Levo-C AL Uses

How do you administer this medicine?
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What is Levo-C AL?

Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) combination is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Extended-release Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) (Levo-C AL®) is also used to treat parkinsonism caused by encephalitis, or parkinsonism caused by carbon monoxide or manganese poisoning.

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa (Levo-C AL) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, Levodopa (Levo-C AL) helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.

Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) is available only with your doctor's prescription.

Levo-C AL indications

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Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets are indicated in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets are indicated in these conditions to permit the administration of lower doses of Levodopa (Levo-C AL) with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).

In some patients, a somewhat smoother antiparkinsonian effect results from therapy with Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) than with Levodopa (Levo-C AL). However, patients with markedly irregular (“on-off”) responses to Levodopa (Levo-C AL) have not been shown to benefit from Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) therapy.

Although the administration of Carbidopa (Levo-C AL) permits control of parkinsonism and Parkinson’s disease with much lower doses of Levodopa (Levo-C AL), there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to Levodopa (Levo-C AL).

Certain patients who responded poorly to Levodopa (Levo-C AL) have improved when Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) was substituted. This is most likely due to decreased peripheral decarboxylation of Levodopa (Levo-C AL) which results from administration of Carbidopa (Levo-C AL) rather than to a primary effect of Carbidopa (Levo-C AL) on the nervous system. Carbidopa (Levo-C AL) has not been shown to enhance the intrinsic efficacy of Levodopa (Levo-C AL) in parkinsonian syndromes.

In considering whether to give Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets to patients already on Levodopa (Levo-C AL) who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) with Levodopa (Levo-C AL), about half of the patients with nausea and/or vomiting on Levodopa (Levo-C AL) improved spontaneously despite being retained on the same dose of Levodopa (Levo-C AL) during the controlled portion of the trial.

How should I use Levo-C AL?

Use Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Carbidopa (Levo-C AL) and Levodopa (Levo-C AL).

Uses of Levo-C AL in details

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This medication is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving).

Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa (Levo-C AL) changes into dopamine in the brain, helping to control movement. Carbidopa (Levo-C AL) prevents the breakdown of Levodopa (Levo-C AL) in the bloodstream so more Levodopa (Levo-C AL) can enter the brain. Carbidopa (Levo-C AL) can also reduce some of Levodopa (Levo-C AL)'s side effects such as nausea and vomiting.

By giving this medication as a continuous infusion, it can help reduce the amount of "off" time (periods of slow movement or stiffness).

How to use Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) via j-tube

Read the Medication Guide and the Instructions for Use provided by your health care professional before you start using this medication and each time you get a refill. If you have any questions, ask your health care professional.

Give this medication as directed as a continuous infusion into the small intestine using an infusion pump. It is usually given over 16 hours a day and stopped at bedtime. At bedtime, take your dose of immediate-release Levo-C AL tablets by mouth as directed.

When you first start using this medication, it is given through a tube through the nose into the small intestine. After a few days, if the doctor decides that this product is right for you, then the medication will be given through a tube through the abdomen into the small intestine. Getting the tube through the abdomen will require surgery.

Follow all instructions from your health care professional about how to properly use this medication and the infusion pump. Take a cassette containing the medication from the refrigerator and leave it at room temperature for 20 minutes before using. Do not use a cassette for longer than 16 hours or re-use it, even if there is medication left in it. Learn how to store and discard medical supplies safely. Also learn how to properly care for the small hole in your abdomen and the skin area around the tube, and how to avoid infection.

The dosage is based on your medical condition and response to treatment. Your daily dose is made up of a morning dose, a continuous dose, and extra doses. An extra dose is a small dose of this medication that can be given as needed during the day to treat sudden "off" symptoms. Extra doses should not be given more often than one every 2 hours to avoid causing or worsening movements you cannot control.

Do not suddenly decrease the dose or suddenly stop using this medication because doing either may lead to a serious condition. If you must stop this medication, slowly reduce the dose as directed by your doctor. Contact your doctor right away if your infusion is interrupted. You may need to take the tablet form of Levo-C AL by mouth.

