SUBOXONE sublingual tablets contain buprenorphine HCI and naloxone HCI dihydrate at a ratio of 4:1 buprenorphine: naloxone (ratio of free bases).

SUBUTEX sublingual tablets contain buprenorphine HCI.

Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an antagonist at the mu-opioid receptor.

Buprenorphine is a Schedule III narcotic under the Controlled Substances Act.

Buprenorphine hydrochloride is a white powder, weakly acidic with limited solubility in water (17 mg/mL). Chemically, buprenorphine is 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α,7α(S|]-. Buprenorphine hydrochloride has the molecular formula C₂₉H₄₁NO₄ HCI and the molecular weight is 504.10.

STRUCTURAL FORMULA OF BUPRENORPHINE

Naloxone hydrochloride is a white to slightly off-white powder and is soluble in water, in dilute acids and in strong alkali. Chemically, naloxone is 17-Allyl-4,5 α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. Naloxone Hydrochloride has the molecular formula C₁₉H₂₁N0₄HCI.2H₂0 and the molecular weight is 399.87.

STRUCTURAL FORMULA OF NALOXONE

SUBOXONE is an uncoated hexagonal orange tablet intended for sublingual administration. It is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, and 8 mg buprenorphine with 2 mg naloxone free bases. Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate< FD&C Yellow N0.6 color, magnesium stearate, and the tablets also contain Acesulfame K sweetener and a lemon / lime flavor.

SUBUTEX is an uncoated oval white tablet intended for sublingual administration. It is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine free base. Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate.

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