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Buprenorphine HCl-Naloxone HCl
Buprenorphine HCl-Naloxone HCl is a combination medication used to treat opioid dependence. Buprenorphine is a partial opioid agonist, which helps to alleviate withdrawal symptoms and reduce cravings, while naloxone is an opioid antagonist designed to deter misuse. When taken as directed (sublingually or buccally), naloxone has minimal effects, but if the medication is tampered with (e.g., crushed and injected), naloxone will block the opioid effects of buprenorphine, reducing the potential for abuse.
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Frequently Asked Questions
How long does Buprenorphine HCl-Naloxone HCl take to work?
Buprenorphine typically starts to relieve opioid withdrawal symptoms within 30 to 60 minutes when administered sublingually or buccally. The combination with naloxone helps prevent misuse but does not affect the onset of action for proper use.
Can Buprenorphine HCl-Naloxone HCl be used long-term?
Yes, this combination is often used long-term as part of a comprehensive treatment plan for opioid dependence. Long-term use should be carefully monitored by a healthcare provider to manage potential side effects and the risk of dependence.
What should I do if I miss a dose of Buprenorphine HCl-Naloxone HCl?
If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for the missed one.
Is Buprenorphine HCl-Naloxone HCl safe to use during pregnancy?
Buprenorphine can be used during pregnancy, but it should be done under strict medical supervision. The combination with naloxone is often preferred over other treatments because it has a lower risk of causing severe neonatal withdrawal symptoms. Pregnant women should consult their healthcare provider to weigh the potential risks and benefits.
Can Buprenorphine HCl-Naloxone HCl cause withdrawal symptoms?
Yes, if the medication is misused (e.g., injected), the naloxone component can precipitate withdrawal symptoms. Even with proper use, abrupt discontinuation of buprenorphine can cause withdrawal symptoms, so it's important to taper off the medication under medical supervision.
Comprehensive Drug Guide
How Does Buprenorphine HCl-Naloxone HCl Work?
Buprenorphine: Acts as a partial agonist at the mu-opioid receptors, helping to alleviate withdrawal symptoms and cravings in individuals with opioid dependence. Its partial agonist property provides a ceiling effect that reduces the risk of overdose.
Naloxone: Acts as an opioid antagonist, blocking the effects of opioids if the combination drug is misused (e.g., injected). Naloxone is included to deter misuse, as it precipitates withdrawal symptoms if injected by someone dependent on opioids.
What is Buprenorphine HCl-Naloxone HCl Used For?
Treatment of Opioid Dependence: As part of a comprehensive treatment plan that includes counseling and psychosocial support, this combination medication is used to manage withdrawal symptoms, reduce cravings, and prevent relapse in patients with opioid use disorder.
Common Dosages
Buprenorphine HCl-Naloxone HCl is available by prescription only and is classified as a Schedule III controlled substance, indicating it has a potential for abuse, though less than Schedule II drugs. It is commonly available in sublingual tablets and sublingual or buccal films.
Administration: The medication should be placed under the tongue (sublingual) or inside the cheek (buccal) and allowed to dissolve completely without chewing or swallowing. It's important to take the medication exactly as prescribed to avoid precipitated withdrawal symptoms or other complications.
Monitoring: Patients should be monitored regularly during treatment to ensure effective management of withdrawal symptoms and cravings, as well as adherence to the treatment plan.
Typical Dosing
FDA Approved Indications
The typical dosage of Buprenorphine HCl-Naloxone HCl varies depending on the stage of treatment:
For Induction Phase:
- Initial Dose: 2 mg/0.5 mg to 8 mg/2 mg buprenorphine/naloxone, administered sublingually, with the dose adjusted based on the patient’s response and withdrawal symptoms.
For Maintenance Phase:
- Typical Dose: The maintenance dose generally ranges from 8 mg/2 mg to 16 mg/4 mg per day, administered sublingually or buccally. The dose is adjusted to the lowest effective dose.
Who Shouldn't Take Buprenorphine HCl-Naloxone HCl?
Buprenorphine HCl-Naloxone HCl is contraindicated in patients with:
- Significant respiratory depression or severe asthma in unmonitored settings.
- Known hypersensitivity to buprenorphine, naloxone, or any other components of the formulation.
- Paralytic ileus.
Advice From The Pharmacist
Patients using Buprenorphine HCl-Naloxone HCl should be advised to:
- Follow the prescribed dosage regimen closely and not to alter the dose without consulting their healthcare provider, as improper use can lead to withdrawal symptoms or inadequate control of cravings.
- Avoid consuming alcohol or using other central nervous system (CNS) depressants, such as benzodiazepines, as these can increase the risk of severe side effects, including respiratory depression.
- Store the medication securely to prevent misuse by others and to follow any special instructions for disposal.
- Be aware that if they attempt to misuse the medication by injecting it, they may experience sudden and severe withdrawal symptoms due to the naloxone component.
- Discuss with their healthcare provider any other medications they are taking, especially other opioids, antidepressants, or muscle relaxants.
Side Effects of Buprenorphine HCl-Naloxone HCl
Common Side Effects
- Headache
- Nausea or vomiting
- Sweating
- Constipation
- Drowsiness or dizziness
- Insomnia
Uncommon/Severe Side Effects
- Respiratory Depression: Although less likely due to the ceiling effect of buprenorphine, respiratory depression can still occur, especially in overdose situations or when combined with other CNS depressants.
- Hepatic Effects: Buprenorphine can cause liver damage, and patients should report symptoms like jaundice, dark urine, or severe fatigue.
- Precipitated Withdrawal: If the medication is misused by injection, naloxone can precipitate severe withdrawal symptoms.
- Allergic Reactions: Such as rash, itching, swelling, or difficulty breathing.
Risks and Warnings of Buprenorphine HCl-Naloxone HCl
Abuse and Dependence: While the combination of buprenorphine and naloxone is designed to reduce the potential for abuse, there is still a risk of misuse and dependence, particularly when the medication is taken in a manner other than prescribed.
Respiratory Depression: Even though the risk is lower than with full opioid agonists, respiratory depression can still occur, particularly when combined with other CNS depressants or in overdose situations.
Neonatal Opioid Withdrawal Syndrome (NOWS): Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which can be life-threatening if not recognized and treated.
Interactions with Buprenorphine HCl-Naloxone HCl
Common Drug Interactions
Buprenorphine HCl-Naloxone HCl may interact with other medications, including:
- Benzodiazepines and Other CNS Depressants: Increased risk of sedation, respiratory depression, and death.
- Monoamine Oxidase Inhibitors (MAOIs): May increase the effects of opioids and the risk of serotonin syndrome.
- CYP3A4 Inhibitors: Such as ketoconazole, erythromycin, or HIV protease inhibitors, can increase plasma concentrations of buprenorphine, enhancing effects and side effects.
- CYP3A4 Inducers: Such as rifampin, carbamazepine, or phenytoin, may decrease buprenorphine levels, reducing its effectiveness.
Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions.
Alternatives to Buprenorphine HCl-Naloxone HCl
Alternative treatments for opioid dependence include:
- Methadone: A full opioid agonist used in the treatment of opioid dependence, particularly in individuals who do not respond well to buprenorphine.
- Naltrexone: An opioid antagonist used in the treatment of opioid dependence but without the risk of dependence or abuse.
- Comprehensive Addiction Treatment Programs: Including counseling, behavioral therapy, and support groups, which are essential components of opioid dependence treatment.
The choice of treatment depends on the patient’s individual needs, the severity of their condition, and their response to previous treatments.
