2.1 Important Dosage and Administration Instructions
Administer TUZISTRA XR by the oral route only. TUZISTRA XR may be administered with or without food.Administer TUZISTRA XR by the oral route only. TUZISTRA XR may be administered with or without food.
Always use an accurate milliliter measuring device when administering TUZISTRA XR to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Warnings and Precautions (5.6)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.
Advise patients not to increase the dose or dosing frequency of TUZISTRA XR because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of TUZISTRA XR 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 (5.5)].
2.3 Monitoring, Maintenance, and Discontinuation of Therapy
Prescribe TUZISTRA XR 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 (5.5)]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with TUZISTRA XR, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions (5.1)].
Do not abruptly discontinue TUZISTRA XR in a physically-dependent patient [ see Drug Abuse and Dependence (9.3)]. When a patient who has been taking TUZISTRA XR regularly and may be physically dependent no longer requires therapy with TUZISTRA XR, 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.
