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How to talk to your doctor about opioid dependency
This may be a confusing or frustrating time in your life. Talking with your doctor may help.
What you need to know.
Terms and Conditions
Orexo US, Inc. ("Orexo") is required to disclose the following information to all participants of the Orexo Find a Doctor Locator. This free service provides a list of doctors who are qualified according to the Drug Addiction Treatment Act of 2000 (DATA 2000) to treat opioid dependence with FDA-approved medications and who have agreed to be in the ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) Doctor Locator.
- The maximum number of patients that a doctor may treat is limited by law; therefore, some doctors may not always be able to accept new patients
- Participating doctors do not pay a fee to be listed in the Locator, and their participation does not impose any requirements on the manner in which they treat or provide services to patients
- Participating doctors are listed based on the geographical search information entered
- Some of the participating doctors may be consultants to Orexo and may receive payment for services rendered. Some may have other financial relationships with Orexo as recipients of research grants or other similar payments, or they may have an ownership interest in Orexo
Doctors may request to be removed from the Locator and Orexo retains the right to remove doctors from the Locator for any of the following reasons:
- The doctor's contact information is no longer valid
- The doctor's DATA 2000 waiver or medical license is suspended, revoked, or restricted
- The doctor is not in compliance with DATA 2000 and its implementing regulations
- Orexo has information or determines after investigation that the doctor may be engaging in unsafe prescription of Orexo's product(s)
Orexo does not warrant, whether expressed or implied, that the Locator is accurate or complete. Orexo does not recommend or endorse any doctor included in the Locator for any purpose, nor is the Locator a tool to verify a specific doctor's credentials or qualifications. It is your responsibility to select a doctor appropriate for your needs and you assume full responsibility for your interactions with any doctor you contact through the Locator. Orexo is not responsible for the medical care or advice given by any participating doctor you choose to contact.
Do you acknowledge that you understand how the Locator works and that you would like to continue your results?
ZUBSOLV is a licensed trademark of Orexo US, Inc.
What is ZUBSOLV®?
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
IMPORTANT SAFETY INFORMATION
Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone as serious negative side effects, including anaphylactic shock, have been reported.
ZUBSOLV can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV.
ZUBSOLV contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
Your doctor may monitor liver function before and during treatment with ZUBSOLV.
ZUBSOLV is not recommended for initiation of treatment in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. However, ZUBSOLV may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.
Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away.
The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your doctor about any side effect that bothers you or that does not go away.
Opioid use may cause adrenal insufficiency, a potentially life-threatening condition. Seek immediate medical attention if you experience nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure as these are signs and symptoms that may be associated with adrenal insufficiency.
Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of ZUBSOLV is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking.
ZUBSOLV is not for occasional or “as needed” use. An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death.
Do not inject (”shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking ZUBSOLV, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Cases of serotonin syndrome, a rare but potentially life-threatening condition, have been reported when opioids are used along with serotonergic drugs (such as medications used to treat depression and migraines). Be sure to inform your doctor if you are taking or plan to take any serotonergic medications while taking ZUBSOLV.
Before taking ZUBSOLV, tell your doctor if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have signs of withdrawal at birth and that withdrawal is treatable. Talk to your doctor if you are pregnant or plan to become pregnant.
Before taking ZUBSOLV, tell your doctor if you are breastfeeding or plan to breastfeed. Nursing mothers: Caution should be exercised when buprenorphine-containing products are administered to a nursing woman. Talk to your doctor about the best way to feed your baby. If you take ZUBSOLV, monitor your baby for drowsiness and difficulty breathing.
Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
This is not a complete list of negative side effects associated with ZUBSOLV. For a complete list please see full Prescribing Information.
To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.