Buprenorphine 2 mg sublingual tablets

2 mg tablet: White to off-white, round, biconvex uncoated sublingual tablet

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.

Treatment is intended for use in adults and adolescents aged 16 years or older .

The dosage should be individualised for each patient. The maintenance dosage will vary between individuals and should be determined by progressively increasing the dose until the minimal effective dose is identified. The mean maintenance daily dose is 8mg. The majority of patients will not require doses exceeding 16mg/day, however, the efficacy and safety of buprenorphine tablets was tested in clinical trials in doses up to 24mg per day.

After a satisfactory period of stabilisation has been achieved, the dosage may be reduced gradually to a lower maintenance dose; when deemed appropriate treatment may be discontinued in some patients. Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.

Administration is sublingual. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this medicinal product. The tablet should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes.

The result of the treatment depends on the dosage prescribed as well as on the combined medical, psychological, social and educational measures taken in monitoring the patient.

Contraindications

- children less than 16 years of age

- severe respiratory insufficiency

- severe hepatic insufficiency

- acute alcoholism

- breast-feeding

When initiating buprenorphine treatment ,the physician should be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal  in opioid-dependent patients.

Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type. Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist.

This product can cause drowsiness, which may be exacerbated by other centrally acting agents, such as: alcohol, tranquillisers, sedatives, hypnotics .

Buprenorphine is excreted in human breast milk.

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of the addicted patient for drugs.