Hydromorphone Hydrochloride 2 mg
1 INDICATIONS AND USAGE Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.2 ) , reserve hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets 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 Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2) ] , reserve hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets 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. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Rhodes Pharmaceuticals L.P.
ROUND ORANGE 2 P
2 P ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
HYDROMORPHONE HYDROCHLORIDE is available as follows: Oral Solution 5 mg/5 mL : a clear, colorless to pale yellow, slightly viscous liquid. NDC 42858-304-16: Bottles of 1 pint (473 mL) 2 mg Tablets: light orange, round, flat-faced tablets, with beveled edges, debossed with a "P" on one side and the number "2" on the opposite side. NDC 42858-301-01: Bottles of 100 4 mg Tablets : light yellow, round, flat-faced tablets, with beveled edges, debossed with a "P" on one side and the number "4" on the opposite side. NDC 42858-302-01: Bottles of 100 NDC 42858-302-50: Bottles of 500 8 mg Tablets : white, triangular shaped tablets debossed with a "P" and an inverted "P" separated with a bisect on one side of the tablet and debossed with the number "8" on the other side of the tablet. NDC 42858-303-01: Bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store
HYDROMORPHONE HYDROCHLORIDE oral solution and
HYDROMORPHONE HYDROCHLORIDE tablets securely and dispose of properly.
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