Adult Dosing

Adjunct treatment in Parkinson's disease

• 200 mg PO with each dose of levodopa/carbidopa up to a maximum of 8 doses/day
• Max: 1600 mg/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As an adjunct to levodopa/carbidopa in patients with idiopathic Parkinson's disease and end-of-dose wearing off

• Hypersensitivity to any of the ingredients of the product
• Concomitantly with entacapone and a non-selective MAO inhibitor

• N/A

Renal dose adjustment

• Renal impairment: Dose adjustments not defined

Hepatic dose adjustment

• Hepatic impairment: Use with caution in hepatic impairment (dose adjustment not defined)

See Supplemental Patient Information

• Entacapone administration has been associated with orthostatic hypotension, hallucinations, dyskinesia, rhabdomylosis, hyperpyrexia, confusion and fibrotic complications
• Avoid abrupt cessation. Taper dose gradually. Rapid reduction may lead to symptoms resembling neuroleptic malignant syndrome; monitor patient for signs similar to neuroleptic malignant syndrome
• Discontinue entacapone if prolonged diarrhea is suspected, appropriate medical therapy should be considered

Cautions: Use cautiously in

• Hepatic impairment
• Concurrent use of drugs metabolized by COMT
• Dyskinesias
• Biliary obstruction
• Nursing mothers

Supplemental Patient Information

• May cause dizziness or hallucinations. Advise patient to avoid driving or other activities that require alertness until response to the drug is known
• Patients should be cautioned to change positions slowly to minimize orthostatic hypotension
• Inform patients that treatment with entacapone may cause a change in the color of their urine (a brownish orange discoloration) that is not clinically relevant
• Inform patients that diarrhea may occur with entacapone, may have a delayed onset; advise patients to drink fluids to maintain adequate hydration and monitor for weight loss

Pregnancy Category:C

Breastfeeding: Safety unknown; is excreted in breast milk of lactating rats. Manufacturer advises caution.

• CNS: Dyskinesia/hyperkinesia, hypokinesia, psychiatric reasons, aggravation of Parkinson’s Disease symptoms, syncope, hallucinations, neuroleptic malignant syndrome, dizziness, fatigue, somnolence, anxiety, agitation
• GI: Nausea, urine discoloration, diarrhea, abdominal pain, colitis, constipation, dry mouth, fibrotic complications
• CV: Orthostatic hypotension
• MUSC: Rhabdomyolysis, back pain
• GU: Urine discoloration
• METABOLIC: Hypokalemia, weight loss
• RESP: Dyspnea, flatulence, dyspepsia
• MISC: Increased sweating

• Antiparkinson agent; acts as a selective and reversible inhibitor of enzyme catechol O-methyltransferase (COMT), Inhibition of COMT prevents breakdown of levodopa, increasing availability to the CNS
• Absolute bioavailability of 35% after oral administration
• Extensively metabolized by isomerization and glucuronidation; CYP450: unknown
• Renally excreted: 10% (0.2% unchanged); Feces 90%
• Half life: Biphasic
• Initial phase: 0.4-0.7 hrs
• Terminal phase: 2.4 hrs

US Trade Name(s)

• Comtan

US Availability

entacapone (generic)

• TABS: 200 mg

Comtan

• TABS: 200 mg

Canadian Trade Name(s)

• Comtan

Canadian Availability

Comtan

• TABS: 200 mg

UK Trade Name(s)

• Comtess

UK Availability

Comtan

• TABS: 200 mg

Australian Trade Name(s)

• Comtan

Australian Availability

Comtan

• TABS: 200 mg

[Outline]

Neurologic

Antiparkinson Agents

Dopaminergic Agents

Pricing data from www.DrugStore.com in U.S.A.

• Comtan 200 MG TABS [Bottle] (NOVARTIS)
  30 mg = $115.99
  90 mg = $329.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Comtan 200 MG Oral Tablet

Ingredient(s): Entacapone

Imprint: COMTAN

Color(s): Orange

Shape: Oval

Size (mm): 17.00

Score: 1

Inactive Ingredient(s): croscarmellose sodium / glycerin / ferric oxide red / hydroxypropyl cellulose / magnesium stearate / mannitol / cellulose, microcrystalline / polysorbate 80 / sucrose / titanium dioxide / ferric oxide yellow

Drug Label Author:
Novartis Pharmaceuticals Corporation

DEA Schedule:
Non-Scheduled