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HALCION®, CIV (triazolam) Drug Interactions

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)].

Table 2: Clinically Important Drug Interactions with Halcion
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)].
Examples Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol.
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.
Examples Psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs which themselves produce CNS depression.
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 (5.7)].
Examples Ketoconazole, clarithromycin, grapefruit juice, itraconazole, nefazodone, and several HIV protease inhibitors (e.g. ritonavir, indinavir, nelfinavir, saquinavir and lopinavir).
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 (5.7)].
Examples Macrolide antibiotics (such as erythromycin), cimetidine, isoniazid, oral contraceptives, ranitidine.
 
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 (5.7)].
Examples Fluvoxamine, diltiazem, verapamil, sertraline, paroxetine, ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine.

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