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Tasmar Drug Description
TASMAR®
(tolcapone) Tablets
Before prescribing TASMAR, the physician should be thoroughly familiar with
the details of this prescribing information.
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS
HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF
RISKS SECTION).

WARNING
Because of the risk of potentially fatal, acute fulminant liver failure,
TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's
experiencing symptom fluctuations and are not responding satisfactorily to
or are not appropriate candidates for other adjunctive therapies (see INDICATIONS
and DOSAGE AND ADMINISTRATION sections).
Because of the risk of liver injury and because TASMAR, when it is effective,
provides an observable symptomatic benefit, the patient who fails to show substantial
clinical benefit within 3 weeks of initiation of treatment, should be withdrawn
from TASMAR.
TASMAR therapy should not be initiated if the patient exhibits clinical
evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than
the upper limit of normal. Patients with severe dyskinesia or dystonia should
be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND
ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER
INJURY IF TASMAR IS REINTRODUCED. A CCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY
BE CONSIDERED FOR RETREATMENT.
Cases of severe hepatocellular injury, including fulminant liver failure
resulting in death, have been reported in postmarketing use. As of May 2005,
3 cases of fatal fulminant hepatic failure have been reported from more than
40,000 patient years of worldwide use. This incidence may be 10- to 100-fold
higher than the background incidence in the general population. Underreporting
of cases may lead to significant underestimation of the increased risk associated
with the use of TASMAR. All 3 cases were reported within the first six months
of initiation of treatment with TASMAR. Analysis of the laboratory monitoring
data in over 3,400 TASMAR­treated patients participating in clinical trials
indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred
within the first 6 months of treatment with TASMAR.
A prescriber who elects to use TASMAR in face of the increased risk of liver
injury is strongly advised to monitor patients for evidence of emergent liver
injury. Patients should be advised of the need for self-monitoring for both
the classical signs of liver disease (eg, clay colored stools, jaundice) and
the nonspecific ones (eg, fatigue, loss of appetite, lethargy).
Although a program of periodic laboratory monitoring for evidence of hepatocellular
injury is recommended, it is not clear that periodic monitoring of liver enzymes
will prevent the occurrence of fulminant liver failure. However, it is generally
believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly,
the following liver monitoring program is recommended.
Before starting treatment with TASMAR, the physician should conduct appropriate
tests to exclude the presence of liver disease. In patients determined to
be appropriate candidates for treatment with TASMAR, serum glutamic-pyruvic
transaminase (SGPT/ALT) and serum glutamic-oxaloacetic transaminase (SGOT/AST)
levels should be determined at baseline and periodically (i.e. every 2 to
4 weeks) for the first 6 months of therapy. After the first six months, periodic
monitoring is recommended at intervals deemed clinically relevant. Although
more frequent monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement. If the dose is
increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing the
dose and then be conducted every 2 to 4 weeks for the following 6 months of
therapy. After six months, periodic monitoring is recommended at intervals
deemed clinically relevant.
TASMAR should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times
the upper limit of normal or if clinical signs and symptoms suggest the onset
of hepatic dysfunction (persistent nausea, fatigue, lethargy, anorexia, jaundice,
dark urine, pruritus, and right upper quadrant tenderness).

DRUG DESCRIPTION



What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
fever, stiff muscles, confusion, and sweating (especially when you first start taking...
Read All Potential Side Effects for Tasmar »




TASMAR® is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used
in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an
adjunct non- to hygroscopic, crystalline compound with a relative molecular
mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone.
Its empirical formula is C14H11NO5 and its
structural formula is:








Inactive ingredients
Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate
anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate.
Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose,
triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg
— yellow and red iron oxide; 200 mg — red iron oxide.Last reviewed on RxList: 3/12/2009




Tasmar Drug Description
TASMAR®
(tolcapone) Tablets
Before prescribing TASMAR, the physician should be thoroughly familiar with
the details of this prescribing information.
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS
HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF
RISKS SECTION).

