Zetazolex

Brand Name: Zetazolex 0.25mg , 0.5mg , 1mg , 2mg , 3mg , 4mg Tablet

Composition

Each Zetazolex 1mg tablet contains: 

Brexpiprazole 0.25mg , 0.5mg , 1mg , 2mg , 3mg , 4mg 1 mg

Therapeutic Indications

• is an atypical antipsychotic indicated for:
  •  Use as an 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

• 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