buprenorphine hydrochloride and naloxone hydrochloride dihydrate 8 mg

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 to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are 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 )

Hikma Pharmaceuticals USA Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] off label use` `[4] drug ineffective` `[5] nausea` `[6] pain` `[7] headache` `[8] diarrhoea` `[9] arthralgia` `[10] vomiting`

9 months ago

ROUND ORANGE 54 375

16 HOW SUPPLIED/STORAGE AND HANDLING Buprenorphine and Naloxone Sublingual Tablets, USP 2 mg/0.5 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “122” on one side and plain on the other. NDC 0054-0188-13: Bottle of 30 Tablets 8 mg/2 mg are supplied as speckled-peach to peach, flat faced beveled edge tablets with product identification “54” [above] “375” on one side and plain on the other. NDC 0054-0189-13: Bottle of 30 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in USP. Store Buprenorphine and Naloxone Sublingual Tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .

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