Zubsolv is a combination of two medications: buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist). It's used for the treatment of opioid use disorder (OUD) in adults, typically together with counseling and social and emotional support. Zubsolv (buprenorphine / naloxone) is a tablet that's dissolved under the tongue once per day. The dosage strength differs from person to person because it depends on many factors, such as the severity of your condition. Side effects of the medication include headache and nausea.
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
Zubsolv (buprenorphine / naloxone) is a combination of two medications that work together to treat opioid use disorder.
Buprenorphine is a partial opioid agonist. It works by attaching to opioid receptors in the brain similar to other opioid medications. But buprenorphine doesn't turn on these receptors as strongly as other opioids. This helps ease opioid cravings and lessen the risk for withdrawal symptoms in someone with opioid use disorder without causing the same "high" as other opioid medications.
Naloxone is an opioid antagonist. It blocks the opioid receptors in your brain. Naloxone doesn't affect the actions of buprenorphine when Zubsolv (buprenorphine / naloxone) is dissolved on the tongue. But it will block the effects of buprenorphine and cause withdrawal symptoms if Zubsolv (buprenorphine / naloxone) were to be misused by injection or by other ways. This is meant to prevent people from misusing buprenorphine.
Zubsolv (buprenorphine / naloxone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of alcohol or substance use disorder | Taking more Zubsolv (buprenorphine / naloxone) than prescribed
Zubsolv is a schedule III controlled substance because it contains the opioid buprenorphine. Buprenorphine has a risk for misuse and dependence. Misusing Zubsolv (buprenorphine / naloxone) can raise the risk for addiction and other serious side effects, such as dangerously slow breathing and overdose. Take Zubsolv (buprenorphine / naloxone) exactly as prescribed. Don't change how much you take or how often you take it without talking to your prescriber first.
Risk factors: Age 65 years or older | Chronic obstructive pulmonary disease (COPD) | Other medical conditions that cause or raise the risk for slow breathing | Taking sedatives or other medications that can slow down breathing | Drinking alcohol
Zubsolv contains buprenorphine, which can cause dangerously slow breathing. This can be life-threatening. Your risk is higher if you take other medications that can slow your body down like benzodiazepines and opioids. Drinking alcohol with Zubsolv (buprenorphine / naloxone) also raises your risk for slowed breathing. In addition, people getting treated for opioid use disorder can sometimes relapse, which puts them at high risk for breathing problems from opioid use.
Your prescriber might recommend that you always have naloxone (Narcan) with you in case you need to quickly treat any slowed breathing from Zubsolv (buprenorphine / naloxone) or other opioids. It's important for you and your loved ones to know how to use naloxone (Narcan) if you start breathing extremely slowly. Give naloxone (Narcan) and call 911 right away if you or a loved one notices that you're having trouble breathing or that you have bluish-colored lips.
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high opioid doses | Taking more opioids than prescribed | Taking sedatives or other medications that can cause slowed breathing | Drinking alcohol | Age 65 years and older | Age 18 years and younger
People who are getting treated for opioid use disorder are at risk for relapse, meaning that they can fall back into taking opioids again. In general, opioids have a risk for overdose. An opioid overdose can happen at recommended doses of opioids. It can also happen if you take higher doses than prescribed or take the medication more often than prescribed. What's more, a fatal overdose can happen in children if they take just one dose of an opioid medication like Zubsolv (buprenorphine / naloxone) by mistake.
An opioid overdose can be life-threatening if it's not recognized or treated in time. Overdose symptoms include extremely slowed breathing, slow heartbeat, extreme sleepiness, cold or clammy skin, or not responding to sound or touch. Call 911 right away if you think an overdose has happened.
Your prescriber might suggest to always carry naloxone (Narcan), a medication that's used to help reverse life-threatening opioid overdose. It's important for you and your loved ones to know when and how to use naloxone (Narcan) in case an accidental overdose happens. Store your medications out of reach from children, pets, and visitors.
Risk factors: Age 65 years and older | Taking other medications that make you less alert or slow your body down | Drinking alcohol
Zubsolv (buprenorphine / naloxone) can cause extreme sleepiness. It can also lower your ability to think, react, and focus. Drinking alcohol and taking other medications that slow your body down, like benzodiazepines, sedatives, and muscle relaxants, can worsen these side effects.
Make sure you know how Zubsolv (buprenorphine / naloxone) affects you before driving a car or doing activities that require your concentration. Avoid drinking alcohol or taking medications that make you sleepy while you're taking Zubsolv (buprenorphine / naloxone). Talk to your care team right away if you get too sleepy from taking the medication.
