Parkinsonism:

Indications for STALEVO 125:

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.

Adult Dosage:

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 Dosage:

Not established.

STALEVO 125 Contraindications:

During or within 2 weeks of nonselective MAOIs (eg, phenelzine, tranylcypromine). Narrow-angle glaucoma.

STALEVO 125 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 Classification:

Dopa-decarboxylase inhibitor + dopamine precursor + COMT inhibitor.

STALEVO 125 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.

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.

Generic Drug Availability:

YES

How Supplied:

Tabs—100