Hydromorphone (Hydromorphone Hydrochloride) - Description

Hydromorphone Hydrochloride Tablets, USP CII
2 mg, 4 mg, and 8 mg

R_x Only

P4953-2 12/06

WARNING: HYDROMORPHONE HYDROCHRLORIDE 2 MG, 4 MG, and 8 MG TABLETS CONTAIN HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVE-HYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.

DESCRIPTION

Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.

The chemical name of hydromorphone hydrochloride is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is:

C₁₇H₁₉NO₃·HCl

Hydromorphone hydrochloride tablets, for oral administration, contain 2 mg hydromorphone hydrochloride (blue tablet), 4 mg hydromorphone hydrochloride (tan tablet), and 8 mg hydromorphone hydrochloride (white tablet).

Other ingredients include colloidal silicon dioxide, lactose hydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 2 mg tablet also contains FD&C Blue No. 1 aluminum lake. The 4 mg tablet also contains FD&C Blue No. 1 aluminum lake, FD&C Red No. 40 aluminum lake, and FD&C Yellow No. 6 aluminum lake.