PRESCRIBING INFORMATION

 

The treatment is reserved for adults and voluntary adolescents under care of Institutions and specialists associated with specialized care centers. 

PRESCRIPTION: 

The doctors, in the form of a total therapeutic dose, should prescribe ADDNOK to patients addicted to opioids, only after medical examination of the patients. The total regimen should not exceed more than 28 days. However it is recommended to the doctor, specifically at the start of the treatment, to prescribe for a shorter duration in order to limit the risk of indirect use by the intravenous route which under no circumstances be used with addnok tablets. 

The long term substitution treatment is recommended to the doctor who is treating an addict, along with the opinion of colleagues or doctors practicing at specialized care centers for addicts or specialized doctors engaged in treating addicts. This treatment will be jointly given by specialized centers for care of addicts and Hospital Centre. This team effort is put to work at the de-addiction centers, or approved hospitals. This enables to develop and implement a therapeutic package along with a socio- psychological support. 


ADMINISTRATION : 

The doctor will specify on the prescription, whether he wants a fractional dose and according to which cycle. The treatment can be stopped at the request of the patients, or with his agreement by progressive diminishing of the doses, the choice of which is left on the specialist attending the patient. At the onset of a treatment with Buprenorphine, the doctor must take into consideration The partial agonistic profile of the molecule to receptors of opioids , susceptible to induce a withdrawal syndrome among addicted patients. The result of the treatment depends partly on the prescribed dosage and partly on the medical - psychological and socio-educative measures associated with the followups of the patients. 

Administration by the sublingual route:

 Initial treatment - the initial dose is of 0.8 to 2 mg per day for non-deprived opiate addicts: At the beginning of the treatment, the effect of Buprenorphine must occur at least 4 hours after the last narcotic dose or at the appearance of the first signs of want among patients receiving methadone: reduce the previous dose of Methadone to a maximum of 30 mg per day; otherwise a withdrawal syndrome precipitated by Buprenorphine can occur. 

Adaption dosage till the maintenance dosage: 

The dosage is adjusted progressively depending upon the patient’s condition at the time of induction of treatment and minimum dose requirement, up to a maximum of 16 mg per day. The modifications of the dosage are determined after re-evaluation of the clinical state of the patient. A fortnightly administration of Bupernorphine is recommended, notably during the initial period of treatment. Some quantities of the product for several days of treatment will enable patients to recope after stabilisation of their state. It is however recommended to limit such administration of the product to a maximum of 7 days. 

Reduction of the dosage and stoppage of treatment: 

After a satisfactorily judged period of stabilization, the doctor will be able to propose to patients to progressively reduce their daily dose of Buprenorphine till a total stoppage of the substituted treatment in the favorable cases. 

The availability of the formulation in 0.4mg, 2mg strength permits a progressive reduction of the dosage. During the discontinuation of the treatment, a particular attention should be given to rate of relapse or withdrawal symptoms and it should be reported.

 

RUSAN  II ADDNOK