Carbidopa and Levodopa (Page 6 of 6)

Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with carbidopa and levodopa extended-release tablets is started. Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually one tablet of 50 mg/200 mg carbidopa and levodopa extended-release tablets b.i.d.

Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is one tablet of 50 mg/200 mg carbidopa and levodopa extended-release tablets b.i.d. Initial dosage should not be given at intervals of less than 6 hours.

Titration with carbidopa and levodopa extended-release tablets

Following initiation of therapy, doses and dosing intervals may be increased or decreased depending upon therapeutic response. Most patients have been adequately treated with doses of carbidopa and levodopa extended-release tablets that provide 400 mg to 1,600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of carbidopa and levodopa extended-release tablets (2,400 mg or more of levodopa per day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended.

When doses of carbidopa and levodopa extended-release tablets are given at intervals of less than 4 hours, and/or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day.

An interval of at least 3 days between dosage adjustments is recommended.

Maintenance

Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended; adjustment of the dosage regimen of carbidopa and levodopa extended-release tablets may be required.

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 and levodopa immediate-release tablets 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 hyperpyrexia and confusion 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.

HOW SUPPLIED

Carbidopa and levodopa extended-release tablets, USP are available containing 25 mg of carbidopa, USP and 100 mg of levodopa , USP or 50 mg of carbidopa, USP and 200 mg of levodopa, USP.

The 25 mg/100 mg tablets are light blue, mottled, oval, uncoated tablets debossed with ‘SG’ on one side and ‘460’ on the other side. They are available as follows:

Blistercards of 30’s NDC 0615-8460-39

The 50 mg/200 mg tablets are light blue, mottled, oval, uncoated tablets debossed with ‘SG’ on one side and ‘461’ on the other side. They are available as follows:

Blistercards of 30’s NDC 0615-8461-39

Storage and Handling

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container.

Manufactured by:
ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788

Rev. 8/2021

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
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CARBIDOPA AND LEVODOPA carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8460(NDC:50228-460)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA (CARBIDOPA ANHYDROUS) CARBIDOPA ANHYDROUS 25 mg
LEVODOPA (LEVODOPA) LEVODOPA 100 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FD&C BLUE NO. 2
Product Characteristics
Color blue (light blue) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code SG;460
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8460-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214091 10/05/2021
CARBIDOPA AND LEVODOPA carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8461(NDC:50228-461)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBIDOPA (CARBIDOPA ANHYDROUS) CARBIDOPA ANHYDROUS 50 mg
LEVODOPA (LEVODOPA) LEVODOPA 200 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
FD&C BLUE NO. 2
Product Characteristics
Color blue (light blue) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code SG;461
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8461-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214091 10/05/2021
Labeler — NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack (0615-8460), repack (0615-8461)

Revised: 04/2023 NCS HealthCare of KY, LLC dba Vangard Labs

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