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Does Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihyd Interact with Ketoconazole?

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihyd and Ketoconazole have a moderate drug interaction according to U.S. FDA drug labeling data. CYP3A4 inhibitor increases buprenorphine plasma concentration, resulting in increased or prolonged opioid effects including respiratory depression and sedation. The mechanism involves cyp3a4 inhibition. Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This information is based on official FDA drug labeling sourced from OpenFDA and the NIH National Library of Medicine.

Severity
Moderate
Ketoconazole Class
Azole Antifungal
Management
Monitor for effects
Data Source
U.S. FDA via OpenFDA

How This Interaction Works

The interaction between Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihyd and Ketoconazole occurs because cyp3a4 inhibition. Clinically, this means cyp3a4 inhibitor increases buprenorphine plasma concentration, resulting in increased or prolonged opioid effects including respiratory depression and sedation. This is classified as a moderate interaction. While it may not require stopping either medication, your healthcare provider should be aware you are taking both so they can monitor for potential effects and adjust treatment if necessary.

What To Tell Your Doctor or Pharmacist

If you are taking Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihyd and your doctor is considering prescribing Ketoconazole (or vice versa), make sure to:

  • Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
  • Ask whether the benefits of combining these medications outweigh the risks for your specific situation
  • Ask what symptoms to watch for that would indicate the interaction is causing problems
  • Ask whether any dosage adjustments are needed
  • Never stop or change either medication without first consulting your healthcare provider
💊 Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihyd(Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate)+💊 Ketoconazole

Severity & Interaction Details

🟡
moderate
Be aware — moderate interaction
Documented interaction with manageable risk. May require dose adjustment or monitoring.
Severity scale
MinorContra
On record
Yes
Drug A class
—
Drug B class
Azole Antifungal
Source
NLP:buprenorphine hydrochloride and naloxone hydrochloride dihydrate

What this means in plain English

CYP3A4 inhibitor increases buprenorphine plasma concentration, resulting in increased or prolonged opioid effects including respiratory depression and sedation.

What the FDA label says

"CYP3A4 inhibition"

📖 Source: NLP:buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Recent research & FDA safety updates

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Auto-aggregated from PubMed E-utilities and FDA safety data.

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Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.