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Vraylar
Overview
What is Vraylar?
The active ingredient of VRAYLAR is cariprazine HCl, an atypical antipsychotic. The chemical name is -N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is CHClNO and its molecular weight is 463.9 g/mol.The chemical structure is:
VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains a white to off-white powder of cariprazine HCl, which is equivalent to 1.5, 3, 4.5, or 6 mg of cariprazine base. In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (1.5, 3, and 6 mg), FD&C Blue 1 (3, 4.5, and 6 mg), FD&C Red 3 (6 mg), FD&C Red 40 (3 and 4.5 mg), or yellow iron oxide (3 and 4.5 mg).
What does Vraylar look like?
What are the available doses of Vraylar?
Capsules: 1.5 mg, 3 mg, 4.5 mg, and 6 mg ()
What should I talk to my health care provider before I take Vraylar?
How should I use Vraylar?
VRAYLAR® is indicated for the:
VRAYLAR is given orally once daily and can be taken with or without food.
Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change
.
The maximum recommended dose is 6 mg daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [
].
What interacts with Vraylar?
Sorry No Records found
What are the warnings of Vraylar?
Sorry No Records found
What are the precautions of Vraylar?
Sorry No Records found
What are the side effects of Vraylar?
Sorry No records found
What should I look out for while using Vraylar?
VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and events suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face).
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR (cariprazine) is not approved for the treatment of patients with dementia-related psychosis
[see Warnings and Precautions (
)].
What might happen if I take too much Vraylar?
How should I store and handle Vraylar?
Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.Haloperidol Injection, USP (For Immediate Release) equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows:NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton.Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not freeze.Haloperidol Injection, USP (For Immediate Release) equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows:NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton.Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not freeze.Haloperidol Injection, USP (For Immediate Release) equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows:NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton.Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not freeze.Haloperidol Injection, USP (For Immediate Release) equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows:NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton.Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not freeze.Haloperidol Injection, USP (For Immediate Release) equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows:NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton.Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and events suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face).Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR (cariprazine) is not approved for the treatment of patients with dementia-related psychosis
[see Warnings and Precautions (
)].
Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks and largely in patients taking atypical antipsychotic drugs) revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis .
The following 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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