Generic Sinemet Cr

LEVODOPA AND CARBIDOPA
Tablets: 10 mg carbidopa and 100 mg levodopa, 25 mg Various, Sinemet (DuPont) carbidopa and 100 mg levodopa, 25 mg carbidopa and
250 mg levodopa (Rx)
Tablets, sustained release: 50 mg carbidopa and Sinemet CR (DuPont)
200 mg levodopa, 25 mg carbidopa and 100 mg levodopa (Rx)

Indications
Treatment of symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and sympathetic parkinsonism that may follow injury to the nervous system by carbon monoxide and manganese intoxication.

Administration and Dosage
Patients not receiving levodopa:
Sinemet - 1 tablet of 25 mg carbidopa/100 mg levodopa 3 times/day or 10 mg carbidopa/100 mg levodopa 3 or 4 times/day. Dosage may be increased by 1 tablet every day or every other day, as necessary, until a dosage of 8 tablets a day is reached.
Tablets of the 2 ratios (e.g., 1:4, 25/100 or 1:10, 10/100 and 25/250) may be given separately or combined as needed to provide the optimum dosage.
Provide at least 70 to 100 mg carbidopa per day. When more carbidopa is required, substitute one 25/100 tablet for each 10/100 tablet. When more levodopa is required, substitute the 25/250 tablet for the 25/100 or 10/100 tablet.
Sinemet CR - 1 tablet twice/day at intervals of not less than 6 hours. Doses and dosing intervals may be increased or decreased based on response. Most patients have been adequately treated with 2 to 8 tablets per day (divided doses) at intervals of 4 to 8 hours while awake. Higher doses (> 12 tablets per day) and intervals Sinemet CR - Sinemet CR may be administered as whole or half tablets which should not be crushed or chewed.
Patients currently treated with levodopa: Levodopa must he discontinued at least 8 hours before therapy with levodopa/carbidopa. Substitute the combination drug at a dosage that will provide approximately 25% of the previous levodopa dosage.
Sinemet - Suggested starting dosage is 1 tablet of 25 mg catbidopa/250 mg Levodopa 3 or 4 times a day for patients taking > 1500 mg levodopa or 25 mg carbidopa/100 mg levodopa for patients taking Sinemet CR - Usually 1 tablet twice/day.
Patterns currently treated with conventional carbidopa/levodopa preparations: Substitute dosage with Sinemet CR at an amount that provides about 10% more levodopa per day, although
this may need to be increased to a dosage that provides up to 30% mote levodopa per day. Use intervals of 4 to 8 hours while awake.
Combination therapy: Other anti-Parkinson drugs can be given concurrently; dosage adjustment may be necessary.
Sinemet - Sinemet (25/100 or 10/100) can be added to the dosage regimen of Sinemet CR in selected patients with advanced disease who need additional levodopa.

Actions
Pharmacology: These agents are used in combination because carbidopa inhibits decarboxylation of levodopa and makes more levodopa available for transport to the brain. There is less variation in plasma levodopa levels than with the conventional formulation. However, the sustained release form is less systemically bioavailable (70% to 75%) and may require increased daily doses to achieve the same level of symptomatic relief.
Pharmacokinetics: The half-life of levodopa may be prolonged following the sustained release form because of continuous absorption. In elderly subjects, the mean time to peak levodopa concentration was 2 hours for sustained-release vs 0.5 hours for conventional. The maximum concentration following the sustained-release form was about 35% of the conventional form.

Warnings
CNS effects: Certain adverse CNS effects (e.g., dyskinesias) will occur at lower dosages and sooner during therapy with the sustained-release form.

Drug Interactions
Drug/Food interactions: Administration of a single dose of the sustained-release form with food increased the extent of levodopa availability by 50% and increased peak levodopa concentrations by 25%.

Adverse Reactions
In clinical trials, the adverse reaction profile of the sustained-release form did not differ substantially from that of the conventional form.
PARKINSON & ALZHEIMER

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