Sinemet Information
Sinemet (Carbidopa; levodopa) Description
Sinemet (Carbidopa; levodopa) CR (carbidopa-levodopa) is a sustained-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is CHNO•HO, and its structural formula is:
Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (—)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is CHNO, and its structural formula is:
Sinemet (Carbidopa; levodopa) CR is supplied as sustained-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. Sinemet (Carbidopa; levodopa) CR 25-100 and Sinemet (Carbidopa; levodopa) CR 50-200 also contain FD&C Blue #2/Indigo Carmine AL and FD&C Red #40/Allura Red AC AL.
The 50-200 tablet is supplied as an oval, compressed tablet that is dappled-purple in color and is coded "521" on one side and plain on the other. The 25-100 tablet is supplied as an oval, compressed tablet that is dappled-purple in color and is coded "601" on one side and plain on the other. The Sinemet (Carbidopa; levodopa) CR tablet is a polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Sinemet (Carbidopa; levodopa) CR 25-100 is available to facilitate titration when 100 mg steps are required.
Sinemet (Carbidopa; levodopa) Clinical Pharmacology
Parkinson's disease is a progressive, neurodegenerative disorder of the extrapyramidal nervous system affecting the mobility and control of the skeletal muscular system. Its characteristic features include resting tremor, rigidity, and bradykinetic movements. Symptomatic treatments, such as levodopa therapies, may permit the patient better mobility.
Current evidence indicates that symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum. Administration of dopamine is ineffective in the treatment of Parkinson's disease apparently because it does not cross the blood-brain barrier. However, levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.
When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. For this reason, large doses of levodopa are required for adequate therapeutic effect, and these may often be accompanied by nausea and other adverse reactions, some of which are attributable to dopamine formed in extracerebral tissues.
Since levodopa competes with certain amino acids for transport across the gut wall, the absorption of levodopa may be impaired in some patients on a high protein diet.
Carbidopa inhibits decarboxylation of peripheral levodopa. It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.
Since its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available for transport to the brain.
Patients treated with levodopa therapy for Parkinson's disease may develop motor fluctuations characterized by end-of-dose failure, peak dose dyskinesia, and akinesia. The advanced form of motor fluctuations (‘on-off’ phenomenon) is characterized by unpredictable swings from mobility to immobility. Although the causes of the motor fluctuations are not completely understood, in some patients they may be attenuated by treatment regimens that produce steady plasma levels of levodopa.
Sinemet (Carbidopa; levodopa) CR contains either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa in a sustained-release dosage form designed to release these ingredients over a 4- to 6-hour period. With Sinemet (Carbidopa; levodopa) CR there is less variation in plasma levodopa levels than with Sinemet (Carbidopa; levodopa) (carbidopa-levodopa) immediate release tablets, the conventional formulation.
In clinical trials, patients with moderate to severe motor fluctuations who received Sinemet (Carbidopa; levodopa) CR in ‘off’ time when compared to Sinemet (Carbidopa; levodopa) . However, global ratings of improvement as assessed by both patient and physician were better during therapy with Sinemet (Carbidopa; levodopa) CR than with Sinemet (Carbidopa; levodopa) . In patients without motor fluctuations, Sinemet (Carbidopa; levodopa) CR, under controlled conditions, provided the same therapeutic benefit with less frequent dosing when compared to Sinemet (Carbidopa; levodopa) .
Carbidopa reduces the amount of levodopa required to produce a given response by about 75% and, when administered with levodopa, increases both plasma levels and the plasma half-life of levodopa, and decreases plasma and urinary dopamine and homovanillic acid.
Elimination half-life of levodopa in the presence of carbidopa is about 1.5 hours. Following Sinemet (Carbidopa; levodopa) CR, the apparent half-life of levodopa may be prolonged because of continuous absorption.
In healthy elderly subjects (56-67 years old) the mean time-to-peak concentration of levodopa after a single dose of Sinemet (Carbidopa; levodopa) CR 50-200 was about 2 hours as compared to 0.5 hours after standard Sinemet (Carbidopa; levodopa) . The maximum concentration of levodopa after a single dose of Sinemet (Carbidopa; levodopa) CR was about 35% of the standard Sinemet (Carbidopa; levodopa) (1151 vs. 3256 ng/mL). The extent of availability of levodopa from Sinemet (Carbidopa; levodopa) CR was about 70-75% relative to intravenous levodopa or standard Sinemet (Carbidopa; levodopa) in the elderly. The absolute bioavailability of levodopa from Sinemet (Carbidopa; levodopa) CR (relative to I.V.) in young subjects was shown to be only about 44%. The extent of availability and the peak concentrations of levodopa were comparable in the elderly after a single dose and at steady state after t.i.d. administration of Sinemet (Carbidopa; levodopa) CR 50-200. In elderly subjects, the average trough levels of levodopa at steady state after the CR tablet were about 2-fold higher than after the standard Sinemet (Carbidopa; levodopa) (163 vs. 74 ng/mL).
In these studies, using similar total daily doses of levodopa, plasma levodopa concentrations with Sinemet (Carbidopa; levodopa) CR fluctuated in a narrower range than with Sinemet (Carbidopa; levodopa) . Because the bioavailability of levodopa from Sinemet (Carbidopa; levodopa) CR relative to Sinemet (Carbidopa; levodopa) is approximately 70-75%, the daily dosage of levodopa necessary to produce a given clinical response with the sustained-release formulation will usually be higher.
The extent of availability and peak concentrations of levodopa after a single dose of Sinemet (Carbidopa; levodopa) CR 50-200 increased by about 50% and 25%, respectively, when administered with food.
At steady state, the bioavailability of carbidopa from Sinemet (Carbidopa; levodopa) Tablets is approximately 99% relative to the concomitant administration of carbidopa and levodopa. At steady state, carbidopa bioavailability from Sinemet (Carbidopa; levodopa) CR 50-200 is approximately 58% relative to that from Sinemet (Carbidopa; levodopa) .
Pyridoxine hydrochloride (vitamin B), in oral doses of 10 mg to 25 mg, may reverse the effects of levodopa by increasing the rate of aromatic amino acid decarboxylation. Carbidopa inhibits this action of pyridoxine.
Sinemet (Carbidopa; levodopa) Indications And Usage
Sinemet (Carbidopa; levodopa) CR is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Sinemet (Carbidopa; levodopa) Contraindications
Nonselective MAO inhibitors are contraindicated for use with Sinemet (Carbidopa; levodopa) CR. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Sinemet (Carbidopa; levodopa) CR. Sinemet (Carbidopa; levodopa) CR may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see ).
Sinemet (Carbidopa; levodopa) CR is contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.
Because levodopa may activate a malignant melanoma, Sinemet (Carbidopa; levodopa) CR should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
Sinemet (Carbidopa; levodopa) Warnings
When patients are receiving levodopa without a decarboxylase inhibitor, levodopa must be discontinued at least twelve hours before Sinemet (Carbidopa; levodopa) CR is started. In order to reduce adverse reactions, it is necessary to individualize therapy. Sinemet (Carbidopa; levodopa) CR should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage (see ).
Patients receiving Sinemet (Carbidopa; levodopa) CR may develop increased dyskinesias compared to Sinemet (Carbidopa; levodopa) . Dyskinesias are a common side effect of carbidopa-levodopa treatment. The occurrence of dyskinesias may require dosage reduction.
As with levodopa, Sinemet (Carbidopa; levodopa) CR may cause mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution.
Sinemet (Carbidopa; levodopa) CR should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
As with levodopa, care should be exercised in administering Sinemet (Carbidopa; levodopa) CR to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care.
As with levodopa, treatment with Sinemet (Carbidopa; levodopa) CR may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
Sinemet (Carbidopa; levodopa) Precautions
As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function are recommended during extended therapy.
Patients with chronic wide-angle glaucoma may be treated cautiously with Sinemet (Carbidopa; levodopa) CR provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Dopaminergic agents, including levodopa, may be associated with somnolence and very rarely episodes of sudden onset of sleep. In some cases, these episodes may occur without awareness or warning during daily activities. Patients must be informed of this and advised to exercise caution while driving or operating machines while being treated with dopaminergic agents, including levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see ).
Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear.
For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Sinemet (Carbidopa; levodopa) CR for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
The patient should be informed that Sinemet (Carbidopa; levodopa) CR is a sustained-release formulation of carbidopa-levodopa which releases these ingredients over a 4- to 6-hour period. It is important that Sinemet (Carbidopa; levodopa) CR be taken at regular intervals according to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other carbidopa-levodopa preparations, without first consulting the physician.
If abnormal involuntary movements appear or get worse during treatment with Sinemet (Carbidopa; levodopa) CR, the physician should be notified, as dosage adjustment may be necessary.
Patients should be advised that sometimes the onset of effect of the first morning dose of Sinemet (Carbidopa; levodopa) CR may be delayed for up to 1 hour compared with the response usually obtained from the first morning dose of Sinemet (Carbidopa; levodopa) . The physician should be notified if such delayed responses pose a problem in treatment.
Patients should be advised that, occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of Sinemet (Carbidopa; levodopa) CR. Although the color appears to be clinically insignificant, garments may become discolored.
The patient should be informed that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multivitamin tablets) may also reduce the amount of levodopa available to the body. The above factors may reduce the clinical effectiveness of the levodopa or carbidopa-levodopa therapy.
Patients must be advised that the whole or half tablet should be swallowed without chewing or crushing.
Patients should be alerted to the possibility of sudden onset of sleep during daily activities, in some cases without awareness or warning signs, when they are taking dopaminergic agents, including levodopa. Patients should be advised to exercise caution while driving or operating machinery and that if they have experienced somnolence and/or sudden sleep onset, they must refrain from these activities. (See .)
There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease, including Sinemet (Carbidopa; levodopa) CR. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Sinemet (Carbidopa; levodopa) CR. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking Sinemet (Carbidopa; levodopa) CR. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Sinemet (Carbidopa; levodopa) CR.
NOTE: The suggested advice to patients being treated with Sinemet (Carbidopa; levodopa) CR is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, and bilirubin. Abnormalities in blood urea nitrogen and positive Coombs test have also been reported. Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of carbidopa-levodopa preparations than with levodopa.
Carbidopa-levodopa preparations, such as Sinemet (Carbidopa; levodopa) and Sinemet (Carbidopa; levodopa) CR, may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria. This reaction will not be altered by boiling the urine specimen. False-negative tests may result with the use of glucose-oxidase methods of testing for glucosuria.
Cases of falsely diagnosed pheochromocytoma in patients on carbidopa-levodopa therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or carbidopa-levodopa therapy.
Caution should be exercised when the following drugs are administered concomitantly with Sinemet (Carbidopa; levodopa) CR.
Symptomatic postural hypotension has occurred when carbidopa-levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with Sinemet (Carbidopa; levodopa) CR is started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving monoamine oxidase (MAO) inhibitors (Type A or B), see . Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see ).
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations.
Dopamine D receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Sinemet (Carbidopa; levodopa) CR should be carefully observed for loss of therapeutic response.
Iron salts may reduce the bioavailability of levodopa and carbidopa. The clinical relevance is unclear.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
In a two-year bioassay of Sinemet (Carbidopa; levodopa) , no evidence of carcinogenicity was found in rats receiving doses of approximately two times the maximum daily human dose of carbidopa and four times the maximum daily human dose of levodopa (equivalent to 8 Sinemet (Carbidopa; levodopa) CR tablets).
In reproduction studies with Sinemet (Carbidopa; levodopa) , no effects on fertility were found in rats receiving doses of approximately two times the maximum daily human dose of carbidopa and four times the maximum daily human dose of levodopa (equivalent to 8 Sinemet (Carbidopa; levodopa) CR tablets).
Sinemet (Carbidopa; levodopa) Adverse Reactions
In controlled clinical trials, patients predominantly with moderate to severe motor fluctuations while on Sinemet (Carbidopa; levodopa) were randomized to therapy with either Sinemet (Carbidopa; levodopa) or Sinemet (Carbidopa; levodopa) CR. The adverse experience frequency profile of Sinemet (Carbidopa; levodopa) CR did not differ substantially from that of Sinemet (Carbidopa; levodopa) , as shown in Table 1.
Abnormal laboratory findings occurring at a frequency of 1% or greater in approximately 443 patients who received Sinemet (Carbidopa; levodopa) CR and 475 who received Sinemet (Carbidopa; levodopa) during controlled clinical trials included: decreased hemoglobin and hematocrit; elevated serum glucose; white blood cells, bacteria and blood in the urine.
The adverse experiences observed in patients in uncontrolled studies were similar to those seen in controlled clinical studies.
Other adverse experiences reported overall in clinical trials in 748 patients treated with Sinemet (Carbidopa; levodopa) CR, listed by body system in order of decreasing frequency, include:
Asthenia, fatigue, abdominal pain, orthostatic effects.
Palpitation, hypertension, hypotension, myocardial infarction.
Gastrointestinal pain, dysphagia, heartburn.
Weight loss.
Leg pain.
Chorea, somnolence, falling, anxiety, disorientation, decreased mental acuity, gait abnormalities, extrapyramidal disorder, agitation, nervousness, sleep disorders, memory impairment.
Cough, pharyngeal pain, common cold.
Rash.
Blurred vision.
Urinary incontinence.
Decreased white blood cell count and serum potassium; increased BUN, serum creatinine and serum LDH; protein and glucose in the urine.
The following adverse experiences have been reported in post-marketing experience with Sinemet (Carbidopa; levodopa) CR:
Cardiac irregularities, syncope.
Taste alterations, dark saliva.
Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions).
Neuroleptic malignant syndrome (NMS, see ), increased tremor, peripheral neuropathy, psychotic episodes including delusions and paranoid ideation, pathological gambling, increased libido including hypersexuality, impulse control symptoms.
