Subutex 2mg sublingual tablets (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | RB Pharmaceuticals Limited |
|---|---|
| Διεύθυνση | 103 - 105 Bath Road,, Slough, Berkshire, SL1 3UH, UK |
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Name of the medicinal product
SUBUTEX 2 mg sublingual tablets.
Qualitative and quantitative composition
Buprenorphine hydrochloride equivalent to buprenorphine base: 2 mg.
Pharmaceutical form
Sublingual tablet.
Therapeutic indications
Substitution treatment for opioid drug dependence, within framework of medical, social and psychological treatment.
Posology and method of administration
Treatment with SUBUTEX sublingual tablets is intended for use in adults and children aged 16 years or over who have agreed to be treated for addiction. Administration is sublingual. Physicians must advise ...
Contraindications
Hypersensitivity to buprenorphine or any other component of the tablet Children less than 16 years of age Severe respiratory insufficiency Severe hepatic insufficiency Acute alcoholism or delirium tremens ...
Special warnings and precautions for use
Warnings SUBUTEX sublingual tablets are recommended only for the treatment of opioid drug dependence. It is also recommended that that treatment is prescribed by a physician who ensures comprehensive management ...
Interaction with other medicinal products and other forms of interaction
SUBUTEX should not be taken together with alcoholic drinks or medications containing alcohol. Alcohol increases the sedative effect of buprenorphine (see 4.7 Effects on the ability to drive vehicles or ...
Pregnancy and lactation
Pregnancy Studies in rats and rabbits have evidenced foetotoxicity including post-implantation loss. In addition, maternal oral administration at high doses during gestation and lactation resulted in a ...
Effects on ability to drive and use machines
SUBUTEX may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants. Therefore, patients should be warned against driving or operation machinery (see 4.5 Interaction ...
Undesirable effects
The onset of side effects depends on the patients tolerance threshold. Which is higher in drug addicts than in general population. The symptoms most frequently observed with buprenorphine administration ...
Overdose
In the event of accidental overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of patient. The major symptom requiring intervention ...
Pharmacodynamic properties
OPIOID ANALGESIC (N: central nervous system) Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the µ (mu) k (kappa) receptors of the brain. Its activity in opioid maintenance ...
Pharmacokinetic properties
Absorption When taken orally, buprenorphine undergoes first-pass hepatic metabolism with N-dealkylation and glucuroconjungation in the small intestine. The use of this medication by oral route is therefore ...
Preclinical safety data
Acute toxicity of buprenorphine was determined in the mouse and rat following oral and parenteral administration. The median lethal dose (LD<sub>50</sub>) in the mouse were 26, 94 and 261 mg/kg for intravenous, ...
List of excipients
Monohydrated lactose Mannitol Maize starch Povidone excipients k30 Citric Acid Sodium citrate Magnesium stearate
Incompatibilities
None known.
Shelf life
2 Years.
Special precautions for storage
Do not store above 30°C. Store in the original package.
Nature and contents of container
7 or 28 tablets in nylon/aluminium/uPVC blister packs.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
RB Pharmaceuticals Ltd 103 – 105 Bath Road, Slough Berkshire SL1 3UH
Marketing authorization number(s)
Subutex 2 mg, sublingual tablets: PL 36699/0002
Date of first authorization / renewal of the authorization
February 1998 (UK)
Date of revision of the text
7th February 2012