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The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August Because of reports of fatal liver injury, the marketing authorisation was suspended on 11 December The suspension was lifted on 31 August The marketing-authorisation holder is Meda AB.

More detail is available in the summary of product characteristics. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

Tasmar RSS. Table of contents Overview Authorisation details Product information Assessment history.

Expand section Collapse section. The medicine can only be obtained with a prescription. It must not be used in patients with: signs of liver disease or increased liver enzymes; phaeochromocytoma a tumour of the adrenal gland ; a history of neuroleptic malignant syndrome a dangerous nervous disorder usually caused by antipsychotic medicines , rhabdomyolysis breakdown of muscle fibres or hyperthermia heat stroke ; severe dyskinesia.

Authorisation details. Product details Name Tasmar. Parkinson Disease. Publication details Marketing-authorisation holder Meda AB. Product information.

List item. You are therefore advised to be selective about which sections or pages you wish to print. Anti-Parkinson drugs.

Other dopaminergic agents. Assessment history. Changes since initial authorisation of medicine List item.

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International non-proprietary name INN or common name. Anatomical therapeutic chemical ATC code. Before initiating treatment with Tasmar, advise patients about the potential to develop drowsiness and ask specifically about factors that may increase the risk for somnolence with Tasmar such as the use of concomitant sedating medications and the presence of sleep disorders.

Consider discontinuing Tasmar in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation e.

If treatment with Tasmar continues, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if 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.

Dopaminergic therapy in Parkinson's disease patients has been associated with orthostatic hypotension. Tolcapone enhances levodopa bioavailability and, therefore, may increase the occurrence of orthostatic hypotension.

Patients with orthostasis at baseline were more likely than patients without symptoms to have orthostatic hypotension during the study, irrespective of treatment group.

In addition, the effect was greater in tolcapone-treated patients than in placebo-treated patients. Baseline treatment with dopamine agonists or selegiline did not appear to increase the likelihood of experiencing orthostatic hypotension when treated with Tasmar.

Approximately 0. Reports of syncope were generally more frequent in patients in all three treatment groups who had an episode of documented hypotension although the episodes of syncope, obtained by history, were themselves not documented with vital sign measurement compared to patients who did not have any episodes of documented hypotension.

Discontinuing Tasmar for diarrhea was related to the severity of the symptom. Although diarrhea generally resolved after discontinuation of Tasmar, it led to hospitalization in 0.

Typically, diarrhea presents 6 to 12 weeks after tolcapone is started, but it may appear as early as 2 weeks and as late as many months after the initiation of treatment.

Clinical trial data suggested that diarrhea associated with tolcapone use may sometimes be associated with anorexia decreased appetite.

No consistent description of tolcapone-induced diarrhea has been derived from clinical trial data, and the mechanism of action is currently unknown.

It is recommended that all cases of persistent diarrhea should be followed up with an appropriate work-up including occult blood samples.

Hallucinations led to drug discontinuation and premature withdrawal from clinical trials in 0. Hallucinations led to hospitalization in 0.

In general, hallucinations present shortly after the initiation of therapy with tolcapone typically within the first 2 weeks.

Clinical trial data suggest that hallucinations associated with tolcapone use may be responsive to levodopa dose reduction.

Hallucinations were commonly accompanied by confusion and to a lesser extent sleep disorder insomnia and excessive dreaming. The incidence of hallucination may be increased in elderly patients over 75 years treated with Tasmar [see Geriatric use ].

Post-marketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Tasmar treatment or after starting or increasing the dose of Tasmar.

This abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.

Ordinarily, patients with a major psychotic disorder should not be treated with Tasmar because of the risk of exacerbating psychosis.

In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of Tasmar.

Although decreasing the dose of levodopa may ameliorate this side effect, many patients in controlled trials continued to experience frequent dyskinesias despite a reduction in their dose of levodopa.

The rates of withdrawal for dyskinesia were 0. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued.

Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with Tasmar.

Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Tasmar [see Information for Patient ].

Cases of severe rhabdomyolysis, with one case of multi-organ system failure rapidly progressing to death, have been reported. The complicated nature of these cases makes it impossible to determine what role, if any, Tasmar played in their pathogenesis.

