"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"...
Zelapar Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zelapar (selegiline hydrochloride) is used together with other medicines to treat symptoms of Parkinson's disease. It is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin). Common side effects include dizziness, abdominal pain, dry mouth, nausea, stomach upset, trouble sleeping, and headache. Redness, pain, and swelling of the mouth/throat may also occur.
Treatment with Zelapar should be initiated with a 1.25 mg dose given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if prescribed. Zelapar may interact with arbamazepine, diet pills or cold medicines that contain ephedrine, pseudoephedrine, or phenylephrine, nafcillin, phenobarbital, rifampin, or antidepressants. Many other medicines can cause serious medical problems if taken together with Zelapar. Tell your doctor all medications and supplements you use. During pregnancy, Zelapar should be used only when prescribed. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Our Zelapar (selegiline hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zelapar in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking selegiline and call your doctor at once if you have any of these serious side effects:
- sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
- feeling light-headed, fainting;
- feeling restless, agitated, or irritable;
- twitching muscle movements; or
- painful or difficult urination.
Less serious side effects may include:
- dizziness, weakness;
- sleep problems (insomnia);
- runny or stuffy nose;
- back pain;
- constipation; or
- mouth sores or ulcers, pain with swallowing (while using Zelapar).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zelapar (Selegiline Hydrochloride)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zelapar Overview - Patient Information: Side Effects
If you are also taking levodopa, you may experience more side effects from the levodopa when taking selegiline. Tell your doctor immediately if any of these side effects occur: nausea, shakiness, muscle stiffness, mental/mood changes such as hallucinations/abnormal dreams. Your doctor may need to change your medication or dose. Do not stop or change the dose of your levodopa without talking with your doctor first.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people taking selegiline have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with selegiline, including up to 1 year after starting the medication. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Tell your doctor right away if you have any serious side effects, including: fainting, loss of balance, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), worsening muscle stiffness/twitching, changes in sexual ability/interest, increased shaking (tremor), swollen ankles/legs, difficulty urinating, unusual weight gain, easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds.
This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. (See also Drug Interactions section.) Get medical help right away if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (e.g., double/blurred vision), sudden sensitivity to light (photophobia).
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscle.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zelapar (Selegiline Hydrochloride)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zelapar FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of labeling.
- Risk for Hypertension [see WARNINGS AND PRECAUTIONS]
- Risk of Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
- Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Hallucinations/Psychotic-Like Behavior [see WARNINGS AND PRECAUTIONS]
- Impulse Control / Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
- Withdrawal Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
- Melanoma [see WARNINGS AND PRECAUTIONS]
- Irritation of the Buccal Mucosa [see WARNINGS AND PRECAUTIONS]
- Risk for Phenylketonuric Patients [see WARNINGS AND PRECAUTIONS]
- Effect on Renal Function [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction per total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.
Because the controlled trials performed during premarketing development both used a titration design (1.25 mg per day for 6 weeks, followed by 2.5 mg per day for 6 weeks), with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse events.
The most common adverse reactions (treatment difference incidence at least 3% greater than placebo incidence) reported in the double-blind, placebo-controlled trials during ZELAPAR treatment were constipation, skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea, myalgia, and rash (See Table 1).
Of the 194 patients treated with ZELAPAR in the double-blind, placebo-controlled trials, 5% discontinued due to adverse reactions compared to 1% of the 98 patients who received placebo. Most common adverse reactions causing discontinuation of treatment included dizziness, chest pain, accidental injury, and myasthenia.
Incidence In Controlled Clinical Trials
Table 1 lists the adverse events reported in the placebo-controlled trials after at least one dose of ZELAPAR (incidence 2% or greater).
Table 1: Treatment-Emergent Adverse Events* Incidence
in Double-Blind, Placebo-Controlled Trials (Events ≥ 2% of Patients
Treated with ZELAPAR and Numerically More Frequent than the Placebo Group)
|Body System/ Adverse Event||ZELAPAR† 1.25/2.5 mg
|Body as a Whole|
|Hemic and Lymphatic System|
|Metabolic and Nutritional Disorders|
|Skin and Appendages|
|* Patients may have reported multiple adverse experiences
during the study or at discontinuation; thus patients may be included in more
than one category.
** Skin disorders represent any new skin abnormality that would not be characterized as rash or neoplastic lesion. These include events such as skin ulcer, fungal dermatitis, skin hypertrophy, contact dermatitis, herpes simplex, dry skin, sweating, urticaria, and pruritus.
† Patients received concomitant levodopa.
Treatment-emergent adverse reactions for certain events were reported at a higher frequency by patients ≥ 65 years of age compared to patients < 65 years [see Use in Specific Populations].
No consistent differences in the incidences of adverse reactions were observed between male and female patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Read the entire FDA prescribing information for Zelapar (Selegiline Hydrochloride)
Additional Zelapar Information
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