Classes
DEA Class; Rx
Common Brand Names; Stalevo
- Antiparkinson Agents, COMT Inhibitors;
- Decarboxylase Inhibitors;
- Antiparkinson Agents, Dopamine Precursors
Description
Used for adults with Parkinson’s disease
Addition of a COMT inhibitor helpful for patients whoexperience the end-of dose ‘wearing off’ effect of levodopa
Indications
Indicated for the treatment of idiopathic Parkinson’s disease.
Contraindications
Hypersensitivity
Concurrency with nonselective MAOIs (discontinue 2 weeks before starting treatment)
Narrow angle glaucoma
Undiagnosed skin lesions, history of melanoma
Adverse Effects
Entacapone
- Dyskinesia (25%)
- Nausea (14%)
- Diarrhea (10%)
- Hyperkinesia (10%)
- Urine discoloration (10%)
- Hypokinesia (9%), dizziness (8%), Fatigue (6%), hallucinations (1-4%), anxiety (2%), somnolence (2%), asthenia (2%), agitation (1%)
- Increased sweating (2%)
- Purpura (2%)
- Abdominal pain (8%), constipation (6%), vomiting (4%), dry mouth (3%), dyspepsia (2%), flatulence (2%), taste perversion (1%), gastritis (1%)
- Back pain (4%)
- Dyspnea (3%)
- Bacterial infection (1%)
Levodopa/Carbodopa
- Edema
- Agitation, anxiety, ataxia, bruxism, confusion, daytime somnolence decreased attention span, dyskinesia, dystonia, euphoria, insomnia, fainting, fatigue, increased trembling of hands, insouciance, malaise, memory loss, nightmares, nervousness, restlessness, trismus, vivid dreams
- Alopecia, hot flushes, increased &/or dark perspiration, skin eruptions
- Abdominal pain & discomfort, burning feeling in tongue, constipation, diarrhea, dysgeusia, dry mouth, dysphagia, hiccups, meteorism, sialorrhea, nausea, weight loss
- Muscular spasms, muscular cramp
- Hematuria, dark urine, incontinence, priapism, urine retention
- Blurred vision, diplopia, dilated pupil, oculogyric problems
Warnings
Hepatic disease, severe cardiovascular/pulmonary disease, bronchial asthma, renal/endocrine disease, open-angle glaucoma
Age >75 yr
History/active psychoses, history of MI or peptic ulcer
Residual atrial, nodal, ventricular arrhythmias
Risk of uncontrollable sexual, gambling or other urges
May be linked to higher melanoma risk in patient with Parkinson disease
May cause NMS if reduced abruptly or discontinued
Risk of syncope
Risk of developing prostate cancer
Diarrhea may occur and be associated entacapone; may cause weight loss, dehydration, and hypokalemia; if severe, may be a sign of drug-induced microscopic colitis
Pregnancy and Lactation
There are no adequate data on developmental risk associated with use of drug in pregnant women
Levodopa has been detected in human milk after administration of carbidopa-levodopa; there are no data on presence of entacapone or carbidopa in human milk, effects of levodopa, carbidopa, or entacapone on breastfed infant, or on milk production; however, inhibition of lactation may occur because levodopa decreases secretion of prolactin; carbidopa and entacapone are excreted in rat milk; in lactating rat, oral administration of radiolabeled entacapone resulted in levels of entacapone and/or metabolites in milk up to 2 to 3 times that in plasma;
Maximum Dosage
Do not exceed 1 tablet of carbidopa; levodopa; entacapone per dose. Daily limits: 300 mg/day PO carbidopa; 1,200 mg/day PO levodopa; 1,600 mg/day PO of entacapone. The maximum for tablets (50-, 75-, 100- or 150-mg of levodopa) is 8 tablets/day PO. The maximum for tablets with 200-mg of levodopa is 6 tablets/day PO.
Do not exceed 1 tablet of carbidopa; levodopa; entacapone per dose. Daily limits: 300 mg/day PO carbidopa; 1,200 mg/day PO levodopa; 1,600 mg/day PO of entacapone. The maximum for tablets (50-, 75-, 100- or 150-mg of levodopa) is 8 tablets/day PO. The maximum for tablets with 200-mg of levodopa is 6 tablets/day PO.
Safe and effective use has not been established.
Safe and effective use has not been established.
Not indicated.
How supplied
Levodopa/carbidopa/entacapone
tablet
- 50mg/12.5mg/200mg
- 75mg/18.75mg/200mg
- 100mg/25mg/200mg
- 125mg/31.25mg/200mg
- 150mg/37.5mg/200mg
- 200mg/50mg/200mg