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Stalevo 125 Generic Name & Formulations
Legal Class
Rx
General Description
Carbidopa 31.25mg, levodopa 125mg, entacapone 200mg; tabs.
Pharmacological Class
Dopa-decarboxylase inhibitor + dopamine precursor + COMT inhibitor.
How Supplied
Tabs—100
Manufacturer
Generic Availability
YES
Stalevo 125 Indications
Indications
In idiopathic Parkinson's disease: to substitute for equivalent doses of previously-administered carbidopa/ levodopa and entacapone; and to replace immediate-release carbidopa and levodopa in patients with end-of-dose "wearing-off" symptoms who are taking levodopa up to 600mg/day without having dyskinesias.
Stalevo 125 Dosage and Administration
Adult
Swallow whole; max one tablet per dosing interval. Previously on carbidopa/levodopa and entacapone: substitute on a mg/mg basis. Stalevo 50, 75, 100, 125, 150: max 8 tabs/day; Stalevo 200: max 6 tabs/day. Others: individualize; see full labeling. Avoid abrupt cessation.
Children
Not established.
Stalevo 125 Contraindications
Contraindications
During or within 2 weeks of nonselective MAOIs (eg, phenelzine, tranylcypromine). Narrow-angle glaucoma.
Stalevo 125 Boxed Warnings
Not Applicable
Stalevo 125 Warnings/Precautions
Warnings/Precautions
Risk of falling asleep during activities of daytime living and somnolence; discontinue if occurs or avoid potential dangerous activities. Dyskinesia. Biliary obstruction. Orthostatic hypotension. History of peptic ulcer. Depression. Suicidal tendencies. Psychosis. Impulse control and/or compulsive behavior: consider dose reduction or discontinuation if develops. Discontinue and treat if prolonged diarrhea is suspected; consider colonoscopy and biopsies if cause is unclear. Renal or hepatic impairment. Elderly (>75yrs). Pregnancy. Nursing mothers.
Stalevo 125 Pharmacokinetics
See Literature
Stalevo 125 Interactions
Interactions
See Contraindications. Orthostatic hypotension with antihypertensives. Antagonized by isoniazid, dopamine D2 receptor antagonists (eg, metoclopramide, phenothiazines, butyrophenones, risperidone), phenytoin, papaverine; possibly iron, high protein diets, excessive gastric acidity. Hypertension, dyskinesia with tricyclics. May cause false (+) urinary ketone test or false (–) urinary glucose (glucose oxidase) test. Potentiates CNS depression with alcohol, other CNS depressants. Chelates iron. Cardiac effects with drugs metabolized by COMT (eg, epinephrine, isoproterenol, dopamine, dobutamine, methyldopa, apomorphine, bitolterol). Caution with drugs that interfere with biliary excretion, glucuronidation, or intestinal beta-glucuronidase (eg, probenecid, cholestyramine, erythromycin, rifampicin, ampicillin, chloramphenicol) or other drugs metabolized via CYP2C9. Monitor INR with warfarin.
Stalevo 125 Adverse Reactions
Adverse Reactions
Dyskinesias, hyperkinesia, diarrhea, nausea, abdominal pain, vomiting, dry mouth, urine discoloration; hypotension, syncope, CNS disturbances (eg, hallucinations, confusion, depression, psychosis), rhabdomyolysis, hyperpyrexia and confusion upon withdrawal, fibrotic complications, lab abnormalities.
Stalevo 125 Clinical Trials
See Literature
Stalevo 125 Note
Not Applicable
Stalevo 125 Patient Counseling
See Literature
