Suboxone (Buprenorphine and Naloxone Sublingual Tablets) (Buprenorphine and Naloxone Sublingual Tablets) Drug Instructions, Dosage and Clinical Data

Basic information

Drug category type

Buprenorphine 8 mg/naloxone 2 mg (as base); Buprenorphine 2 mg/naloxone

Specification

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Standard dose

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Approval number

Execution standard

Imported Drug Registration Standard: JM20180003

Shelf life

Product information

Description

This product is a white to off-white hexagonal tablet.

Storage

Store sealed at or below 25 ℃. Brief exposure to 30 ℃ during transport is permitted.

Packaging

Shelf life

Execution standard

Imported Drug Registration Standard: JM20180003

Approval number

Approval date

Modified date

Category path

Level 1 categoryOther Nervous System Drugs

Level 2 categoryMedications for Pathological Addiction

Level 3 categoryMedications for Opioid Dependence

Level 4 category—

Ingredients

This product is a compound preparation containing buprenorphine hydrochloride and naloxone. Buprenorphine hydrochloride: (2S)-2-[(-)-(5R,6R,7R,14S)-N-cyclopropylmethyl-4,5-epoxy-6,14-ethano-3-hydroxy-6-methoxymorphinan-7-yl]-3,3-dimethylbutan-2-ol hydrochloride Molecular formula: C29H41NO4.HCl Molecular weight: 504.1 Naloxone: Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride (5α)-, dihydrate; 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate Structural formula: Molecular formula: C19H21NO4·HCL·2 H2O Molecular weight: 399.87 Excipients include: lactose monohydrate, mannitol, corn starch, povidone K30, anhydrous citric acid, sodium citrate, magnesium stearate, acesulfame potassium, natural lemon and lime flavor.

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