Carbidopa and Levodopa 10 mg/1
Carbidopa and Levodopa · TABLET · A-S Medication Solutions
Carbidopa and Levodopa is a tablet containing carbidopa and levodopa at 10 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Carbidopa and Levodopa
- Generic Name
- Carbidopa and Levodopa
- NDC Code (Product)
50090-7186- Manufacturer
- A-S Medication Solutions
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214092
- Drug Class
- Aromatic Amino Acid Decarboxylation Inhibitor [EPC]; Aromatic Amino Acid [EPC]
- Marketing Start
- 05/07/2021
Recall History
AbbVie Inc.
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Teva Pharmaceuticals USA
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Mayne Pharma Inc
Product Mix-Up: A foreign tablet was found in bottle.
The Harvard Drug Group
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Sun Pharmaceutical Industries, Inc.
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Dosage & Administration
DOSAGE AND ADMINISTRATION Carbidopa and levodopa extended-release tablets contain carbidopa and levodopa in a 1:4 ratio as either the 50-200 tablet or the 25-100 tablet. The daily dosage of carbidopa and levodopa extended-release tablets must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. Carbidopa and levodopa extended-release tablets should not be chewed or crushed. Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa extended-release tablets are being administered, although their dosage may have to be adjusted. Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, carbidopa and levodopa extended-release tablets can be given to patients receiving supplemental pyridoxine (vitamin B 6 ). Initial Dosage Patients Currently Treated with Conventional Carbidopa-Levodopa Preparations Studies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater…
Warnings
WARNINGS When patients are receiving levodopa without a decarboxylase inhibitor, levodopa must be discontinued at least twelve hours before carbidopa and levodopa extended-release is started. In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy. Carbidopa and levodopa extended-release should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage (see DOSAGE AND ADMINISTRATION ). Carbidopa does not decrease adverse reactions due to central effects of levodopa. By permitting more levodopa to reach the brain, particularly when nausea and vomiting is not a dose-limiting factor, certain adverse central nervous system (CNS) effects, e.g., dyskinesias, will occur at lower dosages and sooner during therapy with carbidopa and levodopa extended-release than with levodopa alone. Patients receiving carbidopa and levodopa extended-release may develop increased dyskinesias compared to carbidopa and levodopa immediate-release. Dyskinesias are a common side effect of carbidopa-levodopa treatment. The occurrence of dyskinesias may require dosage reduction. All patients …
Contraindications
CONTRAINDICATIONS Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa extended-release. Carbidopa and levodopa extended-release may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see PRECAUTIONS: Drug Interactions ). Carbidopa and levodopa extended-release is contraindicated in patients with known hypersensitivity to any component of this drug and in patients with narrow-angle glaucoma.
Drug Interactions
Drug Interactions Caution should be exercised when the following drugs are administered concomitantly with carbidopa and levodopa extended-release. Symptomatic postural hypotension has occurred when carbidopa-levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa extended-release is started, dosage adjustment of the antihypertensive drug may be required. For patients receiving MAO inhibitors (Type A or B), see CONTRAINDICATIONS . Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see CONTRAINDICATIONS ). There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations. Dopamine D 2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients ta…
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on carbidopa and levodopa immediate-release were randomized to therapy with either carbidopa and levodopa immediate-release or carbidopa and levodopa extended-release. The adverse experience frequency profile of carbidopa and levodopa extended-release did not differ substantially from that of carbidopa and levodopa immediate-release, as shown in Table 1. Table 1: Clinical Adverse Experiences Occurring in 1% or Greater of Patients Adverse Experience Carbidopa and Levodopa Extended-Release n = 491 % Carbidopa and Levodopa Immediate-Release n = 524 % Dyskinesia 16.5 12.2 Nausea 5.5 5.7 Hallucinations 3.9 3.2 Confusion 3.7 2.3 Dizziness 2.9 2.3 Depression 2.2 1.3 Urinary tract infection 2.2 2.3 Headache 2.0 1.9 Dream abnormalities 1.8 0.8 Dystonia 1.8 0.8 Vomiting 1.8 1.9 Upper respiratory infection 1.8 1.0 Dyspnea 1.6 0.4 ‘On-Off’ phenomena 1.6 1.1 Back pain 1.6 0.6 Dry mouth 1.4 1.1 Anorexia 1.2 1.1 Diarrhea 1.2 0.6 Insomnia 1.2 1.0 Orthostatic hypotension 1.0 1.1 Shoulder pain 1.0 0.6 Chest pain 1.0 0.8 Muscle cramps 0.8 1.0 Paresthesia 0.8 1.1 Urinary frequency 0…
Frequently Asked Questions
What is Carbidopa and Levodopa used for?
Carbidopa and Levodopa contains Carbidopa and Levodopa. It is a tablet taken oral. Consult your doctor for specific uses.
Is Carbidopa and Levodopa a controlled substance?
Carbidopa and Levodopa is not classified as a controlled substance by the DEA.
What is the generic name for Carbidopa and Levodopa?
The generic name for Carbidopa and Levodopa is Carbidopa and Levodopa. There are 6 other brand versions of Carbidopa and Levodopa.
What is the NDC code for Carbidopa and Levodopa 10 mg/1?
The NDC (National Drug Code) for Carbidopa and Levodopa 10 mg/1 is 50090-7186, listed by A-S Medication Solutions.