If you plan to be disconnected from the pump for a short period of time (less than 2 hours, for example, to shower), ask your doctor ahead of time if you should use an extra dose of this medication before you disconnect. If you plan to be disconnected from the pump for longer than 2 hours, ask your doctor what you should do and discuss how you should take Levo-C AL tablets by mouth during this time.

Avoid high-protein diets because they may reduce how much of the medication you can absorb.

Tell your doctor if your condition does not improve or if it worsens.

Levo-C AL description

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The naturally occurring form of dihydroxyphenylalanine and the immediate precursor of dopamine. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to dopamine. It is used for the treatment of parkinsonian disorders and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.

Levo-C AL dosage

Dosage in Patients Naïve to Levodopa (Levo-C AL) Therapy

The recommended starting dosage of Levo-C AL in Levodopa (Levo-C AL)-naïve patients is 23.75 mg / 95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of Levo-C AL may be increased to 36.25 mg / 145 mg taken three times a day.

Based upon individual patient clinical response and tolerability, the Levo-C AL dose may be increased up to a maximum recommended dose of 97.5 mg / 390 mg taken three times a day. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of Levo-C AL is 612.5 mg / 2450 mg.

Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea.

Converting from Immediate-Release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) to Levo-C AL

To convert patients from immediate-release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) to Levo-C AL, determine the recommended starting dosage of Levo-C AL using Table 1.

The dosages of other Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) products are not interchangeable with the dosages of Levo-C AL.

Adjust the dose to maintain patient tolerance and sufficient symptomatic control. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of Levo-C AL is 612.5 mg / 2450 mg.

For patients currently treated with Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) plus catechol-O-methyl transferase (COMT) inhibitors (such as entacapone), the initial total daily dose of Levodopa (Levo-C AL) in Levo-C AL described in Table 1 may need to be increased.

Use of Levo-C AL in combination with other Levodopa (Levo-C AL) products has not been studied.

Table 1: Conversion from Immediate-Release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) to Levo-C AL
Total Daily Dose of Levodopa (Levo-C AL) in Immediate-Release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) Recommended Starting Dosage of Levo-C AL
Total Daily Dose of Levodopa (Levo-C AL) in Levo-C AL Levo-C AL Dosing Regimen
*
TID: three times a day
400 mg to 549 mg 855 mg 3 capsules Levo-C AL 23.75 mg / 95 mg taken TID*
550 mg to 749 mg 1140 mg 4 capsules Levo-C AL 23.75 mg / 95 mg taken TID
750 mg to 949 mg 1305 mg 3 capsules Levo-C AL 36.25 mg / 145 mg taken TID
950 mg to 1249 mg 1755 mg 3 capsules Levo-C AL 48.75 mg / 195 mg taken TID
Equal to or greater than 1250 mg 2340 mg or 4 capsules Levo-C AL 48.75 mg / 195 mg taken TID or
2205 mg 3 capsules Levo-C AL 61.25 mg / 245 mg taken TID

Discontinuation of Levo-C AL

Avoid sudden discontinuation or rapid dose reduction of Levo-C AL. The daily dose of Levo-C AL should be tapered at the time of treatment discontinuation.

Administration Information

Swallow Levo-C AL whole with or without food. A high-fat, high-calorie meal may delay the absorption of Levodopa (Levo-C AL) by about 2 hours.

Do not chew, divide or crush Levo-C AL capsules. For patients who have difficulty swallowing intact capsules, administer Levo-C AL by carefully opening the capsule, sprinkling the entire contents on a small amount of applesauce (1 to 2 tablespoons), and consuming immediately. Do not store the drug/food mixture for future use.

Levo-C AL interactions

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What other drugs will affect Levo-C AL?

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Monoamine Oxidase (MAO) Inhibitors

The use of nonselective MAO inhibitors with Levo-C AL is contraindicated. Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating Levo-C AL.

