WARNINGS
Impaired Respiration
Respiratory depression is the chief hazard of DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS. Respiratory depression occurs most frequently in overdose situations, 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 8 mg 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.
Drug Dependence
DILAUDID is a Schedule II narcotic. DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS can produce drug dependence of the morphine type and therefore have the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of DILAUDID, which should be prescribed and administered with the degree of caution appropriate to the use of morphine. Abrupt discontinuance in the administration of DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS in patients who are physically dependent on opioids is likely to result in a withdrawal syndrome (see DRUG ABUSE AND DEPENDENCE).
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 8 mg 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 8 mg TABLETS (hydromorphone hydrochloride) may produce effects 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 8 mg 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 8 mg 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 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.
Precautions
Special Risk Patients
In general, opioids should be given 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.
The administration of opioid analgesics including DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS may obscure the diagnoses or clinical course in patients with acute abdominal conditions and may aggravate preexisting convulsions in patients with convulsive disorders.
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. Opioid administration at very high doses is associated with seizures and myoclonus in a variety of diseases where pain control is the primary focus.
Use in Ambulatory Patients
DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients should be cautioned accordingly. DILAUDID may produce orthostatic hypotension in ambulatory patients. The addition of other CNS depressants to DILAUDID therapy may produce additive depressant effects, and DILAUDID should not be taken with alcohol.
Use in Biliary Surgery
Opioid analgesics, including DILAUDID ORAL LIQUID and DILAUDID 8 mg 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.
Use in Drug and Alcohol Dependent Patients
DILAUDID should be used 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. Abuse of DILAUDID in combination with other CNS depressant drugs can result in serious risk to the patient.
Drug Interactions
The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Opioid analgesics, including DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS, may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal carcinogenicity studies have not been performed with DILAUDID.
DILAUDID was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro chromosome aberration assay in human lymphocytes, or in the in vivo mouse bone marrow micronucleus test.
Fertility in male or female rats was not affected after daily oral administration at doses up to 7 mg/kg/day (41 mg/m2). DILAUDID was dosed from 4 weeks prior to mating in males and 2 weeks prior to mating in females.
Pregnancy
Pregnancy Category C
Neither embryo-fetal toxicity nor teratogenic effects were observed following administration of DILAUDID at oral doses up to 7 mg/kg/day (41 mg/m2) in rats from Day 6 to Day 17 of gestation and up to 25 mg/kg/day (315 mg/m2) in rabbits from Day 6 to Day 20 of gestation.
Literature reports of hydromorphone hydrochloride administration to pregnant Syrian hamsters show that DILAUDID is teratogenic at a dose of 20 mg/kg which is 600 times the human dose. A maximal teratogenic effect (50% of fetuses affected) in the Syrian hamster was observed at a dose of 125 mg/kg (738 mg/m2).
There are no well-controlled studies in women. Hydromorphone is known to cross placental membranes. DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus (see Labor and Delivery and DRUG ABUSE AND DEPENDENCE).
Nonteratogenic effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Approaches to the treatment of this syndrome have included supportive care and, when indicated, drugs such as paregoric or phenobarbital.
Labor and Delivery
DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS are contraindicated in Labor and Delivery (see CONTRAINDICATIONS).
Nursing Mothers
Low levels of opioid analgesics have been detected in human milk. As a general rule, nursing should not be undertaken while a patient is receiving DILAUDID ORAL LIQUID and DILAUDID 8 mg TABLETS since it, and other drugs in this class, may be excreted in the milk.
Pediatric Use
Safety and effectiveness in children have not been established.
Geriatric Use
Clinical studies of DILAUDID did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see INDIVIDUALIZATION OF DOSAGES and PRECAUTIONS).
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