"Nevro Corp has received an "approvable" letter from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) system for treatment of chronic pain.
The Senza SCS system delivers Nevro's proprietary HF10"...
Patients should be advised a hypersensitivity reaction to NUEDEXTA could occur. Patients should be instructed to seek medical attention immediately if they experience symptoms indicative of hypersensitivity after taking NUEDEXTA [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Patients should be advised to consult their healthcare provider immediately if they feel faint or lose consciousness. Patients should be counseled to inform their healthcare provider if they have any personal or family history of QTc prolongation [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
Patients should be advised that NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Inform patients that NUEDEXTA increases the risk of adverse drug interactions, Instruct patients to inform their healthcare provider about all the medications that they are taking before taking NUEDEXTA. Before taking any new medications, patients should tell their healthcare provider that they are taking NUEDEXTA [see DRUG INTERACTIONS].
Instruct patients to take NUEDEXTA exactly as prescribed. Instruct patients not to take more than 2 capsules in a 24-hour period and to make sure that there is an approximate 12-hour interval between doses, and not to take a double dose after they miss a dose [see DOSAGE AND ADMINISTRATION].
Patients should not share or give NUEDEXTA to others, even if they have the same symptoms, because it may harm them.
Advise patients to contact their healthcare provider if their PBA symptoms persist or worsen.
Advise patients to keep this and all medications out of reach of children and pets.
Last reviewed on RxList: 1/30/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Nuedexta Capsules Information
- Nuedexta Capsules Drug Interactions Center: dextromethorphan-quinidine oral
- Nuedexta Capsules Side Effects Center
- Nuedexta Capsules in detail including Side Effects and Drug Images
- Nuedexta Capsules Overview including Precautions
- Nuedexta Capsules FDA Approved Prescribing Information including Dosage
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