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What is Subutex (Buprenorphine)?
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.
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.
DOSAGE AND ADMINISTRATION OF Subutex (Buprenorphine)
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.
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.
- Subutex (Buprenorphine) 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 (Buprenorphine) must be administered whole. Do not cut, chew, or swallow Subutex (Buprenorphine). Advise patients not to eat or drink anything until the tablet is completely dissolved. Subutex (Buprenorphine) 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.
SIDE EFFECTS OF Subutex (Buprenorphine)
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse
- Respiratory and CNS Depression
- Neonatal Opioid Withdrawal Syndrome
- Adrenal Insufficiency
- Opioid Withdrawal
- Hepatitis, Hepatic Events
- Hypersensitivity Reactions
- Orthostatic Hypotension
- Elevation of Cerebrospinal Fluid Pressure
- Elevation of Intracholedochal Pressure
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