Latuda Lurasidone Hydrochloride Tablets

1. Indications and Usage
Schizophrenia:
Treatment of schizophrenia in adults and pediatric patients 13 to 17 years of age.
Bipolar Depression:
Treatment of depressive episodes associated with Bipolar I Disorder (monotherapy or adjunctive with lithium or valproate) in adults and pediatric patients 10 to 17 years of age.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Schizophrenia (Adults):
Starting Dose: 40 mg once daily.
Maintenance: 40 mg to 120 mg once daily.
Maximum: 120 mg once daily.
Bipolar Depression (Adults):
Starting Dose: 20 mg once daily.
Maintenance: 20 mg to 120 mg once daily.
Critical Administration Instruction:
MUST BE TAKEN WITH FOOD: Must be taken with food (at least 350 calories). Taking with food significantly increases absorption (bioavailability).
Dosing Time:
Administer once daily at the same time each day (morning or evening).
3. Mechanism of Action
Receptor Profile:
Lurasidone binds with high affinity to dopamine D2 receptors and serotonin 5-HT2A receptors.
Agonist/Antagonist Activity:
Antagonist: Acts as an antagonist at D2 and 5-HT2A receptors (reducing positive symptoms like hallucinations).
Partial Agonist: Acts as a partial agonist at 5-HT1A receptors (potentially improving negative symptoms and cognition).
Antagonist: Has high affinity for 5-HT7 receptors (blocking which is linked to antidepressant and cognitive effects).
4. Safety and Warnings
Increased Mortality in Elderly with Dementia (Boxed Warning):
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Suicidal Thoughts and Behaviors:
Monitor for the emergence of suicidal ideation and behavior.
Metabolic Changes:
Monitor for hyperglycemia, dyslipidemia, and weight gain.
Neuroleptic Malignant Syndrome (NMS):
A potentially fatal reaction characterized by hyperpyrexia, muscle rigidity, and autonomic instability.
Tardive Dyskinesia:
Risk of developing abnormal, involuntary movements, which may be irreversible.
5.Adverse Reactions
Most Common (Schizophrenia):
Nausea, somnolence, akathisia (inner restlessness), and vomiting.
Most Common (Bipolar Depression):
Somnolence, nausea, akathisia, and vomiting.
6.Drug Interactions
CYP3A4 Substrate:
Lurasidone is primarily metabolized by CYP3A4.
Strong CYP3A4 Inhibitors:
Contraindicated (e.g., ketoconazole, clarithromycin, ritonavir) as they significantly increase lurasidone levels.
Strong CYP3A4 Inducers:
Contraindicated (e.g., rifampin, carbamazepine, St. John’s wort) as they significantly decrease lurasidone levels.
Moderate Inhibitors/Inducers:
Dose adjustments are necessary when used with moderate CYP3A4 inhibitors (e.g., diltiazem) or inducers (e.g., modafinil).
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Lurasidone Hydrochloride.
Available Strength: 20 mg, 40 mg, 60 mg, 80 mg, 120 mg tablets.
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).