Equetro
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder.
The efficacy of EQUETRO in acute mania was established in 2 randomized, double-blind, placebo-controlled, 3-week studies in adult patients meeting DSM-IV criteria for bipolar I disorder who had an acute manic or mixed episode [see Clinical Studies (14.1)]. The effectiveness of EQUETRO for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use EQUETRO for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
History
There is currently no drug history available for this drug.
Other Information
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 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: 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.
Sources
Equetro Manufacturers
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Validus Pharmaceuticals Llc
![Equetro (Carbamazepine) Capsule, Extended Release [Validus Pharmaceuticals Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Equetro | Validus Pharmaceuticals Llc
2.1 Dosing InformationThe recommended initial dose of EQUETRO is 200 mg administered twice daily. The dose may be increased by 200 mg per day to achieve optimal clinical response. Doses higher than 1600 mg per day have not been studied in mania associated with bipolar disorder.
When discontinuing treatment, reduce the dose gradually and avoid abrupt discontinuation in order to decrease the risk of seizure [see Warnings and Precautions (5.6)].
2.2 Monitoring Serum Carbamazepine ConcentrationMonitoring serum carbamazepine concentrations may be useful for dose selection, minimizing toxicity, and verifying drug compliance, especially in clinical conditions in which alterations in EQUETRO metabolism can occur (e.g., drug interactions) [see Drug Interactions (7)].
2.3 Laboratory Testing Prior to DosingPrior 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 [see Boxed Warning, Warnings and Precautions (5.1)].
Prior to initiating EQUETRO in all patients, obtain a pre-treatment complete blood count including platelets and differential. Monitor CBC periodically [see Warnings and Precautions (5.2)].
2.4 Administration InstructionsThe EQUETRO capsules may be taken orally or may be opened and the beads sprinkled over food, such as a teaspoon of applesauce. Do not crush or chew EQUETRO capsules. EQUETRO can be taken with or without meals.
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