Severe prolonged motor activity including dyskinesia may account for rhabdomyolysis. Some cases, however, included fever, alteration of consciousness and muscular rigidity.

When rats were dosed daily for 1 or 2 years exposures 6 times the human exposure or greater there was a high incidence of proximal tubule cell damage consisting of degeneration, single cell necrosis, hyperplasia, karyocytomegaly and atypical nuclei.

These effects were not associated with changes in clinical chemistry parameters, and there is no established method for monitoring for the possible occurrence of these lesions in humans.

Although it has been speculated that these toxicities may occur as the result of a species-specific mechanism, experiments that would confirm the theory have not been conducted.

Because of the risk of liver injury, Tasmar therapy should not be initiated in any patient with liver disease. The etiology of the increase with Tasmar has not always been explained for example, by urinary tract infection or warfarin therapy.

The events listed below are known to be associated with the use of drugs that increase dopaminergic activity, although they are most often associated with the use of direct dopamine agonists.

While cases of Hyperpyrexia and Confusion have been reported in association with tolcapone withdrawal see paragraph below , the expected incidence of fibrotic complications is so low that even if tolcapone caused these complications at rates similar to those attributable to other dopaminergic therapies, it is unlikely that even a single example would have been detected in a cohort of the size exposed to tolcapone.

In clinical trials, four cases of a symptom complex resembling the neuroleptic malignant syndrome characterized by elevated temperature, muscular rigidity, and altered consciousness , similar to that reported in association with the rapid dose reduction or withdrawal of other dopaminergic drugs, have been reported in association with the abrupt withdrawal or lowering of the dose of tolcapone.

In 3 of these cases, CPK was elevated as well. One patient died, and the other 3 patients recovered over periods of approximately 2, 4 and 6 weeks.

Rare cases of this symptom complex have been reported during marketed use. It is difficult to determine if Tasmar played a role in the pathogenesis of these events because these patients received several concomitant medications affecting the central nervous system such as monoaminergic i.

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, and pleural thickening have been reported in some patients treated with ergot derived dopaminergic agents.

While these complications may resolve when the drug is discontinued, complete resolution does not always occur. Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived drugs e.

Three cases of pleural effusion, one with pulmonary fibrosis, occurred during clinical trials. These patients were also on concomitant dopamine agonists pergolide or bromocriptine and had a prior history of cardiac disease or pulmonary pathology nonmalignant lung lesion.

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 Tasmar for any indication.

Ideally, periodic skin examination should be performed by appropriately qualified individuals e. Inform patients about clinical signs and symptoms that suggest the onset of hepatic injury persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, and right upper quadrant tenderness see WARNINGS.

If symptoms of hepatic failure occur, patients should be advised to contact their physician immediately.

Advise patients to exercise caution while driving, operating machines, or working at heights during treatment with Tasmar. Because of the possible additive sedative effects, caution should also be used when patients are taking other CNS depressants in combination with Tasmar.

Inform patients that nausea may occur, especially at the initiation of treatment with Tasmar. Advise patients that they may develop postural orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating.

Advise patients to rise slowly, especially after long periods of sitting or lying down. Hypotension may be more likely when patients first start treatment with Tasmar.

Instruct patients and caregivers to report intense urges to gamble, increased sexual urges, increase in spending money, binge eating, and other intense urges as well as the inability to control these urges to the prescriber while taking Tasmar.

Tolcapone is excreted into maternal milk in rats. Because of the possibility that tolcapone may be excreted into human milk, advise patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant.

Although a program of frequent laboratory monitoring for evidence of hepatocellular injury is deemed essential, it is not clear that periodic monitoring of liver enzymes will prevent the occurrence of fulminant liver failure.

The experiments included warfarin 0. Tolcapone may influence the pharmacokinetics of drugs metabolized by COMT.

However, no effects were seen on the pharmacokinetics of the COMT substrate carbidopa. A dose reduction of such compounds should be considered when they are co-administered with tolcapone.

In vitro experiments have been performed to assess the potential of tolcapone to interact with isoenzymes of cytochrome P CYP.

The absence of an interaction with desipramine, a drug metabolized by cytochrome P 2D6, was also confirmed in an in vivo study where tolcapone did not change the pharmacokinetics of desipramine.

