SINEMET CR (Page 5 of 5)

Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with SINEMET CR is started. SINEMET CR 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 1 tablet of SINEMET CR 50-200 b.i.d.

Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of SINEMET CR 50-200 b.i.d. Initial dosage should not be given at intervals of less than 6 hours.

Titration with SINEMET CR

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 SINEMET CR that provide 400 to 1600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of SINEMET CR (2400 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 SINEMET CR 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 SINEMET CR may be required.

Addition of Other Antiparkinson Medications

Anticholinergic agents, dopamine agonists, and amantadine can be given with SINEMET CR. Dosage adjustment of SINEMET CR may be necessary when these agents are added.

A dose of SINEMET (Carbidopa-Levodopa) 25-100 or 10-100 (one half or a whole tablet) can be added to the dosage regimen of SINEMET CR 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 a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of SINEMET (Carbidopa-Levodopa) or SINEMET CR.

Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET CR is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, SINEMET CR 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

SINEMET CR 50-200 (Carbidopa-Levodopa) Sustained-Release Tablets containing 50 mg of carbidopa and 200 mg of levodopa, are peach colored, oval, biconvex, compressed tablets, that are scored and coded “521″ on one side and SINEMET CR on the other side. They are supplied as follows:

NDC 0056-0521-68 bottles of 100
NDC 0056-0521-85 bottles of 500.

SINEMET CR 25-100 (Carbidopa-Levodopa) Sustained-Release Tablets containing 25 mg of carbidopa and 100 mg of levodopa, are pink colored, oval, biconvex, compressed tablets, that are coded “601” (with bar) on one side and SINEMET CR on the other side. They are supplied as follows:

NDC 0056-0601-68 bottles of 100.

Storage

Store below 30°C (86°F). Store in a tightly closed container.

Manufactured by:
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

Marketed by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

7873515
Printed in USA
Rev January 2009

———————————————
REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of SINEMET CR.

SINEMET® CR
(CARBIDOPA-LEVODOPA)
SUSTAINED-RELEASE
50-200
500 TABLETS
NDC 0056-0521-85
USUAL ADULT DOSAGE:
See accompanying circular.
Tablets should be swallowed without chewing or crushing.
Dispense in tightly closed container.
Avoid temperatures above 30°C (86°F). Store in a tightly closed container.
This is a bulk package and not intended for dispensing.
Rx only SINEMET is a registered trademark of MERCK & CO., INC.

Sinemet CR 50/200 mg Bottle Label
(click image for full-size original)

SINEMET® CR
(CARBIDOPA-LEVODOPA)
SUSTAINED-RELEASE
25-100
100 TABLETS
USUAL ADULT DOSAGE:
See accompanying circular.
Tablets should be swallowed without chewing or crushing.
Dispense in tightly closed container.
Store below 30°C (86°F). Store in a tightly closed container.
This is a bulk package and not intended for dispensing.
Rx only SINEMET is a registered trademark of MERCK & CO., INC.

Sinemet CR 25/100 mg Bottle Label
(click image for full-size original)
SINEMET CR carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0056-0521
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
carbidopa (carbidopa) carbidopa 50 mg
levodopa (levodopa) levodopa 200 mg
Inactive Ingredients
Ingredient Name Strength
hydroxypropyl cellulose
magnesium stearate
ferric oxide red
D&C Yellow No. 10
Product Characteristics
Color ORANGE (Peach) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code 521;SINEMET;CR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0056-0521-68 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
2 NDC:0056-0521-85 500 TABLET, EXTENDED RELEASE (500 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019856 06/01/2009 06/22/2014
SINEMET CR carbidopa and levodopa tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0056-0601
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
hydroxypropyl cellulose
magnesium stearate
ferric oxide red
Product Characteristics
Color PINK Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 601;SINEMET;CR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0056-0601-68 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019856 06/01/2009 10/31/2012
Labeler — Bristol-Myers Squibb Pharma Company (830615030)

Revised: 01/2009 Bristol-Myers Squibb Pharma Company

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