buprenorphine hcl and naloxone hcl buprenorphine and naloxone tablet

1 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets are indicated for the 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 Tablets contain 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 )

amneal pharmaceuticals llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] nausea` `[3] off label use` `[4] dyspnoea` `[5] fatigue` `[6] diarrhoea` `[7] vomiting` `[8] pyrexia` `[9] disease progression` `[10] thrombocytopenia`

5 years ago

ROUND ORANGE A 14

5 years ago

A 14 ROUND ORANGE

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPRENORPHINE AND NALOXONE Sublingual Tablets USP, 2 mg/0.5 mg are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows: Bottles of 30 NDC 65162-416-03 Bottles of 90 NDC 65162-416-09

BUPRENORPHINE AND NALOXONE Sublingual Tablets USP, 8 mg/2 mg are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows: Bottles of 30 NDC 65162-415-03 Bottles of 90 NDC 65162-415-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store

BUPRENORPHINE AND NALOXONE Sublingual Tablets, USP securely and dispose of properly [see Patient Counseling Information (17) ] .

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