Morphine (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Black Box Warning
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Warning: addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; and interaction with alcohol
See full prescribing information for complete Boxed Warning.
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Overview
Morphine (injection) is an analgesic opioid that is FDA approved for the {{{indicationType}}} of oramorph(R) SR 15, 30, 60, and 100 mg have been discontinued from the market. Pain, chronic, intractable, pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic, pain (moderate to severe), not responsive to non-narcotic analgesics.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dermatologic: pruritus (up to 80% ), gastrointestinal: constipation (9% or greater ), nausea (oral, 7% and greater than 10% ; epidural or intrathecal, 15% to 70% ), vomiting (greater than 10% ), neurologic: dizziness (6% ), headache (less than 2% to greater than 10% ), lightheadedness, somnolence ( 3% or greater ), ophthalmic: miosis,renal: Urinary retention (oral, less than 5% ; epidural/intrathecal, 15% to 70% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Recall Info:Oramorph(R) SR 15, 30, 60, and 100 mg have been discontinued from the market.
- An opioid-tolerant patient is defined as use of at least 60 mg/day of morphine, at least 30 mg/day of oral oxycodone, at least 8 mg/day of oral hydromorphone, or an equianalgesic dose of another opioid for a week or longer.
- Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is reserved for opioid-tolerant patients only; fatal respiratory depression has resulted from the mistaken interchange of high concentration oral solution with other available oral solutions (eg. 20 mg/5 mL and 10 mg/5 mL); verify dose in mg and mL.
- Preservative-free morphine sulfate sterile solutions 200 mg/20 mL or 500 mg/20 mL (high-potency) are reserved for intrathecal or epidural continuous infusion via microinfusion devices and may require dilution before use; high-potency formulations are not intended for use as single-dose IV/IM/subQ administration.
- (Immediate-release formulations) for conversion from parenteral to oral morphine immediate-release formulations, a dose ranging from 3 to 6 mg of oral morphine may be required for analgesia equivalent to 1 mg of parenteral morphine.
- Do not abruptly discontinue therapy after treatment for more than a few weeks, gradually taper dose to avoid precipitating withdrawal symptoms.
- Analgesia for a mechanically ventilated patient, Intensive care unit: continuous infusion, 0.07 to 0.5 mg/kg/hr IV.
- Analgesia for a mechanically ventilated patient, Intensive care unit: intermittent dosing, 0.01 to 0.15 mg/kg IV every 1 to 2 hours.
- Pain, chronic, Intractable: individualize dose based on response to in-hospital serial single-dose epidural or intrathecal injections of standard morphine sulfate 0.5 mg/mL or 1 mg/mL.
- Pain, chronic, Intractable: (epidural infusion via continuous microinfusion device, preservative-free) initial 3.5 to 7.5 mg (non-opioid-tolerant) or 4.5 to 10 mg (opioid-tolerant) per day epidurally; may increase to 20 to 30 mg/day; Max dose individualized.
- Pain, chronic, Intractable: (intrathecal infusion via continuous microinfusion device, preservative-free) initial 0.2 to 1 mg (non-opioid-tolerant) or 1 to 10 mg/day (opioid-tolerant) intrathecally; Max dose individualized; caution with doses greater than 20 mg/day.
- Pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic: individualize dose; initial dose selection must take into account patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse; due to substantial inter-patient variability in relative potency of different opioid products, including differences in extended-release morphine products, when converting it is recommended to underestimate a patient's 24-hour oral morphine requirements and provide rescue mediation as needed.
- Pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic: (Avinza(R) extended-release): as first opioid analgesic, when not opioid tolerant, or when converting from other opioids: initiate with 30 mg orally every 24 hours; conversion from other oral morphine formulations: initiate with patient's total daily oral morphine requirement orally every 24 hours; conversion from parenteral morphine or other non-morphine opioids: initiate with one-half of the estimated daily morphine requirement and provide rescue medication as needed (an oral dose that is 3 times the daily parenteral requirement is usually sufficient); titrate in increments not greater than 30 mg orally every 3 to 4 days; Max: 1600 mg/day; use of Avinza(R) 90-mg and 120-mg capsules is restricted to opioid-tolerant patients.
- Pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic: (Kadian(R) extended-release): when not opioid tolerant or when converting from other opioids: initiate with 30 mg orally every 24 hours; conversion from immediate-release morphine, take one-half of the total daily oral morphine requirement orally once every 12 hours OR take total daily oral morphine requirement orally once every 24 hours; conversion from parenteral morphine or other non-morphine opioids: initiate with one-half of the estimated daily morphine requirement and provide rescue medication as needed (an oral dose that is 3 times the daily parenteral requirement is usually sufficient); may titrate every 1 to 2 days; use of 100-mg, 130-mg, 150-mg, or 200-mg capsules is restricted to opioid-tolerant patients.
- Pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic: (MS Contin(R) controlled-release) when not opioid tolerant: initiate with 15 mg every orally every 12 hours; as first opioid analgesic: initiate with 15 mg orally every 8 to 12 hours; conversion from immediate-release morphine, take one-half of the total daily oral morphine requirement orally every 12 hours OR one-third of the total daily oral morphine requirement orally every 8 hours; conversion from parenteral morphine or other non-morphine opioids: initiate with one-half of the estimated daily morphine requirement and provide rescue medication as needed (an oral dose that is 3 times the daily parenteral requirement is usually sufficient); may titrate every 1 to 2 days; use of 100-mg and 200-mg tablets is restricted to opioid-tolerant patients.
- Pain, chronic (severe), in patients requiring a long-term daily around-the-clock opioid analgesic: (extended-release tablets; (Mallinckrodt, Inc)) as a conversion from immediate-release morphine, convert one-half of the estimated total daily oral morphine requirement orally once every 12 hours, or one-third of the total daily oral morphine requirement orally every 8 hours; when the daily morphine requirement is expected to be less than 60 mg/day, then the 15-mg tablet strength is recommended, and when the daily requirement is expected to be between 60 mg to 120 mg per day, then the 30-mg tablet strength is recommended; as a conversion from parenteral morphine or other non-morphine opioids, underestimate patient's 24-hour oral morphine requirement and provide rescue medication as needed; may titrate every 1 to 2 days; use of 100-mg and 200-mg tablets is restricted to opioid-tolerant patients only.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: individualize dose.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (IV) initial, 2 mg to 10 mg slow IV per 70 kg body weight; may repeat every 4 hours as needed.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (subQ/IM) 10 mg (range, 5 to 20 mg) SUBQ/IM may repeat every 4 hours as needed.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (epidural, preservative-free) initial, 5 mg epidurally in lumbar region; may increase incrementally by 1 to 2 mg within 1 hour; MAX: 10 mg/24 hours.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (intrathecal, preservative-free) 0.2 to 1 mg intrathecally into lumbar region; repeat dosing not recommended; max 10 mg.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (immediate-release oral solution) 10 to 20 mg orally every 4 hours as needed.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (immediate-release tablet) initial, 15 to 30 mg (non-opioid-tolerant) orally every 4 hours as needed.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (rectal suppositories) 10 to 20 mg rectally every 4 hours.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (myocardial infarction) initial, 4 to 8 mg IV, then 2 to 8 mg IV every 5 to 15 minutes as needed (guideline dosing).
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (myocardial infarction) 8 to 15 mg slow IV or IM/SUBQ; for very severe pain, may administer additional smaller doses every 3 to 4 hours (manufacturer dosing).
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (labor) 10 mg SUBQ/IM.
- Pain (moderate to severe), not responsive to non-narcotic analgesics: (IV patient-controlled analgesia) initial after loading dose, 1 mg IV; range, 0.5 to 2.5 mg with lockout of 5 to 10 minutes (Anon, 2003)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- Oramorph(R) SR 15, 30, 60, and 100 mg have been discontinued from the market.
- Analgesia for a mechanically ventilated patient, intensive care unit.
- Pain in eye.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Morphine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Recall Info:Oramorph(R) SR 15, 30, 60, and 100 mg have been discontinued from the market.
- An opioid-tolerant patient is defined as use of at least 60 mg/day of morphine, at least 30 mg/day of oral oxycodone, at least 8 mg/day of oral hydromorphone, or an equianalgesic dose of another opioid for a week or longer.
- Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is reserved for opioid-tolerant patients only; fatal respiratory depression has resulted from the mistaken interchange of high concentration oral solution with other available oral solutions (eg. 20 mg/5 mL and 10 mg/5 mL); verify dose in mg and mL.
- Use in premature infants not recommended.
- Safety and effectiveness in newborn infants not established.
- Safety and effectiveness of spinal administration not studied in pediatric patients.
- Safety and effectiveness of morphine sulfate formulations have not been studied in patients younger than 18 years.
- Analgesia for a mechanically ventilated patient, Intensive care unit: continuous infusion, 0.01 to 0.03 mg/kg/hr.
- Pain (moderate to severe),not responsive to non-narcotic analgesics: individualize dose
- Pain (moderate to severe),not responsive to non-narcotic analgesics: (intermittent dosing) 0.03 to 0.1 mg/kg/dose IV, IM, or SUBQ; MAX 0.2 mg/kg or 10 mg/dose; repeat as required (usually every 2 to 4 hours).
- Pain (moderate to severe),not responsive to non-narcotic analgesics: (continuous infusion) 0.02 to 0.06 mg/kg/hour IV or SUBQ.
- Pain (moderate to severe),not responsive to non-narcotic analgesics: (epidural, preservative-free) single-dose 0.02 to 0.05 mg/kg epidurally
- Pain (moderate to severe),not responsive to non-narcotic analgesics: (oral, immediate-release) children less than 50 kg, initial, 0.3 mg/kg orally; repeat as required (usually every 3 to 4 hours); MAX 15 to 20 mg/dose for oral solution and 15 to 30 mg/dose for oral tablets.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Morphine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Morphine in pediatric patients.
