Suboxone 2 mg0.5 mg sublingual tablets

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BUPRENORPHINE HCL; NALOXONE HCL

Available from:

ZUELLIG PHARMA PTE. LTD.

ATC code:

N02AE01

Dosage:

2.16MG

Pharmaceutical form:

TABLET, ORALLY DISINTEGRATING

Composition:

BUPRENORPHINE HCL 2.16MG; NALOXONE HCL 0.61MG

Administration route:

SUBLINGUAL

Prescription type:

Prescription Only

Manufactured by:

RECKITT BENCKISER HEALTHCARE (UK) LTD

Authorization status:

ACTIVE

Authorization date:

2008-01-28

Patient Information leaflet

SUBOXONE** Sublingual Tablet 
Brand of buprenorphine hydrochloride and naloxone hydrochloride 

DESCRIPTION: 
Each SUBOXONE 2 mg/0.5mg tablet contains 2 mg buprenorphine as buprenorphine 
hydrochloride and 0.5 mg naloxone as naloxone hydrochloride
dihydrate. Each tablet is white, hexagonal, and 
biconvex, embossed with a sword logo on one side and “N2” on the
reverse side. 

Each SUBOXONE 8 mg/2mg tablet contains 8 mg buprenorphine as
buprenorphine hydrochloride and 2 mg 
naloxone as naloxone hydrochloride dihydrate. Each tablet is white,
hexagonal, and biconvex, and embossed 
with a sword logo on one side and “N8” on the reverse side. 

Each Suboxone sublingual tablet contains buprenorphine and naloxone.
Suboxone containing 2 mg 
buprenorphine and 0.5 mg naloxone is referred to as the "2 mg"
tablets.  Suboxone containing 8mg 
buprenorphine and 2 mg naloxone is referred to as the "8 mg"
tablets. 

Inactive Ingredients:  Lactose monohydrate, mannitol, maize starch,
povidone K 30, citric acid anhydrous, 
sodium citrate, magnesium stearate, acesulfame potassium and
natural lemon and lime flavor. 

ACTIONS:  Buprenorphine is an opioid partial agonist/antagonist
which binds to the 
μ (mu) and κ (kappa) 
receptors of the brain. Its activity in opioid maintenance treatment
is attributed to its slowly reversible properties 
with the 
μ receptors, which over a prolonged period, might minimize the need
of addicted patients for drugs. 

Opioid agonist ceiling effects were observed during clinical
pharmacology studies in opioid-dependent persons. 

Naloxone is an antagonist at 
μ (mu)-opioid receptors. Because of its almost complete first pass
metabolism, 
naloxone_ _administered orally_ _or sublingually has no detectable
pharmacological activity_. _However_, _when 
administered intravenously to opioid dependent persons, naloxone
may produce marked_ _opioid_ _antagonist 
effects and opioid withdrawal. 

PRECLINICAL TOXIC

Summary of Product characteristics

NAME OF THE MEDICAL PRODUCT
Suboxone 2 mg/0.5 mg sublingual tablets
Suboxone 8 mg/2 mg sublingual tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
SUBOXONE
2
mg/0.5mg
tablet
contains
2
mg
buprenorphine
as
buprenorphine
hydrochloride and 0.5 mg naloxone as naloxone hydrochloride dihydrate.
Each SUBOXONE 8 mg/2mg tablet contains 8 mg buprenorphine as
buprenorphine hydrochloride
and 2 mg naloxone as naloxone hydrochloride dihydrate.
Excipients: Lactose, mannitol, maize starch, povidone K 30, citric
acid anhydrous, sodium
citrate, magnesium stearate, acesulfame potassium and natural lemon
and lime flavor.
PHARMACEUTICAL FORM
Sublingual tablet
Suboxone 2mg/0.5mg Sublingual Tablet
White hexagonal biconvex tablets of 6.5 mm x 5.9 mm AF (across face),
embossed with a “N2”
on one side of the tablet
Suboxone 8mg/2mg Sublingual Tablet
White hexagonal biconvex tablets of 11.0 mm x 10.1 mm AF (across
face), embossed with a “N8”
on one side of the tablet
The sublingual formulation is not designed to be split or broken.
MECHANISM OF ACTION
Buprenorphine is an opioid partial agonist/antagonist which binds to
the μ (mu) and κ (kappa)
receptors of the brain. Its activity in opioid maintenance treatment
is attributed to its slowly
reversible properties with the μ receptors, which over a prolonged
period, might minimize the need
of addicted patients for drugs.
Opioid agonist ceiling effects were observed during clinical
pharmacology studies in opioid-
dependent persons.
Naloxone is an antagonist at μ (mu)-opioid receptors. Because of its
almost complete first
pass
metabolism,
naloxone
administered
orally
or
sublingually
has
no
detectable
pharmacological activity
_. _
However
_, _
when administered intravenously to opioid dependent
persons, naloxone may produce marked opioid antagonist effects and
opioid withdrawal.
PRECLINICAL SAFETY DATA
The combination of buprenorphine and naloxone has been investigated in
acute and repeated
dose (up to 90 days in rats) toxicity studies in animals. No
synergistic enhancement of to