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carbidopa
Overview
What is Lodosyn?
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:
LODOSYN (carbidopa) tablets contain 25 mg of carbidopa. Inactive ingredients are cellulose, FD&C Yellow No. 6, magnesium stearate and starch.
Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3.
What does Lodosyn look like?
What are the available doses of Lodosyn?
Sorry No records found.
What should I talk to my health care provider before I take Lodosyn?
Sorry No records found
How should I use Lodosyn?
LODOSYN is indicated for use with 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 carbidopa-levodopa in patients for whom the dosage of
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 medication.
LODOSYN is used with 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 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 deciding whether to give LODOSYN with 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.
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.
What interacts with Lodosyn?
LODOSYN is contraindicated in patients with known hypersensitivity to any component of this drug.
Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with levodopa or carbidopa-levodopa combination products with or without LODOSYN. These inhibitors must be discontinued at least two weeks prior to initiating therapy with levodopa. Carbidopa-levodopa, or levodopa 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 ).
Levodopa or carbidopa-levodopa products, with or without LODOSYN, are contraindicated in patients with narrow-angle glaucoma.
What are the warnings of Lodosyn?
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
LODOSYN (carbidopa) has no antiparkinsonian effect when given alone. It is indicated
for use with 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 section before initiating therapy.
The addition of LODOSYN with levodopa or carbidopa-levodopa reduces the peripheral
effects (nausea, vomiting) due to decarboxylation of levodopa; however, LODOSYN does
not decrease the adverse reactions due to the central effects of levodopa. Because LODOSYN permits more levodopa to reach the brain and more dopamine to be formed,
certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary
movements), may occur at lower dosages and sooner with levodopa in combination with
LODOSYN than with levodopa alone.
Falling Asleep During Activities of Daily Living and Somnolence
Patients taking carbidopa-levodopa products alone or with other dopaminergic drugs have
reported suddenly falling asleep without prior warning of sleepiness while engaged in activities
of daily living (includes operation of motor vehicles). Some of these episodes resulted in
automobile accidents. Although many of these patients reported somnolence while on
dopaminergic medications, some did perceive that they had no warning signs, such as excessive
drowsiness, and believed that they were alert immediately prior to the event. Some patients
reported these events one year after the initiation of treatment.
Falling asleep while engaged in activities of daily living usually occurs in patients experiencing
pre-existing somnolence, although some patients may not give such a history. For this reason,
prescribers should continually reassess patients for drowsiness or sleepiness especially since
some of the events occur after the start of treatment. Prescribers should be aware that patients
may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or
sleepiness during specific activities. Patients who have already experienced somnolence or an
episode of sudden sleep onset should not participate in these activities during treatment with
LODOSYN when taking it with other carbidopa-levodopa products.
Before initiating treatment with LODOSYN, advise patients about the potential to develop
drowsiness and ask specifically about factors that may increase the risk for somnolence with
LODOSYN such as the use of concomitant sedating medications and the presence of sleep
disorders. Consider discontinuing LODOSYN in patients who report significant daytime
sleepiness or episodes of falling asleep during activities that require active participation (e.g.,
conversations, eating, etc.). If treatment with LODOSYN continues, patients should be advised
not to drive and to avoid other potentially dangerous activities that might result in harm if the
patients become somnolent. There is insufficient information to establish that dose reduction
will eliminate episodes of falling asleep while engaged in activities of daily living.
Hyperpyrexia and Confusion:
Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have
been reported in association with dose reductions or withdrawal of certain antiparkinsonian
agents such as levodopa, carbidopa-levodopa, or carbidopa-levodopa extended release. Therefore, patients should be observed carefully when the dosage of levodopa or carbidopa-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.
What are the precautions of Lodosyn?
General
As with levodopa alone, periodic evaluations of hepatic, hematopoietic, cardiovascular, and
renal function are recommended during extended concomitant therapy with LODOSYN and
levodopa, or with LODOSYN and carbidopa-levodopa, or any combination of these drugs.
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Laboratory Tests
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 concomitant administration of carbidopa and levodopa than with levodopa alone.
Levodopa and carbidopa-levodopa combination products 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.
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
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Mutagenicity studies have not been performed with either carbidopa or the combination of carbidopa and levodopa.
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Pregnancy
There are no adequate and well-controlled studies with LODOSYN in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus, and is metabolized. Carbidopa concentrations in fetal tissue appeared to be minimal. LODOSYN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Carbidopa, at doses as high as 120 mg/kg/day, was without teratogenic effects in the mouse or rabbit. In the rabbit, but not in the mouse, carbidopa-levodopa produced visceral anomalies, similar to those seen with levodopa alone, at approximately 7 times the maximum recommended human dose. The teratogenic effect of levodopa in rabbits was unchanged by the concomitant administration of carbidopa.
Geriatric Use
Clinical studies of LODOSYN did not include sufficient numbers of subjects aged 65 and over
to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease and other drug therapy.
What are the side effects of Lodosyn?
Carbidopa has not been demonstrated to have any overt pharmacodynamic actions in the recommended doses. The only adverse reactions that have been observed have been with concomitant use of carbidopa with other drugs such as levodopa, and with carbidopa-levodopa combination products.