WARNING
Because of the risk of potentially fatal, acute fulminant liver failure,
TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's
experiencing symptom fluctuations and are not responding satisfactorily to
or are not appropriate candidates for other adjunctive therapies (see INDICATIONS
and DOSAGE AND ADMINISTRATION sections).
Because of the risk of liver injury and because TASMAR, when it is effective,
provides an observable symptomatic benefit, the patient who fails to show substantial
clinical benefit within 3 weeks of initiation of treatment, should be withdrawn
from TASMAR.
TASMAR therapy should not be initiated if the patient exhibits clinical
evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than
the upper limit of normal. Patients with severe dyskinesia or dystonia should
be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND
ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER
INJURY IF TASMAR IS REINTRODUCED. A CCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY
BE CONSIDERED FOR RETREATMENT.
Cases of severe hepatocellular injury, including fulminant liver failure
resulting in death, have been reported in postmarketing use. As of May 2005,
3 cases of fatal fulminant hepatic failure have been reported from more than
40,000 patient years of worldwide use. This incidence may be 10- to 100-fold
higher than the background incidence in the general population. Underreporting
of cases may lead to significant underestimation of the increased risk associated
with the use of TASMAR. All 3 cases were reported within the first six months
of initiation of treatment with TASMAR. Analysis of the laboratory monitoring
data in over 3,400 TASMAR­treated patients participating in clinical trials
indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred
within the first 6 months of treatment with TASMAR.
A prescriber who elects to use TASMAR in face of the increased risk of liver
injury is strongly advised to monitor patients for evidence of emergent liver
injury. Patients should be advised of the need for self-monitoring for both
the classical signs of liver disease (eg, clay colored stools, jaundice) and
the nonspecific ones (eg, fatigue, loss of appetite, lethargy).
Although a program of periodic laboratory monitoring for evidence of hepatocellular
injury is recommended, it is not clear that periodic monitoring of liver enzymes
will prevent the occurrence of fulminant liver failure. However, it is generally
believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly,
the following liver monitoring program is recommended.
Before starting treatment with TASMAR, the physician should conduct appropriate
tests to exclude the presence of liver disease. In patients determined to
be appropriate candidates for treatment with TASMAR, serum glutamic-pyruvic
transaminase (SGPT/ALT) and serum glutamic-oxaloacetic transaminase (SGOT/AST)
levels should be determined at baseline and periodically (i.e. every 2 to
4 weeks) for the first 6 months of therapy. After the first six months, periodic
monitoring is recommended at intervals deemed clinically relevant. Although
more frequent monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement. If the dose is
increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing the
dose and then be conducted every 2 to 4 weeks for the following 6 months of
therapy. After six months, periodic monitoring is recommended at intervals
deemed clinically relevant.
TASMAR should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times
the upper limit of normal or if clinical signs and symptoms suggest the onset
of hepatic dysfunction (persistent nausea, fatigue, lethargy, anorexia, jaundice,
dark urine, pruritus, and right upper quadrant tenderness).

DRUG DESCRIPTION



What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
fever, stiff muscles, confusion, and sweating (especially when you first start taking...
Read All Potential Side Effects for Tasmar »




TASMAR® is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used
in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an
adjunct non- to hygroscopic, crystalline compound with a relative molecular
mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone.
Its empirical formula is C14H11NO5 and its
structural formula is:








Inactive ingredients
Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate
anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate.
Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose,
triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg
— yellow and red iron oxide; 200 mg — red iron oxide.Last reviewed on RxList: 3/12/2009




Tasmar Drug Description
TASMAR®
(tolcapone) Tablets
Before prescribing TASMAR, the physician should be thoroughly familiar with
the details of this prescribing information.
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS
HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF
RISKS SECTION).

