Applies to the following strengths: 15 mg/mL; 10 mg; 15 mg; 30 mg; 2 mg/mL; 4 mg/mL; 8 mg/mL; 10 mg/mL; 200 mg/12 hours; 15 mg/12 hr; 30 mg/12 hr; 60 mg/12 hours; 100 mg/12 hours; 10 mg/5 mL; 20 mg/5 mL; 20 mg/mL; 5 mg; 20 mg; 25 mg/mL; 50 mg/mL; 25 mg/mL preservative-free; 0.5 mg/mL preservative-free; 1 mg/mL preservative-free; 1 mg/mL; 5 mg/mL; 1 mg/mL-D5%; 5%-20 mg/100 mL; 20 mg/12 to 24 hr; 30 mg/12 to 24 hr; 50 mg/12 to 24 hr; 60 mg/12 to 24 hr; 80 mg/12 to 24 hr; 100 mg/12 to 24 hr; 30 mg/24 hours; 60 mg/24 hours; 90 mg/24 hours; 120 mg/24 hours; 45 mg/24 hours; 75 mg/24 hours; 10 mg/12 to 24 hr; 15 mg/8 to 12 hr; 30 mg/8 to 12 hr; 60 mg/8 to 12 hr; 100 mg/8 to 12 hr; 200 mg/8 to 12 hr; 100 mg/24 hours; 20 mg/24 hr; 50 mg/24 hours; 10 mg-0.9%/100 mL; 1 mg/mL-NaCl 0.9%; 2 mg/mL-D5%; 0.5 mg/mL; sulfate; 2 mg/mL preservative-free; 4 mg/mL preservative-free; 8 mg/mL preservative-free; 10 mg/mL preservative-free; 15 mg/mL preservative-free; 5 mg/mL preservative-free; 2 mg/mL-NaCl 0.9%; 4 mg/mL-NaCl 0.9%; 40 mg/12 to 24 hr; 70 mg/12 to 24 hr; 130 mg/12 to 24 hr; 150 mg/12 to 24 hr; 200 mg/24 hours; 10 mg/24 hr; 0.5 mg/mL-NaCl 0.9%; 200 mg/12 to 24 hr; 0.5 mg/mL-NaCl 0.9% preservative-free; 1 mg/mL-NaCl 0.9% preservative-free; 5 mg/mL-NaCl 0.9%; 50 mg/mL preservative-free; 0.4 mg/mL
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Pain
The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Immediate release tablets:
Initial dose: 15 to 30 mg orally every 4 hours as needed
Initial dose: 10 to 20 mg orally every 4 hours as needed
-Oral solution: Opioid naive patients should be initiated on 10 mg per 5 mL or 20 mg per 5 mL strengths. Opioid-tolerant patients that have already been titrated to a stable analgesic regimen using lower strengths of morphine may be initiated on the 100 mg per 5 mL (20 mg/mL).
Different extended-release products are not bioequivalent. Conversion from one extended-release product to the same total daily dose of another extended-release product may lead to either excessive sedation at peak or inadequate analgesia at trough. Individual product information should be consulted before prescribing and the dosage should be adjusted to the individual patient.
Initial dose: 30 mg orally every 24 hours
Dose should be taken 1 to 2 times daily depending upon the product prescribed.
10 to 20 mg rectally every 4 hours needed
Initial dose: 10 mg every 4 hours as needed
Dose range: 5 to 20 mg every 4 hours as needed
-For relief of pain and as preanesthetic:
Initial dose: 4 to 10 mg every 4 hours administered slowly over 4 to 5 minutes
Dose range: 5 to 15 mg
Daily dose range: 12 to 120 mg
Alternate dose: 2 to 10 mg/70 kg of body weight
-Acute myocardial infarction:
Initial dose: 4 to 8 mg
Maintenance dose: 2 to 8 mg every 4 to 15 minutes as needed
Severe chronic pain associated with terminal cancer:
-Continuous IV Infusion: Prior to initiation of the infusion (in concentrations between 0.2 to 1 mg/mL), a loading dose of 15 mg or higher of morphine sulfate may be administered by IV push to alleviate pain.