When LODOSYN is administered concomitantly with levodopa or carbidopa-levodopa combination products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements, and nausea. Other adverse reactions reported with LODOSYN when administered concomitantly with levodopa alone or carbidopa-levodopa combination products were psychotic episodes including delusions, hallucinations, and paranoid ideation, depression with or without development of suicidal tendencies, and dementia. Convulsions also have occurred; however, a causal relationship with concomitant use of LODOSYN and levodopa has not been established.
The following other adverse reactions have been reported with levodopa and carbidopa-levodopa combination products. These same adverse reactions may also occur when LODOSYN is administered with these products.
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Hypersensitivity:
Metabolic:
Musculoskeletal:
Nervous System/Psychiatric:
paranoid ideation, NMS,( see ), bradykinetic
episodes (“on-off” phenomenon), confusion, agitation, dizziness, somnolence, dream
abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without
development of suicidal tendencies, dementia, pathological gambling, increased libido including
hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal
relationship with LODOSYN and levodopa, has not been established.
Respiratory:
Skin:
Special Senses:
Urogenital:
Laboratory Tests:
Miscellaneous:
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
What should I look out for while using Lodosyn?
LODOSYN is contraindicated in patients with known hypersensitivity to any component of this drug.
Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with levodopa or carbidopa-levodopa combination products with or without LODOSYN. These inhibitors must be discontinued at least two weeks prior to initiating therapy with levodopa. Carbidopa-levodopa, or levodopa 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 ).
Levodopa or carbidopa-levodopa products, with or without LODOSYN, are contraindicated in patients with narrow-angle glaucoma.
LODOSYN (carbidopa) has no antiparkinsonian effect when given alone. It is indicated
for use with 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 section before initiating therapy.
The addition of LODOSYN with levodopa or carbidopa-levodopa reduces the peripheral
effects (nausea, vomiting) due to decarboxylation of levodopa; however, LODOSYN does
not decrease the adverse reactions due to the central effects of levodopa. Because LODOSYN permits more levodopa to reach the brain and more dopamine to be formed,
certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary
movements), may occur at lower dosages and sooner with levodopa in combination with
LODOSYN than with levodopa alone.
Falling Asleep During Activities of Daily Living and Somnolence
Patients taking carbidopa-levodopa products alone or with other dopaminergic drugs have
reported suddenly falling asleep without prior warning of sleepiness while engaged in activities
of daily living (includes operation of motor vehicles). Some of these episodes resulted in
automobile accidents. Although many of these patients reported somnolence while on
dopaminergic medications, some did perceive that they had no warning signs, such as excessive
drowsiness, and believed that they were alert immediately prior to the event. Some patients
reported these events one year after the initiation of treatment.
Falling asleep while engaged in activities of daily living usually occurs in patients experiencing
pre-existing somnolence, although some patients may not give such a history. For this reason,
prescribers should continually reassess patients for drowsiness or sleepiness especially since
some of the events occur after the start of treatment. Prescribers should be aware that patients
may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or
sleepiness during specific activities. Patients who have already experienced somnolence or an
episode of sudden sleep onset should not participate in these activities during treatment with
LODOSYN when taking it with other carbidopa-levodopa products.
Before initiating treatment with LODOSYN, advise patients about the potential to develop
drowsiness and ask specifically about factors that may increase the risk for somnolence with
LODOSYN such as the use of concomitant sedating medications and the presence of sleep
disorders. Consider discontinuing LODOSYN in patients who report significant daytime
sleepiness or episodes of falling asleep during activities that require active participation (e.g.,
conversations, eating, etc.). If treatment with LODOSYN continues, patients should be advised
not to drive and to avoid other potentially dangerous activities that might result in harm if the
patients become somnolent. There is insufficient information to establish that dose reduction
will eliminate episodes of falling asleep while engaged in activities of daily living.
What might happen if I take too much Lodosyn?
No reports of overdose with LODOSYN have been received. Management of overdosage with carbidopa is the same as that with levodopa or carbidopa-levodopa preparations.
In the event of overdosage, 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 LODOSYN should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. Pyridoxine is not effective in reversing the actions of LODOSYN.
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.
How should I store and handle Lodosyn?
Store NEXPLANON (etonogestrel implant) Radiopaque at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Avoid storing NEXPLANON at temperatures above 30ºC (86ºF).LODOSYN Tablets, 25 mg, are orange, round, compressed tablets that are scored and coded711 on one side and LODOSYN on the other.They are supplied as follows:NDC 25010-711-15 bottles of 100.LODOSYN Tablets, 25 mg, are orange, round, compressed tablets that are scored and coded711 on one side and LODOSYN on the other.They are supplied as follows:NDC 25010-711-15 bottles of 100.LODOSYN Tablets, 25 mg, are orange, round, compressed tablets that are scored and coded711 on one side and LODOSYN on the other.They are supplied as follows:NDC 25010-711-15 bottles of 100.LODOSYN Tablets, 25 mg, are orange, round, compressed tablets that are scored and coded711 on one side and LODOSYN on the other.They are supplied as follows:NDC 25010-711-15 bottles of 100.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
LODOSYN is contraindicated in patients with known hypersensitivity to any component of this drug.Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with levodopa or carbidopa-levodopa combination products with or without LODOSYN. These inhibitors must be discontinued at least two weeks prior to initiating therapy with levodopa. Carbidopa-levodopa, or levodopa 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 ).
