Buprenorphine/naloxone
What Is Buprenorphine/naloxone?[edit | edit source]
- Buprenorphine/naloxone(Suboxone) tablets contain buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) indicated for the maintenance treatment of opioid dependence.
What are the uses of this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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
Buprenorphine/naloxone Resources | ||
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Buprenorphine/naloxone Resources | ||
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Translate to: East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski
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