-IV patient controlled analgesia or subcutaneous patient controlled analgesia:
1 to 2 mg injected 30 minutes after a standard IV dose of 5 to 20 mg. The lockout period is 6 to 15 minutes.
Initial dose: 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given.
Maximum dose: 10 mg per 24 hr
-Dosage is usually one-tenth that of epidural dosage
-Initial dose: 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours. Repeated intrathecal injections are not recommended.
Usual Pediatric Dose for Pain
-The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
-Safety and efficacy of this drug in neonates have not been established. Opiate agonists should not be used in premature neonates since the drugs cross the immature blood-brain barrier more readily than in the mature barrier producing disproportionate respiratory depression. Opiates should be administered with caution and in monitored dosages to infants and small children since they may be relatively more sensitive to opiates on a body weight basis.
-Subcutaneous: 0.1 to 0.2 mg per kg as needed. Not to exceed 15 mg per dose.
-IV: 50 to 100 mcg (0.05 to 0.1 mg) per kg, administered very slowly. Not to exceed 10 mg per dose.
Usual Pediatric Dose for Neonatal Abstinence Syndrome
Less than 1 month:
WEIGHT-BASED DOSING: 0.04 mg/kg orally every 3 to 4 hours
Maximum dose: 0.2 mg/kg
SYMPTOM-BASED DOSING (Neonatal Abstinence Syndrome [NAS] Score):
-NAS Score 9 to 12; Dose: 0.04 mg orally every 4 hours
-NAS Score 13 to 16; Dose: 0.08 mg orally every 4 hours
-NAS Score 17 to 20; Dose: 0.12 mg orally every 4 hours
-NAS Score 21 to 24; Dose: 0.16 mg orally every 4 hours
-NAS Score greater than 25; Dose: 0.2 mg orally every 4 hours
WEANING: After 48 hours of Clinical Stability
-Reduce dose by 10% every 24 to 48 hours
-Cease therapy when dose is 0.15 mg/kg/day
-Approximately 60% to 80% of neonates with NAS may not respond to nonpharmacologic treatment and will require medication.
-The optimal pharmacologic treatment approach continues to be studied, however, oral morphine has been commonly used for this purpose.
-Pharmacologic treatment is initiated/titrated/weaned as part of an overall treatment strategy based on neonatal abstinence scores (e, g. Finnegan scores).
-The Finnegan scoring system has been standardized for use in term infants; its use in preterm or older infants should be considered not standardized; additionally, significant intra-observer variability has been documented.
Use: For the pharmacologic treatment of neonatal abstinence syndrome in accordance with treatment protocols developed by neonatology experts.
Renal Dose Adjustments
End-stage renal disease: Start at the lower suggested dosage for the indication and the patient needs; titrate dosage upwards slowly and increase the dosage intervals to prevent accumulation of the metabolite morphine-6-glucoronide.
Liver Dose Adjustments
Caution is recommended. Dosage reductions should be considered.
The dosing regimen of this drug should be adjusted for each patient individually, taking into account prior analgesic treatment experience. In the selection of the initial dose consider the following:
-Different formulations of this drug are not bioequivalent. When switching a patient from one form to another, consult the product labeling or local protocol.
-The total daily dose and potency of the opioid the patient took previously.
-The degree of opioid tolerance of the patient
-The general condition and medical status of the patient
-Type and severity of the pain
-Risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.
-As needed "rescue doses" of immediate release oral formulations may be needed for patients with cancer pain. The need for more than 2 rescue doses per day may require a review of the controlled release dose.
-The parenteral morphine tartrate and sulfate salt formulations contain almost an equivalent amount of morphine base per milligram, and may be used interchangeably.
-Morphine sulfate controlled release oral formulations have not been shown to be bioequivalent; adjustment between these formulations should be done with caution and careful titration.
-This drug should be used with caution in patients greater than 50 years of age, debilitated patients, and patients with impaired respiratory function; doses may need to be reduced by up to half of the usual daily adult dose.
-Titrate dosage slowly upward, taking into consideration the dosages received for breakthrough pain, to meet the specific needs of the patient.
-Factors such as age, disease state, concomitant drug therapy, analgesic history, and tolerance to narcotics can have variable but important effects on dose and response. In some patients with severe, chronic pain, it may be necessary to exceed the usual dose. Doses should be maintained at the lowest effective dose.
