Morphine

DRUG INFORMATION

  ADULT
    - Adults: Initiate treatment with Morphine Sulfate Oral Solution 10 to 20 mg every 4
      hours as needed for pain, and at the lowest dose necessary to achieve adequate
      analgesia.
      Source: US FDA label for morphine (Morphine Sulfate), section 'dosage and
      administration', retrieved 2026-08-29
    - Adult patients considered to be opioid tolerant are those who are 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, 60 mg oral hydrocodone per day, or an
      equianalgesic dose of another opioid.
      Source: US FDA label for morphine (Morphine Sulfate), section 'dosage and
      administration', retrieved 2026-08-29
    - Strongly advise patients and caregivers to always use the enclosed calibrated oral
      syringe when administering Morphine Sulfate Oral Solution 20 mg/mL to ensure the
      dose is measured and administered accurately.
      Source: US FDA label for morphine (Morphine Sulfate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Morphine Sulfate Oral Solution (2 mg/mL) have been
      established for the management of pediatric patients 2 to 17 years of age with
      acute pain severe enough to require an opioid analgesic when alternative
      treatments are inadequate.
      Source: US FDA label for morphine (Morphine Sulfate), section 'pediatric use',
      retrieved 2026-08-29
    - Morphine Sulfate Oral Solution 20 mg/mL is only for opioid-tolerant adult patients
      . (2.1) Morphine Sulfate Oral Solution should be prescribed only by healthcare
      professionals who are knowledgeable about the use of opioids and how to mitigate
      the associated risks. (2.2) Use the lowest effective dosage for the shortest
      duration of time consistent with individual patient treatment goals.
      Source: US FDA label for morphine (Morphine Sulfate), section 'dosage and
      administration', retrieved 2026-08-29
    - Pharmacokinetic modeling and simulation indicate that an initial dose of 0.3 mg/kg
      in pediatric patients 2 years of age and older is expected to produce a maximum
      systemic exposure (C max ) similar to that achieved after single dose
      administration of 10 mg Morphine Sulfate Oral Solution to adults [ see Clinical
      Pharmacology (12.3) ].
      Source: US FDA label for morphine (Morphine Sulfate), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Start these patients with a lower than usual dosage of Morphine Sulfate Oral
      Solution and titrate slowly while regularly evaluating for signs of respiratory
      depression, sedation, and hypotension [ see Clinical Pharmacology (12.3) ]. 8.7
      Renal Impairment Morphine pharmacokinetics are altered in patients with renal
      failure.
      Source: US FDA label for morphine (Morphine Sulfate), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Because elderly patients are more likely to have decreased renal function, care
      should be taken in dose selection, and it may be useful to regularly evaluate
      renal function. 8.6 Hepatic Impairment Morphine pharmacokinetics have been
      reported to be significantly altered in patients with cirrhosis.
      Source: US FDA label for morphine (Morphine Sulfate), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Use of opioid analgesics for an extended period of time during
      pregnancy can cause neonatal opioid withdrawal syndrome [ see Warnings and
      Precautions (5.5) ].
      Source: US FDA label for morphine (Morphine Sulfate), section 'pregnancy',
      retrieved 2026-08-29
    - There are no available data with Morphine Sulfate Oral Solution in pregnant women
      to inform a drug-associated risk for major birth defects and miscarriage.
      Source: US FDA label for morphine (Morphine Sulfate), section 'pregnancy',
      retrieved 2026-08-29
    - Published studies with morphine use during pregnancy have not reported a clear
      association with morphine and major birth defects ( see Human Data) .
      Source: US FDA label for morphine (Morphine Sulfate), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Infertility Use of opioids for an extended period of time may cause reduced
      fertility in females and males of reproductive potential.
      Source: US FDA label for morphine (Morphine Sulfate), section 'nursing mothers',
      retrieved 2026-08-29
    - It is not known whether these effects on fertility are reversible [ see Adverse
      Reactions ( 6 ) and Clinical Pharmacology (12.2) ].
      Source: US FDA label for morphine (Morphine Sulfate), section 'nursing mothers',
      retrieved 2026-08-29
    - In published animal studies, morphine administration adversely effected fertility
      and reproductive endpoints in male rats and prolonged estrus cycle in female rats
      [ see Nonclinical Toxicology (13) ].
      Source: US FDA label for morphine (Morphine Sulfate), section 'nursing mothers',
      retrieved 2026-08-29