morphine sulfate injection, USP VIAL Adverse Reactions

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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 (5.2)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4)]
Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)]
Myoclonic Activity [see Warnings and Precautions (5.6)]
Opioid Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)]
Adrenal Insufficiency [see Warnings and Precautions (5.11)]
Severe Hypotension [see Warnings and Precautions (5.12)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)]
Seizures [see Warnings and Precautions (5.15)]
Withdrawal [see Warnings and Precautions (5.16)]
Urinary Retention [see Warnings and Precautions (5.17)]
Orthostatic Hypotension [see Warnings and Precautions (5.18)]

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 most serious adverse reactions encountered during administration of preservative-free morphine sulfate injection were respiratory depression and/or respiratory arrest.

Cardiovascular System: While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.

Central Nervous System: Myoclonus, seizures, dysphoric reactions, toxic psychosis, dizziness, euphoria, anxiety, confusion, headache. Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation and generally responds to bed rest and/or other conventional therapy.

Gastrointestinal System: Nausea, vomiting, constipation.

Skin: Generalized pruritus, urticaria, wheals, and/or local tissue irritation. Single-dose epidural or intrathecal administration is accompanied by a high incidence of dose-related generalized pruritus.

Urinary System: Urinary retention, oliguria.

Peripheral edema: There are several reports of peripheral edema.

Other: Other adverse reactions reported following morphine therapy include depression of cough reflex, interference with thermal regulation, peripheral edema.

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 preservative-free morphine sulfate injection.

Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time. [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8)].

Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

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Adverse Reactions

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 (5.2)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4)]
Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)]
Myoclonic Activity [see Warnings and Precautions (5.6)]
Opioid Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)]
Adrenal Insufficiency [see Warnings and Precautions (5.11)]
Severe Hypotension [see Warnings and Precautions (5.12)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)]
Seizures [see Warnings and Precautions (5.15)]
Withdrawal [see Warnings and Precautions (5.16)]
Urinary Retention [see Warnings and Precautions (5.17)]
Orthostatic Hypotension [see Warnings and Precautions (5.18)]

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 most serious adverse reactions encountered during administration of preservative-free morphine sulfate injection were respiratory depression and/or respiratory arrest.

Cardiovascular System: While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.

Central Nervous System: Myoclonus, seizures, dysphoric reactions, toxic psychosis, dizziness, euphoria, anxiety, confusion, headache. Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation and generally responds to bed rest and/or other conventional therapy.

Gastrointestinal System: Nausea, vomiting, constipation.

Skin: Generalized pruritus, urticaria, wheals, and/or local tissue irritation. Single-dose epidural or intrathecal administration is accompanied by a high incidence of dose-related generalized pruritus.

Urinary System: Urinary retention, oliguria.

Peripheral edema: There are several reports of peripheral edema.

Other: Other adverse reactions reported following morphine therapy include depression of cough reflex, interference with thermal regulation, peripheral edema.

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 preservative-free morphine sulfate injection.

Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time. [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8)].

Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

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