Morphine Sulfate

MORPHINE SULFATE- morphine sulfate injection, solution
Fresenius Kabi

1 INDICATIONS AND USAGE

Morphine sulfate is an opioid agonist indicated for the management of pain not responsive to non-narcotic analgesics.

2 DOSAGE AND ADMINISTRATION

Morphine Sulfate Injection is intended for intravenous and intramuscular administration.

2.1 General Dosing Considerations

Avoid Medication Errors

Morphine Sulfate Injection is available in five concentrations for direct injection. Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and total dose in volume.

Administration of Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

2.2 Individualization of Dosage

Adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of Morphine Sulfate Injection, USP, give attention to the following:

  • the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  • the reliability of the relative potency estimate used to calculate the equivalent Morphine Sulfate Injection, USP dose needed;
  • the patient’s degree of opioid tolerance;
  • the general condition and medical status of the patient;
  • concurrent medications;
  • the type and severity of the patient’s pain;
  • risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction.

The following dosing recommendation, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in management of the pain of each individual patient.

Continual re-evaluation of the patient receiving Morphine Sulfate Injection, USP is important, with special attention to the management of pain and the occurrence of side effects associated with therapy.

2.3 Direct Intravenous Injection

The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain.

  • Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration.
  • Administer the injection slowly.
  • Monitor the patient closely for signs of respiratory and central nervous system depression.

2.4 Intramuscular Injection

The initial IM dose is 10 mg, every 4 hours as needed to manage pain (based on a 70 kg adult).

  • Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration.
  • Monitor the patient closely for signs of respiratory and central nervous system depression.

2.5 Dosing with Hepatic and Renal Impairment

Morphine Sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients with lower doses of Morphine Sulfate Injection, USP and titrate slowly while carefully monitoring for respiratory and central nervous system depression [see Use in Specific Populations (8.7 and 8.8)].

3 DOSAGE FORMS AND STRENGTHS

Morphine Sulfate Injection, USP is available in the following strengths for intravenous and intramuscular administration.

2 mg/mL in 1 mL prefilled disposable syringe for IV or IM use.

4 mg/mL in 1 mL prefilled disposable syringe for IV or IM use.

5 mg/mL in 1 mL prefilled disposable syringe for IV or IM use.

8 mg/mL in 1 mL prefilled disposable syringe for IV or IM use.

10 mg/mL in 1 mL prefilled disposable syringe for IV or IM use.

4 CONTRAINDICATIONS

Morphine sulfate is contraindicated in:

  • patients with known hypersensitivity to morphine.
  • patients with respiratory depression in the absence of resuscitative equipment.
  • patients with acute or severe bronchial asthma or hypercarbia.
  • any patient who has or is suspected of having paralytic ileus.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Medication Errors

Morphine Sulfate Injection is available in five concentrations for direct injection. Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

5.2 Cardiovascular Instability

While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulatory catecholamines. Have Naloxone Injection and resuscitative equipment immediately available for use in case of life-threatening or intolerable side effects and whenever morphine therapy is being initiated.

5.3 Respiratory Depression

Respiratory depression is the primary risk of Morphine Sulfate Injection, USP. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. Morphine administration should be limited to use by those familiar with the management of respiratory depression. Rapid intravenous administration may result in chest wall rigidity.

Patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia or pre-existing respiratory depression have an increased risk of increased airway resistance and decrease respiratory drive to the point of apnea with use of Morphine Sulfate Injection, USP. Therefore, consider alternative non-opioid analgesics, and use Morphine Sulfate Injection, USP only under careful medical supervision at the lowest effective dose in such patients.

5.4 Central Nervous System (CNS) Toxicity

Excitation of the central nervous system, resulting in convulsion, may accompany high doses of morphine given intravenously. Dysphoric reactions may occur after any size dose and toxic psychoses have been reported.

5.5 Misuse, Abuse and Diversion of Opioids

Morphine sulfate is an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty [see Drug Abuse and Dependence (9)].

Morphine sulfate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Morphine Sulfate Injection, USP in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Concerns about abuse, addiction and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

5.6 Central Nervous System (CNS) Depressants

The depressant effects of morphine are potentiated by the presence of other CNS depressants such as alcohol, sedatives, antihistamines or psychotropic drugs. Use of morphine in conjunction with other CNS active drugs may increase the risk of respiratory depression, hypotension, profound sedation, coma, or death.

5.7 Increased Intracranial Pressure or Head Injury

Use Morphine Sulfate Injection with extreme caution in patients with head injury or increased intracranial pressure. In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of Morphine Sulfate Injection, USP and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Pupillary changes (miosis) from morphine may obscure the existence, extent and course of intracranial pathology. Clinicians should maintain a high index of suspicion for adverse drug reactions when evaluating altered mental status or movement abnormalities in patients receiving this modality of treatment.

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