Suboxone

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-4,5?-epoxy-3-hydroxy-6-methoxy-6?,14-ethano-14?-morphinan-7?-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, 5? -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:

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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Suboxone Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, drowsiness, dizziness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist immediately.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Although this medication is used to prevent withdrawal reactions, it may rarely cause narcotic withdrawal symptoms. This is more likely when you first start treatment or if you have been using long-acting narcotics such as methadone. If such symptoms occur, tell your doctor or pharmacist immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe (possibly fatal) breathing problems can occur, especially if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other narcotics). Get medical help right away if any of these serious side effects occur: slow/shallow breathing, fainting, mental/mood changes (such as agitation, confusion, hallucinations), unusual drowsiness/difficulty waking up.

This drug may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, yellowing eyes/skin, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol increases your risk for serious, possibly fatal, breathing problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Suboxone Patient Information Including Side Effects

Brand Names: Suboxone

Generic Name: buprenorphine and naloxone (Pronunciation: byoo PREH nor feen and NAH lox own)

  • What is buprenorphine and naloxone (Suboxone)?
  • What are the possible side effects of buprenorphine and naloxone (Suboxone)?
  • What is the most important information I should know about buprenorphine and naloxone (Suboxone)?
  • What should I discuss with my healthcare provider before taking buprenorphine and naloxone (Suboxone)?
  • How should I take buprenorphine and naloxone (Suboxone)?
  • What happens if I miss a dose (Suboxone)?
  • What happens if I overdose (Suboxone)?
  • What should I avoid while taking buprenorphine and naloxone (Suboxone)?
  • What other drugs will affect buprenorphine and naloxone (Suboxone)?
  • Where can I get more information?

What is buprenorphine and naloxone (Suboxone)?

Buprenorphine is an opioid medication. Buprenorphine is similar to other opioids such as morphine, codeine, and heroin however, it produces less euphoric ("high") effects and therefore may be easier to stop taking.

Naloxone blocks the effects of opioids such as morphine, codeine, and heroin. If buprenorphine and naloxone is injected, naloxone will block the effects of buprenorphine and lead to withdrawal symptoms in a person with an opioid addiction. When administered under the tongue as directed, naloxone will not affect the actions of buprenorphine.

Buprenorphine and naloxone is used to treat opiate addiction.

Buprenorphine and naloxone may also be used for purposes other than those listed in this medication guide.

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 doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat, swelling of the lips, tongue, or face; or hives);
  • slow breathing;
  • dizziness or confusion; or
  • liver problems such as yellowing of the skin or eyes, dark colored urine, light colored stools (bowel movements), decreased appetite for several days or longer, nausea, or lower stomach pain.

Other less serious side effects may be more likely to occur. Continue to take buprenorphine and naloxone and talk to your doctor if you experience

  • headache;
  • pain;
  • problems sleeping;
  • nausea;
  • sweating;
  • stomach pain; or
  • constipation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about buprenorphine and naloxone (Suboxone)?

Buprenorphine and naloxone can cause death from overdose, especially if it is injected with a tranquilizer. Use buprenorphine and naloxone exactly as directed by your doctor.

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.

In an emergency, have family members tell emergency room staff that you are taking buprenorphine and naloxone and that you are dependent on opioids.

Use caution when driving, operating machinery, or performing other hazardous activities. Buprenorphine and naloxone may cause drowsiness, dizziness, or impaired thinking. If you experience drowsiness, dizziness, or impaired thinking, avoid these activities.

Avoid alcohol while taking buprenorphine and naloxone. Alcohol may dangerously increase drowsiness and dizziness caused by the medication.

Buprenorphine and naloxone may dangerously increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other prescription or over-the-counter medicine, including herbal products, without first talking to your doctor.

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