te impaired driving in RLS patients in the absence of medication.
16 HOW SUPPLIED/STORAGE AND HANDLING
HORIZANT Extended-Release Tablets containing 300 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS TF7".
HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS LFG". They are supplied as follows:
300 mg: NDC 53451-0103-1: Bottles of 30
600 mg: NDC 53451-0101-1: Bottles of 30
Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Do not remove desiccants.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Physicians should instruct their patients to read the Medication Guide before starting therapy with HORIZANT and to reread it upon prescription renewal for new information regarding the use of HORIZANT.
17.1 Effects on DrivingPatients should be told that HORIZANT may cause a significant driving impairment. Accordingly, they should be advised not to drive a car until they have gained sufficient experience on HORIZANT to assess whether HORIZANT impairs their ability to drive, although patients’ ability to determine their level of impairment can be unreliable. Patients should be told that it is not known how long this effect lasts.
17.2 Somnolence/Sedation and DizzinessPatients should be told that HORIZANT can cause significant somnolence and dizziness. This typically resolves within several weeks of initiating treatment. Accordingly, they should be told not to operate dangerous machinery until they have gained sufficient experience on HORIZANT to assess whether HORIZANT impairs their ability to operate dangerous machinery safely.
17.3 Suicidal Behavior and IdeationPatients, their caregivers, and families should be counseled that HORIZANT may increase the risk of suicidal thoughts and behavior, and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
17.4 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan HypersensitivityPatients should be instructed that multiorgan hypersensitivity reactions may occur with HORIZANT. Patients should contact their physician immediately if they experience any signs or symptoms of these conditions [see Warnings and Precautions (5.5)].
17.5 Lack of Interchangeability With GabapentinPatients should be advised that doses of HORIZANT and other gabapentin products are not interchangeable.
17.6 Dosing InstructionsInstruct patients to take HORIZANT only as prescribed.
Instruct patients to swallow tablets whole and do not cut, crush, or chew tablets.
Instruct patients to take HORIZANT with food.
For Restless Legs Syndrome, 600 mg HORIZANT should be taken once daily at about 5 PM. If the dose is not taken at the recommended time, the patient should take the next dose at about 5 PM the following day.
For Postherpetic Neuralgia, the starting dose is 600 mg HORIZANT in the morning for 3 days. Starting on day 4, 6 |