Due to its affinity to cytochrome P 2C9 in vitro, tolcapone may interfere with drugs, whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin.

However, in an in vivo interaction study, tolcapone did not change the pharmacokinetics of tolbutamide. Therefore, clinically relevant interactions involving cytochrome P 2C9 appear unlikely.

Similarly, tolcapone did not affect the pharmacokinetics of desipramine, a drug metabolized by cytochrome P 2D6, indicating that interactions with drugs metabolized by that enzyme are unlikely.

Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these two drugs are co-administered.

Tolcapone did not influence the effect of ephedrine, an indirect sympathomimetic, on hemodynamic parameters or plasma catecholamine levels, either at rest or during exercise.

Since tolcapone did not alter the tolerability of ephedrine, these drugs can be co-administered. Overall, the frequency of adverse events increased slightly.

These adverse events were predictable based on the known adverse reactions to each of the three drugs individually.

Carcinogenicity studies in which tolcapone was administered in the diet were conducted in mice and rats.

Tolcapone exposures were 1, 6. There was an increased incidence of uterine adenocarcinomas in female rats at exposure equivalent to There was evidence of renal tubular injury and renal tubular tumor formation in rats.

A low incidence of renal tubular cell adenomas occurred in middle- and high-dose female rats; tubular cell carcinomas occurred in middle- and high-dose male and high-dose female rats, with a statistically significant increase in high-dose males.

Exposures were equivalent to 6. Minimal-to-marked damage to the renal tubules, consisting of proximal tubule cell degeneration, single cell necrosis, hyperplasia and karyocytomegaly, occurred at the doses associated with renal tumors.

These histopathological changes suggest the possibility that renal tumor formation might be secondary to chronic cell damage and sustained repair, but this relationship has not been established, and the relevance of these findings to humans is not known.

There was no evidence of carcinogenic effects in the long-term mouse study. It was not clastogenic in an in vitro chromosomal aberration assay in cultured human lymphocytes, or in an in vivo micronucleus assay in mice.

Plasma exposures to tolcapone based on AUC were 0. Tolcapone exposures were 0. There is no experience from clinical studies regarding the use of Tasmar in pregnant women.

Therefore, Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether tolcapone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tolcapone is administered to a nursing woman.

Consequently, the mean age of patients in tolcapone clinical trials was 60 to 65 years. To investigate safety as it relates to advancing age, three subgroups were identified: less than 65 years, 65 to 75 years, and greater than 75 years.

There were generally no consistent age-related trends in safety parameters. The imprecision of the estimated increase is due to uncertainties about the base rate and the actual number of cases occurring in association with Tasmar.

The incidence of idiopathic potentially fatal fulminant hepatic failure i. Whether this estimate is an appropriate basis for estimating the increased risk of liver failure among Tasmar users is uncertain.

Tasmar users, for example, differ in age and general health status from candidates for liver transplantation.

Similarly, underreporting of cases may lead to significant underestimation of the increased risk associated with the use of Tasmar.

During the premarketing development of tolcapone, two distinct patient populations were studied, patients with end-of-dose wearing-off phenomena and patients with stable responses to levodopa therapy.

All patients received concomitant treatment with levodopa preparations, however, and were similar in other clinical aspects.

Adverse reactions are shown for these two populations combined. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies.

Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

However, the cited figures do provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse reactions incidence rate in the population studied.

During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing.

To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of adverse events were grouped into a smaller number of standardized categories using COSTART dictionary terminology.

These categories are used in the listing below. All reported events that occurred at least twice or once for serious or potentially serious events , except those already listed above, trivial events and terms too vague to be meaningful are included, without regard to determination of a causal relationship to Tasmar.

Nervous System — frequent: depression, hypesthesia, tremor, speech disorder, vertigo, emotional lability; infrequent: neuralgia, amnesia, extrapyramidal syndrome, hostility, libido increased, manic reaction, nervousness, paranoid reaction, cerebral ischemia, cerebrovascular accident, delusions, libido decreased, neuropathy, apathy, choreoathetosis, myoclonus, psychosis, thinking abnormal, twitching; rare: antisocial reaction, delirium, encephalopathy, hemiplegia, meningitis.

