Caplyta (Lumateperone)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Caplyta (lumateperone) is a prescription medication used for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder in adults.
Caplyta comes in 10.5 mg, 21 mg, and 42 mg capsules for oral administration.
Fact Table
Formula
C24H28N4O2S
License
US FDA
Bioavailability
4.4%
Legal status
Prescription only (Rx)
Chemical Name
Lumateperone
Elimination half-life
13-21 hours
Dosage (Strength)
42 mg capsules
Pregnancy
Consult a doctor
Brands
Caplyta
Protein binding
97%
PubChem CID
11289567
MedlinePlus
a620043
ChEBI
134574698
ATC code
N05AX15
DrugBank
DB12362
KEGG
D11274
Routes of administration
Oral
Directions
Caplyta should be taken as your healthcare provider has directed. Your healthcare provider will decide on a treatment plan that’s appropriate for you. Caplyta dosing will also be determined by your healthcare provider.
The medication guide that accompanies your prescription should be thoroughly read. Reach out to your healthcare provider or pharmacist about any questions or concerns you have about the medication.
Recommended dosing: Take 42 mg by mouth one time a day. The medication may be taken with or without food. A smaller dose (21 mg one time a day) is recommended for patients with moderate or severe liver problems.
Caplyta medication should be stored away from children and kept at room temperature (68°F to 77°F [20°C to 25°C]).
Ingredients
Lumateperone is the active ingredient in Caplyta.
Croscarmellose sodium, gelatin, magnesium stearate, mannitol, talc, FD&C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD&C red #3 (10.5 mg), and titanium dioxide (10.5 mg, 21 mg, and 42 mg) are the inactive ingredients included.
Contraindications
Patients who are allergic to lumateperone or to any of the other ingredients in Caplyta should not take it.
Cautions
- Caplyta is associated with the following FDA Boxed Warning:
- Elderly patients with dementia-related psychosis who are receiving antipsychotic drugs are at increased risk of death. Caplyta is not approved for treating patients with dementia-related psychosis.
- Pediatrics and young adults who take antidepressants are at increased risk of risk of suicidal thoughts and behaviors. The worsening or occurrence of suicidal thoughts and behaviors should be monitored in all patients who are receiving antidepressants. Caplyta’s safety and efficacy in pediatric patients is not known.
- Before Caplyta treatment is initiated, inform your healthcare provider:
- Of all the medications you take, including prescription and nonprescription medications, vitamins, herbals, and supplements
- Of your allergies
- Of your current health problems
- Of your past medical history
- If you are pregnant or breastfeeding
- The following may occur during treatment with Caplyta:
- Cerebrovascular adverse reactions in elderly patients who have dementia-related psychosis
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- Metabolic changes, such as high blood sugar, abnormal lipid levels, and increased weight
- Abnormal levels of blood cells, including white blood cells
- Blood pressure that is low, episodes of fainting, and dehydration
- Seizures
- Cognitive and motor dysfunction
Side Effects
Caplyta side effects include but are not limited to sleepiness, sedation, dry mouth, dizziness, and nausea. Notify your healthcare provider right away if you have bothersome or persistent side effects.
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Reference
Caplyta. New York, NY: Intra-Cellular Therapies, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14554
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