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Hydromorphone HCI Tablets, USP CII 2 mg

INDICATIONS AND USAGE

Hydromorphone Hydrochloride Tablets, USP (CII) are indicated for the management of pain in patients where an opioid analgesic is appropriate.

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

  • Hydromorphone hydrochloride tablets are contraindicated in: patients with known
    • hypersensitivity to hydromorphone
    • patients with respiratory depression in the absence of resuscitative equipment
    • patients with status asthmaticus
  • Hydromorphone hydrochloride tablets are also contraindicated for use in obstetrical analgesia.

WARNINGS AND PRECAUTIONS

  • HYDROMORPHONE HYDROCHLORIDE TABLETS CONTAIN HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVE HYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.
  • Respiratory depression is the chief hazard of hydromorphone hydrochloride tablets. Respiratory depression is more likely to occur in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.
  • Use with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or in patients with preexisting respiratory depression.
  • The adverse effects of narcotics may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may obscure the clinical course of patients with head injuries or acute abdominal conditions.
  • Use with caution and the initial dose should be reduced in the elderly or debilitated and those with severe impairment of hepatic, pulmonary or renal functions; myxedema or hypothyroidism; adrenocortical insufficiency (e.g., Addison’s Disease); CNS depression or coma; toxic psychoses; prostatic hypertrophy or   urethral stricture; gall bladder disease; acute alcoholism; delirium tremens; kyphoscoliosis or following gastrointestinal surgery.
  • Reports of mild to severe seizures and myoclonus have been reported in severely compromised patients, administered high doses of parenteral hydromorphone, for cancer and severe pain.
  • Use with caution in patients with alcoholism and other drug dependencies due to the increased frequency of opioid tolerance, dependence, and the risk of addiction observed in these patient populations.
  • Opioid analgesics including hydromorphone hydrochloride tablets should also be used with caution in patients about to undergo surgery of the biliary tract since it may cause spasm of the sphincter of Oddi.
  • Hydromorphone hydrochloride tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery).

ADVERSE REACTIONS

  • Severe adverse reactions: respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, shock, and cardiac arrest.
  • The most common adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

USE IN SPECIFIC POPULATIONS

  • Hydromorphone crosses the placenta. Hydromorphone is also found in low levels in breast milk, and may cause respiratory compromise in newborns when administered during labor or delivery. Infants born to mothers physically dependent on hydromorphone hydrochloride tablets will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
  • Safety and effectiveness in pediatric patients have not been established.
  • Hydromorphone should be used with caution in the elderly and in those with hepatic or renal impairment.

Description White/Round Tab
Dosage Strength 2 mg
Compares To Dilaudid®
Identification Code Debossed with M one side; 2 on the reverse side
Rating AB

Order Information

NDC # Package Size Case Quantity
0406-3243-01 100's 12

For additional information on Hydromorphone HCI Tablets, USP CII 2 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

Dilaudid is a registered trademark of Purdue Pharma L.P.