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Cautions

Contraindications

• Concomitant use with a nonselective MAO inhibitor. (See Specific Drugs and Foods under Interactions.)
• Angle-closure glaucoma.
• Known hypersensitivity to levodopa, carbidopa, or any ingredient in the formulation.
• Malignant melanoma, history of melanoma, or suspicious undiagnosed skin lesions.

Warnings/Precautions

Warnings

Nervous System and Muscular Effects

Therapy associated with dyskinesias; dosage reduction may be needed.

Mental disturbances reported. Observe patients for depression with concomitant suicidal tendencies. Use with caution in patients with current or past psychoses.

Bradykinetic Episodes

“On-off” phenomenon: Sudden loss of effectiveness with abrupt onset of akinesia (“off” effect; persists 1–60 minutes) followed by sudden return of effectiveness (“on” effect); may recur many times daily and respond to increased dosing frequency.

Akinesia Paradoxica (“start hesitation”): Sudden hypotonic freezing (patient falls frequently while attempting to walk); may respond to decreased dosage.

Cardiovascular Effects

Risk of orthostatic hypotension; usually asymptomatic and tolerance usually develops within a few months.

Use with care in patients with a history of MI who have residual atrial, nodal, or ventricular arrhythmias; monitor cardiac function in a facility with intensive cardiac care immediately available during the initial dosage adjustment.

Use with caution in patients with severe cardiovascular disease.

Respiratory Effects

Caution in patients with pulmonary disease (e.g., emphysema) or asthma who may require use of sympathomimetics.

GI Effects

Use with caution in patients with a history of peptic ulcers; possibility of upper GI hemorrhage in these patients.

Neuroleptic Malignant Syndrome (NMS)

Symptom complex resembling NMS reported following dosage reduction or abrupt withdrawal of levodopa.

Observe closely when dosage is reduced or the drug discontinued; especially important in patients receiving concomitant therapy with an antipsychotic agent.

General Precautions

Evaluate hepatic, hematopoietic, cardiovascular, and renal function periodically.

Use of Fixed Combinations

When the fixed-combination preparation containing levodopa, carbidopa, and entacapone (Stalevo^®) is used, observe the usual precautions and contraindications associated with all drugs in the preparation.

Glaucoma

Can be used with caution in patients with well-controlled open-angle glaucoma; monitor IOP. (See Contraindications under Cautions.)

Endocrine Disorders

Use with caution.

Closely monitor diabetic patients; levodopa may affect glycemic control.

Phenylketonuria

Levodopa-carbidopa orally disintegrating tablets contain aspartame (NutraSweet^®), which is metabolized in the GI tract to phenylalanine.

Specific Populations

Pregnancy

Category C.

Lactation

Carbidopa is distributed into milk in rats. Not known whether levodopa-carbidopa distributes into human milk; caution advised.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

Common Adverse Effects

Dyskinesias (choreiform, dystonic, other adventitious movements), nausea.