Digestive System — frequent: tooth disorder; infrequent: dysphagia, gastrointestinal hemorrhage, gastroenteritis, mouth ulceration, increased salivation, abnormal stools, esophagitis, cholelithiasis, colitis, tongue disorder, rectal disorder; rare: cholecystitis, duodenal ulcer, gastrointestinal carcinoma, stomach atony.

Body as a Whole — frequent: flank pain, accidental injury, abdominal pain, infection; infrequent: hernia, pain, allergic reaction, cellulitis, infection fungal, viral infection, carcinoma, chills, infection bacterial, neoplasm, abscess, face edema; rare: death.

Cardiovascular System — frequent: palpitation; infrequent: hypertension, vasodilation, angina pectoris, heart failure, atrial fibrillation, tachycardia, migraine, aortic stenosis, arrhythmia, arteriospasm, bradycardia, cerebral hemorrhage, coronary artery disorder, heart arrest, myocardial infarct, myocardial ischemia, pulmonary embolus; rare: arteriosclerosis, cardiovascular disorder, pericardial effusion, thrombosis.

Musculoskeletal System — frequent: myalgia; infrequent: tenosynovitis, arthrosis, joint disorder. Urogenital System — frequent: urinary incontinence, impotence; infrequent: prostatic disorder, dysuria, nocturia, polyuria, urinary retention, urinary tract disorder, hematuria, kidney calculus, prostatic carcinoma, breast neoplasm, oliguria, uterine atony, uterine disorder, vaginitis; rare: bladder calculus, ovarian carcinoma, uterine hemorrhage.

Respiratory System — frequent: bronchitis, pharyngitis; infrequent: cough increased, rhinitis, asthma, epistaxis, hyperventilation, laryngitis, hiccup; rare: apnea, hypoxia, lung edema.

Skin and Appendages — frequent: rash; infrequent: herpes zoster, pruritus, seborrhea, skin discoloration, eczema, erythema multiforme, skin disorder, furunculosis, herpes simplex, urticaria.

Special Senses — frequent: tinnitus; infrequent: diplopia, ear pain, eye hemorrhage, eye pain, lacrimation disorder, otitis media, parosmia; rare: glaucoma.

Metabolic and Nutritional — infrequent: edema, hypercholesteremia, thirst, dehydration. Hemic and Lymphatic System — infrequent: anemia; rare: leukemia, thrombocytopenia.

Endocrine System — infrequent: diabetes mellitus. Unclassified — infrequent: surgical procedure. Studies conducted in rats and monkeys did not reveal any potential for physical or psychological dependence.

Although clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

This was in a 1-week study in elderly, healthy volunteers. Respiratory difficulties were observed in rats at high oral gavage and intravenous doses and in dogs with rapidly injected intravenous doses.

Hospitalization is advised. General supportive care is indicated. Based on the physicochemical properties of the compound, hemodialysis is unlikely to be of benefit.

These patients should not ordinarily be considered for retreatment with Tasmar. Only prescribe Tasmar for patients taking concomitant carbidopa levodopa therapy.

The initial dose of Tasmar is always mg three times per day. The recommended daily dose of Tasmar is also mg tid. In clinical trials, elevations in ALT occurred more frequently at the dose of mg tid.

If a patient fails to show the expected incremental benefit on the mg dose after a total of 3 weeks of treatment regardless of dose , Tasmar should be discontinued.

To optimize an individual patient's response, reductions in daily levodopa dose may be necessary. No dose adjustment of Tasmar is recommended for patients with mild to moderate renal impairment.

In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of Tasmar.

Although decreasing the dose of levodopa may ameliorate this side effect, many patients in controlled trials continued to experience frequent dyskinesias despite a reduction in their dose of levodopa.

The rates of withdrawal for dyskinesia were 0. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued.

Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with Tasmar.

Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Tasmar [see Information for Patient ].

Cases of severe rhabdomyolysis, with one case of multi-organ system failure rapidly progressing to death, have been reported.

The complicated nature of these cases makes it impossible to determine what role, if any, Tasmar played in their pathogenesis. Severe prolonged motor activity including dyskinesia may account for rhabdomyolysis.

