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HALCION®, CIV (triazolam) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risks from Concomitant Use with Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when Halcion is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1), Drug Interactions (7.1)].

"Sleep-driving" and Other Complex Behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. Advise patients to report similar experiences to their healthcare provider immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other CNS depressants [see Warnings and Precautions (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative hypnotic. As with sleep-driving, patients usually do not remember these events.

Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.

Effects on Driving and Operating Heavy Machinery

Caution patients against driving a motor vehicle or operating heavy machinery until the effects of taking Halcion are determined due to its CNS depressant effects. Also advise patients to avoid the use of alcohol or other CNS depressants while taking Halcion [see Warnings and Precautions (5.6)].

Patients with Depression

Advise patients, their families and caregivers to look out for any signs of suicidality or worsening depression, and to inform the patient's prescriber or healthcare provider immediately [see Warnings and Precautions (5.8)].

Concomitant Medications

Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medicines, vitamins and herbal supplements [see Drug Interactions (7.1, 7.2)].

Grapefruit Juice

Advise patients to avoid eating grapefruit or drinking grapefruit juice while taking Halcion [see Drug Interactions (7.2)].

Pregnancy

Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using Halcion to monitor neonates for signs of sedation, respiratory depression, withdrawal, and feeding problems [see Warnings and Precautions (5.9), Use in Specific Populations (8.1)].

Lactation

Advise mothers using benzodiazepines to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. A lactating woman may consider pumping and discarding breastmilk during treatment and for 28 hours after Halcion administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2)].

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