Zubsolv sublingual tablets contain a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Zubsolv is used to treat opioid addiction.

Zubsolv is not approved for use as a pain medication.

Zubsolv can slow or stop your breathing, and may be habit-forming. MISUSE OF ZUBSOLV CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Zubsolv during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Zubsolv with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Zubsolv if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Zubsolv is safe for you, tell your doctor if you have ever had:

• tooth problems, including a history of cavities;

• breathing problems, sleep apnea;

• enlarged prostate, urination problems;

• liver or kidney disease;

• abnormal curvature of the spine that affects breathing;

• problems with your gallbladder, adrenal gland, or thyroid;

• a head injury, brain tumor, or seizures; or

• alcoholism or drug addiction.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Zubsolv exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Zubsolv in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Zubsolv comes in a blister pack with 10 blister units. Each blister unit contains one Zubsolv tablet. Remove one single blister unit by tearing along the perforations until it is fully separated. Then fold the single unit along the dotted line. Do not push the Zubsolv tablets through the foil as this could cause the tablet to break.

Use dry hands when handling Zubsolv sublingual tablets. Place the sublingual tablet under your tongue. Allow the tablet to dissolve slowly. Do not chew or swallow the tablet whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Zubsolv suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Zubsolv. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Rinse your mouth with water after the Zubsolv tablet dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Zubsolv..

Never crush or break a Zubsolv sublingual tablet and inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Zubsolv securely in its original blister packaging at room temperature, away from moisture and heat. Discard an empty blister in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Zubsolv accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused tablets from the blister pack and flush the tablets down the toilet. Throw the empty blister pack into the trash.

Usual Adult Dose for Opiate Dependence - Induction:

INDUCTION: For those Dependent on Heroin or Other Short-acting Opioid Products:
-INITIAL DOSES should begin when objective signs of moderate opioid withdrawal appear and not less than 6 hours after the patient last used opioids to avoid precipitating an opioid withdrawal syndrome:

Zubsolv Sublingual Tablets:
Day 1: up to 5.7 mg/1.4 mg sublingually; administer as an initial dose of 1.4 mg/0.36 mg and then up to 4.2 mg/1.08 mg should be divided into doses 1.4 mg/0.36 mg or 2.8 mg/0.72 mg and administered in 1.5 to 2 hour intervals (some patients with recent exposure to buprenorphine may tolerate a single second dose of 4.2 mg/1.08 mg)
Day 2: 11.4 mg/2.9 mg sublingually as a single dose

Comments:
-Patients dependent on heroin or other short-acting opioid products may be inducted with combination buprenorphine/naloxone or buprenorphine monotherapy; to avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear, and no sooner than 6 hours after last use of heroin or other short-acting opioid.
-In some studies, too-gradual induction over several days has led to a high dropout; it is recommended that an adequate treatment dose, titrated to clinical effectiveness, be achieved as rapidly as possible.
-For patient's dependent on methadone or long-acting opioid products, buprenorphine monotherapy should be used during the induction phase as naloxone may be absorbed in small amounts and could precipitate or prolong withdrawal during induction.
-Maintenance treatment begins on day 3.

Usual Adult Dose for Opiate Dependence - Maintenance:

MAINTENANCE Treatment:
-Doses of buprenorphine/naloxone should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.

Zubsolv Sublingual Tablets:
-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg
-Maximum dose: 17.2 mg/4.2 mg per day

Comments:
-Following induction, maintenance therapy is provided to hold a patient in treatment and suppress opioid withdrawal signs and symptoms; there is no maximum recommended duration for maintenance treatment and some patients may require treatment indefinitely.
-There are multiple buprenorphine/naloxone products available for maintenance treatment; these products are not bioequivalent and dose adjustments may be necessary when switching products; e.g., Zubsolv 4.2 mg/0.7 mg buccal film provides equivalent buprenorphine exposure as Suboxone 8 mg/2 mg sublingual tablet.

Use: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

You should not use Zubsolv if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Zubsolv is safe for you, tell your doctor if you have ever had:

• tooth problems, including a history of cavities;

• breathing problems, sleep apnea;

• enlarged prostate, urination problems;

• liver or kidney disease;

• abnormal curvature of the spine that affects breathing;

• problems with your gallbladder, adrenal gland, or thyroid;

• a head injury, brain tumor, or seizures; or

• alcoholism or drug addiction.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Zubsolv: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

• any problems with your teeth or gums;

• weak or shallow breathing, breathing that stops during sleep;

• a light-headed feeling, like you might pass out;

• confusion, loss of coordination, extreme weakness;

• blurred vision, slurred speech;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Zubsolv side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;

• withdrawal symptoms;

• tongue pain, redness or numbness inside your mouth;

• nausea, vomiting, constipation;

• headache, back pain;

• fast or pounding heartbeats, increased sweating; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids - opioid pain medicine or prescription cough medicine;

• a sedative like Valium> - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.