Risk factors: Taking Zubsolv (buprenorphine / naloxone) during pregnancy
During pregnancy, opioids can travel through your bloodstream to your unborn baby. Long-term opioid use during pregnancy can cause your unborn baby to become dependent on the medication.
Once your baby is born, they can experience withdrawal symptoms, including high-pitched crying, poor feeding and sucking behavior, trembling, irritability, abnormal sleep patterns, and even seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare team know if you've taken Zubsolv (buprenorphine / naloxone) during pregnancy and if you notice your newborn having these withdrawal symptoms.
Risk factors: Taking Zubsolv (buprenorphine / naloxone) for longer than 1 month
Some people who take medications containing opioids, like Zubsolv (buprenorphine / naloxone), can have a drop in their adrenal hormone levels. This is more likely if people take the medication for longer than 1 month. Let your prescriber know right away if you have symptoms of low adrenal hormones, including nausea, vomiting, not feeling hungry, tiredness, dizziness, and weakness. You might need to work with your prescriber to stop Zubsolv (buprenorphine / naloxone) and then get treated with corticosteroids.
Risk factors: Long-term use of Zubsolv (buprenorphine / naloxone) or other opioids | Stopping or lowering the dose of Zubsolv (buprenorphine / naloxone) suddenly | Starting Zubsolv (buprenorphine / naloxone) before the full effect of other opioids have worn off | Liver damage
Taking Zubsolv (buprenorphine / naloxone) for a long period of time can cause physical dependence. This means that your body relies on the medication to function and you can experience withdrawal if you lower the dose too quickly or stop taking the medication suddenly. Withdrawal symptoms include anxiety, restlessness, irritability, cravings, runny nose, yawning, sweating, chills, and body aches.
Withdrawal can also happen if you take Zubsolv (buprenorphine / naloxone) before the effects of any other opioids have worn off. In addition, misusing Zubsolv (buprenorphine / naloxone) by self-injection can lead to withdrawal symptoms in people who are physically dependent on other opioids.
It's important that you take Zubsolv (buprenorphine / naloxone) exactly as prescribed. Don't lower your dose or stop taking the medication suddenly without talking to your prescriber. They will slowly lower your dose to prevent withdrawal symptoms.
Risk factors: History of liver damage | Hepatitis B or C infection | Taking other medications that can cause liver damage | Injection drug use
Some people who've taken buprenorphine-containing medications developed liver damage. This damage can range from mild to severe and life-threatening (liver failure). You'll need to get blood tests done before you start taking Zubsolv (buprenorphine / naloxone) and periodically during treatment to make sure your liver is healthy.
It's not recommended for people with moderate-to-severe liver conditions to take Zubsolv (buprenorphine / naloxone). Liver damage lowers your body's ability to clear naloxone from your system, much more so than buprenorphine. This can make the levels of naloxone in your body to rise and lead to withdrawal symptoms when you first start Zubsolv (buprenorphine / naloxone). Talk to your prescriber about other options that can help with your opioid dependence if you have liver problems.
Some people who took buprenorphine-containing medications that are dissolved in the mouth have had dental problems. These problems included cavities, tooth infections, damaged teeth, and even tooth loss.
Be sure to get regular dental cleanings and check-ups with your dentist. Practice good oral hygiene, and brush your teeth and floss every day. After Zubsolv (buprenorphine / naloxone) dissolves under the tongue, swish some water around in your mouth and then swallow. Make sure to wait at least 1 hour after you take Zubsolv (buprenorphine / naloxone) before you brush your teeth.
Risk factors: Heart rhythm problems | Heart failure | Electrolyte levels that aren't balanced in the body
Suboxone contains buprenorphine, which can cause QT prolongation (the time it takes for the heart to relax and contract again is longer than usual). This can potentially lead to a dangerous heart rhythm problem.
Tell your prescriber about your full medical history before you start taking Zubsolv (buprenorphine / naloxone). Your risk for QT prolongation might be higher if you already have heart problems or if you have abnormal electrolyte levels in your body. Contact your prescriber if you have symptoms of heart problems, such as a pounding chest, trouble breathing, feeling faint or lightheaded, or chest pain, while you're taking this medication.
Zubsolv (buprenorphine / naloxone) can cause extremely low blood pressure. Your blood pressure might drop when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. Talk to a healthcare professional if any dizziness or lightheadedness doesn't go away.