Some cases, however, included fever, alteration of consciousness and muscular rigidity. When rats were dosed daily for 1 or 2 years exposures 6 times the human exposure or greater there was a high incidence of proximal tubule cell damage consisting of degeneration, single cell necrosis, hyperplasia, karyocytomegaly and atypical nuclei.

These effects were not associated with changes in clinical chemistry parameters, and there is no established method for monitoring for the possible occurrence of these lesions in humans.

Although it has been speculated that these toxicities may occur as the result of a species-specific mechanism, experiments that would confirm the theory have not been conducted.

Because of the risk of liver injury, Tasmar therapy should not be initiated in any patient with liver disease.

The etiology of the increase with Tasmar has not always been explained for example, by urinary tract infection or warfarin therapy.

The events listed below are known to be associated with the use of drugs that increase dopaminergic activity, although they are most often associated with the use of direct dopamine agonists.

While cases of Hyperpyrexia and Confusion have been reported in association with tolcapone withdrawal see paragraph below , the expected incidence of fibrotic complications is so low that even if tolcapone caused these complications at rates similar to those attributable to other dopaminergic therapies, it is unlikely that even a single example would have been detected in a cohort of the size exposed to tolcapone.

In clinical trials, four cases of a symptom complex resembling the neuroleptic malignant syndrome characterized by elevated temperature, muscular rigidity, and altered consciousness , similar to that reported in association with the rapid dose reduction or withdrawal of other dopaminergic drugs, have been reported in association with the abrupt withdrawal or lowering of the dose of tolcapone.

In 3 of these cases, CPK was elevated as well. One patient died, and the other 3 patients recovered over periods of approximately 2, 4 and 6 weeks.

Rare cases of this symptom complex have been reported during marketed use. It is difficult to determine if Tasmar played a role in the pathogenesis of these events because these patients received several concomitant medications affecting the central nervous system such as monoaminergic i.

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, and pleural thickening have been reported in some patients treated with ergot derived dopaminergic agents.

While these complications may resolve when the drug is discontinued, complete resolution does not always occur. Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived drugs e.

Three cases of pleural effusion, one with pulmonary fibrosis, occurred during clinical trials.

These patients were also on concomitant dopamine agonists pergolide or bromocriptine and had a prior history of cardiac disease or pulmonary pathology nonmalignant lung lesion.

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 Tasmar for any indication.

Ideally, periodic skin examination should be performed by appropriately qualified individuals e. Inform patients about clinical signs and symptoms that suggest the onset of hepatic injury persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, and right upper quadrant tenderness see WARNINGS.

If symptoms of hepatic failure occur, patients should be advised to contact their physician immediately.

Advise patients to exercise caution while driving, operating machines, or working at heights during treatment with Tasmar.

Because of the possible additive sedative effects, caution should also be used when patients are taking other CNS depressants in combination with Tasmar.

Inform patients that nausea may occur, especially at the initiation of treatment with Tasmar. Advise patients that they may develop postural orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating.

Advise patients to rise slowly, especially after long periods of sitting or lying down. Hypotension may be more likely when patients first start treatment with Tasmar.

Instruct patients and caregivers to report intense urges to gamble, increased sexual urges, increase in spending money, binge eating, and other intense urges as well as the inability to control these urges to the prescriber while taking Tasmar.

Tolcapone is excreted into maternal milk in rats. Because of the possibility that tolcapone may be excreted into human milk, advise patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant.

Although a program of frequent laboratory monitoring for evidence of hepatocellular injury is deemed essential, it is not clear that periodic monitoring of liver enzymes will prevent the occurrence of fulminant liver failure.

The experiments included warfarin 0. Tolcapone may influence the pharmacokinetics of drugs metabolized by COMT. However, no effects were seen on the pharmacokinetics of the COMT substrate carbidopa.

A dose reduction of such compounds should be considered when they are co-administered with tolcapone. In vitro experiments have been performed to assess the potential of tolcapone to interact with isoenzymes of cytochrome P CYP.

The absence of an interaction with desipramine, a drug metabolized by cytochrome P 2D6, was also confirmed in an in vivo study where tolcapone did not change the pharmacokinetics of desipramine.

