Hydromorphone Hydrochloride (Page 5 of 10)

5.14 Sulfites

Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Use of Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets is contraindicated in patients with hypersensitivity to sulfite-containing medications.

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)]
Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.5)]
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)]

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious adverse reactions associated with Hydromorphone Hydrochloride include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Less Frequently Observed Adverse Reactions

Cardiac Disorders: tachycardia, bradycardia, palpitations

Eye Disorders: vision blurred, diplopia, miosis, visual impairment

Gastrointestinal Disorders: constipation, ileus, diarrhea, abdominal pain

General Disorders and Administration Site Conditions: weakness, feeling abnormal, chills

Hepatobiliary Disorders: biliary colic

Metabolism and Nutrition Disorders: decreased appetite

Musculoskeletal and Connective Tissue Disorders: muscle rigidity

Nervous System Disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope

Psychiatric Disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams

Renal and Urinary Disorders: urinary retention, urinary hesitation, antidiuretic effects

Respiratory, Thoracic, and Mediastinal Disorders: bronchospasm, laryngospasm

Skin and Subcutaneous Tissue Disorders: urticaria, rash, hyperhidrosis

Vascular Disorders: flushing, hypotension, hypertension

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydromorphone. Because these reactions are 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.

Confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.

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 Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets.

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 Hydromorphone Hydrochloride.

Table 1: Clinically Significant Drug Interactions with Hydromorphone Hydrochloride

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 (5.5)].

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, particularly during treatment initiation and dose adjustment. Discontinue Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets 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 affect 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 (5.3)].

If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.

Intervention:

The use of Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets is not recommended for patients taking MAOIs or within 14 days of stopping treatment.

Examples:

Phenelzine, tranylcypromine, linezolid.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Clinical Impact:

May reduce the analgesic effect of Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets and/or precipitate withdrawal symptoms.

Intervention:

Avoid concomitant use.

Examples:

Butorphanol, nalbuphine, pentazocine, buprenorphine.

Muscle Relaxants

Clinical Impact:

Hydromorphone 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 dosage of Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets and/or 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 Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets is used concomitantly with anticholinergic drugs.

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