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(buprenorphine and naloxone)
ZUBSOLV (buprenorphine and naloxone) sublingual tablets are white menthol-flavored tablets in a triangular shape for the dosage strength 1.4 mg /0.36 mg, a D shape for the dosage strength 2.9mg/0.71mg, a round shape for the dosage strength 5.7 mg/1.4 mg, a diamond shape for the dosage strength 8.6 mg/2.1 mg and a capsule shape for the dosage strength 11.4 mg/2.9 mg. They are debossed with the respective dosage strength of buprenorphine. They contain buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). ZUBSOLV is intended for sublingual administration and is available in five dosage strengths, 1.4 mg buprenorphine with 0.36 mg naloxone, 2.9mg buprenorphine with 0.71mg naloxone, 5.7 mg buprenorphine with 1.4 mg naloxone, 8.6 mg buprenorphine with 2.1 mg naloxone and 11.4 mg buprenorphine with 2.9 mg naloxone. Each sublingual tablet also contains mannitol, citric acid, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, menthol, silicon dioxide and sodium stearyl fumarate and menthol flavor.
Chemically, buprenorphine HCl is (2S)-2-[17-(cyclopropylmethyl)4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan- 2-ol hydrochloride. It has the following chemical structure:
Buprenorphine HCl has the molecular formula C29H41NO4 •HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.
Chemically, naloxone HCl dihydrate is 17-Allyl-4,5α-epoxy-3,14dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:
Naloxone HCl dihydrate has the molecular formula C19H21NO4•HCl•2H20 and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.
Last reviewed on RxList: 8/26/2015
This monograph has been modified to include the generic and brand name in many instances.
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