Subutex

Subutex is a prescription medication used to treat patients who are dependent on opioids (addiction to opioid drugs, including heroin and narcotic painkillers). Subutex belongs to a group of drugs called opioid partial agonist-antagonists, which work because it produces similar effects to opioids.

This medication comes in tablet form to be dissolved under the tongue (sublingual) once daily.

Some of the common side effects of Subutex include constipation, nausea, and headache. Subutex can cause dizziness and drowsiness. Do not drive or operate machinery until you know how Subutex will affect you. Do not drink alcohol while taking this medication.

Brand name Subutex sublingual tablets are no longer available. Generic versions are made available by several manufacturers.

Subutex is a prescription medication used to treat patients who are dependent on opioids (addiction to opioid drugs, including heroin and narcotic painkillers).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Subutex can cause serious side effects that can lead to death, including:

The most common side effects of Subutex include:

• nausea
• headache
• dizziness
• constipation
• drowsiness
• vomiting
• dry mouth and
• itching, redness, or rash (patch form)

Constipation (incomplete or hard bowel movements) is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using Subutex.

Talk to your doctor about any side effect that bother you or do not go away.

These are not all the possible side effects of Subutex. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with Subutex. Sometimes, the doses of certain medicines and Subutex need to be changed if used together.

Especially tell your doctor if you take:

• other pain medicines
• antidepressant medicines
• sleeping pills
• antihistamines
• anti-anxiety medicines
• muscle relaxants
• anti-nausea medicines
• sedative or tranquilizer medicines (medicines that make you sleepy)
• a medicine for abnormal heartbeats

You should not take Subutex if you already take a monoamine oxidase inhibitor medicine (MAOI) or within 14 days after you stop taking an MAOI medicine.

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist. Your doctor will tell you if it is safe to take other medicines while you are using Subutex.

Subutex overdose can cause serious and life threatening breathing problems. Serious and life-threatening breathing problems can occur with Subutex. This can occur if the dose you are using is too high for you.

Serious breathing problems that can be life threatening. Call your doctor right away or get emergency medical help if you:

• have trouble breathing
• have changes in breathing
• unusual deep “sighing” breathing
• slow or shallow breathing
• new or unusual snoring
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally

Allergic reactions. Rash, itching, and hives are the most common symptoms of an allergic reaction. Call your doctor if you have these symptoms. Get medical help right away if you have swelling of your lips or tongue, breathing problems, wheezing, chest pain while taking Subutex.

• Subutex can cause a drop in your blood pressure. Low blood pressure can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
• Liver problems. Your skin or the white part of your eyes can turn yellow (jaundice), urine can turn dark, stools can turn light in color, you may have less of an appetite, and nausea. Your doctor may do tests before you start and while you take Subutex.
• Subutex can cause physical dependence. Do not stop using Subutex or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
• There is a chance of abuse or addiction with Subutex. The chance is higher if you are or have been addicted to or abused other medicines, street drugs or alcohol in the past. You may have a greater risk of developing abuse or addiction again while using Subutex.
• Do not drive, operate heavy machinery, or do other dangerous activities, until you know how you react to this medicine. Subutex can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react. Ask your doctor when it is okay to do these activities.
• Do not drink alcohol while taking this medication or use prescription or non-prescription medicines that have alcohol in them while using Subutex. Alcohol can increase your chances of having serious side effects including death.

Do not use Subutex if you:

• have trouble breathing, severe asthma or severe lung problems
• have a bowel blockage called paralytic ileus
• are allergic to any of the ingredients in Subutex

Subutex sublingual tablets are not for occasional or “as needed” use.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Subutex, grapefruit and grapefruit juice may interact with Subutex and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Subutex, tell your doctor about all of your medical conditions including if you have:

• breathing or lung problems
• history of a heart problem called Long QT syndrome (or if a family member has this condition)
• head injury or brain problems
• low blood pressure
• liver problems
• kidney problems
• hepatitis B or hepatitis C
• had convulsions or seizures
• severe scoliosis
• thyroid problems
• prostate problems or trouble urinating
• Addison’s disease
• alcoholism, or a family history of this problem
• depression or hallucinations (seeing or hearing things that are not there)
• drug abuse or addiction problem, or a past problem, or a family history of this problem
• have any other medical conditions

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. The medication in Subutex passes into your breast milk. You and your doctor should decide if you will take Subutex or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Subutex.

Always take Subutex sublingual (under the tongue) tablets exactly as your doctor tells you. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.

• Do not take Subutex sublingual tablets more often than prescribed by your doctor. Ask your doctor or pharmacist for instructions on the right way to take Subutex sublingual tablets.
• Follow the same instructions every time you take a dose of Subutex sublingual tablets.
• Put the tablets under your tongue. Let them dissolve completely.
• While Subutex sublingual tablets are dissolving, do not chew or swallow the tablet because the medicine will not work as well.
• Talking while the tablet is dissolving can affect how well the medicine in Subutex sublingual tablets is absorbed.
• If you miss a dose of Subutex sublingual tablets, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
• Do not stop taking Subutex sublingual tablets suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using Subutex sublingual tablets the right way.

The dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose range with Subutex sublingual tablets is 4 mg to 24 mg per day. 

If you take too much Subutex call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Subutex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Subutex at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep Subutex in a safe place out of the reach of children.
• Subutex is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs. Prevent theft, misuse and abuse. Keep Subutex in a safe place to protect from being stolen. Never give Subutex to anyone else, even if they have the same symptoms you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.