buprenorphine 8 mg naloxone 2 mg
1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Rhodes Pharmaceuticals L.P.
ROUND ORANGE RP 8u
RP 8u ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPRENORPHINE AND NALOXONE Sublingual Tablet, USP is an orange, round flat faced beveled edge tablet debossed with an alphanumeric word identifying the product strength (RP on one side for each strength, and "n2" and "n8" on 2 mg and 8 mg tablets, respectively), supplied in white HDPE bottles: NDC 42858-601-03 (buprenorphine 2 mg and naloxone 0.5mg/sublingual tablet; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP) – 30 tablets per bottle NDC 42858-602-03 (buprenorphine 8 mg and naloxone 2 mg/sublingual tablet; content expressed in terms of free base, equivalent to 8.62 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP) – 30 tablets per bottle Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store
BUPRENORPHINE AND NALOXONE Sublingual Tablets securely and dispose of properly [see Patient Counseling Information (17) ].
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