-Dosage reductions may be required with concomitant CNS depressant therapy.
-Patients may initially experience drowsiness or increased sedation due to exhaustion that may be mistaken as excessive analgesia. Initial doses should be maintained for at least 3 days before any dose reduction, as long as sedation is not excessive or associated with unsteadiness, and confusion, and that respiratory activity and other vital signs are adequate.
-The daily dose should be gradually tapered to minimize or prevent withdrawal symptoms.
-Caution and reduced doses are recommended with concomitant use of other narcotic analgesics, general anesthetics, phenothiazines, and other tranquillizers, sedatives/hypnotics, tricyclic antidepressants, and other CNS depressants, including alcohol.
-Continual reevaluation of the patient receiving this drug is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer related pain, the continued need for the use of opioid analgesics should be periodically reassessed.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics. The REMS consists of a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/REMS.
US BOXED WARNINGS:
ADDICTION/ABUSE/MISUSE: This drug exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Addiction can occur at recommended doses, and if the drug is misused or abused. These risks are particularly important for extended release formulations. Accidental ingestion of this drug by children or pets can result in a fatal overdose.
-Each patient should be assessed for risks prior to prescribing, and monitored regularly for the development of these risks.
-Patients should be instructed to swallow extended release dose units whole. They should not be chewed, crushed, or dissolved to avoid rapid release of a potentially fatal dose. Some individual formulations may be opened and mixed with applesauce and consumed immediately; consult product labeling.
-Patients should be instructed to keep this medication out of the reach of children and pets.
ALCOHOL: Patients should be instructed to avoid alcohol ingestion while taking this drug. Concomitant use of this drug with alcohol can cause fatal plasma levels of drug.
PREGNANCY: Prolonged use of this drug during pregnancy can result in withdrawal signs (e.g., irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, failure to gain weight) in the neonate, which, unlike opioid withdrawal in adults, may be life-threatening if not recognized and treated, and requires management by neonatology experts.
Recommendation: If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk to the neonate.
Serious adverse events and deaths have resulted from accidental overdose of this drug in oral solution form. In most of these cases, the oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. When this occurs with a high concentration oral solution, the result can be up to a 20 fold overdose. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors.
This drug, particularly in large doses or when administered by parenteral routes, may cause life-threatening respiratory depression. Treatment includes maintenance of the airway, artificial ventilation if necessary, and the opiate antagonist, naloxone (the usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary, or consult local protocol). This dose can be administered IV, IM, or subcutaneously.
This drug should be administered with caution to patients with head injuries, increased intracranial pressure, acute undiagnosed abdominal pain, hypothyroidism, severe renal disease, severe liver disease, Addison's disease, prostatic hyperplasia, urethral stricture, and general debilitation. Even small doses may jeopardize cerebral circulation in the postoperative period following craniotomy.
Safety and efficacy have not been established neonates. Consult product labeling for pediatric warnings for individual dosage forms.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Data not available
-This drug should be prescribed only by healthcare professionals knowledgeable in the use of potent opioids for the management of chronic pain.
-Patients should not consume alcoholic beverages while on morphine.
-When this drug is administered intravenously, an opiate antagonist and facilities for administration of oxygen and control of respiration should be available.
-This drug has been reported to be physically or chemically incompatible with various drug products. Specialized references should be consulted for specific compatibility information.
-Dose should be titrated based upon individual response to the initial dose.
-Extended-release capsules should be taken whole, not crushed, chewed, or dissolved; for patients who have difficulty swallowing, Kadian(R) and Avinza(R) may be opened and the contents of the capsule sprinkled on applesauce, immediately swallow without chewing.
-Patients considered opioid tolerant are those taking, for 1 week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
-The extended-release formulations should not be used for breakthrough pain or on an as needed basis.
-Use only the preservative free injectable formulations for preparations given via the epidural and intrathecal routes, and in neonates.
-Immediate-release tablets: The 10 and 20 mg tablets are not recommended for children under 3 years. The 50 mg tablets are not recommended for children.
-Side effects associated with opioids, apart from constipation, generally reduce with time. Anticipation and management of these effects may improve tolerability. Patients taking this drug may require an antiemetic during early therapy.
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