Latuda Tablets / Film-coated
Lurasidone
18.5mg
SUNOVION PHARMACEUTICALS EUROPE LTD.
| Pack size | 28's (14's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 591.50 AED |
Available as:
Indications
Latuda Tablets / Film-coated is used for:
Psychotic Disorder, Schizophrenia, bipolar depression.
Adult Dose
Schizophrenia
40 mg PO once daily initially; may increase to 80 mg/day if needed; not to exceed 160 mg/day
Bipolar Depression
Indicated for major depressive episodes associated with bipolar I disorder; may be used as either monotherapy or adjunctive therapy with lithium or valproate
20 mg PO once daily initially; may increase dose if needed, not to exceed 120 mg/day
Hepatic impairment
Mild (Child-Pugh class A): Dosage adjustment may not be necessary; use caution
Moderate (Child-Pugh class B): 20 mg/day initially; not to exceed 80 mg/day
Severe (Child-Pugh class C): 20 mg/day initially; not to exceed 40 mg/day
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
CrCl 50 mL/min or greater: Dosage adjustment not required
CrCl <50 mL/min: 20 mg/day initially; not to exceed 80 mg/day
Administration
Should be taken with food
Contra Indications
Hypersensitivity. Concurrent administration of strong CYP3A4 inhibitors (eg, Ketoconazole). Concurrent administration of strong CYP3A4 inducers (eg, Rifampin).
Dementia-related psychosis.
Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants
Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack).
Neuroleptic malignant syndrome: Manage with immediate discontinuation and close monitoring.
Tardive dyskinesia: Discontinue if clinically appropriate.
Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that may
increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
Hyperglycemia and diabetes mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia,
polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.
Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
Weight Gain: Gain in body weight has been observed. Monitor weight.
Hyperprolactinemia: Prolactin elevations may occur.
Leukopenia, neutropenia and agranulocytosis: Perform complete blood counts (CBC) in patients with a
pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Lurasidone if a clinically significant decline in WBC occurs in the absence of other causative factors.
Orthostatic hypotension and syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. In patients with known cardiovascularor cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.
Lactation: Unknown whether drug is distributed in breast milk; use caution
Pregnancy-Lactation
Pregnancy
Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone during pregnancy
National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearchprograms/pregnancyregistry
Lactation
Unknown whether drug is distributed in breast milk
Lurasidone is present in rat milk
Consider development and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Adverse Effects
Side effects of Lurasidone :
>10%
Somnolence, dose related (22%), Akathisia, dose related (15%), Fasting glucose increased (10-14%), Nausea (12%), Parkinsonism (11%)
1-10%
Vomiting (8%), Dyspepsia (8%), Anxiety (8%), Agitation (6%), Anxiety (6%), Dystonia (5%), Dizziness (5%), Fatigue (4%), Back pain (4%), Restlessness (3%), Salivary hypersecretion (2%)
Mechanism of Action
The mechanism of action of Lurasidone in the treatment of schizophrenia and bipolar depression is unknown. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.
Note
Latuda 18.5mg Tablets / Film-coated manufactured by SUNOVION PHARMACEUTICALS EUROPE LTD.. Its generic name is Lurasidone. Latuda is availble in United Arab Emirates.
Farmaco UAE drug index information on Latuda Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.