FDA label 7d7994d2-6a0e-1e5a-e053-2a91aa0a2163

WARNINGS LODOSYN (Carbidopa) has no antiparkinsonian effect when given alone. It is indicated for use with SINEMET (Carbidopa-Levodopa) or levodopa. LODOSYN (Carbidopa) does not decrease adverse reactions due to central effects of levodopa. When LODOSYN (Carbidopa) is to be given to carbidopa-naive patients who are being treated with levodopa alone, the two drugs should be given at the same time. At least twelve hours should elapse between the last dose of levodopa and initiation of therapy with LODOSYN (Carbidopa) and levodopa in combination. Start with no more than one-fifth (20%) to one-fourth (25%) of the previous daily dosage of levodopa when given without LODOSYN (Carbidopa). See the DOSAGE AND ADMINISTRATION section before initiating therapy. As with levodopa, concomitant administration of LODOSYN and levodopa may cause involuntary movements and mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Because LODOSYN (Carbidopa) permits more levodopa to reach the brain and, thus, more dopamine to be formed, dyskinesias may occur at lower levodopa dosages and sooner with concomitant use of LODOSYN (Carbidopa) and levodopa or carbidopa-levodopa combination products than with levodopa alone. The occurrence of dyskinesias may require levodopa dosage reduction. Levodopa, with or without LODOSYN, should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic, or endocrine disease. Care should be exercised in administering levodopa, with or without LODOSYN, to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care. As with levodopa alone there is a possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer. Neuroleptic Malignant Syndrome (NMS) Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, SINEMET (Carbidopa-Levodopa), or SINEMET CR (Carbidopa-Levodopa) Sustained-Release. Therefore, patients should be observed carefully when the dosage of levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin, have been reported. The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.

ADVERSE REACTIONS Carbidopa has not been demonstrated to have any overt pharmacodynamic actions in the recommended doses. The only adverse reactions that have been observed have been with concomitant use of carbidopa with other drugs such as levodopa, and with carbidopalevodopa combination products. When LODOSYN is administered concomitantly with levodopa or carbidopa-levodopa combination products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements, and nausea. Other adverse reactions reported with LODOSYN when administered concomitantly with levodopa alone or carbidopa-levodopa combination products were psychotic episodes including delusions, hallucinations, and paranoid ideation, depression with or without development of suicidal tendencies, and dementia. Convulsions also have occurred; however, a causal relationship with concomitant use of LODOSYN and levodopa has not been established. The following other adverse reactions have been reported with levodopa and carbidopa-levodopa combination products. These same adverse reactions may also occur when LODOSYN is administered with these products. Body as a Whole: abdominal pain and distress, asthenia, chest pain, fatigue. Cardiovascular: cardiac irregularities, hypertension, myocardial infarction, hypotension including orthostatic hypotension, palpitation, phlebitis, syncope. Gastrointestinal: anorexia, bruxism, burning sensation of the tongue, constipation, dark saliva, development of duodenal ulcer, diarrhea, dry mouth, dyspepsia, dysphagia, flatulence, gastrointestinal bleeding, gastrointestinal pain, heartburn, hiccups, sialorrhea, taste alterations, vomiting. Hematologic: hemolytic and non-hemolytic anemia, leukopenia, thrombocytopenia, agranulocytosis. Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions). Metabolic: edema, weight gain, weight loss. Musculoskeletal: back pain, leg pain, muscle cramps, shoulder pain. Nervous System/Psychiatric: agitation, anxiety, ataxia, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), bradykinetic episodes ("on-off" phenomenon), confusion, decreased mental acuity, disorientation, euphoria, dizziness, dream abnormalities including nightmares, extrapyramidal disorder, falling, gait abnormalities, headache, increased tremor, insomnia, memory impairment, muscle twitching, nervousness, numbness, paresthesia, peripheral neuropathy, somnolence, trismus, activation of latent Horner's syndrome, increased libido. Respiratory: upper respiratory infection, dyspnea, pharyngeal pain, cough. Skin: flushing, increased sweating, malignant melanoma (see also CONTRAINDICATIONS ), rash, alopecia, dark sweat. Special Senses: oculogyric crises, diplopia, blurred vision, dilated pupils. Urogenital: dark urine, priapism, urinary frequency, urinary incontinence, urinary retention, urinary tract infection. Laboratory Tests: abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), Coombs test; elevated serum glucose; decreased hemoglobin and hematocrit; decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; white blood cells, bacteria and blood in the urine; protein and glucose in the urine. Miscellaneous: bizarre breathing patterns, faintness, hoarseness, hot flashes, malaise, neuroleptic malignant syndrome, sense of stimulation.