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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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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