Carbidopa and Levodopa (Page 5 of 5)

Addition of Other Antiparkinson Medications

Anticholinergic agents, dopamine agonists, and amantadine can be given with carbidopa and levodopa extended-release tablets. Dosage adjustment of carbidopa and levodopa extended-release tablets may be necessary when these agents are added.

A dose of carbidopa-levodopa 25 mg/100 mg or 10 mg/100 mg (one half or a whole tablet) can be added to the dosage regimen of carbidopa and levodopa extended-release tablets in selected patients with advanced disease who need additional immediate-release levodopa for a brief time during daytime hours.

Interruption of Therapy

Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of carbidopa and levodopa tablets or carbidopa and levodopa extended-release tablets.

Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa extended-release tablets is required, especially if the patient is receiving neuroleptics (see WARNINGS).

If general anesthesia is required, carbidopa and levodopa extended-release tablets may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual dosage should be administered as soon as the patient is able to take oral medication.


Carbidopa and levodopa extended-release tablets 50 mg/200 mg, containing 50 mg of carbidopa and 200 mg of levodopa, are oval-shaped, light orange tablets, debossed “ETH” on right side of bisect on one side and “383” on other side, packaged as follows:

NDC 58177-383-19 bottle of 30 tablets

NDC 58177-383-09 bottle of 1000 tablets

NDC 58177-383-11 unit dose package of 100 tablets (10 x 10 blister cards)

Store at 20º-25ºC (68º-77º F). (See USP Controlled Room Temperature.)

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation St. Louis, MO 63044

CARBIDOPA AND LEVODOPA carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-383
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbidopa (Carbidopa) Carbidopa 50 mg
Levodopa (Levodopa) Levodopa 200 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
D&C Yellow No. 10
FD&C Red No. 3
fumaric acid
sodium stearyl fumarate
Product Characteristics
Color orange (light orange) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code ETH;383
Coating false Symbol true
# Item Code Package Description Multilevel Packaging
1 NDC:58177-383-19 30 TABLET, EXTENDED RELEASE (30 TABLET) in 1 BOTTLE None
2 NDC:58177-383-09 1000 TABLET, EXTENDED RELEASE (1000 TABLET) in 1 BOTTLE None
3 NDC:58177-383-11 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOX, UNIT-DOSE None
Labeler — ETHEX

Revised: 08/2007 ETHEX

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