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DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic. It is available in:
Ampules (for parenteral administration) containing:
1 mg, 2 mg, and 4 mg hydromorphone hydrochloride per mL with 0.2% sodium citrate, 0.2% citric acid solution. DILAUDID ampules are sterile.
Multiple Dose Vials (for parenteral administration) containing:
20 mL of solution. Each mL contains 2 mg hydromorphone hydrochloride and 0.5 mg edetate disodium with 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives. Sodium hydroxide or hydrochloric acid is used for pH adjustment. DILAUDID multiple dose vials are sterile.
Color Coded Tablets (for oral administration) containing:
2 mg hydromorphone hydrochloride (orange tablet) and D&C red #30 Lake dye, D&C yellow #10 Lake dye, lactose, and magnesium stearate.
4 mg hydromorphone hydrochloride (yellow tablet) and D&C yellow #10 Lake dye, lactose, and magnesium stearate.
Suppositories (for rectal administration) containing:
3 mg hydromorphone hydrochloride in a cocoa butter base with silicon dioxide.
Non-Sterile Powder (for prescription compounding) containing hydromorphone hydrochloride. The chemical name of DILAUDID (hydromorphone hydrochloride) is 4,5(alpha)-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is:
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DILAUDID is an opioid analgesic; its principal therapeutic effect is relief of pain. The precise mechanism of action of DILAUDID and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. There is no intrinsic limit to the analgesic effect of DILAUDID; like morphine, adequate doses will relieve even the most severe pain. Clinically, however, dosage limitations are imposed by the adverse effects, primarily respiratory depression, nausea, and vomiting, which can result from high doses.
DILAUDID has diverse additional actions. It may produce drowsiness, changes in mood and mental clouding, depress the respiratory center and the cough center, stimulate the vomiting center, produce pinpoint constriction of the pupil, enhance parasympathetic activity, elevate cerebrospinal fluid pressure, increase biliary pressure, produce transient hyperglycemia.
Generally, the analgesic action of parenterally administered DILAUDID is apparent within 15 minutes and usually remains in effect for more than five hours. The onset of action of oral DILAUDID is somewhat slower, with measurable analgesia occurring within 30 minutes.
In human plasma the half-life of a DILAUDID 4 mg tablet is 2.6 hours. In a random crossover study in six subjects, 4 mg of oral DILAUDID produced a mean concentration/time curve similar to that of 2 mg DILAUDID I.V., after the first hour.
The dosage of opioid analgesics like hydromorphone hydrochloride should be individualized for any given patient, since adverse events can occur at doses that may not provide complete freedom from pain (see INDIVIDUALIZATION OF DOSAGE ).
Safe and effective administration of opioid analgesics to patients with acute or chronic pain depends upon a comprehensive assessment of the patient. The nature of the pain (severity, frequency, etiology, and pathophysiology), as well as the concurrent medical status of the patient, will affect selection of the starting dosage.
In non-opioid-tolerant patients, therapy with hydromorphone hydrochloride is typically initiated at an oral dose of 2-4 mg every four hours, but elderly patients may require lower doses (see PRECAUTIONS - Geriatric Use ).
In patients receiving opioids, both the dose and duration of analgesia will vary substantially depending on the patient's opioid tolerance. The dose should be selected and adjusted so that at least 3-4 hours of pain relief may be achieved. In patients taking opioid analgesics, the starting dose of DILAUDID should be based on prior opioid usage. This should be done by converting the total daily usage of the previous opioid to an equivalent total daily dosage of oral DILAUDID using an equianalgesic table (see below). For opioids not in the table, first estimate the equivalent total daily usage of oral morphine, then use the table to find the equivalent total daily dosage of DILAUDID.
Once the total daily dosage of DILAUDID has been estimated, it should be divided into the desired number of doses. Since there is individual variation in response to different opioid drugs, only 1/2 to 2/3 of the estimated dose of DILAUDID calculated from equivalence tables should be given for the first few doses, then increased as needed according to the patient's response.
In chronic pain, doses should be administered around-the-clock. A supplemental dose of 5-15% of the total daily usage may be administered every two hours on an "as-needed" basis.
Periodic reassessment after the initial dosing is always required. If pain management is not satisfactory, and in the absence of significant opioid-induced adverse events, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, the hydromorphone hydrochloride dose should be reduced. If this results in breakthrough pain at the end of the dosing interval, the dosing interval may need to be shortened. Dose titration should be guided more by the need for analgesia than the absolute dose of opioid employed.
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DILAUDID is indicated for the relief of moderate to severe pain such as that due to:
DILAUDID is contraindicated in: patients with known hypersensitivity to hydromorphone, patients with respiratory depression in the absence of resuscitative equipment, and in patients with status asthmaticus. DILAUDID is also contraindicated for use in obstetrical analgesia.
Impaired Respiration: Respiratory depression is the chief hazard of DILAUDID. 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 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 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 in patients who are physically dependent on opioids is likely to result in a withdrawal syndrome (see DRUG ABUSE AND DEPENDENCE ).
Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of DILAUDID 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 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, 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 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.
Special Risk Patients: DILAUDID should be used with caution and the initial dose should be reduced in elderly or debilitated patients and those with impaired renal, pulmonary, or hepatic function; myxedema or hypothyroidism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; toxic psychosis; prostatic hypertrophy or urethral stricture; gall bladder disease; acute alcoholism; delirium tremens; kyphoscoliosis or following gastrointestinal surgery. As with any opioid analgesic agent, the usual precautions should be observed and the possibility of respiratory depression should be kept in mind.
The administration of opioid analgesics, including DILAUDID, may obscure the diagnosis or clinical course of 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.
Cough Reflex: DILAUDID suppresses the cough reflex; as with all opioids, caution should be exercised when DILAUDID is used postoperatively and in patients with pulmonary disease.
Usage in Ambulatory Patients: DILAUDID may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or 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, 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: Patients receiving other opioid analgesics, general anesthetics, phenothiazines, tranquilizers, sedative hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with DILAUDID may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Opioid analgesics, including DILAUDID, may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression.
Parenteral Administration: The parenteral form of DILAUDID may be given intravenously, but the injection should be given very slowly. Rapid intravenous injection of opioid analgesics increases the possibility of side effects such as hypotension and respiratory depression.
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.
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/m 2 ). 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/m 2 ) in rats from day 6 to day 17 of gestation and up to 25 mg/kg/day (315 mg/m 2 ) 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/m 2 ). There are no well-controlled studies in pregnant women. Hydromorphone hydrochloride is known to cross placental membranes. DILAUDID 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 is 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 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.
General and Central Nervous System: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes (nervousness, apprehension, depression, floating feelings, dreams), light-headedness, weakness, headache, agitation, tremor, uncoordinated muscle movements, muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, sweating, flushing, dysphoria, euphoria and increased intracranial pressure may occur.
Gastrointestinal System: Dry mouth, constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, and taste alteration have been reported. Nausea and vomiting occur infrequently; they are more frequent in ambulatory than in recumbent patients. The antiemetic phenothiazines are useful in suppressing these effects; however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of opioid required to produce pain relief, while other phenothiazines reduce the amount of opioid required to produce a given level of analgesia. Prolonged administration of DILAUDID (hydromorphone hydrochloride) may produce constipation. Opiate agonist-induced increase in intraluminal pressure may endanger surgical anastomosis.
Cardiovascular System: Chills, shock, tachycardia, bradycardia, hypotension and hypertension have been reported. Circulatory depression, peripheral circulatory collapse and cardiac arrest have occurred after rapid intravenous injection. Orthostatic hypotension and fainting may occur if a patient stands up suddenly after receiving an injection of DILAUDID.
Genitourinary System: Ureteral spasm, antidiuretic effects, spasm of vesical sphincters and urinary retention or hesitancy have been reported.
Respiratory Depression: Bronchospasm and laryngospasm have been known to occur. DILAUDID produces dose-related respiratory depression by acting directly on brain stem respiratory centers. DILAUDID also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride (see OVERDOSAGE ) .
Dermatologic: Pruritis, urticaria, other skin rashes, and diaphoresis.
DILAUDID is a Schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore DILAUDID should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when DILAUDID is used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy. Withdrawal symptoms also may be precipitated in the patient with physical dependence by the administration of a drug with opioid antagonist activity, e.g., naloxone (see OVERDOSAGE ). Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. In chronic pain patients, and in opioid-tolerant cancer patients, the dose of DILAUDID should be guided by the degree of tolerance manifested.
In chronic pain patients in whom opioid analgesics including DILAUDID are abruptly discontinued, a severe abstinence syndrome should be anticipated. This may be similar to the abstinence syndrome noted in patients who withdraw from heroin. The latter abstinence syndrome may be characterized by restlessness, lacrimation, rhinorrhea, yawning, perspiration, gooseflesh, restless sleep or "yen" and mydriasis during the first 24 hours. These symptoms may increase in severity and over the next 72 hours may 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.
Because of excessive loss of fluids through sweating, or vomiting and diarrhea, patients experiencing the syndrome usually exhibit marked weight loss, dehydration, ketosis, and disturbances in acid-base balance. Cardiovascular collapse can occur. Without treatment most observable symptoms disappear in 5-14 days; however, there appears to be a phase of secondary or chronic abstinence, which may last for 2-6 months, characterized by insomnia, irritability, muscular aches, and autonomic instability.
In the treatment of physical dependence on DILAUDID, the patient may be detoxified by gradual reduction of the dosage, although this is unlikely to be necessary in the terminal cancer patient. If abstinence symptoms become severe, the patient may be detoxified with methadone. Temporary administration of tranquilizers and sedatives may aid in reducing patient anxiety. Gastrointestinal disturbances or dehydration should be treated accordingly.
Signs and Symptoms: Serious overdosage with DILAUDID is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.
Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. In cases of overdosage with oral DILAUDID, gastric lavage or induced emesis may be useful in removing unabsorbed drug from conscious patients. In unconscious patients with a secure airway, instill activated charcoal (30-100 g in adults, 1-2 g/kg in infants) via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal.
Opioid-Tolerant Patient: Since tolerance to the respiratory and CNS depressant effects of opioids develops concomitantly with tolerance to their analgesic effects, serious respiratory depression due to an acute overdose is unlikely to be seen in opioid-tolerant patients receiving the usual therapeutic dosage of DILAUDID for chronic pain.
NOTE : In such an individual who is physically dependent on opioids, administration of the usual dose of an opioid antagonist will precipitate an acute withdrawal syndrome. The severity will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed. If necessary to treat serious respiratory depression in the physically-dependent patient, the opioid antagonist should be administered with extreme care and by titration, using fractional (one fifth to one tenth) doses of the antagonist.
Non-Tolerant Patient: The opioid antagonist, naloxone, is a specific antidote against respiratory depression which may result from overdosage, or unusual sensitivity to DILAUDID. A dose of naloxone (usually given as a test dose of 0.4 mg, followed by up to 2.0 mg if needed) should be administered intravenously, if possible, simultaneously with respiratory resuscitation. The dose can be repeated in 3 minutes. Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression. Naloxone should be administered cautiously to persons who are known, or suspected to be physically dependent on DILAUDID (see Opioid-Tolerant Patient ). In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. Since the duration of action of DILAUDID may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. Apply other supportive measures when indicated.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
Parenteral: The usual starting dose is 1-2 mg subcutaneously or intramuscularly every 4 to 6 hours as necessary for pain control. The dose should be adjusted according to the severity of pain, as well as the patient's underlying disease, age, and size. Patients with terminal cancer may be tolerant to opioid analgesics and may, therefore, require higher doses for adequate pain relief. Intravenous or subcutaneous administration is usually not painful. Should intravenous administration be necessary, the injection should be given slowly , over at least 2 to 3 minutes, depending on the dose. A gradual increase in dose may be required if analgesia is inadequate, tolerance occurs, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in DILAUDID ampules and multiple dose vials. No loss of potency has been demonstrated.
Oral: The usual oral dose is 2 mg every 4 to 6 hours as necessary. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 4 mg or more every 4 to 6 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required. If pain is exceedingly severe, or if prompt response is desired, parenteral DILAUDID should be used initially in adequate amounts to control the pain.
Rectal: DILAUDID suppositories (3 mg) may provide longer duration of relief which could obviate additional medication during the sleeping hours. The usual adult dose is one (1) suppository inserted rectally every 6 to 8 hours or as directed by physician.
DILAUDID poses little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Patients and their families should be instructed to flush any DILAUDID that is no longer needed.
Access to abusable drugs such as DILAUDID presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.
Ampules: (One mL sterile solution for parenteral administration)
1 mg/mL ampules-Boxes of 10-
NDC #0074-2332-11.
2 mg/mL ampules-Boxes of 10-
NDC #0074-2333-11.
Boxes of 25-
NDC #0074-2333-26.
4 mg/mL ampules-Boxes of 10-
NDC #0074-2334-11.
Multiple Dose Vials: (20 mL sterile solution for parenteral administration)
2 mg/mL-20 mL multiple dose vials-
NDC #0074-2414-21.
Caution: The packaging (package) (vial stopper) of this product contains rubber latex which may cause allergic reactions.
2 mg tablet (orange, debossed with the Abbott logo on one side and the number 2 on the opposite side)-Bottles of 100-
NDC #0074-2415-14.
Abbo-Pac ® Unit Dose Packages of 100 (4 × 25)-
NDC #0074-2415-12.
Bottles of 500-NDC #0074-2415-54.
4 mg tablet (yellow, debossed with the Abbott logo on one side and the number 4 on the opposite side)-Bottles of 100-
NDC #0074-2416-14.
Abbo-Pac ® Unit Dose Packages of 100 (4 × 25)-
NDC #0074-2416-12.
Bottles of 500-NDC #0074-2416-54.
Rectal Suppositories: 3 mg suppositories-Boxes of 6-
NDC #0074-2451-07.
Non-Sterile Powder: For prescription compounding.
15 grain vial-NDC #0074-2428-16.
STORAGE: Parenteral and oral dosage forms of DILAUDID should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Protect from light. DILAUDID suppositories should be stored in a refrigerator between 2°-8°C (36°-46°F).
A Schedule II Narcotic. DEA order form required.
DILAUDID Ampules (1 mg/mL, 2 mg/mL and 4 mg/mL) and Multiple Dose Vials
Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA
DILAUDID Color Coded Tablets (2 mg and 4 mg), Rectal Suppositories and Non-Sterile Powder
Manufactured by Abbott Laboratories, North Chicago, IL 60064, USA
Revised: March, 2005
Ref. 03-5389-R3
ABBOTT LABORATORIES
NORTH CHICAGO, IL 60064, U.S.A.
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