SUBOXONE FILM 8MG2MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Units in package:

28sachet Sachets

Manufactured by:

Aquestive Therapeutics Inc

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
SUBOXONE
®
FILM
2MG/0.5MG & 8MG/2MG
NAME OF THE MEDICINE
SUBOXONE FILM contains buprenorphine (as hydrochloride) and naloxone
(as hydrochloride
dihydrate) at a ratio of 4:1 buprenorphine: naloxone (ratio of free
bases).
DESCRIPTION
SUBOXONE FILM is a soluble film intended for sublingual and/or buccal
administration only.
Each SUBOXONE FILM 2MG/0.5MG contains 2 mg buprenorphine (as
hydrochloride) and 0.5
mg naloxone (as hydrochloride dihydrate). Each SUBOXONE FILM 2MG/0.5MG
is an orange
rectangular soluble film imprinted with “N2” in white ink.
Each SUBOXONE FILM 8MG/2MG contains 8 mg buprenorphine (as
hydrochloride) and 2 mg
naloxone (as hydrochloride dihydrate). Each SUBOXONE FILM 8MG/2MG is
an orange
rectangular soluble film imprinted with “N8” in white ink.
Inactive Ingredients: acesulfame potassium, citric acid, maltitol
solution, hypromellose,
polyethylene oxide, sodium citrate, lime flavour, Sunset Yellow FCF
and a white printing ink.
Buprenorphine hydrochloride is a white powder, weakly acidic with
limited solubility in water
(19.5 mg /mL at 37
◦
C, pH 4.1). Chemically, it is 21- Cyclopropyl-7
α
-
[
(S)
-1- hydroxy-1, 2, 2 -
trimethylpropyl
]
-6, 14-endo-ethano-6, 7, 8, 14-tetrahydrooripavine hydrochloride.
Buprenorphine hydrochloride has the molecular formula C
29
H
41
NO
4
HCl and the molecular
weight is 504.09. The CAS number is 53152-21-9.
Naloxone hydrochloride is a white to slightly off-white powder that
exists as the dihydrate and is
soluble in water, in dilute acids and in strong alkali. Chemically, it
is (-)-17-Allyl-4, 5
α
-epoxy-3,
14-dihydroxymorphinan-6-one hydrochloride dihydrate. Naloxone
hydrochloride has the
molecular formula C
19
H
21
NO
4
HCl .2H
2
O and the molecular weight is 399.87. The CAS number
of naloxone hydrochloride dihydrate is 51481-60-8. The chemical
structures of buprenorphine
hydrochloride and naloxone hydrochloride dihydrate are:
.HCl
Buprenorphine hydrochloride Naloxone hydrochloride dihydrate
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Buprenorphine is a µ (