USES
Bunavail is administered as a buccal film, meaning it is placed between the cheek and gum for absorption. The film is designed to slowly release the medication, allowing it to be absorbed directly through the mucous membranes in the mouth. Here’s how to use it properly:
Step-by-Step Instructions:
Place the film: Remove the film from the foil pouch. Place the film between your cheek and gum, on the side of your mouth, as instructed by your doctor. Do not chew or swallow the film.
Press gently: Hold the film in place by gently pressing it with your fingers against the inside of your cheek. This helps it stick and ensures proper absorption.
Allow the film to dissolve: Leave the film in place for 5-10 minutes, during which time it should completely dissolve. Do not drink, eat, or chew.
Do not remove: After the film has dissolved, do not attempt to remove any film remnants from your mouth. Let the drug continue to be absorbed.
Dosage: The recommended starting dose of Bunavail is typically 4.2 mg of buprenorphine/1.4 mg of naloxone once daily. However, your healthcare provider will determine the appropriate dose based on your medical history, current opioid use, and response to treatment. The dose can be adjusted over time to suit your needs.
Timing: Bunavail is administered once daily. Patients should adhere strictly to the dosing regimen and should not take more or less than the prescribed amount. Incorrect dosing will affect the efficacy of the drug.
WORKING
Bunavail’s mechanism of action is based on the combined effects of buprenorphine and naloxone:
Buprenorphine (Partial Agonist): Buprenorphine binds to opioid receptors within the brain, and rather than acting as an activation of these receptors as opioid drugs do, such as heroin and methadone, causes just partial activation. Partially activates these receptors, to produce relief from withdrawal symptom but not that high feeling typically resulting from other opioids use.
Naloxone (Antagonist): The naloxone is added to deter misuse of buprenorphine. In case someone tries to inject Bunavail to have a higher effect, the naloxone will occupy the opioid receptors and inhibit the euphoric effect, leading to withdrawal symptoms.
SIDE EFFECTS
Although Bunavail will treat opioid dependence, it might trigger side effects, similar to other medications. Most of the common side effects are as follows:
- Headache
- Nausea or vomiting
- Constipation
- Sweating
- Inability to sleep
- Sore or irritated mouth
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- Dizziness or drowsiness
If any of these serious adverse reactions occur, seek medical attention right away.
WARNINGS
Misuse and abuse: Buprenorphine, which Bunavail contains, may be associated with misuse and addiction. Use the medication only exactly as prescribed and not for anything else other than your doctor has recommended.
Risk of respiratory depression: Concurrent use of Bunavail with central nervous system depressants like alcohol and benzodiazepine increases the risk for developing respiratory depression and overdose. Concomitant use of alcohol or other sedative medications with Bunavail is contraindicated unless prescribed otherwise by the healthcare provider.
Pregnancy: Buprenorphine is considered a Category C drug during pregnancy. It can be administered if the potential benefits for the mother are thought to outweigh possible fetal risk. However, long-term use during pregnancy can cause withdrawal symptoms in newborns. Talk to your doctor if you are pregnant or planning to become pregnant.
Liver disease: Patients with liver problems should be dose-adjusted and regularly monitored for changes in liver function.
Children: Bunavail is not approved for use in children under 16 years of age.
INTERACTIONS
Opioid Agonists: Bunavail, which contains buprenorphine, may interact with other opioids, increasing the risk of respiratory depression, sedation, or overdose. Caution is advised when co-administering these drugs.
CNS Depressants: Combining Bunavail with central nervous system depressants, like benzodiazepines, can enhance sedative effects, potentially leading to serious respiratory and cardiovascular risks.
Antiretroviral Drugs: Some HIV medications may affect the metabolism of buprenorphine, altering its efficacy or safety. Dosage adjustments may be necessary.
CYP3A4 Inhibitors/Inducers: Medications that inhibit or induce CYP3A4 can impact Bunavail’s levels, requiring monitoring and possible dosage adjustments.
DOSAGE
The dosage of Bunavail varies from patient to patient depending on their condition and response to treatment.