Due to its affinity to cytochrome P 2C9 in vitro, tolcapone may interfere with drugs, whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin.

However, in an in vivo interaction study, tolcapone did not change the pharmacokinetics of tolbutamide. Therefore, clinically relevant interactions involving cytochrome P 2C9 appear unlikely.

Similarly, tolcapone did not affect the pharmacokinetics of desipramine, a drug metabolized by cytochrome P 2D6, indicating that interactions with drugs metabolized by that enzyme are unlikely.

Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these two drugs are co-administered.

Tolcapone did not influence the effect of ephedrine, an indirect sympathomimetic, on hemodynamic parameters or plasma catecholamine levels, either at rest or during exercise.

Since tolcapone did not alter the tolerability of ephedrine, these drugs can be co-administered. Overall, the frequency of adverse events increased slightly.

These adverse events were predictable based on the known adverse reactions to each of the three drugs individually.

Carcinogenicity studies in which tolcapone was administered in the diet were conducted in mice and rats. Tolcapone exposures were 1, 6.

There was an increased incidence of uterine adenocarcinomas in female rats at exposure equivalent to There was evidence of renal tubular injury and renal tubular tumor formation in rats.

A low incidence of renal tubular cell adenomas occurred in middle- and high-dose female rats; tubular cell carcinomas occurred in middle- and high-dose male and high-dose female rats, with a statistically significant increase in high-dose males.

Exposures were equivalent to 6. Minimal-to-marked damage to the renal tubules, consisting of proximal tubule cell degeneration, single cell necrosis, hyperplasia and karyocytomegaly, occurred at the doses associated with renal tumors.

These histopathological changes suggest the possibility that renal tumor formation might be secondary to chronic cell damage and sustained repair, but this relationship has not been established, and the relevance of these findings to humans is not known.

There was no evidence of carcinogenic effects in the long-term mouse study. It was not clastogenic in an in vitro chromosomal aberration assay in cultured human lymphocytes, or in an in vivo micronucleus assay in mice.

Plasma exposures to tolcapone based on AUC were 0. Tolcapone exposures were 0. There is no experience from clinical studies regarding the use of Tasmar in pregnant women.

Therefore, Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether tolcapone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tolcapone is administered to a nursing woman.

Consequently, the mean age of patients in tolcapone clinical trials was 60 to 65 years. To investigate safety as it relates to advancing age, three subgroups were identified: less than 65 years, 65 to 75 years, and greater than 75 years.

There were generally no consistent age-related trends in safety parameters. The imprecision of the estimated increase is due to uncertainties about the base rate and the actual number of cases occurring in association with Tasmar.

The incidence of idiopathic potentially fatal fulminant hepatic failure i. Whether this estimate is an appropriate basis for estimating the increased risk of liver failure among Tasmar users is uncertain.

Tasmar users, for example, differ in age and general health status from candidates for liver transplantation. Similarly, underreporting of cases may lead to significant underestimation of the increased risk associated with the use of Tasmar.

During the premarketing development of tolcapone, two distinct patient populations were studied, patients with end-of-dose wearing-off phenomena and patients with stable responses to levodopa therapy.

All patients received concomitant treatment with levodopa preparations, however, and were similar in other clinical aspects.

Adverse reactions are shown for these two populations combined. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies.

Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

However, the cited figures do provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse reactions incidence rate in the population studied.

During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of adverse events were grouped into a smaller number of standardized categories using COSTART dictionary terminology.

These categories are used in the listing below. All reported events that occurred at least twice or once for serious or potentially serious events , except those already listed above, trivial events and terms too vague to be meaningful are included, without regard to determination of a causal relationship to Tasmar.

Nervous System — frequent: depression, hypesthesia, tremor, speech disorder, vertigo, emotional lability; infrequent: neuralgia, amnesia, extrapyramidal syndrome, hostility, libido increased, manic reaction, nervousness, paranoid reaction, cerebral ischemia, cerebrovascular accident, delusions, libido decreased, neuropathy, apathy, choreoathetosis, myoclonus, psychosis, thinking abnormal, twitching; rare: antisocial reaction, delirium, encephalopathy, hemiplegia, meningitis.