Levodopa or carbidopa-levodopa products, with or without LODOSYN, are contraindicated in patients with narrow-angle glaucoma.
LODOSYN (carbidopa) has no antiparkinsonian effect when given alone. It is indicated
for use with 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 section before initiating therapy.
The addition of LODOSYN with levodopa or carbidopa-levodopa reduces the peripheral
effects (nausea, vomiting) due to decarboxylation of levodopa; however, LODOSYN does
not decrease the adverse reactions due to the central effects of levodopa. Because LODOSYN permits more levodopa to reach the brain and more dopamine to be formed,
certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary
movements), may occur at lower dosages and sooner with levodopa in combination with
LODOSYN than with levodopa alone.
Falling Asleep During Activities of Daily Living and Somnolence
Patients taking carbidopa-levodopa products alone or with other dopaminergic drugs have
reported suddenly falling asleep without prior warning of sleepiness while engaged in activities
of daily living (includes operation of motor vehicles). Some of these episodes resulted in
automobile accidents. Although many of these patients reported somnolence while on
dopaminergic medications, some did perceive that they had no warning signs, such as excessive
drowsiness, and believed that they were alert immediately prior to the event. Some patients
reported these events one year after the initiation of treatment.
Falling asleep while engaged in activities of daily living usually occurs in patients experiencing
pre-existing somnolence, although some patients may not give such a history. For this reason,
prescribers should continually reassess patients for drowsiness or sleepiness especially since
some of the events occur after the start of treatment. Prescribers should be aware that patients
may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or
sleepiness during specific activities. Patients who have already experienced somnolence or an
episode of sudden sleep onset should not participate in these activities during treatment with
LODOSYN when taking it with other carbidopa-levodopa products.
Before initiating treatment with LODOSYN, advise patients about the potential to develop
drowsiness and ask specifically about factors that may increase the risk for somnolence with
LODOSYN such as the use of concomitant sedating medications and the presence of sleep
disorders. Consider discontinuing LODOSYN in patients who report significant daytime
sleepiness or episodes of falling asleep during activities that require active participation (e.g.,
conversations, eating, etc.). If treatment with LODOSYN continues, patients should be advised
not to drive and to avoid other potentially dangerous activities that might result in harm if the
patients become somnolent. There is insufficient information to establish that dose reduction
will eliminate episodes of falling asleep while engaged in activities of daily living.
Symptomatic postural hypotension has occurred when LODOSYN, given with levodopa or
carbidopa-levodopa combination products, was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with LODOSYN, given with or without levodopa or carbidopa-levodopa combination products, is started, dosage adjustment of
the antihypertensive drug may be required.
For patients receiving monoamine oxidase inhibitors (Type A or B), (see . Concomitant therapy with selegiline or rasigiline and LODOSYN 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 LODOSYN and levodopa or carbidopa-levodopa combination products should be carefully observed for loss of therapeutic response.
LODOSYN and iron salts or multivitamins containing iron salts should be coadministered
with caution. Iron salts can form chelates with levodopa and carbidopa and
consequently reduce the bioavailability of carbidopa and levodopa.
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.
As with levodopa alone, periodic evaluations of hepatic, hematopoietic, cardiovascular, and
renal function are recommended during extended concomitant therapy with LODOSYN and
levodopa, or with LODOSYN and carbidopa-levodopa, or any combination of these drugs.
Carbidopa has not been demonstrated to have any overt pharmacodynamic actions in the recommended doses. The only adverse reactions that have been observed have been with concomitant use of carbidopa with other drugs such as levodopa, and with carbidopa-levodopa combination products.
When LODOSYN is administered concomitantly with levodopa or carbidopa-levodopa combination products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements, and nausea. Other adverse reactions reported with LODOSYN when administered concomitantly with levodopa alone or carbidopa-levodopa combination products were psychotic episodes including delusions, hallucinations, and paranoid ideation, depression with or without development of suicidal tendencies, and dementia. Convulsions also have occurred; however, a causal relationship with concomitant use of LODOSYN and levodopa has not been established.
The following other adverse reactions have been reported with levodopa and carbidopa-levodopa combination products. These same adverse reactions may also occur when LODOSYN is administered with these products.
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Hypersensitivity:
Metabolic:
Musculoskeletal:
Nervous System/Psychiatric:
paranoid ideation, NMS,( see ), bradykinetic
episodes (“on-off” phenomenon), confusion, agitation, dizziness, somnolence, dream
abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without
development of suicidal tendencies, dementia, pathological gambling, increased libido including
hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal
relationship with LODOSYN and levodopa, has not been established.
Respiratory:
Skin:
Special Senses:
Urogenital:
Laboratory Tests:
Miscellaneous:
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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