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  • Dilaudid Oral
    (Hydromorphone HCl) - Purdue Pharma

    BOXED WARNING

    Contains hydromorphone, a Schedule II controlled opioid agonist with the highest potential for abuse and risk of respiratory depression. Alcohol, other opioids, and CNS depressants (eg, sedative-hypnotics) potentiate respiratory depressant effects, increasing the risk of respiratory depression that may result in death.

    View FDA-Approved Full Prescribing Information for Dilaudid Liquid and Tablets

    THERAPEUTIC CLASS

    Opioid analgesic

    DEA CLASS

    CII

    INDICATIONS

    Management of pain in patients where an opioid analgesic is appropriate.

    ADULT DOSAGE

    Adults: Individualize dose. Periodically reassess after the initial dosing. (Sol) Usual: 2.5-10mg q3-6h ud by clinical situation. (Tab) Initial: 2-4mg q4-6h. Titrate: May increase gradually if analgesia is inadequate, as tolerance develops, or if pain severity increases. (Sol/Tab): Non-Opioid-Tolerant: Initial: 2-4mg q4h. Patients Taking Opioids: Base starting dose on prior opioid usage; refer to PI for conversion from prior opioid. Give only 1/2 to 2/3 of the estimated dose for the 1st few doses, then increase PRN according to response. Elderly: Start at lower end of dosing range. Hepatic/Renal Impairment: Start on a lower dose and closely monitor during titration; use oral liquid to adjust the dose. Chronic Pain: Administer dose around-the-clock. May give a supplemental dose of 5-15% of the total daily usage q2h PRN.

    HOW SUPPLIED

    Sol: 1mg/mL [473mL]; Tab: 2mg, 4mg, 8mg* *scored

    CONTRAINDICATIONS

    Respiratory depression in the absence of resuscitative equipment, status asthmaticus, obstetrical analgesia.

    WARNINGS/PRECAUTIONS

    Respiratory depression is more likely to occur in elderly, debilitated, and those suffering from conditions accompanied by hypoxia or hypercapnia; extreme caution with chronic obstructive pulmonary disease (COPD) or cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. May cause neonatal withdrawal syndrome. Respiratory depressant effects with carbon dioxide retention and secondary elevation of CSF pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure (ICP). May produce effects on pupillary response and consciousness which can obscure the clinical course and neurologic signs of further increase in ICP in patients with head injuries. May cause severe hypotension; caution with circulatory shock. Contains sodium metabisulfite; may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Caution in elderly/debilitated and those with severe pulmonary/hepatic/renal impairment, myxedema/hypothyroidism, adrenocortical insufficiency (eg, Addison's disease), CNS depression or coma, toxic psychoses, prostatic hypertrophy, urethral stricture, gallbladder disease, acute alcoholism, delirium tremens, kyphoscoliosis, or following GI surgery; reduce initial dose. May obscure the diagnosis or clinical course in patients with acute abdominal conditions. May aggravate preexisting convulsions in patients with convulsive disorders. Mild to severe seizures and myoclonus reported in severely compromised patients administered high doses of parenteral hydromorphone. Caution with alcoholism and other drug dependencies. May impair mental/physical abilities. May produce orthostatic hypotension in ambulatory patients. May cause spasm of the sphincter of Oddi; caution in patients about to undergo biliary tract surgery. Physical dependence and tolerance may occur. Do not abruptly d/c.

    ADVERSE REACTIONS

    Respiratory depression, apnea, lightheadedness, dizziness, sedation, N/V, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus.

    DRUG INTERACTIONS

    See Boxed Warning. Concomitant use with other CNS depressants (eg, general anesthetics, phenothiazines, tranquilizers) may produce additive depressant effects; use with caution and in reduced dosages. Do not give with alcohol. May enhance action of neuromuscular blocking agents and produce an excessive degree of respiratory depression. May cause severe hypotension with phenothiazines or general anesthetics. Mixed agonist/antagonist analgesics (pentazocine, nalbuphine, butorphanol, buprenorphine) may reduce the analgesic effect and/or may precipitate withdrawal symptoms; use with caution.

    PREGNANCY

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    Opioid analgesic; pure opioid agonist. Has not been established. Believed to express pharmacologic effects by combining with specific CNS opiate receptors.

    PHARMACOKINETICS

    Absorption: Rapid. (Tab) Bioavailability (24%); Cmax=5.5ng; Tmax=0.74 hrs; AUC=23.7ng•hr/mL. (Sol) Cmax=5.7ng; Tmax=0.73 hrs; AUC=24.6ng•hr/mL. Distribution: Plasma protein binding (8-19%); Vd=302.9L (IV bolus); crosses placenta; found in breast milk. Metabolism: Liver (extensive) via glucuronidation; hydromorphone-3-glucuronide (metabolite). Elimination: Urine; T1/2=2.6 hrs (tab), 2.8 hrs (sol).

    ASSESSMENT

    Assess for risk factors for drug abuse or addiction, pain type/severity, prior opioid therapy, opioid tolerance, respiratory depression, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, asthma, renal/hepatic impairment, pregnancy/nursing status, possible drug interactions, or any other conditions where treatment is contraindicated or cautioned.

    MONITORING

    Monitor for respiratory depression, sedation, CNS depression, aggravation/induction of seizures/convulsions, increase in ICP, hypotension, tolerance, physical dependence, and other adverse reactions. Routinely monitor for signs of misuse, abuse, and addiction.

    PATIENT COUNSELING

    Inform that medication may cause severe adverse effects (eg, respiratory depression) if not taken ud. Instruct to report pain and adverse experiences occurring during therapy. Advise not to adjust dose or combine with alcohol or other CNS depressants without prescriber's consent. Inform that drug may impair mental/physical abilities; instruct to use caution when performing hazardous tasks (eg, operating machinery/driving). Advise to consult physician if pregnant or planning to become pregnant. Inform that drug has potential for abuse; instruct to protect it from theft and never to share with others. Advise to avoid abrupt withdrawal if taking medication for more than a few weeks and cessation of therapy is indicated. Instruct to keep drug in a secure place, and to destroy unused tabs by flushing down toilet.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Refer to PI for safety and handling instructions. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light.