"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
Hypertension and Non-Selective Inhibition of MAO Above the Recommended Dose
Advise patients (or their caregivers) not to exceed the daily recommended dose of 2.5 mg. Explain the risk of using higher daily doses of ZELAPAR and provide a brief description of the hypertensive tyramine reaction provided. Rare hypertensive reactions with oral selegiline at recommended doses associated with dietary influences have been reported.
Inform patients (or their caregivers) about the potential for MAOI-induced hypertensive reactions and describe their signs and symptoms. Instruct patients to report, immediately, severe headache or other atypical or unusual symptoms not previously experienced or very high blood pressure.
The possibility exists that very tyramine-rich foods (e.g., aged cheese such as Stilton) could possibly cause an increase in blood pressure. Patients should be advised to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of ZELAPAR because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see WARNINGS AND PRECAUTIONS].
Inform patients if they are taking, or planning to take, any prescription or over-thecounter drugs, especially antidepressants and over-the-counter cold medications, because there is a potential for interaction with ZELAPAR. Because patients should not use meperidine or certain other analgesics with ZELAPAR, they should contact their healthcare provider before taking analgesics [see WARNINGS AND PRECAUTIONS].
Falling Asleep During Activities of Daily Living and Somnolence
Advise patients about the potential for sedating effects associated with ZELAPAR, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with ZELAPAR to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if they experience increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Advise patients not to drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of ZELAPAR [see WARNINGS AND PRECAUTIONS].
Advise patients that they may develop symptomatic (or asymptomatic) hypotension while taking ZELAPAR, especially if they are elderly. Hypotension may occur more frequently during initial therapy. Accordingly, caution patients against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with ZELAPAR [see WARNINGS AND PRECAUTIONS].
Inform patients that ZELAPAR may cause and/or exacerbate pre-existing dyskinesias [see WARNINGS AND PRECAUTIONS].
Inform patients that hallucinations and other psychotic-like behavior can occur while taking Neupro and that the elderly are at a higher risk than younger patients with Parkinson's disease. Tell patients to report hallucinations or psychotic-like behavior to their health care provider promptly should they develop [see WARNINGS AND PRECAUTIONS].
Impulse Control/Compulsive Behaviors
Advise patients that they may experience impulse control and/or compulsive behaviors while taking one or more of the medications generally used for the treatment of Parkinson's disease, including ZELAPAR. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with ZELAPAR. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking ZELAPAR. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ZELAPAR [see WARNINGS AND PRECAUTIONS].
Withdrawal Emergent Hyperpyrexia and Confusion
Advise patients to contact their healthcare provider if they wish to discontinue ZELAPAR or decrease the dose of ZELAPAR [see WARNINGS AND PRECAUTIONS].
Advise patients with Parkinson's disease that they have a higher risk of developing melanoma. Advise patients to have periodic examinations of their skin by a qualified healthcare professional on a regular basis when using ZELAPAR [see WARNINGS AND PRECAUTIONS].
Irritation of the Buccal Mucosa
Inform patients that ZELAPAR may cause irritation of the buccal mucosa including swallowing pain, mouth pain, discrete areas of focal reddening, edema, and/or ulceration [see WARNINGS AND PRECAUTIONS].
Risk for Phenylketonuric Patients
Instructions for Use
Patients should be instructed not to remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where the tablet will disintegrate. Patients should also avoid drinking liquids or eating food 5 minutes before and after taking ZELAPAR. Use ZELAPAR within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in pouch. Potency cannot be guaranteed after 3 months of opening the pouch.
Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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