Subutex

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Generic Name: Subutex Brand Name(s): Subutex.

Uses

What is Subutex® (buprenorphine sublingual) used for?

Subutex® is used to treat pain drug (opioid) addiction.

It may be given to you for other reasons.

How should I take Subutex® (buprenorphine sublingual)?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

To gain the most benefit, do not miss doses.

Take Subutex® at the same time of day.

Place tablet under the tongue and let melt.

Do not chew or swallow whole.

Do not eat, drink, smoke, or talk while this medicine is melting.

How do I store Subutex® (buprenorphine sublingual)?

Subutex® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Subutex® in the bathroom or the freezer. There may be different brands of Subutex® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Subutex® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Subutex® (buprenorphine sublingual)?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Subutex® or other medications.
  • You have any other illnesses, disorders, or medical conditions.
  • You have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • You have liver disease.
  • You or a family member have a long QT on ECG.
  • You are taking any of these drugs: Butorphanol, nalbuphine, or pentazocine.
  • You are using another drug that has the same drug in it.
  • You are taking any of these drugs: Certain drugs to treat a heartbeat that is not normal like amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol.
  • You are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • You have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking Subutex® within 14 days of those drugs can cause very bad high blood pressure.
  • You are taking any of these drugs: Linezolid or methylene blue.

Avoid driving and doing other tasks or actions that call for you to be alert until you see how Subutex® (buprenorphine sublingual tablets) affects you.

To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.

Have blood work checked as you have been told by the doctor. Talk with the doctor.

Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop Subutex®, you will want to slowly stop it as ordered by your doctor.

If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if Subutex® stops working well. Do not take more than ordered.

This medicine may cause withdrawal symptoms if you are dependent or addicted to narcotics. Talk with your doctor.

Do not take this medicine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.

If you drink grapefruit juice or eat grapefruit often, talk with your doctor.

Very bad and sometimes deadly liver problems have happened with Subutex®. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking Subutex®.

If you are 65 or older, use this medicine with care. You could have more side effects.

Follow up with the doctor as you have been told.

This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Subutex®, call your doctor right away.

Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

This medicine is not approved for use in children. Talk with the doctor.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Subutex® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Subutex®. Subutex® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur from Subutex® (buprenorphine sublingual)?

Common side effects include:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Trouble breathing, slow breathing, or shallow breathing
  • Very bad dizziness or passing out
  • Too much sweat
  • Fast or slow heartbeat
  • A heartbeat that does not feel normal
  • Feeling confused
  • Very hard stools (constipation)
  • Feeling very tired or weak
  • Feeling nervous and excitable
  • Fever or chills
  • Sore throat
  • Change in balance
  • Mood changes
  • Very bad belly pain
  • Extra muscle action or slow movement
  • Slurred speech
  • Swelling in the arms or legs
  • Change in eyesight
  • A burning, numbness, or tingling feeling that is not normal
  • Trouble speaking
  • Chest pain or pressure
  • Trouble passing urine
  • Hallucinations (seeing or hearing things that are not there)
  • Muscle or joint pain
  • Memory problems or loss
  • Seizures
  • Very bad headache
  • Shakiness
  • Feeling very sleepy

A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take Subutex® with drugs for depression, migraines, or certain other drugs.

Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

Taking an opioid drug like this medicine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Subutex® (buprenorphine sublingual)?

Subutex® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Subutex® (buprenorphine sublingual)?

Subutex® (buprenorphine sublingual) may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Subutex® (buprenorphine sublingual)?

Subutex® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Subutex® (buprenorphine sublingual).

 

What is the dose of Subutex® (buprenorphine sublingual) for an adult?

Usual Adult Dose for Opiate Dependence

To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):

Induction dose:

  • Day 1: 8 mg sublingually once a day
  • Day 2: 16 mg sublingually once a day

Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Buprenorphine IMPLANT for Subdermal Administration:

  • For opioid tolerant patients only
  • Insert 1 dose subdermally in the inner side of the upper arm
  • Remove implant at the end of the sixth month

Usual Adult Dose for Pain

Parenteral:

  • Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat initial dose once after 30 to 60 minutes if required
  • Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
  • Maximum dose: 0.3 mg (IV) or 0.6 mg (IM)

Usual Adult Dose for Chronic Pain

Individualize dosing taking into account prior analgesic treatment; 7.5 mcg, 10 mcg, 15 mcg, and 20 mcg/hr patches are for opioid-experienced patients only.

As first opioid analgesic: Initiate with 5 mcg/hr patch applied transdermally every 7 days

Conversion from Other Opioids to Buprenorphine:

  • Discontinue all other around-the-clock opioid drugs when initiating therapy
  • For patients whose prior total opioid dose is less than 30 mg/day of oral morphine equivalents: Initiate with 5 mcg/hr patch applied transdermally every 7 days at next dosing interval
  • For patients whose prior total opioid dose is between 30 and 80 mg/day of oral morphine equivalents: Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day of oral morphine equivalents, then initiate with 10 mcg/hr patch applied transdermally every 7 days starting at the next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained.
  • For patients whose prior total opioid dose is greater than 80 mg/day of oral morphine equivalents: Consider use of an alternate analgesic as 20 mcg/hr patch may not provide adequate analgesia

Conversion from Methadone:

  • The ratio between methadone and other opioid agonists may vary widely due to its long half-life and accumulation in the plasma; close monitoring is of particular importance.
  • Titration: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
  • Maximum dose: 20 mcg/hr due to risk of QTc interval prolongation

What is the dose of Subutex® (buprenorphine sublingual) for a child?

Usual Pediatric Dose for Pain

Parenteral:

13 years or older:

  • Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes) ; may repeat initial dose once after 30 to 60 minutes if required
  • Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
  • Maximum dose: 0.3 mg

2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours; some patients may not need to be remedicated for 6 to 8 hours

Usual Pediatric Dose for Opiate Dependence

Aged 16 years or older: To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):

Induction dose:

  • Day 1: 8 mg sublingually once a day
  • Day 2: 16 mg sublingually once a day

Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Buprenorphine IMPLANT for Subdermal Administration:

  • For opioid tolerant patients only
  • Insert 1 dose subdermally in the inner side of the upper arm
  • Remove implant at the end of the sixth month

How is Subutex® (buprenorphine sublingual) available?

Subutex® is available in the following dosage forms and strengths:

  • Injectable solution
  • Sublingual tablet
  • Transdermal film
  • Extended release
  • Compounding powder
  • Subcutaneous implant
  • Buccal film

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Subutex®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: September 8, 2017 | Last Modified: September 10, 2017

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