- Generic Name: hydromorphone hydrochloride
- Brand Name: Dilaudid
DILAUDID Tablets are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of hydromorphone hydrochloride in each tablet.
DILAUDID Oral Solution is supplied as 5mg/5 mL (1 mg/mL) viscous liquid.
The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure:
Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride.
The 2 mg, 4 mg, and 8 mg tablets contain the following inactive ingredients: lactose anhydrous and magnesium stearate. DILAUDID Tablets may also contain traces of sodium metabisulfite.
The 2 mg tablets also contain D&C red #30 Lake dye, and D&C yellow #10 Lake dye.
The 4 mg tablets also contain D&C yellow #10 Lake dye.
Each 5 mL (1 teaspoon) of DILAUDID Oral Solution contains 5 mg of hydromorphone hydrochloride. The inactive ingredients are purified water, methylparaben, propylparaben, sucrose, and glycerin. DILAUDID Oral Solution may contain traces of sodium metabisulfite.
DILAUDID Oral Solution and DILAUDID Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve DILAUDID Oral Solution and DILAUDID
Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Ensure accuracy when prescribing, dispensing, and administering DILAUDID Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Instruct patients to obtain a calibrated measuring cup/syringe for administering DILAUDID Oral Solution to ensure that the dose is measured and administered accurately.
Do not use household teaspoons or tablespoons to measure DILAUDID Oral Solution, as using a WARNINGS AND PRECAUTIONS].
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
- Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].
- Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with DILAUDID Oral Solution or DILAUDID Tablets and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
Initiating Treatment With DILAUDID Oral Solution Or DILAUDID Tablets
Dilaudid Oral Solution
Initiate treatment with DILAUDID Oral Solution in a dosing range of one-half (2.5 mL) to two teaspoonsful (10 mL), 2.5 mg to 10 mg, every 3 to 6 hours as needed for pain.
Initiate treatment with DILAUDID Tablets in a dosing range of 2 mg to 4 mg, orally, every 4 to 6 hours.
Conversion From Other Opioids To DILAUDID Oral Solution Or DILAUDID Tablets
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of DILAUDID Oral Solution or DILAUDID Tablets. It is safer to underestimate a patient’s 24-hour DILAUDID dosage than to overestimate the 24-hour dosage and manage an adverse reaction due to overdose.
In general, it is safest to start DILAUDID therapy by administering half of the usual starting dose every 3 to 6 hours for DILAUDID Oral Solution; and every 4 to 6 hours for DILAUDID Tablets. The dose of DILAUDID can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved [see Dosage Modifications In Patients With Renal Impairment].
Conversion From DILAUDID Oral Solution Or DILAUDID Tablets To Extended-Release Hydromorphone Hydrochloride
The relative bioavailability of DILAUDID Oral Solution and DILAUDID Tablets compared to extended-release hydromorphone hydrochloride is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Dosage Modifications In Patients With Hepatic Impairment
Dosage Modifications In Patients With Renal Impairment
Titration And Maintenance Of Therapy
Individually titrate DILAUDID Oral Solution or DILAUDID Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DILAUDID Oral Solution or DILAUDID Tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS AND PRECAUTIONS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DILAUDID Oral Solution or DILAUDID Tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
For chronic pain, doses should be administered around-the-clock. A supplemental dose of 5 to 15% of the total daily usage may be administered every two hours on an as-needed basis.
Disontinuation Of DILAUDID Oral Solution Or DILAUDID Tablets
When a patient who has been taking DILAUDID Oral Solution or DILAUDID Tablets regularly and may be physically dependent no longer requires therapy with DILAUDID, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs and symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue DILAUDID Oral Solution or DILAUDID Tablets in a physically dependent patient. [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence].
Dosage Forms And Strengths
DILAUDID Oral Solution: 5 mg/5 mL (1 mg/mL) of hydromorphone hydrochloride in a clear, colorless to pale yellow, slightly viscous liquid.
