Clidinium bromide 2.5 mg, chlordiazepoxide 5 mg

Black Box Warnings
Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation

Prostatic hypertrophy
Benign bladder neck obstruction
Severe respiratory depression

Decrease dose in debilitated or elderly patients
Paradoxical reactions to chlordiazepoxide have occurred (eg, excitement, stimulation, acute rage)
Anterograde amnesia reported with benzodiazepine use
May cause anticholinergic effects
May cause CNS depression, which may impair ability to perform hazardous tasks, including operating heavy machinery, driving
Use caution in hot weather; may cause heat prostration
Avoid coadministration of other CNS depressants, including alcohol
Withdrawal symptoms may occur if abruptly discontinued after prolonged use
Caution in patients with clinical depression especially if suicidal risk may be present
Caution in patients with impaired gag reflex or respiratory disease
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; if a decision is made to prescribe the drug concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use; follow patients closely for signs and symptoms of respiratory depression and sedation; advise both patients and caregivers about risks of respiratory depression and sedation when the drug is used with opioids