Alopecia, flushing, dark sweat.
Dark urine.
Other adverse reactions that have been reported with levodopa alone and with various carbidopa-levodopa formulations and may occur with Sinemet (Carbidopa; levodopa) CR are:
Phlebitis.
Gastrointestinal bleeding, development of duodenal ulcer, sialorrhea, bruxism, hiccups, flatulence, burning sensation of tongue.
Hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia, agranulocytosis.
Henoch-Schonlein purpura.
Weight gain, edema.
Ataxia, depression with suicidal tendencies, dementia, euphoria, convulsions (however, a causal relationship has not been established); bradykinetic episodes, numbness, muscle twitching, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, activation of latent Horner's syndrome, nightmares.
Malignant melanoma (see also ), increased sweating.
Oculogyric crises, mydriasis, diplopia.
Urinary retention, priapism.
Faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns.
Abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), bilirubin, Coombs test, uric acid.
Sinemet (Carbidopa; levodopa) Overdosage
Management of acute overdosage with Sinemet (Carbidopa; levodopa) CR is the same as with levodopa. Pyridoxine is not effective in reversing the actions of Sinemet (Carbidopa; levodopa) CR.
General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Sinemet (Carbidopa; levodopa) CR should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known.
Based on studies in which high doses of levodopa and/or carbidopa were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1500-2000 mg/kg are expected to die. A significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg. A significant proportion of rats are expected to die after treatment with similar doses of carbidopa. The addition of carbidopa in a 1:10 ratio with levodopa increases the dose at which a significant proportion of mice are expected to die to 3360 mg/kg.
Sinemet (Carbidopa; levodopa) Dosage And Administration
Sinemet (Carbidopa; levodopa) CR contains carbidopa and levodopa in a 1:4 ratio as either the 50-200 tablet or the 25-100 tablet. The daily dosage of Sinemet (Carbidopa; levodopa) CR must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. Sinemet (Carbidopa; levodopa) CR should not be chewed or crushed.
Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while Sinemet (Carbidopa; levodopa) CR is being administered, although their dosage may have to be adjusted.
Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, Sinemet (Carbidopa; levodopa) CR can be given to patients receiving supplemental pyridoxine (vitamin B).
Sinemet (Carbidopa; levodopa) How Supplied
No. 3919 — Sinemet (Carbidopa; levodopa) CR 50-200 (carbidopa-levodopa) Sustained-Release Tablets containing 50 mg of carbidopa and 200 mg of levodopa are dappled-purple in color, oval, compressed tablets that are coded “521” on one side and plain on the other. They are supplied as follows:
0006-3919-68 bottles of 100.
No. 3918 — Sinemet (Carbidopa; levodopa) CR 25-100 (carbidopa-levodopa) Sustained-Release Tablets containing 25 mg of carbidopa and 100 mg of levodopa are dappled-purple in color, oval, compressed tablets that are coded “601” on one side and plain on the other. They are supplied as follows:
0006-3918-68 bottles of 100.
Sinemet (Carbidopa; levodopa) This Is A Representative Sample Of The Packaging. Please See How Supplied Section For A Complete List Of Available Packaging.
Principal Display Panel - Bottle Label Mg/ Mg
Sinemet (Carbidopa; levodopa) CR(carbidopa-levodopa) Sustained-Release Tablets
25 mg/100 mg
Rx only
100 Tablets
NDC 0006-3918-68
Each tablet contains 25 mg carbidopa (anhydrous equivalent) and 100 mg levodopa.
USUAL ADULT DOSAGE: See Package Insert.
Tablets should be swallowed without chewing or crushing.
Dispense in a tightly closed, light-resistant container.
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.
This is a bulk package and not intended for dispensing. Package not child resistant.
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
By: Mylan Pharmaceuticals, Inc.Morgantown, WV 26505, USA
7001127501100 | No. 3918
Sinemet (Carbidopa; levodopa) Principal Display Panel - Bottle Label Mg/ Mg
Sinemet (Carbidopa; levodopa) CR(carbidopa-levodopa) Sustained-Release Tablets
50 mg/200 mg
Rx only
100 Tablets
NDC 0006-3919-68
Each tablet contains 50 mg carbidopa (anhydrous equivalent) and 200 mg levodopa.
USUAL ADULT DOSAGE: See Package Insert.
Tablets should be swallowed without chewing or crushing.
Dispense in a tightly closed, light-resistant container.
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.
This is a bulk package and not intended for dispensing. Package not child resistant.
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC.Whitehouse Station, NJ 08889, USA
By: Mylan Pharmaceuticals, Inc.Morgantown, WV 26505, USA
7001127601100 | No. 3919