WARNING
Because of the risk of potentially fatal, acute fulminant liver failure,
TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's
experiencing symptom fluctuations and are not responding satisfactorily to
or are not appropriate candidates for other adjunctive therapies (see INDICATIONS
and DOSAGE AND ADMINISTRATION sections).
Because of the risk of liver injury and because TASMAR, when it is effective,
provides an observable symptomatic benefit, the patient who fails to show substantial
clinical benefit within 3 weeks of initiation of treatment, should be withdrawn
from TASMAR.
TASMAR therapy should not be initiated if the patient exhibits clinical
evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than
the upper limit of normal. Patients with severe dyskinesia or dystonia should
be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND
ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER
INJURY IF TASMAR IS REINTRODUCED. A CCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY
BE CONSIDERED FOR RETREATMENT.
Cases of severe hepatocellular injury, including fulminant liver failure
resulting in death, have been reported in postmarketing use. As of May 2005,
3 cases of fatal fulminant hepatic failure have been reported from more than
40,000 patient years of worldwide use. This incidence may be 10- to 100-fold
higher than the background incidence in the general population. Underreporting
of cases may lead to significant underestimation of the increased risk associated
with the use of TASMAR. All 3 cases were reported within the first six months
of initiation of treatment with TASMAR. Analysis of the laboratory monitoring
data in over 3,400 TASMAR­treated patients participating in clinical trials
indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred
within the first 6 months of treatment with TASMAR.
A prescriber who elects to use TASMAR in face of the increased risk of liver
injury is strongly advised to monitor patients for evidence of emergent liver
injury. Patients should be advised of the need for self-monitoring for both
the classical signs of liver disease (eg, clay colored stools, jaundice) and
the nonspecific ones (eg, fatigue, loss of appetite, lethargy).
Although a program of periodic laboratory monitoring for evidence of hepatocellular
injury is recommended, it is not clear that periodic monitoring of liver enzymes
will prevent the occurrence of fulminant liver failure. However, it is generally
believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly,
the following liver monitoring program is recommended.
Before starting treatment with TASMAR, the physician should conduct appropriate
tests to exclude the presence of liver disease. In patients determined to
be appropriate candidates for treatment with TASMAR, serum glutamic-pyruvic
transaminase (SGPT/ALT) and serum glutamic-oxaloacetic transaminase (SGOT/AST)
levels should be determined at baseline and periodically (i.e. every 2 to
4 weeks) for the first 6 months of therapy. After the first six months, periodic
monitoring is recommended at intervals deemed clinically relevant. Although
more frequent monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement. If the dose is
increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing the
dose and then be conducted every 2 to 4 weeks for the following 6 months of
therapy. After six months, periodic monitoring is recommended at intervals
deemed clinically relevant.
TASMAR should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times
the upper limit of normal or if clinical signs and symptoms suggest the onset
of hepatic dysfunction (persistent nausea, fatigue, lethargy, anorexia, jaundice,
dark urine, pruritus, and right upper quadrant tenderness).

DRUG DESCRIPTION



What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
fever, stiff muscles, confusion, and sweating (especially when you first start taking...
Read All Potential Side Effects for Tasmar »




TASMAR® is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used
in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an
adjunct non- to hygroscopic, crystalline compound with a relative molecular
mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone.
Its empirical formula is C14H11NO5 and its
structural formula is:








Inactive ingredients
Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate
anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate.
Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose,
triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg
— yellow and red iron oxide; 200 mg — red iron oxide.Last reviewed on RxList: 3/12/2009




Tasmar Drug Description
TASMAR®
(tolcapone) Tablets
Before prescribing TASMAR, the physician should be thoroughly familiar with
the details of this prescribing information.
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS
HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF
RISKS SECTION).

WARNING
Because of the risk of potentially fatal, acute fulminant liver failure,
TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's
experiencing symptom fluctuations and are not responding satisfactorily to
or are not appropriate candidates for other adjunctive therapies (see INDICATIONS
and DOSAGE AND ADMINISTRATION sections).
Because of the risk of liver injury and because TASMAR, when it is effective,
provides an observable symptomatic benefit, the patient who fails to show substantial
clinical benefit within 3 weeks of initiation of treatment, should be withdrawn
from TASMAR.
TASMAR therapy should not be initiated if the patient exhibits clinical
evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than
the upper limit of normal. Patients with severe dyskinesia or dystonia should
be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND
ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER
INJURY IF TASMAR IS REINTRODUCED. A CCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY
BE CONSIDERED FOR RETREATMENT.
Cases of severe hepatocellular injury, including fulminant liver failure
resulting in death, have been reported in postmarketing use. As of May 2005,
3 cases of fatal fulminant hepatic failure have been reported from more than
40,000 patient years of worldwide use. This incidence may be 10- to 100-fold
higher than the background incidence in the general population. Underreporting
of cases may lead to significant underestimation of the increased risk associated
with the use of TASMAR. All 3 cases were reported within the first six months
of initiation of treatment with TASMAR. Analysis of the laboratory monitoring
data in over 3,400 TASMAR­treated patients participating in clinical trials
indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred
within the first 6 months of treatment with TASMAR.
A prescriber who elects to use TASMAR in face of the increased risk of liver
injury is strongly advised to monitor patients for evidence of emergent liver
injury. Patients should be advised of the need for self-monitoring for both
the classical signs of liver disease (eg, clay colored stools, jaundice) and
the nonspecific ones (eg, fatigue, loss of appetite, lethargy).
Although a program of periodic laboratory monitoring for evidence of hepatocellular
injury is recommended, it is not clear that periodic monitoring of liver enzymes
will prevent the occurrence of fulminant liver failure. However, it is generally
believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly,
the following liver monitoring program is recommended.
Before starting treatment with TASMAR, the physician should conduct appropriate
tests to exclude the presence of liver disease. In patients determined to
be appropriate candidates for treatment with TASMAR, serum glutamic-pyruvic
transaminase (SGPT/ALT) and serum glutamic-oxaloacetic transaminase (SGOT/AST)
levels should be determined at baseline and periodically (i.e. every 2 to
4 weeks) for the first 6 months of therapy. After the first six months, periodic
monitoring is recommended at intervals deemed clinically relevant. Although
more frequent monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement. If the dose is
increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing the
dose and then be conducted every 2 to 4 weeks for the following 6 months of
therapy. After six months, periodic monitoring is recommended at intervals
deemed clinically relevant.
TASMAR should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times
the upper limit of normal or if clinical signs and symptoms suggest the onset
of hepatic dysfunction (persistent nausea, fatigue, lethargy, anorexia, jaundice,
dark urine, pruritus, and right upper quadrant tenderness).

DRUG DESCRIPTION



What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
fever, stiff muscles, confusion, and sweating (especially when you first start taking...
Read All Potential Side Effects for Tasmar »




TASMAR® is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used
in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an
adjunct non- to hygroscopic, crystalline compound with a relative molecular
mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone.
Its empirical formula is C14H11NO5 and its
structural formula is:








Inactive ingredients
Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate
anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate.
Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose,
triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg
— yellow and red iron oxide; 200 mg — red iron oxide.Last reviewed on RxList: 3/12/2009




Tasmar Drug Description
TASMAR®
(tolcapone) Tablets
Before prescribing TASMAR, the physician should be thoroughly familiar with
the details of this prescribing information.
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGEMENT THAT THE RISKS
HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGEMENT OF
RISKS SECTION).

WARNING
Because of the risk of potentially fatal, acute fulminant liver failure,
TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's
experiencing symptom fluctuations and are not responding satisfactorily to
or are not appropriate candidates for other adjunctive therapies (see INDICATIONS
and DOSAGE AND ADMINISTRATION sections).
Because of the risk of liver injury and because TASMAR, when it is effective,
provides an observable symptomatic benefit, the patient who fails to show substantial
clinical benefit within 3 weeks of initiation of treatment, should be withdrawn
from TASMAR.
TASMAR therapy should not be initiated if the patient exhibits clinical
evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than
the upper limit of normal. Patients with severe dyskinesia or dystonia should
be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND
ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER
INJURY IF TASMAR IS REINTRODUCED. A CCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY
BE CONSIDERED FOR RETREATMENT.
Cases of severe hepatocellular injury, including fulminant liver failure
resulting in death, have been reported in postmarketing use. As of May 2005,
3 cases of fatal fulminant hepatic failure have been reported from more than
40,000 patient years of worldwide use. This incidence may be 10- to 100-fold
higher than the background incidence in the general population. Underreporting
of cases may lead to significant underestimation of the increased risk associated
with the use of TASMAR. All 3 cases were reported within the first six months
of initiation of treatment with TASMAR. Analysis of the laboratory monitoring
data in over 3,400 TASMAR­treated patients participating in clinical trials
indicated that increases in SGPT/ALT or SGOT/AST, when present, generally occurred
within the first 6 months of treatment with TASMAR.
A prescriber who elects to use TASMAR in face of the increased risk of liver
injury is strongly advised to monitor patients for evidence of emergent liver
injury. Patients should be advised of the need for self-monitoring for both
the classical signs of liver disease (eg, clay colored stools, jaundice) and
the nonspecific ones (eg, fatigue, loss of appetite, lethargy).
Although a program of periodic laboratory monitoring for evidence of hepatocellular
injury is recommended, it is not clear that periodic monitoring of liver enzymes
will prevent the occurrence of fulminant liver failure. However, it is generally
believed that early detection of drug-induced hepatic injury along with immediate
withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly,
the following liver monitoring program is recommended.
Before starting treatment with TASMAR, the physician should conduct appropriate
tests to exclude the presence of liver disease. In patients determined to
be appropriate candidates for treatment with TASMAR, serum glutamic-pyruvic
transaminase (SGPT/ALT) and serum glutamic-oxaloacetic transaminase (SGOT/AST)
levels should be determined at baseline and periodically (i.e. every 2 to
4 weeks) for the first 6 months of therapy. After the first six months, periodic
monitoring is recommended at intervals deemed clinically relevant. Although
more frequent monitoring increases the chances of early detection, the precise
schedule for monitoring is a matter of clinical judgement. If the dose is
increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing the
dose and then be conducted every 2 to 4 weeks for the following 6 months of
therapy. After six months, periodic monitoring is recommended at intervals
deemed clinically relevant.
TASMAR should be discontinued if SGPT/ALT or SGOT/AST levels exceed 2 times
the upper limit of normal or if clinical signs and symptoms suggest the onset
of hepatic dysfunction (persistent nausea, fatigue, lethargy, anorexia, jaundice,
dark urine, pruritus, and right upper quadrant tenderness).

DRUG DESCRIPTION



What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
fever, stiff muscles, confusion, and sweating (especially when you first start taking...
Read All Potential Side Effects for Tasmar »




TASMAR® is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used
in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an
adjunct non- to hygroscopic, crystalline compound with a relative molecular
mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone.
Its empirical formula is C14H11NO5 and its
structural formula is:








Inactive ingredients
Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate
anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate.
Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose,
triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg
— yellow and red iron oxide; 200 mg — red iron oxide.Last reviewed on RxList: 3/12/2009





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Other reviews about Tasmar on web:

The use of TASMAR® (tolcapone) as an adjunct therapy to levodopa and carbidopa can help to bring Parkinson’s disease symptoms under control. Tasmar tolcapone: An Adjunct Parkinson’s Disease Therapy


Learn about the prescription medication Tasmar (Tolcapone), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Tasmar (Tolcapone) Drug Information: Uses, Side Effects, Drug ...


Tasmar information from Drugs.com. Tasmar helps to relieve the muscle stiffness, tremor, and weakness caused by Parkinson's disease. When taken with Sinemet (levodopa/carbidopa ... Tasmar patient advice including side effects


Accurate, FDA approved Tasmar information for healthcare professionals and patients - brought to you by Drugs.com. Tasmar Official FDA information, side effects and uses.


TASMAR® (tolcapone) is an adjunct oral medication that is used in combination levodopa and carbidopa for patients with severe Parkinson's disease who are not responding ... Valeant » Products & Pipeline » Neurology » Tasmar®


TASMAR® (tolcapone) is an adjunct (additional) oral medicine that used in combination with other Parkinson’s medicines, such as Levodopa and Carbidopa. About Tasmar tolcapone


Buy Tasmar (Tolcapone) from our Canadian Online Pharmacy by calling 1-877-888-3562. Fully licensed, fast delivery, free doctor consultation provided. Buy Tasmar (Tolcapone) Online Now


Tasmar is a prescription medication that is approved for treating the symptoms of Parkinson's disease. This eMedTV page takes a closer look at Tasmar, including information on how ... Tasmar


A Drug Recall provides Tasmar information, news and resources on drug recalls. Contact a drug recall lawyer for your legal rights! Tasmar -Defective Drug Information


Tasmar and Tolcapone Information. News and Information on Tasmar, Attorneys and Lawyers at LegalView.info Tasmar and Tolcapone - Attorney, Lawsuit, Law Suit, Case, Claim ...





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