Latuda: How to use, Side Effects, Dosage

Latuda: How to use, Side Effects, Dosage

What is Latuda?

LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives.

LATUDA tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 80 mg, or 120 mg of lurasidone hydrochloride.

Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminium Lake.

Chemical name: (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl) piperazin-1­ylmethyl] cyclohexylmethyl} hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride

Molecular formula: C28H36N4O2S

Molecular weight: 529.14

Color: white to off-white

Soluble in: water, ethanol, methanol, ecetone

Insoluble in: 0.1 N HCL, toluene

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Dosage of Latuda

LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA.

Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day.

Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment.

Concomitant Use of a Strong CYP3A4 Inhibitor (e.g., ketoconazole): LATUDA should not be co-administered with a strong CYP3A4 inhibitor.

Concomitant Use of a Strong CYP3A4 Inducer (e.g., rifampin): LATUDA should not be co-administered with a strong CYP3A4 inducer.

Concomitant Use of a Moderate CYP3A4 inhibitor (e.g., diltiazem): LATUDA dose should be reduced to half of the original dose level. Recommended starting dose is 20 mg per day. Maximum recommended dose is 80 mg per day.

Concomitant Use of a Moderate CYP3A4 Inducer: It may be necessary to increase the dose of LATUDA.

Overdosage

Human Experience: In premarketing clinical studies, accidental or intentional overdosage of LATUDA was identified in one patient who ingested an estimated 560 mg of LATUDA. This patient recovered without sequelae. This patient resumed LATUDA treatment for an additional two months.

Management of Overdosage: Consult a Certified Poison Control Center for up-to-date guidance and advice. There is no specific antidote to LATUDA, therefore, appropriate supportive measures should be instituted and close medical supervision and monitoring should continue until the patient recovers. Consider the possibility of multiple-drug overdose.

Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with an acute overdose of LATUDA.

Similarly, the alpha-blocking properties of bretylium might be additive to those of LATUDA, resulting in problematic hypotension. Hypotension and circulatory collapse should be treated with appropriate measures. Epinephrine and dopamine should not be used, or other sympathomimetics with beta-agonist activity, since beta stimulation may worsen hypotension in the setting of LATUDA-induced alpha blockade. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.

The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis.

Latuda

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Side effects of Latuda

The following adverse reactions are discussed in more detail in other sections of the labeling:

Use in Elderly Patients with Dementia-Related Psychosis.

Cerebrovascular Adverse Reactions, Including Stroke.

Neuroleptic Malignant Syndrome.

Tardive Dyskinesia.

Hyperglycemia and Diabetes Mellitus.

Hyperprolactinemia.

Leukopenia, Neutropenia, and Agranulocytosis.

Orthostatic Hypotension and Syncope.

Seizures.

Potential for Cognitive and Motor Impairment

Body Temperature Regulation.

Suicide.

Dysphagia.

Use in Patients with Concomitant Illness.

Drugs that may interact with Latuda

Given the primary CNS effects of LATUDA, caution should be used when it is taken in combination with other centrally acting drugs and alcohol.

Potential for Other Drugs to Affect LATUDA:

LATUDA is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes. This suggests that an interaction of LATUDA with drugs that are inhibitors or inducers of these enzymes is unlikely.

LATUDA is predominantly metabolized by CYP3A4; interaction of LATUDA with strong and moderate inhibitors or inducers of this enzyme has been observed. LATUDA should not be used in combination with strong inhibitors or inducers of this enzyme.

Potential for LATUDA to Affect Other Drugs:

Digoxin (P-gp substrate): Coadministration of LATUDA (120 mg/day) at steady state with a single dose of digoxin (0.25 mg) increased Cmax and AUC (0-24) for digoxin by approximately 9% and 13%, respectively relative to digoxin alone. Digoxin dose adjustment is not required when coadministered with LATUDA.

Midazolam (CYP3A4 substrate): Coadministration of LATUDA (120 mg/day) at steady state with a single dose of 5 mg midazolam increased midazolam Cmax and AUC (0-24) by approximately 21% and 44%, respectively relative to midazolam alone. Midazolam dose adjustment is not required when coadministered with LATUDA.

Oral Contraceptive (estrogen/progesterone): Coadministration of LATUDA (40 mg/day) at steady state with an oral contraceptive (OC) containing ethinyl estradiol and norelgestimate resulted in equivalent AUC (0-24) and Cmax of ethinyl estradiol and norelgestromin relative to OC administration alone. Also, sex hormone binding globulin levels were not meaningfully affected by coadministration of LATUDA and OC.

Dose adjustment of OC dose is not required when coadministered with LATUDA.

Warnings of Latuda

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 LATUDA 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 cardiovascular or cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.

Latuda

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