Important Dosage and Administration Instructions

Administer hydrocodone bitartrate and homatropine methylbromide oral solution by the oral route only.

Always use an accurate milliliter measuring device when administering hydrocodone bitartrate and homatropine methylbromide oral solution 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 (5.5)]. 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 hydrocodone bitartrate and homatropine methylbromide oral solution because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of hydrocodone bitartrate and homatropine methylbromide oral solution 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)].

Recommended Dosage

Adults 18 years of age and older: 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed 30 mL in 24 hours.

Monitoring, Maintenance, and Discontinuation of Therapy

• Prescribe hydrocodone bitartrate and homatropine methylbromide oral solution 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 to 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 hydrocodone bitartrate and homatropine methylbromide oral solution, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)].

• Do not abruptly discontinue hydrocodone bitartrate and homatropine methylbromide oral solution in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. When a patient who has been taking hydrocodone bitartrate and homatropine methylbromide oral solution regularly and may be physically dependent no longer requires therapy with hydrocodone bitartrate and homatropine methylbromide oral solution, 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.