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Name:Dilaudid

Generic Name: Dilaudid is the brand name for the generic drug hydromorphone hydrochloride.

Strength: DILAUDID Tablets are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration.

Shape and Size: 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.

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Description

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. DILAUDID INJECTION is available in ampules for parenteral administration. Each 1 mL
of sterile solution contains 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION ampules are sterile.
HIGH POTENCY DILAUDID (DILAUDID-HP) is available in AMBER ampules or single dose vials for intravenous (IV), subcutaneous (SC), or intramuscular (IM) administration.
Each 1 mL of sterile solution contains 10 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. It is also available as lyophilized DILAUDID-HP for intravenous (IV), subcutaneous (SC), or intramuscular (IM) administration. Each single dose vial contains 250 mg sterile, lyophilized hydromorphone HCl to be reconstituted with 25 mL of Sterile Water for Injection USP to provide a solution containing 10 mg/mL.

 

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Indications

DILAUDID INJECTION is indicated for the management of pain in patients where an opioid analgesic is appropriate.

DILAUDID-HP is indicated for the relief of moderate-to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Because DILAUDID-HP contains 10 mg of hydromorphone hydrochloride per mL, a smaller injection volume can be used than with other parenteral opioid formulations.
Discomfort associated with the intramuscular or subcutaneous injection of an unusually large volume of solution can therefore be avoided.

Contrindications

DILAUDID INJECTION and DILAUDID-HP are contraindicated in patients with known hypersensitivity to hydromorphone.

DILAUDID INJECTION and DILAUDID-HP are contraindicated in patients with respiratory depression in the absence of resuscitative equipment and in patients with status asthmaticus.

DILAUDID INJECTION and DILAUDID-HP are also contraindicated for use in obstetrical analgesia.

DILAUDID-HP is contraindicated in patients who are not already receiving large amounts of opioids.

 

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Side Effects

The major hazards of DILAUDID INJECTION and DILAUDID-HP 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 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.

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.

 

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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 alterations

Genitourinary

Urinary retention or hesitancy, antidiuretic effects

Dermatologic

Urticaria, other skin rashes, wheal and flare over the vein with intravenous injection, diaphoresis

Other

In clinical trials, neither local tissue irritation nor induration was observed at the site of subcutaneous injection of DILAUDID-HP; pain at the injection site was rarely observed.

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Pregnancy and Lactation

Pregnancy

No effects on teratogenicity or embryotoxicity were observed in female rats given oral doses up to 7 mg/kg/day which is equivalent to and 3-fold higher than the human dose of DILAUDID-HP, 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 and 7-fold higher than the human dose of DILAUDID-HP when substituted for ORAL LIQUID or 8 mg TABLET, respectively, on a body surface area basis. There are no adequate and well-controlled studies of DILAUDID INJECTION or DILAUDID-HP in pregnant women.
Hydromorphone crosses the placenta, resulting in fetal exposures. DILAUDID INJECTION or DILAUDID-HP should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

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 INJECTION and DILAUDID-HP are contraindicated in Labor and Delivery.

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 INJECTION or DILAUDID-HP since it, and other drugs in this class, may be excreted in the milk.

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Pediatric Use

Safety and effectiveness have not been established.

Geriatric Use

Clinical studies of DILAUDID INJECTION and DILAUDID-HP 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.

Drug Interactions

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 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 INJECTION and DILAUDID-HP, may enhance the action of neuromuscular blocking agents and produce an increased 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.

 

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