Buprenorphine + Naloxone

What Is Buprenorphine/naloxone?

Buprenorphine/naloxone(Suboxone) tablets contain buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) indicated for the maintenance treatment of opioid dependence.

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What are the uses of this medicine?

• Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists.
• This medicine work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
• Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.

How does this medicine work?

• Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
• Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.

Who Should Not Use this medicine ?

This medicine cannot be used in following condition:

• Hypersensitivity to buprenorphine or naloxone.
• Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Is this medicine FDA approved?

• The combination formulation was approved for medical use in the United States in October 2002, and in the European Union in November 2017.
• A generic version was approved in the US in June 2018.
• In 2017, it was the 288th most commonly prescribed medication in the United States, with more than one million prescriptions.

How should this medicine be used?

• Buprenorphine and naloxone sublingual tablets are administered sublingually as a single daily dose.
• Buprenorphine and naloxone sublingual tablets must be administered whole.
• Do not cut, chew, or swallow buprenorphine and naloxone sublingual tablets.
• Advise patients not to eat or drink anything until the tablet is completely dissolved.
• Buprenorphine and naloxone sublingual tablets should be placed under the tongue until it is dissolved.
• The recommended target dosage of buprenorphine and naloxone sublingual tablets for maintenance is 16 mg/4 mg.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing dosage forms:

• buprenorphine 2 mg/ naloxone 0.5 mg and
• buprenorphine 8 mg/ naloxone 2 mg.

This medicine is available in fallowing brand names:

• Bunavail® (containing Buprenorphine, Naloxone)
• Suboxone® (containing Buprenorphine, Naloxone)
• Zubsolv® (containing Buprenorphine, Naloxone)

What side effects can this medication cause?

Common possible side effects of this medicine include:

• hypoesthesia
• glossodynia
• oral mucosal erythema
• headache
• nausea
• vomiting
• hyperhidrosis
• constipation

signs and symptoms of withdrawal include:

• insomnia
• pain
• peripheral edema.

What special precautions should I follow?

• Buprenorphine can be abused in a similar manner to other opioids.
• Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.
• Store buprenorphine and naloxone sublingual tablets safely out of the sight and reach of children.
• Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
• Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the risk of adverse reactions including overdose and death.
• When discontinuing buprenorphine and naloxone sublingual tablets, gradually taper the dosage.
• If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
• If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
• Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

What to do in case of emergency/overdose?

The signs and symptoms of overdosage include:

• include pinpoint pupils
• sedation
• hypotension
• respiratory depression
• death

• Oxygen, IV fluids, vasopressors, and other supportive measures should be employed as indicated.
• In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required.

Can this medicine be used in pregnancy?

• If this medicine is used regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Can this medicine be used in children?

• The safety and effectiveness of buprenorphine and naloxone sublingual tablets have not been established in pediatric patients.
• This product is not appropriate for the treatment of neonatal abstinence syndrome in neonates, because it contains naloxone, an opioid antagonist.

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
• Dispense in a tight, light-resistant container as defined in USP.
• Store Buprenorphine and Naloxone Sublingual Tablets USP securely and dispose of properly

• Dailymed label info on Buprenorphine + Naloxone
• FDA Buprenorphine + Naloxone