FDA label 7c5b0ea0-2fcd-4b79-8a09-e32df574c622

WARNING: DILAUDID ORAL LIQUID AND DILAUDID TABLETS CONTAINHYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLEDOPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE,HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OFPRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDSAND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVEHYPNOTICS)POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTSOF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORYDEPRESSION THAT MIGHT RESULT IN DEATH.

WARNINGS Respiratory Depression Respiratory depression is the chief hazard of DILAUDID ORAL LIQUID and DILAUDID 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. DILAUDID ORAL LIQUID and DILAUDID TABLETS should be used 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. In such patients even usual therapeutic doses of opioid analgesics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. DILAUDID ORAL LIQUID and DILAUDID TABLETS containhydromorphone, which is a potent Schedule II controlled opioidagonist. Schedule II opioid agonists, including morphine,oxymorphone, oxycodone, fentanyl, and methadone, have the highestpotential for abuse and risk of producing respiratory depression.Alcohol, other opioids and central nervous system depressants(sedative-hypnotics) potentiate the respiratory depressant effects ofhydromorphone, increasing the risk of respiratory depression thatmight result in death. Misuse, Abuse, and Diversion of Opioids Hydromorphone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. DILAUDID can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing DILAUDID in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Prescribers should monitor all patients receiving opioids for signs of abuse, misuse, and addiction. Furthermore, patients should be assessed for their potential for opioid abuse prior to being prescribed opioid therapy. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness (e.g., depression). Opioids may still be appropriate for use in these patients, however, they will require intensive monitoring for signs of abuse. DILAUDID has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices pose a significant risk to the abuser that could result in overdose or death (see WARNINGS and DRUG ABUSE AND DEPENDENCE ). 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. Interactions with Alcohol and Drugs of Abuse Hydromorphone may be expected to have additive effects whenused in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Neonatal Withdrawal Syndrome Infants born to mothers physically dependent on DILAUDID will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms (see DRUG ABUSE AND DEPENDENCE ). Head Injury and Increased Intracranial Pressure The respiratory depressant effects of DILAUDID ORAL LIQUID and DILAUDID TABLETS with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure. Opioid analgesics including DILAUDID ORAL LIQUID and DILAUDID TABLETS (hydromorphone hydrochloride) may produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in intracranial pressure in patients with head injuries. Hypotensive Effect Opioid analgesics, including DILAUDID ORAL LIQUID and DILAUDID TABLETS, may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics (see PRECAUTIONS - Drug Interactions ). Therefore, DILAUDID ORAL LIQUID and DILAUDID TABLETS should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Sulfites Contains sodium metabisulfite, a sulfite that may cause allergictypereactions 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.

ADVERSE REACTIONS The major hazards of DILAUDID ORAL LIQUID and DILAUDID TABLETS include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred. The most frequently observed 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 General and CNS Weakness, headache, agitation, tremor, uncoordinated musclemovements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure Cardiovascular Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension Respiratory Bronchospasm and laryngospasm Gastrointestinal Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alteration Genitourinary Urinary retention or hesitancy, antidiuretic effects Dermatologic Urticaria, other skin rashes, diaphoresis