Buprenorphine Hydrochloride Solution for injection

What is this medicine?

BUPRENORPHINE (byoo pre NOR feen) is a pain reliever. It is used to treat moderate to severe pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • brain tumor

  • drink more than 3 alcohol-containing drinks per day

  • drug abuse or addiction

  • head injury

  • lung disease such as asthma or COPD

  • an unusual or allergic reaction to buprenorphine, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • butorphanol

  • nalbuphine

  • pentazocine

This medicine may also interact with the following medications:

  • alcohol

  • antibiotics like erythromycin and clarithromycin

  • antihistamines for allergy, cough and cold

  • barbiturates like phenobarbital

  • carbamazepine

  • general anesthetics

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for fungal infections like ketoconazole and itraconazole

  • medicines for sleep

  • medicines used to treat HIV infection or AIDS like ritonavir, saquinavir, and indinavir

  • muscle relaxants

  • narcotic medicines (opiates) for pain

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

  • phenytoin

  • rifampin or rifampicin

  • tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • anxiety, irritability, nervousness or restlessness

  • breathing problems

  • cold, clammy skin or sweating

  • confusion

  • diarrhea

  • feeling faint or lightheaded, falls

  • stomach pain or vomiting

  • swelling of ankles

  • trouble passing urine or change in the amount of urine

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • difficulty sleeping

  • headache

  • nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


Buprenorphine Hydrochloride Sublingual tablet

What is this medicine?

BUPRENORPHINE (byoo pre NOR feen) is used to treat certain types of drug dependence.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • brain tumor

  • drink more than 3 alcohol-containing drinks per day

  • head injury

  • heart disease

  • kidney disease

  • liver disease

  • lung disease such as asthma or COPD

  • an unusual or allergic reaction to buprenorphine, naloxone, morphine, codeine, other medicines, lactose, mannitol, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

The medicine is placed under the tongue and allowed to dissolve. Several minutes will be needed to allow the tablet to fully dissolve. If your dose requires you to take more than 2 tablets at once, either place all the tablets at once under the tongue, or if you cannot fit more than 2 tablets comfortably, place 2 tablets at a time under the tongue. Either way, you should hold the tablets under the tongue until they completely dissolve. Do not swallow or chew the tablet. Do not inject the medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • butorphanol

  • nalbuphine

  • pentazocine

This medicine may also interact with the following medications:

  • alcohol

  • antibiotics like erythromycin and clarithromycin

  • antihistamines for allergy, cough and cold

  • barbiturates like phenobarbital

  • carbamazepine

  • general anesthetics

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for fungal infections like fluconazole, itraconazole, ketoconazole, and voriconazole

  • medicines for sleep

  • medicines used to treat HIV infection or AIDS like ritonavir, saquinavir, and indinavir

  • muscle relaxants

  • narcotic medicines (opiates) for pain

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

  • phenytoin

  • rifampin or rifampicin

  • tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your body becomes used to the medicine. Your doctor will tell you how much medicine to take.

Wear a medical identification bracelet or chain to say that you are taking this medicine. Emergency personnel will need to know that you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

You will likely have your blood checked before you start taking this medicine.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • anxiety, irritability, nervousness or restlessness

  • breathing difficulties, wheezing

  • cold, clammy skin or sweating

  • confusion

  • decrease or difficulty in passing urine

  • diarrhea

  • fainting spells

  • severe stomach pain or vomiting

  • yellowing of the skin or the whites of the eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • headache

  • insomnia

  • nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (56 and 86 degrees F).

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


Buprenorphine Transdermal Patch - weekly

What is this medicine?

BUPRENORPHINE (byoo pre NOR feen) is a pain reliever. It is used to treat moderate to severe pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • brain tumor

  • drink more than 3 alcohol-containing drinks per day

  • drug abuse or addiction

  • fast, irregular heartbeat

  • fever

  • general ill feeling or flu-like symptoms

  • head injury

  • liver disease

  • lung disease such as asthma or COPD

  • taken isocarboxazid, phenelzine, tranylcypromine, or selegiline in the past 2 weeks

  • thyroid disease

  • trouble passing urine or change in the amount of urine

  • an unusual or allergic reaction to buprenorphine, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Apply the patch to your skin. Do not cut or damage the patch. A cut or damaged patch can be very dangerous because you may get too much medicine. Select a clean, dry area of skin on your upper outer arm, upper chest, upper back, or the side of the chest. Do not apply the patch to broken, burned, cut, or irritated skin. Use only water to clean the area. Do not use soap or alcohol to clean the skin because this can increase the effects of the medicine. If the area is hairy, clip the hair with scissors, but do not shave.

Take the patch out of its wrapper. Bend the patch along the faint line and slowly peel the outer portion of the liner, which covers the sticky surface of the patch. Press the patch onto the skin and slowly peel off the protective liner. Do not use a patch if the packaging or backing is damaged. Do not touch the sticky part with your fingers. Press the patch to the skin using the palm of your hand. Press the patch to the skin for 15 seconds. Wash your hands at once.

Take off the old patch before putting on a new patch. Apply each new patch to a different area of skin. If a patch comes off or causes irritation, remove it and apply a new patch to a different site. To get rid of used patches, fold the patch in half with the sticky sides together. Then, flush it down the toilet. Alternately, you may dispose of the patch in the Patch-Disposal Unit provided. Never throw the patch away in the trash without sealing it in the Patch-Disposal unit. Pets and children can be harmed if they find used or lost patches. Replace the patch every 7 days. Follow the directions on the prescription label. Do not use more medicine than you are told to use.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

If a patch accidentally touches the skin, use only water to clean the area. Do not use soap or alcohol to clean the skin because this can increase the effects of the medicine. If someone accidentally uses a buprenorphine patch and is not awake and alert, immediately call 911 for help. If the person is awake and alert, call a doctor, health care professional, or the Poison Control Center.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you forget to replace your patch, take off the old patch and put on a new patch as soon as you can. Do not apply an extra patch to your skin. Do not wear more than one patch at the same time unless told to do so by your doctor or health care professional.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • butorphanol

  • nalbuphine

  • pentazocine

This medicine may also interact with the following medications:

  • alcohol

  • antibiotics like erythromycin and clarithromycin

  • antihistamines for allergy, cough and cold

  • barbiturates like phenobarbital

  • carbamazepine

  • certain medicines for irregular heart beat

  • general anesthetics

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for fungal infections like ketoconazole and itraconazole

  • medicines for sleep

  • medicines used to treat HIV infection or AIDS like ritonavir, saquinavir, and indinavir

  • muscle relaxants

  • narcotic medicines (opiates) for pain

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

  • phenytoin

  • rifampin or rifampicin

  • tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Other pain medicine may be needed when you first start using the patch because the patch can take some time to start working. Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

Heat can increase the amount of medicine released from the patch. Do not get the patch hot by using heating pads, heated water beds, electric blankets, and heat lamps. You can bathe or swim while using the patch. But, do not use a sauna or hot tub. Tell you doctor or health care professional if you get a fever.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • anxiety, irritability, nervousness or restlessness

  • breathing problems

  • cold, clammy skin or sweating

  • confusion

  • diarrhea

  • feeling faint or lightheaded, falls

  • stomach pain or vomiting

  • swelling of ankles

  • trouble passing urine or change in the amount of urine

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • constipation

  • difficulty sleeping

  • dry mouth

  • headache

  • itching, redness, or rash at the patch site

  • nausea

  • vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Do not store the patches out of their wrappers. Flush any unused medicines down the toilet as instructed above. Do not use the medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.