Luradox 40 Tablet

Generic Name: Lurasidone Hydrochloride

Strength: 40 mg

Presentation: Tablets

Manufacturer: Incepta Pharmaceuticals Ltd.

Indications:

• Schizophrenia

• Depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Pharmacology:

• Lurasidone's effectiveness is thought to be related to its combined action on dopamine D2 and serotonin 5HT2A receptors in the brain.

Dosage and Administration:

• Lurasidone should be taken with food (at least 350 calories). Food significantly increases its absorption.

• Schizophrenia:

  • Starting dose: 40 mg once daily.

  • Recommended dose: 40 mg to 160 mg once daily.

• Bipolar Depression:

  • Starting dose: 20 mg once daily, as monotherapy or with lithium or valproate.

  • Recommended dose: 20 mg to 120 mg once daily, as monotherapy or with lithium or valproate.

Contraindications:

• Hypersensitivity to lurasidone or any component of the formulation.

• Concurrent administration of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil).

• Concurrent administration of strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine).

• Dementia-related psychosis.

Precautions & Warnings:

• Elderly patients with dementia-related psychosis: Increased risk of death with antipsychotics. Lurasidone is not approved for this condition.

• Increased risk of suicidal thoughts and behaviors: Monitor closely, especially in children, adolescents, and young adults.

• Neuroleptic Malignant Syndrome (NMS): Discontinue immediately and monitor closely.

• Tardive dyskinesia: Discontinue if clinically appropriate.

• Metabolic changes: May increase risks of hyperglycemia, dyslipidemia, and weight gain.

• Hyperglycemia and diabetes mellitus: Monitor for symptoms and check glucose regularly in susceptible patients.

• Dyslipidemia: Monitor lipid levels.

• Weight Gain: Monitor weight.

• Hyperprolactinemia: May occur.

• Leukopenia, neutropenia, and agranulocytosis: Monitor WBC in at-risk patients; discontinue if significant decline occurs.

• Orthostatic hypotension and syncope: Dizziness and other symptoms may occur, especially early in treatment. Use with caution in patients with cardiovascular or cerebrovascular disease.

Side Effects:

• Common: Somnolence, akathisia, extrapyramidal symptoms, nausea.

• Less common: Weight gain, insomnia, anxiety, and other gastrointestinal and neurological symptoms.

Pregnancy & Lactation:

• Pregnancy Category B. Use only if the potential benefit justifies the risk to the fetus.

• Lurasidone is excreted in human milk. Consider whether to discontinue nursing or the drug.

Drug Interactions:

• Should not be used with strong CYP3A4 inhibitors or inducers.