Levacin 200/50mg Side effects

• Side effects of Levacin 200/50mg in details
• Levacin 200/50mg contraindications
• Levacin 200/50mg reviews

What are the possible side effects of Levacin 200/50mg?

Get emergency medical help if you have signs of an allergic reaction to Levacin 200/50mg: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• worsening of tremors (uncontrolled shaking);

• severe or ongoing vomiting or diarrhea;

• confusion, hallucinations, unusual changes in mood or behavior;

• depression or suicidal thoughts; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Some people taking Levacin 200/50mg have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Common Levacin 200/50mg side effects may include:

• jerky or twisting muscle movements;

• headache, dizziness;

• low blood pressure (feeling light-headed);

• sleep problems, strange dreams;

• dry mouth;

• muscle contractions; or

• nausea, vomiting, constipation.

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.

Levacin 200/50mg side effects (more detail)

Side effects of Levacin 200/50mg in details

The following serious adverse reactions are discussed below and elsewhere in the labeling:

• Falling asleep during activities of daily living and somnolence
• Withdrawal-emergent hyperpyrexia and confusion
• Cardiovascular ischemic events
• Hallucinations/psychosis
• Impulse control/compulsive behaviors
• Dyskinesia
• Peptic Ulcer Disease
• Glaucoma
• Melanoma

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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 rates observed in clinical practice.

The safety population consisted of a total of 978 Parkinson's disease patients who received at least one dose of Levacin 200/50mg, and had an average duration of exposure of 40 weeks.

Adverse Reactions In Early Parkinson's Disease

In a placebo-controlled clinical study in patients with early Parkinson's disease (Study 1), the most common adverse reactions with Levacin 200/50mg (in at least 5% of patients and more frequently than in placebo) were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

Table 2 lists adverse reactions occurring in at least 5% of Levacin 200/50mg-treated patients and at a higher rate than placebo in Study 1.

Table 2: Adverse Reactions in Study 1 in Patients with Early Stage Parkinson's Disease

	Placebo	Levacin 200/50mg 36.25 mg Carbidopa (Levacin 200/50mg) 145 mg Levodopa (Levacin 200/50mg) TID	Levacin 200/50mg 61.25 mg Carbidopa (Levacin 200/50mg) 245 mg Levodopa (Levacin 200/50mg) TID	Levacin 200/50mg 97.5 mg Carbidopa (Levacin 200/50mg) 390 mg Levodopa (Levacin 200/50mg) TID
(N=92) %	(N=87) %	(N=104) %	(N=98) %
Nausea	9	14	19	20
Dizziness	5	9	19	12
Headache	11	7	13	17
Insomnia	3	2	9	6
Abnormal Dreams	0	2	6	5
Dry Mouth	1	3	2	7
Dyskinesia	0	2	4	5
Anxiety	0	2	3	5
Constipation	1	2	6	2
Vomiting	3	2	2	5
Orthostatic
Hypotension	1	1	1	5

Adverse Reactions Leading to Discontinuation in Study 1

In Study 1, 12% of patients discontinued Levacin 200/50mg early due to adverse reactions; a higher proportion of patients in the 61.25 mg / 245 mg Levacin 200/50mg-treated group (14%) and in the 97.5 mg / 390 mg Levacin 200/50mg-treated group (15%) experienced adverse reactions leading to early discontinuation compared to (4%) in the placebo group. The most common adverse reactions resulting in early discontinuation were nausea, dizziness, and vomiting.

Adverse Reactions In Advanced Parkinson's Disease

In an active-controlled clinical study in patients with advanced Parkinson's disease (Study 2), the most common adverse reactions with Levacin 200/50mg that occurred during dose conversion or maintenance (in at least 5% of patients and more frequently than on oral immediate-release Carbidopa (Levacin 200/50mg)-Levodopa (Levacin 200/50mg)) were nausea and headache.

Table 3 lists adverse reactions occurring in at least 5% of Levacin 200/50mg-treated patients and at a higher rate than oral immediate-release Carbidopa (Levacin 200/50mg)-Levodopa (Levacin 200/50mg) in Study 2.

Table 3: Adverse Reactions in Study 2 in Patients with Advanced Parkinson's Disease

Period	Levacin 200/50mg (N=201)	Immediate-Release Carbidopa (Levacin 200/50mg)-Levodopa (Levacin 200/50mg) (N=192)
Dose Convers ion*	Maintenance	Dose Convers ion*	Maintenance
%	%	%	%
Nausea	4	3	6	2
Headache	5	1	3	2
*All patients were converted to Levacin 200/50mg in the open label Dose Conversion period and then received randomized treatment during maintenance.

Adverse Reactions Leading to Discontinuation in Study 2

In Study 2, 5% of patients discontinued treatment due to adverse reactions during conversion to Levacin 200/50mg. The common adverse reactions leading to discontinuation during dose conversion were dyskinesia, anxiety, dizziness, and on and off phenomenon.

What is the most important information I should know about Levacin 200/50mg?

• Levacin 200/50mg may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Levacin 200/50mg with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Levacin 200/50mg; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Levacin 200/50mg may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Tell your doctor or dentist that you take Levacin 200/50mg before you receive any medical or dental care, emergency care, or surgery.
• NMS is a possibly fatal syndrome that can be caused by Levacin 200/50mg. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Levacin 200/50mg have reported suddenly falling asleep while performing daily activities (eg, driving, eating, talking). Some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Some of these events have been reported as late as 1 year after Levacin 200/50mg was started. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using Levacin 200/50mg.
• Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Levacin 200/50mg also increases the risk of melanoma. You may need to have skin exams while you are using Levacin 200/50mg. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.
• Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while taking Levacin 200/50mg. Tell your doctor right away if you notice such effects.
• Diabetes patients - Levacin 200/50mg may cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Do not suddenly stop taking Levacin 200/50mg. Some conditions may become worse when Levacin 200/50mg is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.
• Gradually increase physical activity as your symptoms improve.
• A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Levacin 200/50mg. This is not harmful.
• The effects of Levacin 200/50mg might start to wear off between doses. Talk with your doctor if Levacin 200/50mg stops working well or if your condition worsens.
• Levacin 200/50mg may affect certain lab test results. Make sure your doctors and lab personnel know you take Levacin 200/50mg.
• Lab tests, including complete blood cell counts and liver function, may be performed while you use Levacin 200/50mg. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Levacin 200/50mg with caution in the ELDERLY; they may be more sensitive to its effects.
• Levacin 200/50mg should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Levacin 200/50mg while you are pregnant. It is not known if Levacin 200/50mg is found in breast milk. If you are or will be breast-feeding while you are taking Levacin 200/50mg, check with your doctor. Discuss any possible risks to your baby.

Levacin 200/50mg contraindications

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Levacin 200/50mg orally disintegrating tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Levacin 200/50mg orally disintegrating tablets. Levacin 200/50mg orally disintegrating tablets may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCI).

Levacin 200/50mg orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

Because Levodopa (Levacin 200/50mg) may activate a malignant melanoma, Levacin 200/50mg orally disintegrating tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

References

1. DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "levodopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. DTP/NCI. "carbidopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Levacin 200/50mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Levacin 200/50mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology