"In light of a growing opioid epidemic that includes a spike in overdose deaths and increasing availability of potent, rapid-onset synthetic products such as fentanyl derivatives, a joint US Food and Drug Administration (FDA) advisory committee ha"...
(buprenorphine) Sublingual Tablet for Sublingual Administration
SUBUTEX (buprenorphine) sublingual tablet is an uncoated oval white tablet, imprinted with a sword logo on one side and an alphanumeric imprint identifying the product and strength. It contains buprenorphine HCl and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as free base). 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-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:
Buprenorphine HCl has the molecular formula C29H41NO4 • 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.
What are the possible side effects of buprenorphine (Subutex)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
Call your doctor at once if you have a serious side effect such as:
- slow or shallow breathing;
- feeling light-headed, fainting;
- confusion, unusual thoughts or behavior; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools,...
Last reviewed on RxList: 1/9/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Subutex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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