Zetazolex-1mg
Zetazolex-2
Zetazolex-3
Zetazolex-4
Zetazolex-1mg
Zetazolex-2
Zetazolex-3
Zetazolex-4

Zetazolex

Pharmaceutical

Product Details:

Brand Name: Zetazolex 1mg Tablet

Composition

Each Zetazolex 1mg tablet contains: Brexpiprazole ..................................................... 1 mg.

Each Zetazolex 2mg tablet contains: Brexpiprazole ................................................... 2  mg

Each Zetazolex 3mg tablet contains: Brexpiprazole .................................................... 3 mg

Each Zetazolex 4mg tablet contains: Brexpiprazole ................................................... 4 mg.

Therapeutic Indications                

  • is an atypical antipsychotic indicated for:

○          Use as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

○          Treatment of schizophrenia in adults and pediatric patients ages 13 years and older.

Dosage and Administration:

Administer ZetaZolex once daily with or without food

Indication Starting Dose Recommended Dose Maximum Dose
MDD Adults 0.5 mg/day or 1 mg/day Recommended Dose 3 mg/day

 

Schizophrenia Adults 1 mg/day 2 to 4 mg/day 4 mg/day
Schizophrenia Pediatric (13 - 17 years) 0.5 mg/day 2 to 4 mg/day 4 mg/day

 

 

  • Moderate to Severe Hepatic Impairment (Child-Pugh score ≥7): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia.
  • Moderate, Severe, or End-Stage Renal Impairment (CrCl<60 mL/minute): Maximum recommended dosage is 2 mg once daily for
  • patients with MDD and 3 mg once daily for patients with schizophrenia.
  • Known CYP2D6 Poor Metabolizers: Reduce the usual dosage by half

Contraindications:       

  • Known hypersensitivity to Zetazolex or any of its components

Warnings and precautions:            

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).
  • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring.
  • Tardive Dyskinesia: Discontinue if clinically appropriate.
  • Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
  • Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation.
  • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing Zetazolex if a clinically significant decline in WBC occurs in absence of other causative factors.
  • Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope.

Seizures: Use cautiously in patients with a history of seizures or with conditions that lower

  • the seizure threshold.

Undesirable Effects:       

  • Most common adverse reactions in adults were (6.1):
    • MDD: Weight increased and akathisia (≥5% and at least twice the rate for placebo)
    • Schizophrenia: Weight increased (≥4% and at least twice the rate for placebo).

Pharmacological Properties:       

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-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

Packaging:                

Zetazolex 1mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 2mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 3mg Tablets: Box containing 3 blisters of 10 tablets each.

Zetazolex 4mg Tablets: Box containing 3 blisters of 10 tablets each.