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REXULTI

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Overview

What is REXULTI?

Brexpiprazole, an atypical antipsychotic, is available as REXULTI (brexpiprazole) tablets. Brexpiprazole is 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1)-one. The empirical formula is CHNOS and its molecular weight is 433.57. The chemical structure is:

REXULTI tablets are for oral administration and are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths. Inactive ingredients include lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc. Colorants include titanium dioxide, iron oxide and ferrosferric oxide.



What does REXULTI look like?



What are the available doses of REXULTI?

Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg ()

What should I talk to my health care provider before I take REXULTI?

Pregnancy:

8.1

How should I use REXULTI?

REXULTI is indicated for:

The recommended starting dosage for REXULTI as adjunctive treatment is 0.5 mg or 1 mg once daily, taken orally with or without food

Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment.


What interacts with REXULTI?

Sorry No Records found


What are the warnings of REXULTI?

Sorry No Records found


What are the precautions of REXULTI?

Sorry No Records found


What are the side effects of REXULTI?

Sorry No records found


What should I look out for while using REXULTI?

REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.

Use with Other CNS Depressants

Use with Imipramine and Desipramine

Drugs that inhibit alprazolam metabolism via cytochrome P450 3A

Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)

Drugs and other substances demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam)

in vitro

in vivo

in vitro

Drugs demonstrated to be inducers of CYP3A


What might happen if I take too much REXULTI?

There is limited clinical trial experience regarding human overdosage with REXULTI.

Consult a Certified Poison Control Center ( or ) for up-to-date guidance and advice regarding a REXULTI overdosage. Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.


How should I store and handle REXULTI?

Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .Alprazolam tablets are available as follows: (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’)Bottles of 20 NDC 68788-6865-2Bottles of 30 NDC 68788-6865-3Bottles of 60 NDC 68788-6865-6Bottles of 90 NDC 68788-6865-9 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Alprazolam tablets are available as follows: (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’)Bottles of 20 NDC 68788-6865-2Bottles of 30 NDC 68788-6865-3Bottles of 60 NDC 68788-6865-6Bottles of 90 NDC 68788-6865-9 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Alprazolam tablets are available as follows: (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’)Bottles of 20 NDC 68788-6865-2Bottles of 30 NDC 68788-6865-3Bottles of 60 NDC 68788-6865-6Bottles of 90 NDC 68788-6865-9 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Alprazolam tablets are available as follows: (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’)Bottles of 20 NDC 68788-6865-2Bottles of 30 NDC 68788-6865-3Bottles of 60 NDC 68788-6865-6Bottles of 90 NDC 68788-6865-9 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Alprazolam tablets are available as follows: (White colored, oval shaped biconvex tablets one side debossed by ‘N’ on the left side and ‘A’ on the right side of score line and other side debossed with ‘0.25’)Bottles of 20 NDC 68788-6865-2Bottles of 30 NDC 68788-6865-3Bottles of 60 NDC 68788-6865-6Bottles of 90 NDC 68788-6865-9 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of brexpiprazole in the treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT and dopamine D receptors, and antagonist activity at serotonin 5-HT receptors.

Non-Clinical Toxicology
REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.

Array

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death 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 the placebo group.

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. REXULTI 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:

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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