HALCION®, CIV Drug Interactions

(triazolam)

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)].

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)].

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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)].

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)].

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