However, the usual dose started is 4.2 mg of buprenorphine/1.4 mg of naloxone once a day. The healthcare provider adjusts the dose according to individual needs. The maximum dose recommended is 12.6 mg of buprenorphine/4.2 mg of naloxone per day.
Dosage should not be adjusted without consulting a healthcare provider.
PRESCRIPTION
Bunavail is a prescription-only medication that must be prescribed by a licensed healthcare provider. It is used as part of a comprehensive treatment program for opioid dependence, which may include counseling and other psychosocial interventions. Your healthcare provider will evaluate your medical history and the severity of your opioid dependence before prescribing Bunavail. Regular follow-up visits are necessary to monitor your progress and adjust the treatment as needed.
FAQ's
What is Bunavail?
- Bunavail is a medication used in the treatment of opioid dependence. It contains a combination of buprenorphine and naloxone, which helps reduce cravings and withdrawal symptoms.
How does Bunavail work?
- Bunavail works by partially stimulating opioid receptors in the brain (buprenorphine) while blocking the effects of other opioids (naloxone), which helps to manage addiction and prevent misuse.
What is the purpose of naloxone in Bunavail?
- Naloxone is included to deter misuse. If Bunavail is injected instead of taken as directed, naloxone can precipitate withdrawal symptoms, discouraging abuse.
Who is prescribed Bunavail?
- Bunavail is prescribed to adults who are struggling with opioid dependence and is part of a comprehensive treatment program that may include counseling and psychosocial support.
What forms does Bunavail come in?
- Bunavail is available as a buccal film that is placed in the mouth against the inner cheek, allowing the medication to dissolve and be absorbed.
How should Bunavail be taken?
- Bunavail should be placed in the buccal cavity and allowed to dissolve completely. It should not be swallowed or chewed, and the dosing schedule should be strictly followed as prescribed by a healthcare provider.
What are the possible side effects of Bunavail?
- Common side effects may include headache, constipation, nausea, vomiting, sweating, and insomnia. More serious effects can include respiratory depression and dependency.
Can Bunavail be used during pregnancy?
- If you are pregnant or planning to become pregnant, discuss the potential risks and benefits of using Bunavail with your healthcare provider, as it may affect the fetus.
What should I do if I miss a dose of Bunavail?
- If you miss a dose, take it as soon as you remember. If it’s close to the time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double up.
Can Bunavail be taken with other medications?
- Yes, but it is important to inform your doctor about all medications you are taking, as Bunavail may interact with other drugs, including certain antidepressants, sedatives, and other opioids.
Is Bunavail addictive?
- Bunavail has the potential for misuse and addiction due to the buprenorphine component, so it should be used strictly as prescribed by a healthcare provider.
How long does it take for Bunavail to work?
- Patients may experience a reduction in withdrawal symptoms and cravings within a few hours after taking Bunavail, but optimal effects can take several days as the medication stabilizes in the body.
Can Bunavail be used for pain management?
- Bunavail is specifically designed for the treatment of opioid dependence, not for pain management. There are other formulations of buprenorphine that are used for pain.
What should be avoided while taking Bunavail?
- It’s advisable to avoid alcohol, benzodiazepines, and other central nervous system depressants while taking Bunavail, as they may increase the risk of serious side effects.
Is it safe to suddenly stop taking Bunavail?
- Discontinuing Bunavail abruptly can lead to withdrawal symptoms. Always consult with a healthcare provider before stopping or altering your dose.
Will I need regular follow-up appointments while on Bunavail?
- Yes, regular follow-up appointments are essential to monitor your progress, manage any side effects, and adjust your treatment plan if necessary.
Can Bunavail cause respiratory problems?
- Yes, Bunavail can affect respiratory function, especially if misused or combined with other depressants. Seek immediate medical attention if you experience difficulty breathing.
Is there an age restriction for using Bunavail?
- Bunavail is approved for use in adults aged 18 and older. The safety and efficacy in children or adolescents have not been established.
How do I store Bunavail?
- Store Bunavail at room temperature, away from moisture and heat, and out of reach of children. Do not use expired products.
Where can I find more information about Bunavail?
- To learn more about Bunavail, consult a healthcare professional, check the prescribing information provided with the medication, or visit reputable medical websites.