Dilaudid (hydromorphone) C-II - Abbott Laboratories - Small Molecule

Abstinence syndrome: If drug is abruptly discontinued, an abstinence syndrome may occur that is characterized restlessness, lacrimation, rhinorrhea, yawning, perspiration, gooseflesh, restless sleep, ?yen,? and mydriasis over first 24 h; these symptoms may increase over next 72 h and be accompanied by increasing irritability, anxiety, weakness, twitching and spasms of muscles, kicking movements, severe backache, abdominal and leg pains, abdominal and muscle cramps, hot and cold flashes, insomnia, nausea, anorexia, vomiting, intestinal spasm, diarrhea, coryza and repetitive sneezing, increase in body temperature, blood pressure, respiratory rate, and heart rate. Most observable symptoms disappear in 5-14 days without treatment, although there may be a phase of secondary or chronic abstinence that may last for 2-6 mo that is characterized by insomnia, irritability, and muscular aches. Detoxification is unlikely for the cancer patient. If syndrome becomes severe, patient may be given methadone. Temporary administration of tranquilizers and sedatives may help reduce patient anxiety; treat GI disturbances or dehydration accordingly.
Seizures: Use of this drug may aggravate convulsions in patients with convulsive disorders.
Pancreatic/biliary tract disease: Use this drug may cause spasm of sphincter of Oddi; use caution in patients with biliary tract disease, including acute pancreatitis.
Adverse reactions: Some adverse reactions may be more prominent in ambulatory patients; some adverse reactions in these patients may be alleviated if patient is in a supine position.
Other special-risk patients: Use caution and reduce initial dose in elderly or debilitated patients and those with severe hepatic, pulmonary, or renal impairment, adrenocortical insufficiency (Addison's disease), myxedema or hypothyroidism, CNS depression or coma, toxic psychoses, prostatic hypertrophy or urethral stricture, gallbladder disease, acute alcoholism, delirium tremens, or kyphoscoliosis or following GI surgery.
Pregnancy: Use only if expected benefit justifies potential fetal risk. Neonates of mothers who have used opioids regularly during therapy may exhibit signs of withdrawal, including irritability and excessive crying, tremors, hyperactive reflex, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever; intensity of syndrome does not always correlate with duration of maternal use or dose. In some cases, 0.7-1 mg/kg of chlorpromazine q6h and 2-4 drops/kg of paregoric q4h have been used to treat withdrawal symptoms in infants. Duration of therapy was 4-28 days, with dosage decreased as tolerated (Pregnancy Category C).
Labor and delivery: Use of Dilaudid-HP, oral liquid, and 8-mg tablets is contraindicated during labor and delivery. Administration shortly before delivery may result in neonatal respiratory depression, especially if high doses are used.
Nursing mothers: Do not use in nursing mothers.
Pediatric use: Safety and effectiveness not established.
Adverse Reactions
With Dilaudid
Cardiovascular: Orthostatic hypotension (with sudden standing after receiving an injection); circulatory depression, peripheral circulatory collapse, cardiac arrest (with rapid IV injection).
Digestive: Constipation; nausea and vomiting (infrequent).
Genitourinary: Ureteral spasm, spasm of vesical sphincters, urinary retention.
Neurologic: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.
Respiratory: Respiratory depression.
With Dilaudid oral liquid and 8-mg tablets
The most frequent reactions are italicized. Includes reactions seen with opioid analgesics in general.
Cardiovascular: Chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.
Dermatologic: Pruritus, sweating, urticaria, other skin rashes, diaphoresis.
Digestive: Nausea, vomiting, dry mouth, constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alteration.
Genitourinary: Urinary retention or hesitancy, antidiuretic effects.
Neurologic: Lightheadedness, dizziness, sedation, dysphoria, euphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, alternations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia, miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure.
Respiratory: Bronchospasm, laryngospasm.
With Dilaudid-HP
The most frequent reactions are italicized. Includes reactions seen with opioid analgesics in general.
Cardiovascular: Facial flushing, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.
Dermatologic: Sweating, pruritus, urticaria, other skin rashes, wheal and flare over vein (with IV injection), diaphoresis; pain at injection site (rare).
Digestive: Nausea, vomiting, dry mouth, constipation, biliary tract spasm, anorexia, diarrhea, cramps, taste alterations.
Genitourinary: Urinary retention or hesitancy, antidiuretic effects.
Neurologic: Lightheadedness, dizziness, sedation, dysphoria, euphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, mood alterations (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia, miosis, disorientation, visual disturbances, insomnia, increased intracranial pressure; transient hallucinations.
Respiratory: Bronchospasm, laryngospasm.
Drug Interactions
CNS depressants: Respiratory depression, hypotension, and profound sedation or coma with use of other narcotics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants, or other CNS depressants, including alcohol. Reduce dose of one or both agents.
Neuromuscular blocking agents: Increased degree of respiratory depression.
Phenothiazines: Possible increased or decreased analgesic effect.