Morphine Sulfate (Page 3 of 8)

5.9 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Morphine Sulfate Injection, (Auto-Injector) may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Morphine Sulfate Injection, (Auto-Injector).

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Morphine Sulfate Injection, (Auto-Injector) in patients with impaired consciousness or coma.

5.10 Risks of Use in Patients with Gastrointestinal Conditions

Morphine Sulfate Injection, (Auto-Injector) is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The morphine sulfate in Morphine Sulfate Injection, (Auto-Injector) may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

5.11 Increased Risk of Seizures in Patients with Seizure Disorders

The morphine sulfate in Morphine Sulfate Injection, (Auto-Injector) may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Morphine Sulfate Injection, (Auto-Injector) therapy.

5.12 Withdrawal

Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Morphine Sulfate Injection, (Auto-Injector). In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms.

5.13 Risks of Driving and Operating Machinery

Morphine Sulfate Injection, (Auto-Injector) may impair the mental and/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 Injection, (Auto-Injector) and know how they will react to the medication.

5.14 Exposure, Hypothermia, Immersion, and Shock

Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock, since impaired perfusion may prevent complete absorption. If repeated injections are administered, an excessive amount may be suddenly absorbed if normal circulation is re-established.

5.15 Accidental Activation

Morphine Sulfate Injection, (Auto-Injector) contains a spring-driven injection mechanism and is capable of inflicting injury if accidentally misused. The product should remain in its original container with the safety in place until actually in use, and in no case should the product be carried with the red safety cap removed. Intramuscular or subcutaneous naloxone in the dosage of 0.4 mg is antidotal in case of accidental injection, but may have to be repeated at 30-60 minute intervals for several doses.

6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
  • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)]
  • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.3)]
  • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4)]
  • Adrenal Insufficiency [see Warnings and Precautions (5.7)]
  • Severe Hypotension [see Warnings and Precautions (5.8)]
  • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.10)]
  • Seizures [see Warnings and Precautions (5.11)]
  • Withdrawal [see Warnings and Precautions (5.12)]

The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The major hazards of morphine, as with other narcotic analgesics, are respiratory depression, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest have occurred, particularly with overdosage, rapid intravenous administration, and pre-existing hypovolemic shock. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously.

The most frequently observed adverse reactions included sedation, lightheadedness, dizziness, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down [see Warnings and Precautions (5.8)].

Other possible adverse reactions included:

Central Nervous System: Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation.

Gastrointestinal: Constipation, biliary tract spasm.

Cardiovascular: Tachycardia, bradycardia, palpitation, faintness, syncope, and orthostatic hypotension.

Genitourinary: Oliguria and urinary retention; an antidiuretic effect has been reported.

Allergic: Allergic reactions to opioids occur infrequently; pruritus, urticaria and other skin rashes are most common. Rarely, anaphylactoid reactions have been reported following intravenous administration.

Other: Opioid-induced histamine release may be responsible for the flushing of the face, sweating, and pruritus often seen with these drugs. Wheals and urticaria at the site of injection are probably related to histamine release. Local tissue irritation, pain and induration have been reported following repeated subcutaneous injection. Morphine, like other opioids, may alter temperature regulation in susceptible individuals and will depress the cough reflex.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Morphine Sulfate Injection, (Auto-Injector).

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2)].

7 DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with Morphine Sulfate Injection, (Auto-Injector).

Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Injection, (Auto-Injector)
Benzodiazepines and other Central Nervous System (CNS) Depressants
Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.4)].
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.
Serotonergic Drugs
Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
Intervention: If concomitant use is warranted, carefully observe the patient during treatment initiation. Discontinue Morphine Sulfate Injection, (Auto-Injector) if serotonin syndrome is suspected.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.6)].
Intervention: Do not use Morphine Sulfate Injection, (Auto-Injector) in patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Examples: phenelzine, tranylcypromine, linezolid
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Clinical Impact: May reduce the analgesic effect of Morphine Sulfate Injection, (Auto-Injector) and/or precipitate withdrawal symptoms.
Intervention: Avoid concomitant use.
Examples: butorphanol, nalbuphine, pentazocine, buprenorphine
Muscle Relaxants
Clinical Impact: Morphine sulfate may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the frequency of injections of Morphine Sulfate Injection, (Auto-Injector) and/or decrease the dose of the muscle relaxant as necessary.
Diuretics
Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when Morphine Sulfate Injection, (Auto-Injector) is used concomitantly with anticholinergic drugs.

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