SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white level inclined edged tablet, debossed with an alphanumeric word recognizing the item and quality on one side. It contains buprenorphine HCl, a halfway agonist at the mu-opioid receptor, and is accessible in two dose qualities, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, comparable to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet too contains lactose, mannitol, cornstarch, povidone K30, citric corrosive, 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. It has the taking after chemical structure:
Buprenorphine HCl has the atomic equation C29 H41 NO4 • HCl and the atomic weight is 504.10. It could be a white or off-white crystalline powder, sparingly solvent in water, openly solvent in methanol, dissolvable in liquor and for all intents and purposes insoluble in cyclohexane.
Important Dosage And Administration Instructions
SUBUTEX (buprenorphine) sublingual is administered sublingually as a single daily dose.
SUBUTEX does not contain naloxone and is favored for utilize as it were amid induction. Taking after acceptance, SUBOXONE sublingual film or SUBOXONE sublingual tablet is favored due to the presence of naloxone when clinical utilize incorporates unsupervised administration.
The utilize of SUBUTEX for unsupervised administration ought to be constrained to those patients who cannot endure SUBOXONE sublingual film or SUBOXONE sublingual tablet; for case, those patients who have been appeared to be extremely touchy to naloxone. Medication ought to be endorsed in thought of the recurrence of visits. Arrangement of different refills isn’t prompted early in treatment or without fitting understanding follow-up visits.
Earlier to induction, thought ought to be given to the sort of opioid reliance (i.e., long-or brief– acting opioid items), the time since final opioid utilize, and the degree or level of opioid reliance.
Patients Dependent On Methadone Or Other Long-Acting Opioid Items
Patients dependent upon methadone or other long-acting opioid items may be more helpless to accelerated and delayed withdrawal amid acceptance than those on short-acting opioid items; in this manner, the primary measurements of SUBUTEX ought to as it were be managed when objective and clear signs of direct opioid withdrawal show up, and by and large not less than 24 hours after the quiet final utilized a long-acting opioid product.
There is small controlled encounter with the exchange of methadone-maintained patients to buprenorphine. Accessible prove proposes that withdrawal signs and indications are conceivable amid acceptance onto buprenorphine. Withdrawal shows up more likely in patients kept up on higher measurements of methadone (>30 mg) and when the primary buprenorphine measurements is managed without further ado after the final methadone measurements.