Parcopa (Page 4 of 4)

Addition of Other Antiparkinsonian Medications

Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while PARCOPA^® is being administered, although dosage adjustments may be required.

Interruption of Therapy

Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of carbidopa-levodopa. Patients should be observed carefully if abrupt reduction or discontinuation of PARCOPA^® is required, especially if the patient is receiving neuroleptics. (See Warnings.)

If general anesthesia is required, PARCOPA^® may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

How Supplied

PARCOPA^® (carbidopa-levodopa orally disintegrating tablets) 25/100 are yellow, round, flat-faced, mint-flavored, scored and engraved “25/100” on the unscored side and “SP” above and “342” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3342-01

PARCOPA^® (carbidopa-levodopa orally disintegrating tablets) 10/100 are blue, round, flat-faced, mint-flavored, scored and engraved “10/100” on the unscored side and “SP” above and “341” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3341-01

PARCOPA^® (carbidopa-levodopa orally disintegrating tablets) 25/250 are blue, round, flat-faced, mint-flavored, scored, and engraved “25/250” on the unscored side and “SP” above and “343” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3343-01

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture and light.

Dispense in a tight, light-resistant container as defined in the USP/NF.

By:
CIMA LABS INC.^® Eden Prairie, MN 55344, USA

PARCOPA carbidopa and levodopa tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-3342 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbidopa (Carbidopa) Carbidopa 25 mg Levodopa (Levodopa) Levodopa 100 mg

Inactive Ingredients Ingredient Name Strength Aspartame Citric Acid Crospovidone Magnesium Stearate Mannitol Microcrystalline Cellulose Natural Mint Flavor Artificial Mint Flavor Sodium Bicarbonate Yellow 10 Iron Oxide

Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 25/100;SP;342 Contains Coating false Symbol false

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0091-3342-01 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE None

PARCOPA carbidopa and levodopa tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-3341 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbidopa (Carbidopa) Carbidopa 10 mg Levodopa (Levodopa) Levodopa 100 mg

Inactive Ingredients Ingredient Name Strength Aspartame Citric Acid Crospovidone Magnesium Stearate Mannitol Microcrystalline Cellulose Natural Mint Flavor Artificial Mint Flavor Sodium Bicarbonate FD&C Blue #2 HT Aluminum Lake

Product Characteristics Color BLUE (BLUE) Score 2 pieces Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 10/100;SP;341 Contains Coating false Symbol false

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0091-3341-01 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE None

PARCOPA carbidopa and levodopa tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0091-3343 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbidopa (Carbidopa) Carbidopa 25 mg Levodopa (Levodopa) Levodopa 250 mg

Inactive Ingredients Ingredient Name Strength Aspartame Citric Acid Crospovidone Magnesium Stearate Mannitol Microcrystalline Cellulose Natural Mint Flavor Artificial Mint Flavor Sodium Bicarbonate FDC Blue #2 HT Aluminum Lake

Product Characteristics Color BLUE (BLUE) Score 2 pieces Shape ROUND (ROUND) Size 14mm Flavor Imprint Code 25/250;SP;343 Contains Coating false Symbol false

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0091-3343-01 100 TABLET, ORALLY DISINTEGRATING (100 TABLET) in 1 BOTTLE None

Labeler — Schwarz Pharma

Revised: 11/2007 Schwarz Pharma