Suboxone (Buprenorphine HCl and naloxone HCl) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 8, 2012

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Suboxone

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SUBOXONE
(buprenorphlne and naloxone) Sublingual Tablets for Sublingual Administration

DRUG DESCRIPTION

SUBOXONE (buprenorphine and naloxone) sublingual tablet is an an uncoated hexagonal orange tablet, imprinted with a sword logo on one side and an alphanumeric imprint identifying the product and strength. It contains buprenorphine HCI, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCI dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains lactose, mannitol, comstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, acesulfame K sweetener and a lemon / lime flavor.

Chemically, buprenorphine HCI 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 HCI Structural Formula Illustration

Buprenorphine HCI has the molecular formula C₂₉H₄₁NO₄•HCI 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.

Chemically, naloxone HCI dihydrate is 17-Allyl-4, 5α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:

Naloxone hydrochloride Structural Formula Illustration

Naloxone hydrochloride dihydrate has the molecular formula C₁₉H₂₁NO₄•HCl • 2H₂0 and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.

What are the possible side effects of buprenorphine and naloxone (Suboxone)?

Buprenorphine and naloxone can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine and naloxone is not for occasional ("as needed") use. Do not stop taking buprenorphine and naloxone without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms.

Seek emergency medical attention or contact your...

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What are the precautions when taking buprenorphine hcl and naloxone hcl (Suboxone)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to buprenorphine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged...

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Last reviewed on RxList: 1/17/2012
This monograph has been modified to include the generic and brand name in many instances.