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DILAUDID®
(hydromorphone hydrochloride) Tablets and Oral Solution

DESCRIPTION

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.

DILAUDID Tablets is 8 mg tablets for oral administration. The tablet strengths describe the amount of hydromorphone hydrochloride in each tablet.

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:

DILAUDID® (hydromorphone hydrochloride) Structural Formula Illustration
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 8 mg tablets contain the following inactive ingredients: lactose anhydrous and magnesium stearate. DILAUDID Tablets may also contain traces of sodium metabisulfite.

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.

INDICATIONS

DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

DILAUDID-HP INJECTION is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Patients considered opioid tolerant are those who are taking for one week or longer,around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering DILAUDID-HP.

Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve DILAUDID INJECTION and DILAUDID-HP INJECTION 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

HOW SUPPLIED

Dosage Forms And Strengths
DILAUDID INJECTION: Each 1 mL pre-filled syringe contains 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL, or 4 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

DILAUDID-HP INJECTION (for use in opioid-tolerant patients only): Each 1 mL pre-filled syringe contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

Storage And Handling
DILAUDID INJECTION
DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each 1 mL pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows:

4mg/mL in a 1mL prefilled disposable syringe, NDC 76045-011-10

Available in a carton of twenty-four (24) syringes for each strength.

DILAUDID-HP INJECTION

DILAUDID-HP INJECTION (hydromorphone hydrochloride) is supplied in clear pre-filled syringes with a dark grey plunger rod. Each 1 mL pre-filled syringe of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID-HP INJECTION contains no added preservative and is supplied as follows:

10mg/mL in a 1mL prefilled disposable syringe, NDC 76045-012-10

Available in a carton of twenty-four (24) syringes.

PROTECT FROM LIGHT.
Protect from light until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].