Carbidopa-levodopa 25 mg/1
carbidopa and levodopa · TABLET · TruPharma, LLC
Carbidopa-levodopa is a tablet containing carbidopa and levodopa at 25 mg/1, taken oral. Manufactured by TruPharma, LLC.
Key Facts
- Brand Name
- Carbidopa-levodopa
- Generic Name
- carbidopa and levodopa
- NDC Code (Product)
52817-391- Manufacturer
- TruPharma, LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216505
- Drug Class
- Aromatic Amino Acid [EPC]; Aromatic Amino Acid Decarboxylation Inhibitor [EPC]
- Marketing Start
- 09/21/2022
Recall History
Novartis Pharmaceuticals Corp.
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Aidapak Services, LLC
Labeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD46426_22, EXP: 5/15/2014.
Rising Pharma Holding, Inc.
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
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 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. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.
Dosage & Administration
DOSAGE AND ADMINISTRATION The optimum daily dosage of carbidopa and levodopa tablets must be determined by careful titration in each patient. Carbidopa and levodopa tablets are available in a 1:4 ratio of carbidopa to levodopa (carbidopa and levodopa tablets 25 mg/100 mg) as well as 1:10 ratio carbidopa and levodopa tablets 25 mg/250 mg and carbidopa and levodopa tablets 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. Usual Initial Dosage Dosage is best initiated with one tablet of carbidopa and levodopa 25 mg/100 mg three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of carbidopa and levodopa 25 mg/100 mg a day is reached. If carbidopa and levodopa 10 mg/100 mg is used, dosage may be initiated with one tablet three or four times a day. However, this will not provi…
Warnings
WARNINGS When carbidopa and levodopa tablets are to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with carbidopa and levodopa tablets are started. In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy. The addition of carbidopa with levodopa in the form of carbidopa and levodopa tablets reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Because carbidopa permits more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with carbidopa and levodopa tablets than with levodopa alone. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Carbidopa and levodopa tablets should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepat…
Contraindications
CONTRAINDICATIONS Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. Carbidopa and levodopa tablets 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 tablets are 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 tablets. Symptomatic postural hypotension occurred when carbidopa and levodopa was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa tablets 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 and levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa and 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 and levodopa tablets. 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 taking these drugs with carbido…
Adverse Reactions
ADVERSE REACTIONS The most common adverse reactions reported with carbidopa and levodopa tablets have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea. The following other adverse reactions have been reported with carbidopa and levodopa tablets: Body as a Whole Chest pain, asthenia. Cardiovascular Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation. Gastrointestinal Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations. Hematologic Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia. Hypersensitivity Angioedema, urticaria, pruritus, Henoch-Schönlein purpura, bullous lesions (including pemphigus-like reactions). Musculoskeletal Back pain, shoulder pain, muscle cramps. Nervous System/Psychiatric Psychotic episodes including delusions, hallucinations, and paranoid ideation, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia,…
Frequently Asked Questions
What is Carbidopa-levodopa used for?
Carbidopa-levodopa contains carbidopa and levodopa. It is a tablet taken oral. Consult your doctor for specific uses.
Is Carbidopa-levodopa a controlled substance?
Carbidopa-levodopa is not classified as a controlled substance by the DEA.
What is the generic name for Carbidopa-levodopa?
The generic name for Carbidopa-levodopa is carbidopa and levodopa. There are 10 other brand versions of carbidopa and levodopa.
What is the NDC code for Carbidopa-levodopa 25 mg/1?
The NDC (National Drug Code) for Carbidopa-levodopa 25 mg/1 is 52817-391, listed by TruPharma, LLC.
Other Carbidopa-levodopa Dosages
Other Carbidopa Brands
See all →- Carbidopa and Levodopa10 mg/10615-8555
- CARBIDOPA AND LEVODOPA10 mg/131722-381
- CARBIDOPA AND LEVODOPA10 mg/147335-186
- Carbidopa and Levodopa25 mg/150228-458
- Carbidopa and Levodopa25 mg/159651-457
- Carbidopa and Levodopa25 mg/160687-661
- Carbidopa and Levodopa25 mg/160687-836
- RYTARY23.75 mg/164896-661
- CREXONT52.5 mg/164896-968
- Carbidopa and Levodopa10 mg/167046-1614
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)