Suboxone Dosage/Direction for Use

Administration is sublingual.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction.
Physicians must warn patients that the sublingual route is the only effective and safe route of administration for Suboxone (see Precautions). Suboxone sublingual tablets are to be placed under the tongue until dissolved, which usually requires 5-10 min. The dose is made up from Suboxone 2 mg/0.5 mg and Suboxone 8 mg/2 mg sublingual tab, which may be taken all at the same time or in 2 divided portions; the 2nd portion to be taken directly after the 1st portion has dissolved.
Adults: Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medicines (see Interactions) and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended (see Precautions). Induction: Prior to treatment induction, consideration should be given to the type of opioid dependence (ie, long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence. To avoid precipitating withdrawal, induction with Suboxone or buprenorphine only tablets should be undertaken when objective and clear signs of withdrawal are evident.
Initiation Therapy: Recommended Starting Dose: 1-2 tabs of Suboxone 2 mg/0.5 mg sublingual tablet. An additional 1-2 tablets of the Suboxone 2 mg/0.5 mg sublingual tablet may be administered on day 1 depending on the individual patient's requirement.
Opioid-Dependent Drug Addicts Who Have Not Undergone Withdrawal: When treatment starts, the 1st dose of Suboxone should be taken when signs of withdrawal appear, but not less than 6 hrs after the patient last used opioids (eg, heroin, short-acting opioids). Patients Receiving Methadone: Before beginning Suboxone therapy, the dose of methadone must be reduced to a maximum of 30 mg/day. The 1st dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hrs after the patient last used methadone. Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone.
Dosage Adjustment and Maintenance: The dose of Suboxone should be increased progressively according to the clinical effect of the individual patient and should not exceed a maximum single daily dose of 24 mg. The dosage is titrated according to reassessment of the clinical and psychological status of the patient and should be made in steps of 2-8 mg.
During the initiation of treatment, daily dispensing of buprenorphine is recommended. After stabilization, a reliable patient may be given a supply of Suboxone sufficient for several days of treatment. It is recommended that the amount of Suboxone be limited to 7 days or according to local requirements.
Less Than Daily Dosing: After a satisfactory stabilization has been achieved, the frequency of Suboxone dosing may be decreased to dosing every other day at twice the individually titrated daily dose. For example, a patient stabilized to receive a daily dose of 8 mg may be given 16 mg on alternate days, with no medication on the intervening days. However, the dose given on any day should not exceed 24 mg. In some patients, after a satisfactory stabilization has been achieved, the frequency of Suboxone dosing may be decreased to 3 times a week (eg, on Monday, Wednesday and Friday). The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be 3 times the individually titrated daily dose, with no dose on the intervening days. However, the dose given on any day should not exceed 24 mg. Patients requiring a titrated daily dose >8 mg/day may not find this regimen adequate.
Dosage Reduction and Termination of Treatment: After a satisfactory stabilization has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favorable cases, treatment may be discontinued. The availability of the sublingual tablet in doses of 2 mg and 8 mg allows for a downward titration of dosage. For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg sublingual tablets may be used. Patients should be monitored following termination of treatment because of the potential for relapse.
Elderly: No data is available on elderly patients.
Pediatrics: Suboxone is not recommended for use in children.
Patients with Impaired Hepatic Function: The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone is unknown. Since both active medicines are extensively metabolized, the plasma levels will be expected to be higher in patients with moderate and severe hepatic impairment. It is not known whether both active substances are affected to the same extent.
As Suboxone pharmacokinetics may be altered in patients with hepatic insufficiency, lower initial doses and careful dose titration in patients with mild to moderate hepatic impairment are recommended (see Pharmacology under Actions).
Patients with Impaired Renal Function: Modification of the Suboxone dose is not required in patients with renal insufficiency. Caution is recommended when dosing patients with severe renal impairment (Cl_Cr <30 ml/min) (see Pharmacology under Actions).