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.

Image from Drug Label Content

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

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.