Buprenorphine Hydrochloride/Naloxone Hydrochloride Sublingual, Oral

What are other names for this medicine?

Type of medicine: narcotic agonist; narcotic antagonist

Generic and brand names: buprenorphine hydrochloride and naloxone HCI sublingual, oral; Suboxone

What is this medicine used for?

This medicine is placed under the tongue to treat addiction to narcotic drugs.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• a stroke, head injury, or brain tumor
• an allergic reaction to any medicine
• adrenal gland problems such as Addison's disease
• an enlarged prostate gland or trouble urinating
• delirium tremens
• gallbladder problems
• glaucoma
• liver or kidney disease
• lung disease such as chronic bronchitis or emphysema
• mental disorders such as depression or hallucinations (seeing or hearing things that are not there)
• pancreatitis
• problems with alcohol abuse
• thyroid problems

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

These are sublingual tablets. Do not chew or swallow these tablets. The tablets will not work if chewed or swallowed and may result in withdrawal symptoms. Allow them to dissolve slowly under your tongue. It will take from 2 to 10 minutes for the tablets to dissolve.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider. Do not take more or for a longer period of time than directed by your healthcare provider. Taking too much of this medicine may cause very serious side effects.

Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dosage gradually to avoid withdrawal symptoms.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: slow breathing, seizures, dizziness, weakness, fainting, coma, confusion, tiredness, cold clammy skin, pinpoint pupils.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Taking other medicines that slow down your nervous system or drinking alcohol while you are taking this medicine may lead to coma, serious injury, or death. Ask your healthcare provider about this.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Yellow skin or eyes, dark urine, light-colored bowel movements, severe confusion, severe stomach pain, slow breathing, severe dizziness or drowsiness.

Other: Nausea, vomiting, headache, constipation, dizziness, trouble sleeping, sweating, flushing, nervousness, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods, may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• antibiotics such as clarithromycin (Biaxin, Biaxin XL), ciprofloxacin (Cipro), doxycycline (Doryx, Vibramycin), erythromycin (Erythrocin, EES, E-Mycin, Ery-Tab, EryPed), and rifampin (Rifadin, Rimactane)
• antifungal medicines such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• antihistamines such as diphenhydramine (Benadryl), hydroxyzine (Atarax, Vistaril), and chlorpheniramine (Chlor-Trimeton)
• antinausea medicines such as prochlorperazine (Compazine) and promethazine (Phenergan)
• antipsychotic medicines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine, trifluoperazine (Stelazine), thioridazine, haloperidol (Haldol), clozapine (Clozaril), and olanzapine (Zyprexa)
• barbiturates such as phenobarbital, butabarbital (Butisol), and pentobarbital (Nembutal)
• antiseizure medicines such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• MAO inhibitors such as phenelzine (Nardil), tranylcypromine (Parnate), and isocarboxazid (Marplan) (Do not take an MAO inhibitor and this medicine within 14 days of each other.)
• narcotic cough medications such as hydrocodone and chlorpheniramine (Tussionex), hydrocodone and homatropine (Hycodan), guaifenesin and codeine (Tussi-organidin, Robitussin AC), and promethazine with codeine (Phenergan with codeine)
• muscle relaxants such as cyclobenzaprine (Flexeril), baclofen (Lioresal), carisoprodol (Soma), tizanidine (Zanaflex), methocarbamol (Robaxin), and dantrolene (Dantrium)
• narcotic painkillers such as codeine, morphine, oxycodone (Oxy-Contin), meperidine (Demerol), and hydromorphone (Dilaudid)
• natural remedies such as kava, gotu kola, valerian, and St. John's wort
• protease inhibitors such as ritonavir (Norvir), saquinavir (Fortovase, Invirase), indinavir sulfate (Crixivan), nelfinavir (Viracept), and amprenavir (Agenerase)
• sleeping pills such as zolpidem (Ambien), zaleplon (Sonata), and chloral hydrate
• SSRI antidepressants such as sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil), nefazodone, venlafaxine (Effexor), and fluvoxamine
• tricyclic antidepressants such as amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), desipramine (Norpramin), and doxepin (Sinequan)

DO NOT drink alcohol while you are taking this medicine.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.