Sinemet CR (carbidopa/levodopa)
OTHER BRAND NAMES
Dopa-decarboxylase inhibitor/dopamine precursor
Treatment of Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide or manganese intoxication.
Treatment of Parkinson's Disease, Postencephalitic Parkinsonism, and Symptomatic Parkinsonism Following Carbon Monoxide/Manganese Intoxication:
Initial: One 25mg/100mg tab tid or one 10mg/100mg tab tid-qid
Titrate: May increase by 1 tab (25mg/100mg or 10mg/100mg) qd or qod, as necessary, until a dose of 8 tabs/day is reached
Transfer from Levodopa:
D/C levodopa at least 12 hrs before starting therapy; choose a daily dose of therapy that will provide approx 25% of the previous levodopa dose
Previously Taking <1500mg/day of Levodopa:
Initial: One 25mg/100mg tab tid or qid
Previously Taking >1500mg/day of Levodopa:
Initial: One 25mg/250mg tab tid or qid
At least 70-100mg/day of carbidopa should be provided; may substitute one 25mg/100mg tab for each 10mg/100mg tab when greater proportion of carbidopa is required
When more levodopa is required, substitute 25mg/250mg tab for 25mg/100mg or 10mg/100mg; may increase dose of 25mg/250mg by 1/2 or 1 tab qd or qod to a max of 8 tabs/day if necessary
Max: 200mg/day of carbidopa
Tab, Sustained-Release (SR):
Currently Treated w/ Conventional Carbidopa Levodopa Preparations:
Dosage w/ SR tabs should be substituted at an amount that provides approx 10% more levodopa per day. May need to increase to a dose that provides up to 30% more levodopa per day depending on clinical response; interval between doses should be 4-8 hrs during the waking day
Initial Conversion from IR to SR Tabs (Based on Levodopa Component):
300-400mg: 200mg bid
500-600mg: 300mg bid or 200mg tid
700-800mg: Total of 800mg in ≥3 divided doses (eg, 300mg am, 300mg early pm, and 200mg later pm)
900-1000mg: Total of 1000mg in ≥3 divided doses (eg, 400mg am, 400mg early pm, and 200mg later pm)
Currently Treated w/ Levodopa w/o a Decarboxylase Inhibitor:
D/C levodopa at least 12 hrs before starting therapy; substitute at a dose that will provide approx 25% of the previous levodopa dose
Mild to Moderate Disease:
Initial: One 50mg/200mg tab bid
Patients Not Receiving Levodopa:
Mild to Moderate Disease:
Initial: One 50mg/200mg tab bid at ≥6-hr intervals
Following therapy initiation, may increase/decrease doses and dosing intervals depending on response
Most patients have been adequately treated w/ doses that provide 400-1600mg/day of levodopa given in divided doses at 4- to 8-hr intervals during the waking day
When given at intervals of <4 hrs, and/or if the divided doses are not equal, give the smaller doses at the end of the day
An interval of at least 3 days between dosage adjustments is recommended
Addition of Other Antiparkinsonian Medications:
Tab/Tab, Sustained-Release (SR):
Standard drugs for Parkinson's disease, other than levodopa w/o a decarboxylase inhibitor, may be used concomitantly w/ therapy, although their dosage may have to be adjusted
Anticholinergic agents, dopamine agonists, and amantadine may be given w/ therapy; dosage adjustment of therapy may be necessary when these agents are added
A dose of 25mg/100mg IR or 10mg/100mg IR (1/2 tab or whole tab) may be added to the dosage regimen in selected patients w/ advanced disease who need additional IR levodopa for a brief time during daytime hrs
Interruption of Therapy:
If general anesthesia is required, may continue therapy as long as patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, observe for symptoms resembling neuroleptic malignant syndrome and administer usual daily dose as soon as patient is able to take oral medication
Involuntary movements may require dosage reduction
Tabs w/ different ratios of carbidopa to levodopa may be given separately or combined as needed to provide the optimum dosage
Do not chew or crush
(Carbidopa/Levodopa) Tab, Sustained-Release (SR) (CR): 25mg/100mg, 50mg/200mg; (Sinemet) Tab: 10mg/100mg, 25mg/100mg, 25mg/250mg
During or within 2 weeks of using nonselective MAOIs. Narrow-angle glaucoma.
