Drug: Dilaudid

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of DILAUDID (hydromorphone hydrochloride) is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is: Each 5 mL (1 teaspoon) of DILAUDID ORAL LIQUID contains 5 mg of hydromorphone hydrochloride. In addition, other ingredients include purified water, methylparaben, propylparaben, sucrose, and glycerin. DILAUDID (hydromorphone hydrochloride) ORAL LIQUID may contain traces of sodium metabisulfite. Each DILAUDID 8 mg TABLET contains 8 mg hydromorphone hydrochloride. In addition, the tablets include lactose anhydrous, and magnesium stearate. DILAUDID (hydromorphone hydrochloride) 8 mg TABLET may contain traces of sodium metabisulfite.

Source: http://www.rxlist.com

The major hazards of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg 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 light-headedness, 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 muscle movements, 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. Drug Abuse And Dependence DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 MG TABLETS contain hydromorphone, a Schedule II controlled opioid agonist. Schedule II opioid substances which include morphine, oxycodone, oxymorphone, fentanyl, and methadone have the highest potential for abuse and risk of fatal overdose. Hydromorphone can be abused and is subject to criminal diversion. Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage, but it may occur after as little as a week of opioid use. Physical dependence and tolerance are separate and distinct from abuse and addiction. Addiction is a chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. “Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with, forging or counterfeiting prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are intended for oral use only. Misuse or abuse of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose a risk of overdose and death. This risk is increased with concurrent abuse of alcohol and other CNS depressants. Parenteral drug abuse can potentially result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. In addition, parenteral abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Safety And Handling Instructions DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Significant absorption from dermal exposure is unlikely; accidental dermal exposure to DILAUDID (hydromorphone hydrochloride) ORAL LIQUID should be treated by removal of any contaminated clothing and rinsing the affected area with cool water. Patients and their families should be instructed to flush any DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS that are no longer needed. Access to abuseable drugs such as DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS 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. Read the Dilaudid (hydromorphone hydrochloride) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

DILAUDID (hydromorphone hydrochloride) ORAL LIQUID: The usual adult oral dosage of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID is one-half (2.5 mL) to two teaspoonfuls (10 mL) (2.5 mg - 10 mg) every 3 to 6 hours as directed by the clinical situation. Oral dosages higher than the usual dosages may be required in some patients. DILAUDID (hydromorphone hydrochloride) 8 mg TABLET: The usual starting dose for DILAUDID (hydromorphone hydrochloride) tablets is 2 mg to 4 mg, orally, every 4 to 6 hours. Appropriate use of the DILAUDID (hydromorphone hydrochloride) 8 mg TABLET must be decided by careful evaluation of each clinical situation. A gradual increase in dose may be required if analgesia is inadequate, as tolerance develops, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. Patients with hepatic and renal impairment should be started on a lower starting dose (See CLINCIAL PHARMCOLOGY: Pharmacokinetics and Metabolism). Individualization of Dosage 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. 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 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 (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) . Once the total daily dosage of DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) calculated from equivalence tables should be given for the first few doses, then increased as needed according to the patient's response. Since the pharmacokinetics of hydromorphone are affected in hepatic and renal impairment with a consequent increase in exposure, Patients with hepatic and renal impairment should be started on a lower starting dose (See CLINCIAL PHARMCOLOGY: Pharmcokinetics and Metabolism). 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 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. OPIOID ANALGESIC EQUIVALENTS WITH APPROXIMATELY EQUIANALGESIC POTENCY*
Nonproprietary (Trade) Name IM or SC Dose ORAL Dose Morphine sulfate 10 mg 40-60 mg Hydromorphone HCl (DILAUDID) 1.3-2 mg 6.5-7.5 mg Oxymorphone HCl (Numorphan) 1-1.1 mg 6.6 mg Levorphanol tartrate (Levo-Dromoran) 2-2.3 mg 4 mg Meperidine, pethidine HCl (Demerol) 75-100 mg 300-400 mg Methadone HCl (Dolophine) 10 mg 10-20 mg * Dosages, and ranges of dosages represented, are a compilation of estimated equipotent dosages from published references comparing opioid analgesics in cancer and severe pain.

Source: http://www.rxlist.com

Drug Interactions with Other CNS Depressants: 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. DILAUDID (hydromorphone hydrochloride) should not be taken with alcohol. Opioid analgesics, including DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS, may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression. Interactions with Mixed Agonist/Antagonist Opioid Analgesics Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as hydromorphone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and/or may precipitate withdrawal symptoms in these patients. Read the Dilaudid Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are indicated for the management of pain in patients where an opioid analgesic is appropriate.

Source: http://www.rxlist.com

DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are 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 (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are also contraindicated for use in obstetrical analgesia. Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Serious overdosage with DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS is characterized by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia and hypotension. In serious overdosage, particularly following intravenous injection, apnea, circulatory collapse, cardiac arrest and death may occur. In the treatment of overdosage, 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. A potentially serious oral ingestion, if recent, should be managed with gut decontamination. 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. Supportive measures (including oxygen, vasopressors) 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. The opioid antagonist, naloxone, is a specific antidote against respiratory depression which may result from overdosage, or unusual sensitivity to DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS. Therefore, an appropriate dose of this antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. 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 (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS . In such cases, an abrupt or complete reversal of narcotic effects may precipitate an acute withdrawal syndrome. Since the duration of action of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS 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.

Source: http://www.rxlist.com

DILAUDID (hydromorphone hydrochloride) ORAL LIQUID is a clear, sweet, slightly viscous liquid. It is available in: Bottles of 1 pint (473 mL)-NDC# 0074-2452-02 DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are white and triangular shaped, embossed with the number 8 on one side and bisected and embossed with a double SI on the other side. They are available in: Bottles of 100-NDC# 0074-2426-14 Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Protect from light. A schedule Narcotic. DEA Order Form is Required. Abbott Laboratohbs. North Chicago. IL 60064, U.S.A. Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Special Risk Patients: DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS 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 (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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 Drug and Alcohol Dependent Patients: DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) in combination with other CNS depressant drugs can result in serious risk to the patient. Hydromorphone is an opioid with no approved use in the management of addictive disorders. Use in Ambulatory Patients: DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) may produce orthostatic hypotension in ambulatory patients. Use in Biliary Tract Disease: Opioid analgesics, including DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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. Tolerance and Physical Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids used regularly should not be abruptly discontinued. Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies have been conducted in animals. Hydromorphone was not mutagenic in the in vitro Ames reverse mutation assay or the human lymphocyte chromosome aberration assay. Hydromorphone was not clastogenic in the in vivo mouse micronucleus assay. No effects on fertility, reproductive performance, or reproductive organ morphology were observed y in male or female rats given oral doses up to 7 mg/kg/day, which is equivalent to the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 3-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis.. Pregnancy Pregnancy Category C No effects on teratogenicity or embryotoxicity were observed in female rats given oral doses up to 7 mg/kg/day, which is approximately equivalent to the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 3-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis. Hydromorphone produced skull malformations (exencephaly and cranioschisis) in Syrian hamsters given oral doses up to 20 mg/kg during the peak of organogenesis (gestation days 8-9). The skull malformations were observed at doses approximately 2-fold higher the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 7-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis. There are no adequate and well-controlled studies of DILAUDID (hydromorphone hydrochloride) in pregnant women. Hydromorphone crosses the placenta, resulting in fetal exposure. DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 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 (hydromorphone hydrochloride) 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). Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Senior Healthcare Matters an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Dilaudid. Find what medications you are taking today.