entacapone

REMS

Parkinson’s disease when signs and symptoms of end-of-dose "wearing-off" (so-called fluctuating patients) occur (in combination with levodopa/carbidopa).

Contraindicated in:

Hypersensitivity;
Psychotic disorder.

Use Cautiously in:

Hepatic impairment;
Concurrent use of drugs that are metabolized by COMT;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

CV: hypotension

Derm: MELANOMA

GI: abdominal pain, colitis, diarrhea, nausea (during initiation), retroperitoneal fibrosis

GU: brownish-orange discoloration of urine

MS: dyskinesia, RHABDOMYOLYSIS

Neuro: aggressive behavior, agitation, confusion, delirium, disorientation, dizziness, hallucinations, NEUROLEPTIC MALIGNANT SYNDROME, paranoid ideation, syncope, urges (gambling, sexual)

Resp: pleural effusion, pleural thickening, pulmonary infiltrates

Drug-drug:

Concurrent use with selective MAO inhibitors is not recommended; both agents inhibit the metabolic pathways of catecholamines.
Concurrent use of drugs that are metabolized by COMT, including isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine, may ↑ risk of tachycardia, ↑ BP, and arrhythmias.
Probenecid, cholestyramine, erythromycin, rifampin, ampicillin, and chloramphenicol may interfere with biliary elimination of entacapone; use concurrently with caution.

(Generic available)

Tablets: 200 mg
In combination with: levodopa/carbidopa (Stalevo), see Appendix [not included in this PDA edition].

PO (Adults ): 200 mg with each dose of levodopa/carbidopa up to a maximum of 8 times daily.

Acts as a selective and reversible inhibitor of the enzyme catechol O-methyltransferase (COMT).
Inhibition of COMT prevents the breakdown of levodopa, increasing availability to the CNS.

Therapeutic effects:

Prolongs duration of response to levodopa with end-of-dose motor fluctuations.
Decreased signs and symptoms of Parkinson’s disease.

Therapeutic Classification: antiparkinson agents

Pharmacologic Classification: catechol o methyltransferase comt inhibitors

Absorption: 35% absorbed following oral administration; absorption is rapid.

Distribution: Widely distributed to tissues.

Protein Binding: 98%.

Metabolism/Excretion: Minimal amounts excreted unchanged; highly metabolized followed by biliary excretion.

Half-Life: Initial phase: 0.4–0.7 hr; second phase: 2.4 hr.

(inhibition of COMT)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	up to 8 hr

Encourage patient to take entacapone as directed. Take missed doses as soon as possible, up to 2 hr before the next dose. Taper gradually when discontinuing or a withdrawal reaction may occur.
May cause dizziness or hallucinations. Advise patient to avoid driving or other activities that require alertness until response to the drug is known.
Inform patient that nausea may occur, especially at initiation of therapy, and diarrhea. Advise patient with diarrhea to drink fluids to maintain adequate hydration and monitor for weight loss. If diarrhea is prolonged, may resolve with discontinuation. Therapy may cause change in urine color to brownish orange.
Caution patient to change positions slowly to minimize orthostatic hypotension.
Advise patient to notify health care professional if suspicious or unusual skin changes, agitation, aggression, delirium, hallucinations, or new or increased gambling, sexual, or other intense urges occur.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize the importance of routine follow-up exams.

NDC Code

0078- Novartis Pharmaceuticals Corporation
- 0078-0327- Comtan
  - 0078-0327-05- 100 TABLET, FILM COATED in 1 BOTTLE (0078-0327-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-9080- Entacapone
  - 0378-9080-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-9080-01)

0527- Lannett Company, Inc.
- 0527-1830- Entacapone
  - 0527-1830-35- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-35)

0527- Lannett Company, Inc.
- 0527-1830- Entacapone
  - 0527-1830-37- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37)

0615- NCS HealthCare of KY, Inc dba Vangard Labs
- 0615-8298- Entacapone
  - 0615-8298-39- 30 TABLET in 1 BLISTER PACK (0615-8298-39)

0781- Sandoz Inc
- 0781-5578- Entacapone
  - 0781-5578-01- 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)

0904- Major Pharmaceuticals
- 0904-6822- Entacapone
  - 0904-6822-04- 30 BLISTER PACK in 1 CARTON (0904-6822-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK

27241- Ajanta Pharma Limited
- 27241-049- Entacapone
  - 27241-049-10- 100 TABLET in 1 BOTTLE (27241-049-10)

33342- Macleods Pharmaceuticals Limited
- 33342-260- Entacapone
  - 33342-260-11- 100 TABLET in 1 BOTTLE (33342-260-11)

33342- Macleods Pharmaceuticals Limited
- 33342-260- Entacapone
  - 33342-260-15- 500 TABLET in 1 BOTTLE (33342-260-15)

43353- Aphena Pharma Solutions - Tennessee, LLC
- 43353-996- Entacapone
  - 43353-996-05- 4200 TABLET, FILM COATED in 1 BOTTLE (43353-996-05)

43353- Aphena Pharma Solutions - Tennessee, LLC
- 43353-996- Entacapone
  - 43353-996-83- 3600 TABLET, FILM COATED in 1 BOTTLE (43353-996-83)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-007- Entacapone
  - 47335-007-88- 100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)

48792- Sunshine Lake Pharma Co., Ltd.
- 48792-7830- Entacapone
  - 48792-7830-1- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7830-1)

48792- Sunshine Lake Pharma Co., Ltd.
- 48792-7830- Entacapone
  - 48792-7830-2- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7830-2)

50268- AvPAK
- 50268-295- Entacapone
  - 50268-295-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11)

51079- Mylan Institutional Inc.
- 51079-273- Entacapone
  - 51079-273-03- 30 BLISTER PACK in 1 CARTON (51079-273-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-273-01)

60687- American Health Packaging
- 60687-188- Entacapone
  - 60687-188-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-188-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-188-11)

64679- Wockhardt USA LLC.
- 64679-711- Entacapone
  - 64679-711-01- 30 TABLET, FILM COATED in 1 BOTTLE (64679-711-01)

64679- Wockhardt USA LLC.
- 64679-711- Entacapone
  - 64679-711-02- 100 TABLET, FILM COATED in 1 BOTTLE (64679-711-02)

64679- Wockhardt USA LLC.
- 64679-711- Entacapone
  - 64679-711-03- 500 TABLET, FILM COATED in 1 BOTTLE (64679-711-03)

64679- Wockhardt USA LLC.
- 64679-711- Entacapone
  - 64679-711-04- 10 BLISTER PACK in 1 CARTON (64679-711-04) > 10 TABLET, FILM COATED in 1 BLISTER PACK

64679- Wockhardt USA LLC.
- 64679-781- Entacapone
  - 64679-781-02- 1 BOTTLE in 1 CARTON (64679-781-02) > 100 TABLET, FILM COATED in 1 BOTTLE

64679- Wockhardt USA LLC.
- 64679-781- Entacapone
  - 64679-781-03- 500 TABLET, FILM COATED in 1 BOTTLE (64679-781-03)

65862- Aurobindo Pharma Limited
- 65862-654- Entacapone
  - 65862-654-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)

65862- Aurobindo Pharma Limited
- 65862-654- Entacapone
  - 65862-654-99- 1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)

71610- Aphena Pharma Solutions - Tennessee, LLC
- 71610-247- Entacapone
  - 71610-247-83- 3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