Bunavail

Generic name: Buprenorphine And Naloxone (oral/sublingual)
Drug class: Narcotic analgesic combinations

Usage of Bunavail

Bunavail buccal films contains 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.

Bunavail buccal films are used to treat opioid addiction.

Bunavail is not for use as a pain medication.

Bunavail side effects

Get emergency medical help if you have signs of an allergic reaction to Bunavail: 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 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 Bunavail 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.

Before taking Bunavail

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

To make sure Bunavail 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 Bunavail while you are pregnant, your baby could become dependent on this medicine. 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 Bunavail if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Relate drugs

How to use Bunavail

Usual Adult Dose for Opiate Dependence: Buprenorphine monotherapy is generally used for induction. Bunavail may be used for induction in patients dependent on heroin or short-acting opioid products. Note - one Bunavail 4.2 mg/0.7 mg buccal film provides the equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.

INDUCTION dose: Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptoms Day 2: a single dose up to 8.4 mg/1.4 mg buccally.

MAINTENANCE Treatment: Doses 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. -Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. -Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg Maximum dose: 12.6 mg/ 2.1 mg buccally once a day.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Using Bunavail during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

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

What other drugs will affect Bunavail

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.

Disclaimer

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