Suboxone

Suboxone is a prescription medications used for the maintenance treatment of opioid dependence (addiction to opioid drugs). Suboxone should be used along with a complete treatment plan that includes counseling and psychosocial support. It contains 2 ingredients: buprenorphine and naloxone. Buprenorphine is in a group of drugs called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. These work by producing effects similar to opioid drugs and preventing withdrawal symptoms when someone stops taking opioid medications.

This medication is available as a film that is applied sublingually (under the tongue). Avoid eating or drinking until the film has dissolved entirely. Do not cut, chew, or swallow Suboxone films.

Common side effects of Suboxone include headache, nausea, excessive sweating, constipation, opioid withdrawal symptoms, insomnia, and pain.

Suboxone can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Suboxone affects you.

Suboxone is available in a combination prescription medication that is used for maintenance treatment of opioid addiction. This combination is used to prevent withdrawal symptoms when someone stops taking opioid medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Reckitt Benckiser Pharmaceuticals Inc.

Serious side effects have been reported with Suboxone. See the “Suboxone Precautions” section.

Common side effects of Suboxone include the following:

• Nausea
• Vomiting
• Drug withdrawal syndrome
• Headache
• Sweating
• Numb mouth
• Constipation
• Painful tongue
• The inside of your mouth is more red than normal
• Intoxication (feeling lightheaded or drunk)
• Disturbance in attention
• Irregular heart beat (palpitations)
• Decrease in sleep (insomnia)
• Blurred vision
• Back pain
• Fainting
• Dizziness
• Sleepiness

This is not a complete list of Suboxone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen (Tylenol, others)
• antifungals such as fluconazole (Diflucan), itraconazole (Sporanox) and ketoconazole (Nizoral)
• benzodiazepines such as diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien)
• carbamazepine (Tegretol)
• cholesterol-lowering medications (statins)
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• dexamethasone (Decadron)
• diltiazem (Cardizem, Dilacor, Tiazac)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• ethosuximide (Zarontin)
• fluoxetine (Prozac, Sarafem)
• fluvoxamine (Luvox)
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir)
• iron products
• isoniazid (INH, Nydrazid)
• medications for anxiety, mental illness, and seizures
• methotrexate (Rheumatrex)
• metronidazole (Flagyl)
• nefazodone (Serzone)
• niacin (nicotinic acid)
• oral contraceptives (birth control pills)
• phenobarbital (Luminal, Solfoton)
• phenytoin (Dilantin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• troglitazone (Rezulin)
• troleandomycin (TAO)
• verapamil (Calan, Covera, Isoptin, Verelan)
• zafirlukast (Accolate)

This is not a complete list of Suboxone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Suboxone including the following:

• Respiratory problems. You have a higher risk of death and coma from respiratory problems if you take Suboxone with other medicines that cause respiratory problems, such as benzodiazepines including diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien).
• Sleepiness, dizziness, and problems with coordination
• Decreased blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• Dependency or abuse
• Liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems:
• Yellowing of the skin or eyes
• Dark urine
• Light colored stools
• Decreased appetite
• Stomach pain
• Allergic reaction. Tell your doctor right away if you have any of the following signs or symptoms of an allergic reaction:
  • Rash
  • Hives
  • Swelling of the face
  • Wheezing
  • Decreased blood pressure
  • Loss of consciousness
• Opioid withdrawal. Symptoms of opioid withdrawal may include:
  • Shaking
  • Excessive sweating
  • Feeling hot or cold more than normal
  • Runny nose
  • Watery eyes
  • Goose bumps
  • Diarrhea
  • Vomiting
  • Muscle aches

Suboxone can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take Suboxone if you are allergic to buprenorphine and naloxone or to any of the ingredients in the combination product.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Suboxone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Suboxone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to buprenorphine and naloxone or to any of its ingredients
• have or have had adrenal problems such as Addison's disease
• have or have had benign prostatic hypertrophy (BPH, enlargement of the prostate gland)
• have or have had difficulty urinating
• have or have had a head injury
• have or have had hallucinations (seeing things or hearing voices that do not exist)
• have a curve in the spine that makes it hard to breathe
• have or have had gallbladder disease
• have or have had stomach conditions
• have or have had thyroid disease
• have or have had kidney disease
• have or have had liver disease
• have trouble breathing or lung problems
• have a history of alcoholism
• drink large amounts of alcohol
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Suboxone falls into category C. There are no well-controlled studies that have been done in pregnant women. Suboxone should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Buprenorphine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Suboxone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Suboxone exactly as prescribed.

Suboxone is available as a film that is applied sublingually (under the tongue). Avoid eating or drinking until the film has dissolved entirely. The various forms of medication are not interchangeable.

Directions for Use:

• To open your Suboxone sublingual film foil pouch, fold along the dotted line.
• Tear down at slit or cut with scissors along the arrow
• Before taking Suboxone, drink water to moisten your mouth. This helps the film dissolve more easily.
• Hold the film between two fingers by the outside edges.
• Place Suboxone sublingual film under your tongue, close to the base either to the left or right of the center 
• If your doctor tells you to take 2 films at a time, place the second film under your tongue on the opposite side. Try to avoid having the films touch as much as possible.
• Keep the films in place until they have completely dissolved.
• If you are directed to take a third film, place it under your tongue on either side after the first 2 films have dissolved.
• While Suboxone is dissolving, do not chew or swallow the film because the medicine will not work as well.
• Talking while the film is dissolving can affect how well the medicine in Suboxone is absorbed.

If you miss a dose of Suboxone, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.

Do not stop taking Suboxone suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using Suboxone the right way.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The dose of Suboxone should be increased slowly until reaching a level that maintains the patient’s treatment and suppresses signs and symptoms of opioid withdrawl.

• For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 8 mg/ 2 mg Suboxone sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of Suboxone sublingual film as a single dose. 
• For patients dependent on methadone or long-acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment. 
• For maintenance treatment, the target dosage of Suboxone sublingual film is usually 16 mg/4 mg as a single daily dose.

If you take too much Suboxone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Suboxone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• StoreSuboxone at 25°C (77°F). Do not freeze the films.
• Keep Suboxone films dry.
• Keep this and all medicines out of the reach of children.
• Disposed of unused Suboxone films by removing them from the foil packages and flushing them down the toilet.