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DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an
The chemical name of DILAUDID (hydromorphone hydrochloride) is 4,5a-epoxy-3-
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 ORAL LIQUID may contain traces of
Color Coded Tablets (for oral administration) contain:
2 mg hydromorphone hydrochloride (orange tablet) and D&C red #30 Lake dye, D&C
yellow #10 Lake dye, lactose, and magnesium stearate. DILAUDID 2 mg TABLET may
contain traces of sodium metabisulfite.
4 mg hydromorphone hydrochloride (yellow tablet) and D&C yellow #10 Lake dye, lactose,
and magnesium stearate. DILAUDID 4 mg TABLET may contain traces of sodium
8 mg hydromorphone hydrochloride (white tablet) and lactose anhydrous, and magnesium
stearate. DILAUDID 8 mg TABLET may contain traces of sodium metabisulfite.
DILAUDID ORAL LIQUID and DILAUDID TABLETS are indicated for the management of
pain in patients where an opioid analgesic is appropriate.
The major hazards of DILAUDID ORAL LIQUID and DILAUDID 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
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
Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope,
Bronchospasm and laryngospasm
Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alteration
Urinary retention or hesitancy, antidiuretic effects
Urticaria, other skin rashes, diaphoresis
DILAUDID ORAL LIQUID and DILAUDID 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
ORAL LIQUID and DILAUDID TABLETS are also contraindicated for use in obstetrical
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