- 2 mg tablets (light orange, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “2” on the opposite side)
- 4 mg tablets (light yellow, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “4” on the opposite side)
- 8 mg tablets (white, triangular shaped tablets, debossed with a “P” and an inverted “P” separated with a bisect on one side of the tablet and debossed with the number “8” on the other side of the tablet)
Storage And Handling
DILAUDID is available as follows:
Oral Solution 5 mg/5 mL: a clear, colorless to pale yellow, slightly viscous liquid.
NDC 42858-416-16: Bottles of 1 pint (473 mL)
2 mg Tablets: light orange, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “2” on the opposite side.
NDC 42858-122-01: Bottles of 100
NDC 42858-122-25: Unit Dose Packages of 100 (4×25)
4 mg Tablets: light yellow, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “4” on the opposite side.
NDC 42858-234-01: Bottles of 100
NDC 42858-234-25: Unit Dose Packages of 100 (4×25)
NDC 42858-234-50: Bottles of 500
8 mg Tablets: white, triangular shaped tablets debossed with a “P” and an inverted “P” separated with a bisect on one side of the tablet and debossed with the number “8” on the other side of the tablet.
NDC 42858-338-01: Bottles of 100
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Protect from light.
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Serious adverse reactions associated with DILAUDID include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The most common adverse effects are lightheadedness, 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.
How to use Dilaudid
Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Do not confuse the dose of hydromorphone liquid in milligrams (mg) with the dose in milliliters (mL). Ask your pharmacist or doctor if you are not sure how to check or measure the dose. If your liquid is a suspension, shake the bottle well before each dose.
The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using hydromorphone safely with other drugs.
Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
DILAUDID Oral Solution and DILAUDID Tablets contain hydromorphone, a Schedule II controlled substance.
DILAUDID Oral Solution and DILAUDID Tablets contain hydromorphone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, oxycodone, methadone, morphine, oxymorphone and tapentadol. DILAUDID Oral Solution and DILAUDID Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS].
All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
“Drug-seeking” behavior is very common in persons with substance use disorders. 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 prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers 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 true addiction.
DILAUDID, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to Abuse of DILAUDID
DILAUDID Oral Solution and DILAUDID Tablets are for oral use only. Abuse of DILAUDID Oral Solution or DILAUDID Tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of DILAUDID ORAL LQIUID or DILAUDID Tablets with alcohol and other central nervous system depressants.
Both tolerance and physical dependence can develop during chronic opioid therapy. 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). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.
Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
DILAUDID Oral Solution or DILAUDID Tablets should not be abruptly discontinued in a physically-dependent patient [see DOSAGE AND ADMINISTRATION]. If DILAUDID Oral Solution or DILAUDID Tablets are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and 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.
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use In Specific Populations].
Risk Of Accidental Overdose And Death Due To Medication Errors
Dosing errors can result in accidental overdose and death. Ensure that the dose is communicated clearly and dispensed accurately. A household teaspoon or tablespoon is not an adequate measuring device. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, the enclosed measuring device should be used or a calibrated measuring device obtained from the pharmacist. Healthcare providers should recommend a calibrated device that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
Addiction, Abuse, And Misuse
DILAUDID Oral Solution and DILAUDID Tablets contain hydromorphone, a Schedule II controlled substance. As an opioid, DILAUDID exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse And Dependence].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed DILAUDID Oral Solution or DILAUDID Tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing DILAUDID Oral Solution or DILAUDID Tablets, and monitor all patients receiving DILAUDID Oral Solution or DILAUDID Tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as DILAUDID Oral Solution or DILAUDID Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of DILAUDID Oral Solution and DILAUDID Tablets along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing DILAUDID Oral Solution or DILAUDID Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PATIENT INFORMATION]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Opioid Analgesic Risk Evaluation And Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following:
- Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.
- Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
- Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.
- Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities.