Lodosyn
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Questions & Answers
Side Effects & Adverse Reactions
LODOSYN (Carbidopa) has no antiparkinsonian effect when given alone. It is indicated for use with SINEMET (Carbidopa-Levodopa) or levodopa. LODOSYN (Carbidopa) does not decrease adverse reactions due to central effects of levodopa.
When LODOSYN (Carbidopa) is to be given to carbidopa-naive patients who are being treated with levodopa alone, the two drugs should be given at the same time. At least twelve hours should elapse between the last dose of levodopa and initiation of therapy with LODOSYN (Carbidopa) and levodopa in combination. Start with no more than one-fifth (20%) to one-fourth (25%) of the previous daily dosage of levodopa when given without LODOSYN (Carbidopa). See the DOSAGE AND ADMINISTRATION section before initiating therapy.
As with levodopa, concomitant administration of LODOSYN and levodopa may cause involuntary movements and 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. Because LODOSYN (Carbidopa) permits more levodopa to reach the brain and, thus, more dopamine to be formed, dyskinesias may occur at lower levodopa dosages and sooner with concomitant use of LODOSYN (Carbidopa) and levodopa or carbidopa-levodopa combination products than with levodopa alone. The occurrence of dyskinesias may require levodopa dosage reduction.
Levodopa, with or without LODOSYN, should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic, or endocrine disease.
Care should be exercised in administering levodopa, with or without LODOSYN, 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 alone there is a possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, SINEMET (Carbidopa-Levodopa), or SINEMET CR (Carbidopa-Levodopa) Sustained-Release. Therefore, patients should be observed carefully when the dosage of levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin, have been reported.
The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.
The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
LODOSYN is indicated for use with SINEMET (Carbidopa-Levodopa) or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
LODOSYN is for use with SINEMET (Carbidopa-Levodopa) in patients for whom the dosage of SINEMET (Carbidopa-Levodopa) provides less than adequate daily dosage (usually 70 mg daily) of carbidopa.
LODOSYN is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each entity.
LODOSYN is used with SINEMET (Carbidopa-Levodopa) or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from the addition of carbidopa.
Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, supplemental pyridoxine (vitamin B6), can be given to patients when they are receiving carbidopa and levodopa concomitantly or as SINEMET (Carbidopa-Levodopa).
Although the administration of LODOSYN permits control of parkinsonism and Parkinson's disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.
Certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently. This was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
In considering whether to give LODOSYN with SINEMET (Carbidopa-Levodopa) or with levodopa to patients who have nausea and/or vomiting, the physician should be aware that, while many patients may be expected to improve, some may not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone, about half the patients with nausea and/or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
History
There is currently no drug history available for this drug.
Other Information
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 C10H14N2O4•H2O, and its structural formula is:
LODOSYN (Carbidopa) tablets contain 25 mg of carbidopa. Inactive ingredients are cellulose, FD&C Yellow 6, magnesium stearate and starch.
Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3.
Sources
Lodosyn Manufacturers
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Kaiser Foundation Hospitals
![Lodosyn (Carbidopa) Tablet [Kaiser Foundation Hospitals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lodosyn | Kaiser Foundation Hospitals
Whether given with SINEMET (Carbidopa-Levodopa) or with levodopa, the optimal daily dosage of LODOSYN must be determined by careful titration. Most patients respond to a 1:10 proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since clinical experience with larger dosages is limited. If the patient is taking SINEMET (Carbidopa-Levodopa), the amount of carbidopa in SINEMET (Carbidopa-Levodopa) should be considered when calculating the total amount of LODOSYN to be administered each day.
Patients Receiving SINEMET (Carbidopa-Levodopa) Who Require Additional CarbidopaSome patients taking SINEMET (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 SINEMET 10-1003 (Carbidopa-Levodopa), 25 mg of LODOSYN may be given with the first dose of SINEMET (Carbidopa-Levodopa) each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of SINEMET (Carbidopa-Levodopa). When patients are taking SINEMET 25-2504 (Carbidopa-Levodopa) or SINEMET 25-1005 (Carbidopa-Levodopa), 25 mg of LODOSYN may be given with any dose of SINEMET (Carbidopa-Levodopa) as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as LODOSYN and as SINEMET (Carbidopa-Levodopa), should not exceed 200 mg.
3 SINEMET 10-100 (Carbidopa-Levodopa) contains 10 mg of carbidopa and 100 mg of levodopa. 4 SINEMET 25-250 (Carbidopa-Levodopa) contains 25 mg of carbidopa and 250 mg of levodopa. 5 SINEMET 25-100 (Carbidopa-Levodopa) contains 25 mg of carbidopa and 100 mg of levodopa. Patients Requiring Individual Titration of Carbidopa and Levodopa DosageAlthough SINEMET (Carbidopa-Levodopa) is the preferred method of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, LODOSYN (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 LODOSYN (Carbidopa). In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with LODOSYN (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. Physicians who prescribe separate doses of LODOSYN and levodopa should be thoroughly familiar with the directions for use of each drug.
Dosage AdjustmentDosage of LODOSYN 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 LODOSYN and levodopa are given concomitantly than when levodopa is given without LODOSYN. 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 TherapySporadic cases of a symptom complex resembling the Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of SINEMET (Carbidopa-Levodopa) or SINEMET CR (Carbidopa-Levodopa) Sustained-Release. Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET (Carbidopa-Levodopa) or SINEMET CR (Carbidopa-Levodopa) Sustained-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.
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Aton Pharma, Inc
Lodosyn | Aton Pharma, Inc
Whether given with carbidopa-levodopa or with levodopa, the optimal daily dose of
LODOSYN must be determined by careful titration. Most patients respond to a 1:10
proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or
more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since
clinical experience with larger dosages is limited. If the patient is taking carbidopa-levodopa,
the amount of carbidopa in carbidopa-levodopa should be considered when calculating the
total amount of LODOSYN to be administered each day.
Patients Receiving Carbidopa-Levodopa Who Require Additional CarbidopaSome 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 LODOSYN 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 carbidopalevodopa. LODOSYN may be given with any dose carbidopa-levodopa as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as LODOSYN
and as carbidopa- levodopa), should not exceed 200 mg.
Patients Requiring Individual Titration of Carbidopa and Levodopa DosageAlthough 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, LODOSYN (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 LODOSYN (Carbidopa). In
patients already receiving levodopa therapy, at least twelve hours should elapse between
the last dose of levodopa and initiation of therapy with LODOSYN (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 LODOSYN and levodopa should be
thoroughly familiar with the directions for use of each drug.
Dosage AdjustmentDosage of LODOSYN 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 LODOSYN and levodopa are given concomitantly than when levodopa is given without LODOSYN. 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 TherapySporadic 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.
![Lodosyn (Carbidopa) Tablet [Aton Pharma, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ff8e105b-7415-42d4-bbb2-b36cfb8945a5&name=b3e18113-1156-4995-a7b6-0481b62cdcac-02.jpg)
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