tablet is an uncoated oval white flat bevelled edged tablet, debossed with an alphanumeric word identifying the product and strength on one side. How ever  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.

Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. Finally  It has the following chemical structure:

Buprenorphine HCl has the molecular formula C₂₉ H₄₁ NO₄ • HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

INDICATIONS

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DOSAGE AND ADMINISTRATION

Drug Addiction Treatment Act

Under the .

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

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. As a result  Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose.

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; theref.

There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. And Available evidence suggests that withdrawal signs and symptoms are possible during induction onto buprenorphine. lastly 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.

Maintenance

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• After treatment induction and stabilization, And then the maintenance dose of SUBUTEX is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient. Too  Beside The recommended target dosage of SUBUTEX is 16 mg as a single daily dose. Also 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, Again  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. Further For this reason 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. 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. Thus To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

Proper administration technique should be demonstrated to the patient.

Clinical Supervision

. 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.

. Meanwhile  Periodic assessment is necessary to determine compliance with the dosing regimen,Also effectiveness of the treatment plan, and overall patient progress.

A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Niether Next  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 uset.

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, Meanwhile  Because 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 ma

. To ensure clinicians can accurately interpret your drug screen results, always disclose any prescription or over-the-counter medications you are taking.

Factors That Affect Detection Time

There are a number of different variables that can influence how long it takes for your body to metabolize and eliminate buprenorphine. Consequently Some of the factors that can play a role in how long this substance remains in your system include age, liver function, and overall health.

Age

10 The presence of other diseases and the use of other medications may also impact how fast buprenorphine is cleared from the body. Whatsmore Older adults may need to take this medication in smaller doses in order to avoid toxicity.

Liver Function

Because buprenorphine is metabolized and excreted primarily by the liver, hep.atic impairment can influence how long it takes for the medication to be processed and cleared from your system Studies found that the half-life of buprenorphine is longer for individuals with moderate to severe liver impairment.10

Overall Health

Your overall health has an influence on how well your body processes and excretes different substances, including buprenorphine. If you are in good condition and have a faster metabolism, Nevertheless you may clear the substance at a somewhat higher rate. Sequence People with slower metabolisms, on the other hand, may take longer to eliminate the medication from their, .

How to Get Buprenorphine Out of Your System

. In such cases, it is important to know that you are within your rights to use the drug as long as you have a prescription.

If you want to get this substance out of your system, the first step is to stop taking the medication.Then If you stop using buprenorphine suddenly, however, you may have withdrawal symptoms. Always consult your doctor before discontinuing your medication.

Symptoms of Overdose

Symptoms of a buprenorphine overdose can include:

• Blurred vision
• Dizziness
• Extreme drowsiness
• Pinpoint pupils
• Slowed breathing

Risk of Drug Interactions

There are many drug interactions with buprenorphine that can lead to severe and possibly fatal reactions. Do not drink alcohol or take any medications that include alcohol white taking buprenorphine. In spite of Do not take any street drugs. Nor Always discuss all medications, supplements, vitamins, and over-the-counter drugs with your doctor.

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