The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with Levo-C AL may be associated with orthostatic hypotension. Monitor patients who are taking these drugs.

Antihypertensive Drugs

The concurrent use of Levo-C AL with antihypertensive medications can cause symptomatic postural hypotension. A dose reduction of the antihypertensive medication may be needed after starting or increasing the dose of Levo-C AL.

Dopamine D2 Receptor Antagonists And Isoniazid

Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine) and isoniazid may reduce the effectiveness of Levodopa (Levo-C AL). Monitor patients for worsening Parkinson's symptoms.

Iron Salts

Iron salts or multi-vitamins containing iron salts can form chelates with Levodopa (Levo-C AL), Carbidopa (Levo-C AL), and can cause a reduction in the bioavailability of Levo-C AL. If iron salts or multi-vitamins containing iron salts are co-administered with Levo-C AL, monitor patients for worsening Parkinson's symptoms.

High-Protein Diet

Because Levodopa (Levo-C AL) competes with certain amino acids for transport across the gut wall, the absorption of Levodopa (Levo-C AL) may be decreased in patients on a high-protein diet. Advise patients that a high-protein diet may reduce the effectiveness of Levo-C AL.

Levo-C AL side effects

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What are the possible side effects of Levo-C AL?

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

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 Levo-C AL, 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 Levo-C AL (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 Levo-C AL-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 Levo-C AL 36.25 mg Carbidopa (Levo-C AL)

145 mg Levodopa (Levo-C AL) TID

Levo-C AL 61.25 mg Carbidopa (Levo-C AL)

245 mg Levodopa (Levo-C AL) TID

Levo-C AL 97.5 mg Carbidopa (Levo-C AL)

390 mg Levodopa (Levo-C AL) 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 Levo-C AL early due to adverse reactions; a higher proportion of patients in the 61.25 mg / 245 mg Levo-C AL-treated group (14%) and in the 97.5 mg / 390 mg Levo-C AL-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 Levo-C AL that occurred during dose conversion or maintenance (in at least 5% of patients and more frequently than on oral immediate-release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL)) were nausea and headache.

Table 3 lists adverse reactions occurring in at least 5% of Levo-C AL-treated patients and at a higher rate than oral immediate-release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL) in Study 2.

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

Period Levo-C AL

(N=201)

Immediate-Release Carbidopa (Levo-C AL)-Levodopa (Levo-C AL)

(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 Levo-C AL 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 Levo-C AL. The common adverse reactions leading to discontinuation during dose conversion were dyskinesia, anxiety, dizziness, and on and off phenomenon.

Levo-C AL contraindications

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What is the most important information I should know about Levo-C AL?

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets. Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) 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).

Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) 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 (Levo-C AL) may activate a malignant melanoma, Carbidopa (Levo-C AL) and Levodopa (Levo-C AL) orally disintegrating tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

Active ingredient matches for Levo-C AL:

Carbidopa/Levodopa in Germany.


List of Levo-C AL substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Levo-C 5mg TAB / 10 (Aliud)$ 0.35
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg (Betapharm)
Tablet; Oral; Carbidopa 50 mg; Levodopa 200 mg (Betapharm)
Tablet; Oral; Carbidopa 50 mg; Levodopa 200 mg (Biolab sanus)
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg
Tablet; Oral; Carbidopa 25 mg; Levodopa 250 mg
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg (Hexal)
Tablet; Oral; Carbidopa 50 mg; Levodopa 200 mg (Hexal)
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg (Neuraxpharm)
Tablet; Oral; Carbidopa 50 mg; Levodopa 200 mg (Neuraxpharm)
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg
Tablet; Oral; Carbidopa 50 mg; Levodopa 200 mg
Tablet; Oral; Carbidopa 25 mg; Levodopa 100 mg
Tablet; Oral; Carbidopa 25 mg; Levodopa 250 mg

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. PubChem. "levodopa". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "carbidopa". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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