Important Dosage and Administration Instructions
Administer TUSSIGON by the oral route only.
Advise patients not to increase the dose or dosing frequency of TUSSIGON because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of TUSSIGON should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3), Warnings and Precautions (5.4)].
Monitoring, Maintenance, and Discontinuation of Therapy
Prescribe TUSSIGON for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy [see Warnings and Precautions (5.2)].
Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.4)]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with TUSSIGON, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)].
Do not abruptly discontinue TUSSIGON in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. When a patient who has been taking TUSSIGON regularly and may be physically dependent no longer requires therapy with TUSSIGON, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