Contraindications
- Morphine sulfate extended-release is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions]
Warnings
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Warning: addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; and interaction with alcohol
See full prescribing information for complete Boxed Warning.
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- Addiction, Abuse, and Misuse
- Morphine sulfate extended-release contains morphine, a Schedule II controlled substance. As an opioid, morphine sulfate extended-release exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence]. As modified-release products such as morphine sulfate extended-release deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present.
- Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed morphine sulfate extended-release and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.
- Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing morphine sulfate extended-release, and monitor all patients receiving morphine sulfate extended-release for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of morphine sulfate extended-release for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as morphine sulfate extended-release, but use in such patients necessitates intensive counseling about the risks and proper use of morphine sulfate extended-release along with intensive monitoring for signs of addiction, abuse, and misuse.
- Abuse or misuse of morphine sulfate extended-release by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the morphine and can result in overdose and death [see Overdosage].
- Opioid agonists such as morphine sulfate extended-release are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing morphine sulfate extended-release. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
- Life-Threatening Respiratory Depression
- Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
- While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of morphine sulfate extended-release, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with morphine sulfate extended-release and following dose increases.
- To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate extended-release are essential [see Dosage and Administration]. Overestimating the morphine sulfate extended-release dose when converting patients from another opioid product can result in fatal overdose with the first dose.
- Accidental ingestion of even one dose of morphine sulfate extended-release capsules, especially by children, can result in respiratory depression and death due to an overdose of morphine.
- Neonatal Opioid Withdrawal Syndrome
- Prolonged use of morphine sulfate extended-release during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
- Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.
- Interactions with Central Nervous System Depressants
- Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on morphine sulfate extended-release therapy. The co-ingestion of alcohol with morphine sulfate extended-release may result in increased plasma levels and a potentially fatal overdose of morphine [see Clinical Pharmacology].
- Hypotension, profound sedation, coma, respiratory depression, and death may result if morphine sulfate extended-release is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).
- When considering the use of morphine sulfate extended-release in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient’s use of alcohol or illicit drugs that cause CNS depression. If the decision to begin morphine sulfate extended-release is made, start with morphine sulfate extended-release 30 mg every 24 hours, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant [see Drug Interactions].
- Use in Elderly, Cachectic, and Debilitated Patients
- Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating morphine sulfate extended-release and when morphine sulfate extended-release is given concomitantly with other drugs that depress respiration [see Warnings and Precautions].
- Use in Patients with Chronic Pulmonary Disease
- Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with morphine sulfate extended-release, as in these patients, even usual therapeutic doses of morphine sulfate extended-release may decrease respiratory drive to the point of apnea [see Warnings and Precautions]. Consider the use of alternative non-opioid analgesics in these patients if possible.
- Hypotensive Effect
- Morphine sulfate extended-release may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics) [see Drug Interactions]. Monitor these patients for signs of hypotension after initiating or titrating the dose of morphine sulfate extended-release. In patients with circulatory shock, morphine sulfate extended-release may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of morphine sulfate extended-release in patients with circulatory shock.
- Use in Patients with Head Injury or Increased Intracranial Pressure
- Monitor patients taking morphine sulfate extended-release who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with morphine sulfate extended-release. Morphine sulfate extended-release may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.
- Avoid the use of morphine sulfate extended-release in patients with impaired consciousness or coma.
- Use in Patients with Gastrointestinal Conditions
- Morphine sulfate extended-release is contraindicated in patients with paralytic ileus. Avoid the use of morphine sulfate extended-release in patients with other GI obstruction.
- The morphine in morphine sulfate extended-release may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase.
- Use in Patients with Convulsive or Seizure Disorders
- The morphine in morphine sulfate extended-release may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during morphine sulfate extended-release therapy.
- Avoidance of Withdrawal
- Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a opioid agonist analgesic, including morphine sulfate extended-release. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.
- When discontinuing morphine sulfate extended-release, gradually taper the dose [see Dosage and Administration]. Do not abruptly discontinue morphine sulfate extended-release.
- Driving and Operating Machinery
- Morphine sulfate extended-release may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of morphine sulfate extended-release and know how they will react to the medication.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Morphine (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Morphine (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Morphine (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Morphine (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Morphine (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Morphine (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Morphine (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Morphine (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Morphine (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Morphine (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Morphine (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Morphine (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Morphine (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Morphine (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Morphine (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Morphine (injection) Administration in the drug label.
Monitoring
There is limited information regarding Morphine (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Morphine (injection) and IV administrations.
Overdosage
There is limited information regarding Morphine (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Morphine (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Morphine (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Morphine (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Morphine (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Morphine (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Morphine (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Morphine (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Morphine (injection) How Supplied in the drug label.
Storage
There is limited information regarding Morphine (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Morphine (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Morphine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Morphine (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Morphine (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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