Subutex

Generic name: Buprenorphine (oral/sublingual)

Usage of Subutex

Subutex is an opioid medication. An opioid is sometimes called a narcotic.

Subutex sublingual tablets are used to treat opioid addiction.

Other forms of buprenorphine are used to treat moderate to severe pain.

Subutex sublingual is not for use as a pain medication.

Subutex side effects

Get emergency medical help if you have signs of an allergic reaction to Subutex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

any problems with your teeth or gums;

noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

problems with thinking, blurred vision, slurred speech, a light-headed feeling, like you might pass out;

chest pain, trouble breathing, slow heartbeat or weak pulse;

opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;

low cortisol levels - vomiting, dizziness, worsening tiredness or weakness; or

liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Subutex side effects may include:

constipation, nausea, vomiting;

headache;

increased sweating;

sleep problems (insomnia); or

pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Subutex

You should not use Subutex if you are allergic to buprenorphine, or:

if you have used another opioid medicine within the past 4 hours.

To make sure Subutex is safe for you, tell your doctor if you have ever had:

tooth problems, including a history of cavities;

methadone treatment, breathing problems, sleep apnea;

abnormal curvature of the spine that affects breathing;

kidney or liver disease (especially hepatitis B or C);

enlarged prostate, urination problems;

a head injury or brain tumor;

alcoholism, hallucinations, mental illness; or

problems with your stomach, gallbladder, adrenal gland, or thyroid.

If you use Subutex while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Buprenorphine can pass into breast milk and may cause drowsiness, and breathing problems in a nursing baby. Ask your doctor about any risk.

Subutex is not approved for use by anyone younger than 18 years old.

How to use Subutex

Usual Adult Dose for Opiate Dependence - Maintenance:

SUBLINGUAL Tablets: Following a 2-day induction: -Adjust dose in 2 to 4 mg increments/decrements to a level that holds patient in treatment and suppresses opioid withdrawal signs and symptoms -Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day -Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage Comments: -Buprenorphine with naloxone is the preferred drug for maintenance treatment; unsupervised maintenance treatment with buprenorphine should be limited to those who cannot tolerate buprenorphine-naloxone. -When determining prescription quantity for unsupervised administration, consider the patient's level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medications. -Monthly doses should allow for a minimum of 26 days between doses; occasional delays in dosing of up to 2 weeks are not expected to have a clinically significant impact on treatment effect.

Usual Adult Dose for Opiate Dependence - Induction:

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear, and -at least 4 hours have elapsed since last use of heroin or other short-acting opioids -at least 24 hours have elapsed since last use of methadone or other long-acting opioids INDUCTION: Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred) Day 2: 16 mg sublingually once a day Comments: -This drug should be used as part of a complete treatment plan to include counseling and psychosocial support. -Buprenorphine (without naloxone) is the preferred drug for induction; following induction, unsupervised administration should be limited to those patients who cannot tolerate buprenorphine/naloxone. -Adequate treatment doses should be given as soon as possible as gradual induction over several days has led to higher dropout rates. Uses: For the treatment of opioid dependence and is preferred for induction.

Warnings

Subutex sublingual tablets are not for use as a pain medication.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What other drugs will affect Subutex

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

other opioid medications - opioid pain medicine or prescription cough medicine;

a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Disclaimer

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