ed due to the risk of rapid release and absorption of a potentially fatal dose of oxymorphone [see Warnings and Precautions (5.2)]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
2.5 Patients with Hepatic Impairment
OPANA ER is contraindicated in patients with moderate or severe hepatic impairment.
In opioid-naïve patients with mild hepatic impairment, initiate treatment with the 5 mg dose. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a patient with normal hepatic function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.6 Patients with Renal Impairment
In patients with creatinine clearance rates less than 50 mL/min, start OPANA ER in the opioid-naïve patient with the 5 mg dose. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a patient with normal renal function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
2.7 Geriatric Patients
The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects. Initiate dosing with OPANA ER in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating OPANA ER to adequate analgesia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]. For patients on prior opioid therapy, start OPANA ER at 50% lower than the starting dose for a younger patient on prior opioids and titrate slowly.
3 DOSAGE FORMS AND STRENGTHS
The 5 mg dosage form is a pink, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “5” on the other side.
The 7.5 mg dosage form is a gray, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “7 ½” on the other side.
The 10 mg dosage form is a light orange, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “10” on the other side.
The 15 mg dosage form is a white, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “15” on the other side.
The 20 mg dosage form is a light green, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “20” on the other side.
The 30 mg dosage form is a red, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “30” on the other side.
The 40 mg dosage form is a light yellow to pale yellow, round, film-coated, biconcave extended-release tablet debossed with an “E” on one side and a “40” on the other side.
4 CONTRAINDICATIONS
OPANA ER is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma or hypercarbia
Known or suspected paralytic ileus
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