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 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.

Subutex sublingual is usually taken for only at the start of treatment for addiction. Most people are later switched to another medicine that contains this medicine (Bunavail, Sublocade, Suboxone, Zubsolv).

You may receive your first doses of Subutex sublingual in a hospital or clinic setting until your condition improves.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Rinse your mouth with water after the Subutex sublingual tablet dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. Do not chew the tablet or swallow it whole.

If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.

Do not eat or drink anything until the tablet has completely dissolved in your mouth.

You should receive regular dental checkups while using Subutex.

You may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using Subutex.

Never crush or break a Subutex pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Any medical care provider who treats you should know that you are being treated for opioid addiction, and that you are taking Subutex sublingual. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Do not stop using Subutex suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Subutex.

Store at room temperature away from moisture and heat. Keep track of your medicine. Subutex is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

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.

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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Subutex overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, slow heart rate, weak pulse, very slow breathing, or coma.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how Subutex will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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.

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.