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EQUETRO
Overview
What is EQUETRO?
EQUETRO (carbamazepine) is a mood stabilizer 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. The chemical name of carbamazepine is 5H-dibenz[b,f]azepine-5-carboxamide, and the 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:
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.
What does EQUETRO look like?
What are the available doses of EQUETRO?
Extended-Release Capsules: 100 mg, 200 mg, and 300 mg ()
What should I talk to my health care provider before I take EQUETRO?
Pregnancy
Nursing Mothers
How should I use EQUETRO?
EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder
.
Prior to initiating treatment with EQUETRO, test patients with ancestry in genetically at-risk populations for the presence of the HLA-B*1502 allele. The high resolution genotype test is positive if one or two HLA-B*1502 alleles are present. Avoid use of EQUETRO in patients testing positive for the allele, unless the benefit clearly outweighs the risk
.
Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, 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 EQUETRO should be considered if any evidence of significant bone marrow depression develops
Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with EQUETRO because liver damage may occur. Discontinue EQUETRO in cases of aggravated liver dysfunction or active liver disease
.
Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes
.
Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction.
What interacts with EQUETRO?
Sorry No Records found
What are the warnings of EQUETRO?
Sorry No Records found
What are the precautions of EQUETRO?
Sorry No Records found
What are the side effects of EQUETRO?
Sorry No records found
What should I look out for while using EQUETRO?
Bone marrow depression ()
Known hypersensitivity to carbamazepine ()
Known hypersensitivity to tricyclic antidepressants ()
Concomitant use with monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing an MAOI ()
Concomitant use with delavirdine or other non-nucleoside reverse transcriptase inhibitors that are substrates for CYP3A4. EQUETRO decreases efficacy of these drugs (, )
Concomitant use of nefazodone ()
S
erious Dermatologic Reactions and
HLA-B*1502
Allele
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have
occurred
in patients
treat
ed
with carbamazepine.
These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash.
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
patients
of
Asian
descent
is estimat
ed to be about 10 times higher.
There is
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.
Test fo
r
HLA-B*1502
,
prior to initiating EQUETRO
in patients
with an increased
likelihood of carrying this
allele
.
Avoid use of
EQUETRO
in patients testing positive for the allele
unless the benefit clearly outweighs the risk
.
Discontinue EQ
U
ETRO if
you suspect that the patient has
a serious dermatologic reaction
[see Warnings and Precautions (
)]
.
A
plastic Anemia and Agranulocytosis
Aplastic anemia and agranulocytosis
can occur
during treatment
with
EQUETRO
.
The risk of developing these reactions
with
EQUETRO
is 5-8 times greater
t
han in the general population.
However, the overall risk in the general population is low
(6
cases in a population of one million
per year for agranulocytosis and two
cases in a population of
one million per year for aplastic anemia
)
.
O
btain a complete
blood count before beginning
treatment
with
EQUETRO, and monitor
CBC periodicall
y
.
Consider discontinuing EQUETRO if significant bone marrow depression develops
[see Warnings and Precautions (
)
]
.
What might happen if I take too much EQUETRO?
How should I store and handle EQUETRO?
Store at 25° C (77°F); excursions permitted to 15°–30° C (59°–86° F) [see USP controlled room temperature].Protect from light and moisture.Store at 25° C (77°F); excursions permitted to 15°–30° C (59°–86° F) [see USP controlled room temperature].Protect from light and moisture.Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880Lisinopril Tablets, USP 20 mg: Red, Mottled, Round Tablet; Debossed “WW 268”Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Repacked byAidarex Pharmaceuticals, LLCCorona, CA 92880
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although numerous pharmacological effects of carbamazepine have been described in the published literature (e.g., modulation of ion channels [sodium and calcium], receptor-mediated neurotransmission [GABAergic, glutamatergic, and monoaminergic], and intracellular signaling pathways in experimental preparations), the contribution of these effects to the efficacy of carbamazepine in acute manic or mixed episodes associated with bipolar disorder is unknown.
Non-Clinical Toxicology
Bone marrow depression ()Known hypersensitivity to carbamazepine ()
Known hypersensitivity to tricyclic antidepressants ()
Concomitant use with monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing an MAOI ()
Concomitant use with delavirdine or other non-nucleoside reverse transcriptase inhibitors that are substrates for CYP3A4. EQUETRO decreases efficacy of these drugs (, )
Concomitant use of nefazodone ()
S
erious Dermatologic Reactions and
HLA-B*1502
Allele
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have
occurred
in patients
treat
ed
with carbamazepine.