Digestive System — frequent: tooth disorder; infrequent: dysphagia, gastrointestinal hemorrhage, gastroenteritis, mouth ulceration, increased salivation, abnormal stools, esophagitis, cholelithiasis, colitis, tongue disorder, rectal disorder; rare: cholecystitis, duodenal ulcer, gastrointestinal carcinoma, stomach atony.

Body as a Whole — frequent: flank pain, accidental injury, abdominal pain, infection; infrequent: hernia, pain, allergic reaction, cellulitis, infection fungal, viral infection, carcinoma, chills, infection bacterial, neoplasm, abscess, face edema; rare: death.

Cardiovascular System — frequent: palpitation; infrequent: hypertension, vasodilation, angina pectoris, heart failure, atrial fibrillation, tachycardia, migraine, aortic stenosis, arrhythmia, arteriospasm, bradycardia, cerebral hemorrhage, coronary artery disorder, heart arrest, myocardial infarct, myocardial ischemia, pulmonary embolus; rare: arteriosclerosis, cardiovascular disorder, pericardial effusion, thrombosis.

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While increase of dopamine levels is a desired interaction, tolcapone can theoretically also increase the levels of other drugs metabolised by COMT, such as the AADC inhibitors carbidopa and benzerazide, as well as methyldopa , dobutamine , apomorphine , adrenaline , and isoprenaline.

In studies, a slight interaction with benzerazide was seen, but not with carbidopa. Other interactions with this group of drugs have not been studied.

A related type of theoretical interactions is with drugs that increase catecholamine concentrations, such as monoamine oxidase MAO inhibitors and noradrenaline reuptake inhibitors ; these also showed only slight effects in practice.

Combination with non-selective MAO inhibitors might be dangerous. Due to its affinity to the liver enzyme CYP2C9 , interactions with drugs being metabolised by this enzyme are also possible, but unlikely.

No interaction with tolbutamide , a 2C9 substrate , was observed in studies. Tolcapone selectively and reversibly [6] binds to the catalytic site of COMT in both the periphery and the central nervous system CNS with greater affinity than any of the three catecholamines , including levodopa.

More of the levodopa that is administered reaches the CNS. Additionally, levodopa that has already reached the CNS, after being converted to dopamine, will not be degraded as quickly when tolcapone inhibits COMT activity.

Thus, tolcapone improves the bioavailability and reduces the clearance of levodopa and subsequently dopamine from the CNS. The strength of the binding affinity of tolcapone, represented by the inhibition constant K i 2.

The substance reaches highest blood plasma concentrations after about two hours. The main inactivation step is glucuronidation ; other processes are methylation by COMT, hydroxylation by CYP3A4 and CYP2A6 with subsequent oxidation to a carboxylic acid , and possibly a minor path with reduction to an amine with subsequent acetylation.

The half-life of tolcapone is two to three hours, the volume of distribution V d being 0. Only 0. Tolcapone penetrates the blood—brain barrier much better than two other nitrocatechols, nitecapone and entacapone , because it has higher lipophilicity due to its R-substituent.

There is no current explanation for how these charged molecules permeate the blood—brain barrier. Tolcapone is an intensely yellow, odorless, bitter tasting, non- hygroscopic , crystalline compound with a relative molecular mass of The p K a values are 4.

A synthesis of tolcapone proposed in begins with a Grignard reaction between a benzaldehyde derivative and p -tolyl magnesium bromide. The alcohol thus produced is then converted to a ketone using sodium t -butoxide.

The benzyl protecting group is removed by palladium -catalyzed hydrogenation in the presence of ammonium formate.

A nitro group is introduced at the 5-position adjacent to the hydroxyl group unmasked in the cleavage of the benzyl ether. The synthesis ends with cleavage of the methoxy group using aluminum chloride to yield the product alcohol.

Tolcapone was introduced into European market in August and subsequently into the United States market in March Liver toxicity was reported in four people who were administered tolcapone, three people died due to complications.

Consequentially, the marketing authorization of tolcapone was suspended from December, until August, when it was lifted. In November , the company that manufactured tolcapone voluntarily [15] removed the drug from the market.

The authorization was then renewed in August

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