Fatal overdoses have happened when people who haven't taken opioids before took a buprenorphine tablet for pain. Zubsolv (buprenorphine / naloxone) is only for people who've taken opioids before. Zubsolv (buprenorphine / naloxone) isn't meant to be taken as a pain reliever.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Chills
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
headache
hoarseness
lower back or side pain
painful or difficult urination
sweating
Incidence not known
Agitation
bloating or swelling of the face, arms, hands, lower legs, or feet
darkening of the skin
difficulty swallowing
dizziness
fainting
fast heartbeat
loss of appetite
mental depression
overactive reflexes
poor coordination
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
restlessness shivering talking or acting with excitement you cannot control tightness in the chest
tingling of the hands or feet
trembling or shaking twitching
unusual weight gain or loss
vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Blurred vision
confusion
difficult or troubled breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
irregular, fast, slow, or shallow breathing
pale or blue lips, fingernails, or skin
pinpoint pupils
relaxed and calm feeling
sleepiness
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Burning or sore mouth
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings inside the mouth
decline or loss of libido or sexual desire
irritability
mood swings
poor concentration
redness, swelling, or soreness of the tongue
reduced muscle strength
swelling, inflammation, or redness of the mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Not available as a lower-cost generic
Is a controlled substance because of the risk for misuse and dependency, so there are special requirements for filling a prescription
Zubsolv (buprenorphine / naloxone) is typically given as part of a treatment plan that includes counseling and therapy. Speak with your healthcare team about additional resources to help with your opioid dependence.
Take Zubsolv (buprenorphine / naloxone) exactly as prescribed. Don't lower your dose or stop taking the medication suddenly without talking to your prescriber first. Your prescriber will work with you to lower your dose over a period of time to prevent withdrawal symptoms like shaking, nausea, muscle aches, irritability, and anxiety.
Practice good oral hygiene while you're taking Zubsolv (buprenorphine / naloxone) and remember to get dental cleanings regularly. Zubsolv (buprenorphine / naloxone) can cause problems with your teeth.
If you need to take pain medications, it's important that your prescriber knows you're taking Zubsolv (buprenorphine / naloxone) so they can choose a safe treatment option for you. It's recommended to start with non-opioid medications to relieve pain. Taking an opioid medication with Zubsolv (buprenorphine / naloxone) can raise your risk for serious side effects, such as sleepiness and breathing problems.
Keep Zubsolv (buprenorphine / naloxone) in a safe place that's out of reach from children, pets, and visitors. Get rid of the medication through a take-back program or flush it down the toilet after you remove the tablets from the package if you don't need to take it anymore. This helps prevent misuse and accidental overdose.
You can have a sip of water before you take Zubsolv (buprenorphine / naloxone) if your mouth feels dry. Be sure your hands are dry before you touch the tablet; this makes sure the tablet doesn't start to dissolve early.
Carefully remove the tablet from the packaging. Don't push the tablet through the foil because it can break.
Place the tablet under your tongue. If you need to take more than one tablet at once, put the tablets in different areas under your tongue at the same time.
Leave the tablet under the tongue until it completely dissolves. This usually takes about 5 minutes. As the tablet dissolves, avoid talking. Also don't chew or swallow the tablet. And, don't eat or drink anything until the tablet dissolves all the way. This makes sure that all the medication gets absorbed and that it works as best as it can.
Once the tablet has completely dissolved, be sure to swish some water gently in your mouth and swallow to lower the risk for damage to your teeth.
Dosage | Quantity | Price as low as | Price per unit |
---|---|---|---|
0.7mg/0.18mg | 30 sublingual tablets | $159.94 | $5.33 |
1.4mg/0.36mg | 30 sublingual tablets | $163.77 | $5.46 |
2.9mg/0.71mg | 14 sublingual tablets | $148.84 | $10.63 |
5.7mg/1.4mg | 14 sublingual tablets | $149.60 | $10.69 |
8.6mg/2.1mg | 60 sublingual tablets | $891.10 | $14.85 |
11.4mg/2.9mg | 15 sublingual tablets | $320.75 | $21.38 |
In general, your prescriber will work with you to adjust the dose of your medications for opioid use disorder based on your individual needs.
In general, Zubsolv (buprenorphine / naloxone) is placed under the tongue and dissolved.
Day 1: You'll typically start with Zubsolv tablets that contain 1.4 mg of buprenorphine and 0.36 mg of naloxone. The typical starting dose is 1 tablet as a single dose, then 1 to 2 tablets every 2 hours until you reach a total dose of 5.7 mg/1.4 mg (buprenorphine/naloxone) for day 1.
Day 2: The typical dose is up to 11.4 mg/2.9 mg (buprenorphine/naloxone) as a single dose.
Day 3 and onwards: Your prescriber will continue to adjust your dose until you reach a maintenance dose. The recommended target dose for maintenance is 11.4 mg/2.9 mg (buprenorphine/naloxone) once per day.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Severe allergy to buprenorphine or naloxone
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
Maintenance treatment for opioid use disorder (OUD) in adults (together with counseling and therapy)
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