Equetro: For Treatment of Acute Manic & Mixed Episodes of Bipolar I Disorder

How many times a day do I need to take Equetro?

Equetro is typically taken twice a day,
as determined by your healthcare provider.

What should I do if I miss a dose of Equetro?

If you miss a dose of Equetro, it is usually best to take it as soon as you remember, but check with your doctor.

Can Equetro be taken with other medications?

Equetro can react with other medications. When Equetro is taken in combination with certain medications, including oral contraceptives, over-the-counter drugs, or herbal products, levels of Equetro or the other medications can be affected. Be sure to tell your healthcare provider about any other medications you are taking, since he or she may want to adjust the dose of one or more of the medications.

What are the common side effects of Equetro?

The most common side effects, especially when starting Equetro, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. In clinical trials, these side effects were usually mild to moderate. If you experience side effects while taking Equetro, talk to your doctor. He or she may want to adjust your dose. Caution should be used when operating machinery or an automobile.

Are there serious side effects associated with carbamazepine?

Carbamazepine, the active ingredient in Equetro, has been associated with rare but serious types of blood disorders. Your healthcare provider may order blood tests to check for those disorders. Carbamazepine has also been associated with rare, but serious types of rash and blood cell disorders.

Contact your healthcare provider if you have any unexplained bruising, fever, or infection, or if a rash develops.

Will I Gain a Lot of Weight While Taking Equetro?

No. Most people who took Equetro in clinical trials did not gain weight. In clinical trials lasting 3 weeks, people taking Equetro gained an average of 2.3 lb, while people in the same clinical trials who took sugar pills instead of Equetro gained an average of 0.1 lb. And, in a 6-month long-term study, patients taking Equetro averaged a loss of nearly 1 lb. Minimizing weight gain is an important advantage of Equetro therapy because being overweight or obese may be linked to serious health problems.

People who are currently taking another medication that contains carbamazepine should not begin taking Equetro without discussing it with their healthcare provider. People with a history of bone marrow problems, or who are allergic to carbamazepine, or who are sensitive to tricyclic antidepressants should not take Equetro. If you are currently taking or have recently taken a monoamine oxidase inhibitor, you should inform your physician, and it is important to inform your doctor if you feel you fall into any of the other categories in this list.

Carbamazepine products have been associated with a rare, but serious dermatologic disorder. Although it occurs only rarely, people of Asian descent have a 10 times greater risk of experiencing this disorder than Caucasians and should consult their healthcare provider for more information.

Are there special considerations for women?

You should not take Equetro if you are pregnant, nursing, or may become pregnant. Equetro may reduce the effectiveness of birth control pills. Before taking Equetro, be sure to discuss any questions about pregnancy, nursing, or birth control with your healthcare provider.

It is commonly recognized that depression, especially when associated with Bipolar Disorder, may be associated with weight gain. Some researchers are beginning to believe that the weight gain that has long been attributed to medications may be caused by other factors as well. Studies suggest that changes in behaviors like appetite, diet, and energy expenditure may influence the weight gain often seen during bipolar episodes. Being aware of these changes in behavior can help control their effects on weight

Weight gain doesn't have to be inevitable. A healthy lifestyle and the low risk of weight gain with Equetro can help you keep your weight in balance during treatment. Here are some useful tips to help you manage your weight:

If you are concerned about the possibility of weight gain, talk with your doctor about your concerns. This information should not take the place of talking to your doctor about treatment, dosing and possible side effects. Please talk to your doctor about any concerns you may have.

Please see Full Prescribing Information including contraindications, warnings and boxed warnings concerning serious and sometimes fatal dermatologic reactions, aplastic anemia, and agranulocytosis with carbamazepine. Equetro contains carbamazepine. Please ensure patient is not taking any other form of carbamazepine.

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 5–8 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.