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DESCRIPTION

SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white flat bevelled edged tablet, debossed with an alphanumeric word identifying the product and strength on one side. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate. Where can I Buy Subutex for sale online in USA UK Canada Australia

INDICATIONS

SUBUTEX is indicated for the treatment of opioid dependence and is preferred for induction. SUBUTEX should be used as part of a complete treatment plan to include counseling and psychosocial support.

DOSAGE AND ADMINISTRATION

Drug Addiction Treatment Act

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Where can I Buy Subutex for sale online in USA UK Canada Australia

Important Dosage And Administration Instructions

SUBUTEX is administered sublingually as a single daily dose.

SUBUTEX does not contain naloxone and is preferred for use only during induction. Following induction, SUBOXONE sublingual film or SUBOXONE sublingual tablet is preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of SUBUTEX for unsupervised administration should be limited to those patients who cannot tolerate SUBOXONE sublingual film or SUBOXONE sublingual tablet; for example, those patients who have been shown to be hypersensitive to naloxone.

Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Where can I Buy Subutex for sale online in USA UK Canada Australia

Induction

Prior to induction, consideration should be given to the type of opioid dependence (i.e., long-or short-acting opioid products), the time since last opioid use, and the degree or level of opioid dependence.

Patients Dependent On Heroin Or Other Short-Acting Opioid Products

At treatment initiation, the first dose of SUBUTEX should be administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid.

It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred. In some studies, gradual induction over several days led to a high rate of dropout of buprenorphine patients during the induction period.

In a one-month study, patients received 8 mg of SUBUTEX on Day 1 and 16 mg SUBUTEX on Day 2. From Day 3 onward, patients received either SUBOXONE sublingual tablet or SUBUTEX at the same buprenorphine dose as Day 2 based on their assigned treatment. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose. Where can I Buy Subutex for sale online in USA UK Canada Australia

Patients Dependent On Methadone Or Other Long-Acting Opioid Products

Patients dependent upon methadone or other long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction than those on short-acting opioid products; therefore, the first dose of SUBUTEX should only be administered when objective and clear signs of moderate opioid withdrawal appear, and generally not less than 24 hours after the patient last used a long-acting opioid product.

There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal signs and symptoms are possible during induction onto buprenorphine. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. Where can I Buy Subutex for sale online in USA UK Canada Australia

Maintenance

• SUBOXONE is preferred for maintenance treatment.
• Where SUBUTEX is used in maintenance in patients who cannot tolerate the presence of naloxone, the dosage of SUBUTEX should be progressively adjusted in increments/decrements of 2 mg or 4 mg buprenorphine to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
• After treatment induction and stabilization, the maintenance dose of SUBUTEX is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient. The recommended target dosage of SUBUTEX is 16 mg as a single daily dose. Dosages higher than 24 mg have not been demonstrated to provide any clinical advantage.
• When determining the prescription quantity for unsupervised administration, consider the patient’s level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication.
• There is no maximum recommended duration of maintenance treatment. Patients may require treatment indefinitely and should continue for as long as patients are benefiting and the use of SUBUTEX contributes to the intended treatment goals.

Method Of Administration

SUBUTEX must be administered whole. Do not cut, chew, or swallow SUBUTEX. Advise patients not to eat or drink anything until the tablet is completely dissolved.

SUBUTEX should be placed under the tongue until it is dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product. Where can I Buy Subutex for sale online in USA UK Canada Australia

Proper administration technique should be demonstrated to the patient.

Clinical Supervision

Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient’s clinical stability permits. The use of SUBUTEX for unsupervised administration should be limited to those patients who cannot tolerate SUBOXONE, for example those patients with known hypersensitivity to naloxone. SUBOXONE and SUBUTEX are both subject to diversion and abuse. When determining the prescription quantity for unsupervised administration, consider the patient’s level of stability, the security of his or her home situation, and other factors likely to affect the ability of the patient to manage supplies of take-home medication.

Ideally, patients should be seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress. Where can I Buy Subutex for sale online in USA UK Canada Australia

Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the healthcare provider’s evaluation of treatment outcomes and objectives such as:

1. Absence of medication toxicity.
2. Absence of medical or behavioral adverse effects.
3. Responsible handling of medications by the patient.
4. Patient’s compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities).
5. Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use).

If treatment goals are not being achieved, the healthcare provider should re-evaluate the appropriateness of continuing the current treatment.

Patients With Severe Hepatic Impairment

Consider reducing the starting and titration incremental dose by half and monitor for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.

Unstable Patients

Healthcare providers will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the healthcare provider does not feel that he/she has the expertise to manage the patient. In such cases, the healthcare provider may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment.

Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment. Where can I Buy Subutex for sale online in USA UK Canada Australia

Discontinuing Treatment

The decision to discontinue therapy with SUBOXONE or SUBUTEX after a period of maintenance should be made as part of a comprehensive treatment plan. Advise patients of the potential to relapse to illicit drug use following discontinuation of opioid agonist/partial agonist medication-assisted treatment. Taper patients to reduce the occurrence of withdrawal signs and symptoms [see WARNINGS AND PRECAUTIONS].