May cause or increase dyskinesias; may require dose reduction. Monitor for depression with concomitant suicidal tendencies. Caution with severe cardiovascular (CV) or pulmonary disease, bronchial asthma, renal/hepatic/endocrine disease, chronic wide-angle glaucoma, or history of MI with residual atrial, nodal, or ventricular arrhythmias. May increase the possibility of upper GI hemorrhage in patients with history of peptic ulcer. Falling asleep during activities of daily living and somnolence reported; consider discontinuation if significant daytime sleepiness or episodes of falling asleep during activities that require active participation occur. May impair mental/physical abilities. Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (hyperpyrexia and confusion) reported during dose reductions or withdrawal; observed carefully when the dosage of levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. Hallucinations and psychotic-like behavior reported; do not use in patients with a major psychotic disorder. Intense urge to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges may occur; consider dose reduction or discontinuation if such urges develop. Monitor for melanomas frequently and on a regular basis. Abnormalities in lab tests, including elevations of LFTs, and abnormalities in BUN and (+) Coombs test reported. Lab test interactions may occur. Cases of falsely diagnosed pheochromocytoma reported very rarely; caution when interpreting the plasma and urine levels of catecholamines and their metabolites. Caution in elderly.
Dyskinesias (eg, choreiform, dystonic, other involuntary movements), nausea, hallucinations, confusion.
See Contraindications. Caution with concomitant use of sedating medications; may increase the risk for somnolence. Certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease effectiveness of carbidopa-levodopa. Symptomatic postural hypotension reported with concomitant use of some antihypertensive drugs; dosage adjustment of the antihypertensive drug may be required. Use with selegiline may cause severe orthostatic hypotension. Adverse reactions, including HTN and dyskinesia, reported rarely with TCAs. Dopamine D2 receptor antagonists (eg, phenothiazines, butyrophenones, risperidone) and isoniazid may reduce effects of levodopa. Beneficial effects of levodopa in Parkinson's disease reported to be reversed by phenytoin and papaverine; monitor for loss of therapeutic response. Not recommended with dopamine-depleting agents (eg, reserpine, tetrabenazine) or other drugs known to deplete monoamine stores. Iron salts may reduce bioavailability; caution with iron salts or multivitamins containing iron salts. Metoclopramide may increase bioavailability of levodopa and may also adversely affect disease control.
PREGNANCY AND LACTATION
Category C, caution in nursing.
MECHANISM OF ACTION
Dopa-decarboxylase inhibitor/dopamine precursor. Carbidopa: Inhibits decarboxylation of peripheral levodopa. Levodopa: Crosses blood-brain barrier and presumably is converted to dopamine in the brain.
Absorption: Administration of variable doses resulted in different parameters. Distribution: Levodopa: Crosses the placenta; found in breast milk. Elimination: Levodopa: T1/2=50 min, 1.5 hrs (in the presence of carbidopa).
Assess for hypersensitivity to drug; narrow-angle/chronic wide-angle glaucoma; major psychotic disorder; history of peptic ulcer; risk factors that may increase risk for somnolence (eg, presence of sleep disorders); severe CV or pulmonary disease; bronchial asthma; renal/hepatic/endocrine disease; history of MI with residual atrial, nodal, or ventricular arrhythmias; pregnancy/nursing status; and possible drug interactions.
Monitor for dyskinesias, depression with suicidal tendencies, drowsiness/sleepiness, somnolence, hyperpyrexia and confusion, hallucinations/psychotic-like behavior, impulse control/compulsive behaviors, upper GI hemorrhage in patients with a history of peptic ulcer, and other adverse reactions. In patients with a history of MI who have residual atrial, nodal, or ventricular arrhythmias, monitor cardiac function with particular care during the period of initial dosage adjustment. Monitor for LFT elevations and BUN abnormalities. For patients on extended therapy, perform periodic evaluation of hepatic, hematopoietic, CV, and renal function. Monitor for melanomas frequently and on a regular basis. Monitor for changes in intraocular pressure in patients with chronic wide-angle glaucoma. Monitor closely during the dose adjustment period.
Instruct to take ud and not to change the prescribed dosage regimen or add any additional antiparkinson medications, including other carbidopa-levodopa preparations, without 1st consulting the physician. Inform that, occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of therapy. Inform that high protein diet, excessive acidity, and iron salts may reduce clinical effectiveness. Instruct to exercise caution while driving or operating machinery, and that if somnolence and/or sudden sleep onset is experienced, to refrain from these activities. Instruct to inform physician if new/increased gambling urges, increased sexual urges, or other intense urges develop. (Tab, IR) Advise that sometimes a "wearing-off" effect may occur at the end of the dosing interval; instruct to notify physician if such response poses a problem to lifestyle. (Tab, SR) Instruct to notify physician if abnormal involuntary movements appear or get worse during treatment. Advise that sometimes the onset of effect of the 1st am dose may be delayed for up to 1 hr compared with the response usually obtained from the 1st am dose of IR tab; instruct to notify physician if such delayed responses pose a problem in treatment.
25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture.
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