Morphine (injection)

Morphine (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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. Morphine sulfate extended-release exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow morphine sulfate extended-release capsules whole to avoid exposure to a potentially fatal dose of morphine. (5.2) Accidental ingestion of morphine sulfate extended-release capsules, especially in children, can resultin fatal overdose of morphine. (5.2) Prolonged use of morphine sulfate extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. (5.3) Instruct patients not to consume alcohol or any products containing alcohol while taking morphine sulfate extended-release because co-ingestion can result in fatal plasma morphine levels. (5.

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 [6].View additional information.

       Pain, chronic, IntractableView additional information.
       Pain, chronic (Severe), in patients requiring a long-term daily around-the-clock opioid analgesicView additional information.
       Pain (Moderate to Severe), Not responsive to non-narcotic analgesicsView additional information.. 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 [6].

   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 [7][8][9][10]
   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 [11]
   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 [12][13]
   (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 [14]
   do not abruptly discontinue therapy after treatment for more than a few weeks, gradually taper dose to avoid precipitating withdrawal symptoms [14][7][8][9][10].
   Analgesia for a mechanically ventilated patient, Intensive care unit: continuous infusion, 0.07 to 0.5 mg/kg/hr IV [15]
   Analgesia for a mechanically ventilated patient, Intensive care unit: intermittent dosing, 0.01 to 0.15 mg/kg IV every 1 to 2 hours [15]
   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[12][13]
   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 [12][13]
   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 [12][13]
   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 [16][17][18][10]
   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 [16]
   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 [17]
   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 [18]
   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 [19]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: individualize dose [20]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (IV) initial, 2 mg to 10 mg slow IV per 70 kg body weight [21]; may repeat every 4 hours as needed [20]
   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 [20]
   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 [21]
   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 [21]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (immediate-release oral solution) 10 to 20 mg ORALLY every 4 hours as needed [22]
   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 [14]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (rectal suppositories) 10 to 20 mg RECTALLY every 4 hours [23]
   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)[24]
   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) [20]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (labor) 10 mg SUBQ/IM [20]
   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 [6].View additional information.

       Analgesia for a mechanically ventilated patient, Intensive care unitView additional information.
       Pain in eyeView additional information.

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 [6].

   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 [7]
   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 [11]
   use in premature infants not recommended [20]
   safety and effectiveness in newborn infants not established [20]
   safety and effectiveness of spinal administration not studied in pediatric patients [21]
   safety and effectiveness of morphine sulfate formulations have not been studied in patients younger than 18 years [14][21][12][13][8][7]
   Analgesia for a mechanically ventilated patient, Intensive care unit: continuous infusion, 0.01 to 0.03 mg/kg/hr [25][26][27]
   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) [28][29][30][31][32][33][34][35]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (continuous infusion) 0.02 to 0.06 mg/kg/hour IV or SUBQ [28][30][32][33][36][37][38][39][40]
   Pain (Moderate to Severe), Not responsive to non-narcotic analgesics: (epidural, preservative-free) single-dose 0.02 to 0.05 mg/kg EPIDURALLY [41][42][43][44][45][46]
   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 [28][32][47]

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

There is limited information regarding Morphine (injection) Contraindications in the drug label.

Warnings

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. Morphine sulfate extended-release exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow morphine sulfate extended-release capsules whole to avoid exposure to a potentially fatal dose of morphine. (5.2) Accidental ingestion of morphine sulfate extended-release capsules, especially in children, can resultin fatal overdose of morphine. (5.2) Prolonged use of morphine sulfate extended-release during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. (5.3) Instruct patients not to consume alcohol or any products containing alcohol while taking morphine sulfate extended-release because co-ingestion can result in fatal plasma morphine levels. (5.

There is limited information regarding Morphine (injection) Warnings' in the drug label.

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.