Product Description.:
SPD417, SPD417 200mg
capsule , blue yellow , oblong oblong
OpaqueWhite ink
Equetro may be an appropriate choice for Bipolar I patients who have mood swings with frequent cycles of mania.
The active ingredient in Equetro? --a chemical called carbamazepine-- has been extensively studied and has been in use for many years for the treatment of a number of disorders. The patented Equetro extended release capsule is the only form of carbamazepine that has been studied and FDA-approved for the treatment of Bipolar I Disorder.
* Inside each Equetro capsule is the patented Microtrol? form of carbamazepine which precisely and automatically releases the medication into your system over 12 hours. This patented medication is the only form of carbamazepine approved by the US Food and Drug Administration to treat acute manic, and mixed episodes associated with Bipolar I Disorder.
* Equetro's patented Microtrol? technology uses a unique system designed to help patients maintain a smooth level of medication in their system at all times. This is achieved by using three different types of time-release beads within each capsule. Equetro's Microtrol? technology slowly releases carbamazepine, a medicine which helps stabilize the irregular moods associated with Bipolar Disorder.
Equetro is Safe and Generally Tolerated
It's reassuring to know that Equetro safety and tolerability have been studied over extended periods of time, and studies show that the risk of having adverse reactions to the drug diminishes substantially over the first three months of treatment.
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 populationbased case-control study demonstrate that the risk of developing these reactions is 5�� 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.
