Carbidopa (Page 4 of 4)

Patients Receiving Carbidopa-Levodopa Who Require Additional Carbidopa

Some patients taking carbidopa-levodopa may not have adequate reduction in nausea and vomiting when the dosage of carbidopa is less than 70 mg a day, and the dosage of levodopa is less than 700 mg a day. When these patients are taking carbidopa-levodopa, 25 mg of carbidopa may be given with the first dose of carbidopa-levodopa each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of carbidopa-levodopa. Carbidopa may be given with any dose of carbidopa-levodopa as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as carbidopa and as carbidopa-levodopa, should not exceed 200 mg.

Patients Requiring Individual Titration of Carbidopa and Levodopa Dosage

Although carbidopa-levodopa is the most frequently used of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, carbidopa should be initiated at a dosage of 25 mg three or four times a day. The two drugs should be given at the same time, starting with no more than one-fifth (20%) to one-fourth (25%) of the previous or recommended daily dosage of levodopa when given without carbidopa. In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with carbidopa and levodopa. A convenient way to initiate therapy in these patients is in the morning following a night when the patient has not taken levodopa for at least twelve hours. Health care providers who prescribe separate doses of carbidopa and levodopa should be thoroughly familiar with the directions for use of each drug.

Dosage Adjustment

Dosage of carbidopa may be adjusted by adding or omitting one-half or one tablet a day. Because both therapeutic and adverse responses occur more rapidly with combined therapy than when only levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly when carbidopa and levodopa are given concomitantly than when levodopa is given without carbidopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

Current evidence indicates other standard antiparkinsonian drugs may be continued while carbidopa and levodopa are being administered. However, the dosage of such other standard antiparkinsonian drugs may require adjustment.

Interruption of Therapy

Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa-levodopa or carbidopa-levodopa extended release. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa-levodopa or carbidopa-levodopa extended release is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

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

HOW SUPPLIED

Carbidopa Tablets, 25 mg, are round, orange-colored compressed tablets that are on one side flat beveled edge, bisect, embossed “711” and embossed “LODOSYN” on the other side.

They are supplied as follows:

NDC 68682-200-25 bottles of 100.

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)
[see USP Controlled Room Temperature].

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada

LODOSYN is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2020 Bausch Health Companies Inc. or its affiliates

Rev. 07/2020

9036303 20002944

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 68682-200-25

Rx only

CARBIDOPA
TABLETS

25 mg (anhydrous equivalent)

100 Tablets

OCEANSIDE
PHARMACEUTICALS

//medlibrary.org/lib/images-rx/carbidopa-8/label-300x122.jpg
(click image for full-size original)
CARBIDOPA
carbidopa tablets tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
carbidopa (carbidopa anhydrous) carbidopa anhydrous 25 mg
Inactive Ingredients
Ingredient Name Strength
powdered cellulose
FD&C Yellow No. 6
magnesium stearate
starch, corn
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68682-200-25 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017830 04/04/2014
Labeler — Oceanside Pharmaceuticals (832011691)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies, Inc. 253292734 MANUFACTURE (68682-200)

Revised: 07/2020 Oceanside Pharmaceuticals

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