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Equetro Drug Description
EQUETRO®
(carbamazepine) Extended-Release Capsules

WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL
NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING
TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1
TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS,
BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN
THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY
IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY
IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF
HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH EQUETRO®. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH EQUETRO® UNLESS THE
BENEFIT CLEARLY OUTWEIGHS THE RISK (see WARNINGS
and PRECAUTIONS, Laboratory Tests).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE-CONTROL STUDY DEMONSTRATE
THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE
GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED
GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION
PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER
YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER,
THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE
SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY.
NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED
AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED
WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.
DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.

Before prescribing EQUETRO®, the physician should be thoroughly familiar
with the details of this prescribing information, particularly regarding use
with other drugs, especially those which accentuate toxicity potential.
DRUG DESCRIPTION



What are the possible side effects of carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)?

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 new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these...
Read All Potential Side Effects for Equetro »




EQUETRO® is available for oral administration as 100 mg, 200 mg, and 300
mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white
to off-white powder, practically insoluble in water and soluble in alcohol and
in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide,
and its structural formula is:








EQUETRO® is a multi-component capsule formulation consisting of three different
types of beads: immediate-release beads, extended-release beads, and enteric-release
beads. The three bead types are combined in a specific ratio to provide twice-daily
dosing of EQUETRO®.
Inactive ingredients: citric acid, colloidal silicon dioxide, lactose
monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium
lauryl sulfate, talc, triethyl citrate, and other ingredients.
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron
Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule
shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium
Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain
gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are
imprinted with white ink.Last reviewed on RxList: 5/29/2009




Equetro Drug Description
EQUETRO®
(carbamazepine) Extended-Release Capsules

WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL
NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING
TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1
TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS,
BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN
THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY
IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY
IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF
HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH EQUETRO®. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH EQUETRO® UNLESS THE
BENEFIT CLEARLY OUTWEIGHS THE RISK (see WARNINGS
and PRECAUTIONS, Laboratory Tests).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE-CONTROL STUDY DEMONSTRATE
THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE
GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED
GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION
PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER
YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER,
THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE
SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY.
NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED
AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED
WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.
DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.

Before prescribing EQUETRO®, the physician should be thoroughly familiar
with the details of this prescribing information, particularly regarding use
with other drugs, especially those which accentuate toxicity potential.
DRUG DESCRIPTION



What are the possible side effects of carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)?

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 new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these...
Read All Potential Side Effects for Equetro »




EQUETRO® is available for oral administration as 100 mg, 200 mg, and 300
mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white
to off-white powder, practically insoluble in water and soluble in alcohol and
in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide,
and its structural formula is:








EQUETRO® is a multi-component capsule formulation consisting of three different
types of beads: immediate-release beads, extended-release beads, and enteric-release
beads. The three bead types are combined in a specific ratio to provide twice-daily
dosing of EQUETRO®.
Inactive ingredients: citric acid, colloidal silicon dioxide, lactose
monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium
lauryl sulfate, talc, triethyl citrate, and other ingredients.
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron
Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule
shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium
Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain
gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are
imprinted with white ink.Last reviewed on RxList: 5/29/2009




Equetro Drug Description
EQUETRO®
(carbamazepine) Extended-Release Capsules

WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL
NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING
TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1
TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS,
BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN
THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY
IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY
IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF
HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH EQUETRO®. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH EQUETRO® UNLESS THE
BENEFIT CLEARLY OUTWEIGHS THE RISK (see WARNINGS
and PRECAUTIONS, Laboratory Tests).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE-CONTROL STUDY DEMONSTRATE
THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE
GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED
GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION
PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER
YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER,
THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE
SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY.
NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED
AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED
WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.
DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.

Before prescribing EQUETRO®, the physician should be thoroughly familiar
with the details of this prescribing information, particularly regarding use
with other drugs, especially those which accentuate toxicity potential.
DRUG DESCRIPTION



What are the possible side effects of carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)?

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 new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these...
Read All Potential Side Effects for Equetro »




EQUETRO® is available for oral administration as 100 mg, 200 mg, and 300
mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white
to off-white powder, practically insoluble in water and soluble in alcohol and
in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide,
and its structural formula is:








EQUETRO® is a multi-component capsule formulation consisting of three different
types of beads: immediate-release beads, extended-release beads, and enteric-release
beads. The three bead types are combined in a specific ratio to provide twice-daily
dosing of EQUETRO®.
Inactive ingredients: citric acid, colloidal silicon dioxide, lactose
monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium
lauryl sulfate, talc, triethyl citrate, and other ingredients.
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron
Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule
shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium
Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain
gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are
imprinted with white ink.Last reviewed on RxList: 5/29/2009




Equetro Drug Description
EQUETRO®
(carbamazepine) Extended-Release Capsules

WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL
NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING
TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1
TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS,
BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN
THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY
IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY
IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF
HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH EQUETRO®. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH EQUETRO® UNLESS THE
BENEFIT CLEARLY OUTWEIGHS THE RISK (see WARNINGS
and PRECAUTIONS, Laboratory Tests).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE-CONTROL STUDY DEMONSTRATE
THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE
GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED
GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION
PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER
YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER,
THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE
SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY.
NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED
AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED
WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.
DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.

Before prescribing EQUETRO®, the physician should be thoroughly familiar
with the details of this prescribing information, particularly regarding use
with other drugs, especially those which accentuate toxicity potential.
DRUG DESCRIPTION



What are the possible side effects of carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)?

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 new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these...
Read All Potential Side Effects for Equetro »




EQUETRO® is available for oral administration as 100 mg, 200 mg, and 300
mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white
to off-white powder, practically insoluble in water and soluble in alcohol and
in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide,
and its structural formula is:








EQUETRO® is a multi-component capsule formulation consisting of three different
types of beads: immediate-release beads, extended-release beads, and enteric-release
beads. The three bead types are combined in a specific ratio to provide twice-daily
dosing of EQUETRO®.
Inactive ingredients: citric acid, colloidal silicon dioxide, lactose
monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium
lauryl sulfate, talc, triethyl citrate, and other ingredients.
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron
Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule
shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium
Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain
gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are
imprinted with white ink.Last reviewed on RxList: 5/29/2009




Equetro Drug Description
EQUETRO®
(carbamazepine) Extended-Release Capsules

WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE
SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL
NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING
TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1
TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS,
BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER.
STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN
THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY
IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY
IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF
HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH EQUETRO®. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH EQUETRO® UNLESS THE
BENEFIT CLEARLY OUTWEIGHS THE RISK (see WARNINGS
and PRECAUTIONS, Laboratory Tests).
APLASTIC ANEMIA AND AGRANULOCYTOSIS
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE-CONTROL STUDY DEMONSTRATE
THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5–8 TIMES GREATER THAN IN THE
GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED
GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION
PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER
YEAR FOR APLASTIC ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE
BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE,
DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER,
THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE
SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA,
THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY.
NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED
AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED
WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY.
DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.

Before prescribing EQUETRO®, the physician should be thoroughly familiar
with the details of this prescribing information, particularly regarding use
with other drugs, especially those which accentuate toxicity potential.
DRUG DESCRIPTION



What are the possible side effects of carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR)?

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 new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these...
Read All Potential Side Effects for Equetro »




EQUETRO® is available for oral administration as 100 mg, 200 mg, and 300
mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white
to off-white powder, practically insoluble in water and soluble in alcohol and
in acetone. Its molecular weight is 236.27. Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide,
and its structural formula is:








EQUETRO® is a multi-component capsule formulation consisting of three different
types of beads: immediate-release beads, extended-release beads, and enteric-release
beads. The three bead types are combined in a specific ratio to provide twice-daily
dosing of EQUETRO®.
Inactive ingredients: citric acid, colloidal silicon dioxide, lactose
monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium
lauryl sulfate, talc, triethyl citrate, and other ingredients.
The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron
Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule
shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium
Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain
gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are
imprinted with white ink.Last reviewed on RxList: 5/29/2009





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  by kerriesmyres
Patients taking antiepileptic drugs had nearly twice the risk of suicidal behavior or thoughts than those taking a placebo, according to FDA analysis. Epilepsy drugs are commonly prescribed […]


Link Between Antiepileptic Drugs and Suicidal Thoughts or Behaviors Distilled
  by kerriesmyres
FDA's warning about suicidal thoughts and behaviors in people taking anti-seizure meds distilled: "For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA […]


Suicide risk warning for Lyrica & Neurontin
  by linzworld
The US FDA has recently issued a warning that Lyrica, Neurontin and other anticonvulsants could cause increase a patient's risk of suicidal thoughts and behaviors. Lyrica is the only drug […]


Antiepileptic-Class Drugs Increase Risk for Suicidality
  by pchalita
Patients who take antiepileptics have double the risk for suicidal thoughts and behaviors (suicidality), the FDA warned on Thursday. The agency […]


Hvor lavt kan Hamas synke?
  by Anna Lyttiger
Ubegrænset, ser det ud til. Hamas har fÃ¥et humanitær hjælp af Israel (!!!), blandt andet medicin. Det siger de sÃ¥ tak for ved at bygge medicinemballagen om til […]


Hamas Turned Drug Containers Into Weapons.
  by lilo97423
The world gets crazier every day. Just when you thought you heard it all, here is a new one. During the three weeks of Israel's operation against Hamas, the […]


MedWatch
  by clementine
still taking a break but i just received this email from the FDA and found it interesting: MedWatch- The FDA Safety Information and Adverse Event Reporting Program The April 2009 […]


What Are Mood Stabilizers?
  by depressioninfoblog
The term mood stabilizer is widely used to describe drugs such as lithium (Eskalith CR, Lithobid), valproate (Depacon, Depakene, Depakote), carbamazepine (Equetro, Tegretol) and lamotrigine (Lamictal), which are […]



Other reviews about Equetro on web:

Equetro, the first and only carbamazepine product indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. Equetro: For Treatment of Acute Manic & Mixed Episodes of Bipolar ...


Equetro (carbamazepine) is used for the treatment of acute manic and mixed episodes associated with bipolar disorder. Includes Equetro side effects, interactions and indications. Equetro Information from Drugs.com


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


Equetro information from Drugs.com. Equetro is used to treat acute manic and mixed episodes of Bipolar I Disorder. A manic episode is a time of abnormally elevated, unreserved ... Equetro patient advice including side effects


Equetro is a prescription drug approved to help manage certain episodes of bipolar disorder. This eMedTV article provides a detailed overview of the medication, including tips on ... Equetro


Carbamazepine has been sold under the names Tegretol, Biston, Calepsin, Carbatrol, Epitol, Equetro, Finlepsin, Sirtal, Stazepine, Telesmin, Teril, Timonil, Trimonil, Epimaz ... Carbamazepine - Wikipedia, the free encyclopedia


Why It Is Prescribed. Carbamazepine is used alone or in combination with other medications to treat certain types of seizures in patients with epilepsy. Equetro - Kosmix : Reference, Videos, Images, News, Shopping and ...


Find patient medical information for Equetro Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Equetro Oral : Uses, Side Effects, Interactions, Pictures ...


Carbamazepine (sold under the brand-names Biston, Calepsin, Carbatrol, Epitol, Equetro, Finlepsin, Sirtal, Stazepine, Tegretol, Telesmin, Ti... Equetro: 182 user reviews - DailyStrength


Shire Pharmaceuticals Group has announced that the US Food & Drug Administration (FDA) has approved Equetro, which is an extended-release form of carbamazepine capsules, for the ... Equetro Approved for the Treatment of Bipolar Disorder





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