7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions With Halcion
Table 2 includes clinically significant drug interactions with Halcion [see Clinical Pharmacology (12.3)].
Opioids | |
Clinical implication | The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. |
Prevention or management | Limit dosage and duration of concomitant use of Halcion and opioids, and monitor patients closely for respiratory depression and sedation [see Warnings and Precautions (5.1)]. |
CNS Depressants | |
Clinical implication | Triazolam produces additive CNS depressant effects when co-administered with other CNS depressants. |
Prevention or management | Limit dosage and duration of Halcion during concomitant use with CNS depressants. |
Strong Inhibitors of CYP 3A | |
Clinical implication | Concomitant use of Halcion with strong CYP3A inhibitors has a profound effect on the clearance of Halcion, resulting in increased concentrations of triazolam and increased risk of adverse reactions [see Clinical Pharmacology (12.3)]. |
Prevention or management | Do not administer Halcion with a strong CYP3A4 inhibitor [see Contraindications (4), Warnings and Precautions (5.8)]. |
Moderate and Weak Inhibitors of CYP 3A | |
Clinical implication | Concomitant use of Halcion with moderate or weak inhibitors of CYP3A inhibitors may increase the concentrations of Halcion, resulting in increased risk of adverse reactions [see Clinical Pharmacology (12.3)]. |
Prevention or management | Use with caution and consider appropriate dose reduction of HALCION when coadministered with moderate and weak CYP3A inhibitors [see Warnings and Precautions (5.8)]. |
Strong Inducers of CYP 3A | |
Clinical implication | Coadministration of triazolam with strong inducers of CYP3A4 can significantly decrease the plasma concentration of triazolam and may decrease effectiveness of triazolam. |
Prevention or management | Caution is recommended during coadministration of Halcion with strong inducers of CYP3A4. |
Interactions Based on Experience with Other Benzodiazepines or in vitro Studies with Triazolam | |
Clinical implication | Available data from clinical studies of benzodiazepines other than triazolam, from in vitro studies with triazolam, or from in vitro studies with benzodiazepines other than triazolam suggest a possible drug interaction with triazolam [see Clinical Pharmacology (12.3)]. |
Prevention or management | Caution is recommended during coadministration of Halcion with any of these drugs. [see Warnings and Precautions (5.8)]. |