These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash.
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
patients
of
Asian
descent
is estimat
ed to be about 10 times higher.
There is
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.
Test fo
r
HLA-B*1502
,
prior to initiating EQUETRO
in patients
with an increased
likelihood of carrying this
allele
.
Avoid use of
EQUETRO
in patients testing positive for the allele
unless the benefit clearly outweighs the risk
.
Discontinue EQ
U
ETRO if
you suspect that the patient has
a serious dermatologic reaction
[see Warnings and Precautions (
)]
.
A
plastic Anemia and Agranulocytosis
Aplastic anemia and agranulocytosis
can occur
during treatment
with
EQUETRO
.
The risk of developing these reactions
with
EQUETRO
is 5-8 times greater
t
han in the general population.
However, the overall risk in the general population is low
(6
cases in a population of one million
per year for agranulocytosis and two
cases in a population of
one million per year for aplastic anemia
)
.
O
btain a complete
blood count before beginning
treatment
with
EQUETRO, and monitor
CBC periodicall
y
.
Consider discontinuing EQUETRO if significant bone marrow depression develops
[see Warnings and Precautions (
)
]
.
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. These syndromes may be accompanied by mucous membrane ulcers, fever, or painful rash.Over 90% of carbamazepine-treated patients who experienced SJS/TEN developed these reactions within the first few months of treatment. The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Discontinue EQUETRO if you suspect that the patient has a serious dermatologic reaction. If signs or symptoms suggest SJS/TEN, do not resume treatment with EQUETRO.
SJS, TEN, and HLA-B*1502 Allele
Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with EQUETRO treatment and the presence of the HLA-B*1502 allele (an inherited variant of the HLA-B gene). Prior to initiating EQUETRO therapy in patients at higher likelihood for this allele, perform testing for HLA-B*1502. The high resolution genotype test is positive if one or two HLA-B*1502 alleles are present. Avoid use of EQUETRO in patients positive for the HLA-B*1502 allele unless the benefits clearly outweighs the risks of serious dermatologic reactions. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN associated with carbamazepine treatment.
The prevalence of the HLA-B*1502 allele may be higher in Asian populations: Hong Kong, Thailand, Malaysia, and parts of the Philippines (greater than 15%); Taiwan (10%), North China (4%); south Asians, including Indians (2 to 4%); and Japan and Korea (less than 1%). HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans). The accuracy of estimated rates of the HLA-B*1502 allele in these populations may be limited by wide variability in rates within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry.
The HLA-B*1502 allele has not been found to predict risk of less severe adverse cutaneous reactions from carbamazepine, such as maculopapular eruption (MPE) or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other anti-epileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable .
Hypersensitivity Reactions and HLA-A*3101 Allele
Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-A*3101, an inherited allelic variant of the HLA-A gene, in patients using carbamazepine. These hypersensitivity reactions include SJS/TEN, maculopapular eruptions, and Drug Reaction with Eosinophilia and Systemic Symptoms .
HLA-A*3101 is expected to be present in the following frequencies: greater than 15% in patients of Japanese, Native American, Southern Indian (for example, Tamil Nadu) and some Arabic ancestry; up to about 10% in patients of Han Chinese, Korean, European, Latin American, and other Indian ancestry; and up to about 5% in African-Americans and patients of Thai, Taiwanese, and Chinese (Hong Kong) ancestry.
The risks and benefits of EQUETRO therapy should be weighed before considering EQUETRO in patients known to be positive for HLA-A*3101.
Hypersensitivity
and Limitations of
HLA Genotyping
Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management. Many HLA-B*1502-positive and HLA-A*3101- positive patients treated with EQUETRO will not develop SJS/TEN or other hypersensitivity reactions, and these reactions can still occur infrequently in HLA-B*1502-negative and HLA-A*3101-negative patients of any ethnicity. The role of other possible factors in the development of, and morbidity from, SJS/TEN and other hypersensitivity reactions, such as AED dose, compliance, concomitant medications, co-morbidities, and the level of dermatologic monitoring have not been studied.
The following serious adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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