Suboxone (Buprenorphine Hydrochloride / Naloxone Hydrochloride) - Description

DESCRIPTION

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

SUBUTEX sublingual tablets contain buprenorphine HCl.

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 (17mg/mL). Chemically, buprenorphine is 17-(cyclopropylmethyl)-(alpha)-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-(alpha)-methyl-6, 14-ethenomorphinan-7-methanol, hydrochloride [5(alpha), 7(alpha)(S)]-. Buprenorphine hydrochloride has the molecular formula C₂₉H₄₁NO₄HCl and the molecular weight is 504.10.

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 (alpha)-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride. Naloxone hydro-chloride has the molecular formula C₁₉H₂₁NO₄HCl.2H₂O and the molecular weight is 399.87.

SUBOXONE is an uncoated hexagonal orange tablet intended for sublingual administration. It is available in two dosage strengths, 2mg buprenorphine with 0.5mg naloxone, and 8mg buprenorphine with 2mg naloxone free bases. Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.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, 2mg buprenorphine and 8mg buprenorphine free base. Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate.