Suboxone.com - Dosing Guide: Medically Supervised Withdrawal

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IMPORTANT INFORMATION:

On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

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Dosing Guidance for SUBOXONE & SUBUTEX^® Short- and Long-term Medical Withdrawal (ie, Detoxification) — Inpatient and Outpatient

The goal of medical withdrawal is to rapidly achieve control of withdrawal symptoms so patients can fully participate in treatment, including medical, psychosocial, psychiatric, etc. SUBOXONE (buprenorphine HCl/naloxone HCI dihydrate) or SUBUTEX (buprenorphine HCl) sublingual tablets have been shown to be effective treatments in relieving withdrawal symptoms during medical withdrawal (ie, detoxification) from short-acting opioids and are comparable to, or superior to, other pharmacologic treatment options.¹ SUBUTEX can be administered in a residential setting or physician's office since it will be administered under supervision. SUBOXONE is the preferred medication for use at home.

The following procedure is recommended:

Instruct the patient on how to take a sublingual tablet and provide the patient with information about induction.
To avoid the risk of precipitated withdrawal, the first SUBOXONE or SUBUTEX dose should be administered:
When moderate [see Clinical Opiate Withdrawal Scale (COWS)] signs of opioid withdrawal are observed
At a dose of 4 to 8 mg
Daily dispensing of SUBOXONE or SUBUTEX and review of the patient's status are preferred.
Doses should be titrated upward according to the patient's:
Withdrawal severity
Cravings
Side effects
Other drug use
Administer the patient's first dose (4 mg of SUBOXONE or SUBUTEX) after moderate opiate withdrawal symptoms have developed. Consider the use of an opioid withdrawal scale for patient assessment (eg, COWS). Remind the patient that opioid withdrawal symptoms are usually alleviated in 20 to 40 minutes following the first dose of buprenorphine.

Other withdrawal medications are not routinely required; however, in the event of sleep disturbances, limited amounts of hypnotic or sedative agents (eg, 5-10 mg zolpidem, 10-20 mg temazepam, or trazadone 50-100 mg as sleep aid for 2 nights) may be prescribed. If benzodiazepines are prescribed: instruct the patient that severe, potentially lethal, reactions may result from misuse of SUBOXONE or SUBUTEX with benzodiazepines, especially when the two are misused together by injection.

Outpatient or inpatient dosing regimen

1. Outpatient dosing regimen
A short-term flexible 5 to 8 day and fixed 20 to 36 day SUBOXONE or SUBUTEX sublingual tablets-managed medical withdrawal (ie, detoxification) are shown.

Outpatient Dosing Regimen for Opioid Medical Withdrawal

a) Flexible Dosing Schedule for Buprenorphine:

Day	Recommended upper and lower limits	Recommended buprenorphine dose
1	4 to 8 mg	6 mg
2	4 to 12 mg	8 mg
3	4 to 16 mg	10 mg
4	2 to 12 mg	8 mg
5	0 to 8 mg	4 mg
6	0 to 4 mg	–
7	0 to 2 mg	–
8	0 mg	–

Lintzeris N, Clark NC, Muhleisen P, et al. National Clinical Guidelines on the Use of Buprenorphine in the Management of Heroin Dependence. Canberra: National Drug Strategy, Commonwealth of Australia; 2001.

b) Fixed Dosing Schedule:

The same long-term fixed equal dose or percent dose reduction schedule for medical withdrawal can be used in outpatients who have or have not been previously maintained. See Dose Reduction Schedules.
If the patient continues using opioids during an outpatient withdrawal episode, helpful options are:
Extension of the above regimens over several weeks
Transfer of the patient to inpatient withdrawal services (see examples of inpatient reduction schedules)
Transfer of the patient to long-term maintenance

2. Inpatient dosing regimen

Inpatient regimens can be adapted according to the degree of monitoring and supervision available.
Flexible or fixed dosing schedules can be used.

Flexible and fixed dosing schedule with SUBOXONE or SUBUTEX as shown below.

Inpatient Dosing Regimen for Opioid Medical Withdrawal

a) Flexible Dosing Schedule:

Day	Recommended buprenorphine dose	Total daily dose
1	4 mg at onset of withdrawal, and additional 2 to 4 mg evening dose prn	4 to 8 mg
2	4 mg morning, with additional 2 to 4 mg evening dose prn	4 to 8 mg
3	4 mg morning, with additional 2 mg evening dose prn	4 to 6 mg
4	2 mg morning prn; 2 mg evening prn	0 to 4 mg
5	2 mg prn	0 to 2 mg
6	no dose	–
7	no dose	–

Lintzeris N, Bammer G, Rushworth L, Jolley DJ. Whelian G. Drug Alcohol Depend. 2003;70:287-294.

b) Fixed Dosing Schedule:

Buprenorphine dose
Day	10-day	7-day	3-day
1	8 mg	8 mg	12 mg
2	6 mg	6 mg	8 mg
3	4 mg	4 mg	8 mg
4	4 mg	4 mg	–
5	4 mg	2 mg	–
6	2 mg	2 mg	–
7	2 mg	0 mg	–
8	2 mg	–	–
9	2 mg	–	–
10	0 mg	–	–

Johnson RE, Strain EC, Amass L. Drug Alcohol Depend. 2003;70(suppl 2):S59-S77.

After the withdrawal episode
Having successfully become abstinent, patients should be encouraged to consider further treatment options to help them stay away from opioids. The options should be discussed as early as possible, including the possibility for ongoing psychosocial support and counseling, maintenance therapy, naltrexone treatment, self-help groups, or residential rehabilitation programs. Occasionally patients may, following medical withdrawal, request to be maintained on SUBOXONE sublingual tablets (see induction protocol in these guidelines).