morphine Or Other Opioids (Parenteral Or Oral) To Morphine Sulfate Tablets
When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to morphine sulfate tablets, consider the following general points:
Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.
Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.
Use in specific populations
- Pregnancy and breast feeding: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Chronic maternal use of morphine during pregnancy can affect the fetus with subsequent withdrawal signs.
- Opioids cross the placenta. Morphine sulfate tablets are not recommended for use in women during and immediately prior to labor. Infants born to mothers who have taken opioids chronically may exhibit neonatal withdrawal syndrome.
- Breast Feeding: Morphine is excreted in breast milk. Withdrawal signs can occur in breast-feeding infants when maternal administration of morphine is stopped.
- The safety and effectiveness in pediatric patients below the age of 18 have not been established
- Morphine Sulfate dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Side Effect of Morphine sulfate
The following serious adverse reactions are described elsewhere in the labeling:
Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Interactions with Other CNS Depressants
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Morphine sulfate tablets may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock.