LURAMAX 80 FILM COATED TABLET 80MG

SUN PHARMACEUTICAL INDUSTRIES LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Sep 3, 2025
Approval ID: 977caaaa28ec75d9
Company: SUN PHARMACEUTICAL INDUSTRIES LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 977caaaa28ec75d9
Drug Name: LURAMAX 80 FILM COATED TABLET 80MG
Product Name: LURAMAX 80 FILM COATED TABLET 80MG
Approval Number: SIN17318P
Approval Date: 2025-09-03
Registrant: RANBAXY (MALAYSIA) SDN. BHD.
Licence Holder: RANBAXY (MALAYSIA) SDN. BHD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: DOSE AND METHOD OF ADMINISTRATION 2 LURAMAX 40MG & 80MG is available at the strengths of 40 and 80 mg only and may not be suitable for all the dosing recommendations mentioned below. In such cases, other approved strength must be used. Dose Schizophrenia Adults The efficacy of lurasidone has been established at doses of 40, 80, 120 and 160 mg/day. The recommended starting dose of lurasidone is 40 mg once daily. Initial dose titration is not required. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 40 mg or 80 mg once daily for most patients. Dose increase should be based on physician judgement and observed clinical response. In the six week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose compared to 40 and 80 mg/day. In the pooled analyses, added benefit occurred at 160 mg/day compared to lower doses. Doses above 80 mg may be considered for certain patients based on individual clinical judgement. The maximum recommended dose is 160 mg/day. LURAMAX 40MG & 80MG should be taken with food (at least 350 calories). Patients who have been receiving lurasidone for the treatment of schizophrenia, may continue maintenance therapy at the same dose. Adolescents The recommended starting dose of lurasidone is 40 mg/day. In a placebo-controlled clinical trial, lurasidone has been shown to be effective at doses of 40mg/day and 80mg/day. The maximum recommended dose is 80mg/day. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability. In the placebo-controlled clinical trial, no additional benefit was demonstrated for 80mg over 40mg. LURAMAX 40MG & 80MG should be taken with food. Switching Antipsychotics There are no systematically collected data to specifically address switching patients from other antipsychotics to LURAMAX 40MG & 80MG or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. Depressive Episodes Associated with Bipolar I Disorder Adults The recommended starting dose of lurasidone is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Lurasidone has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). As the incidence of certain adverse events increase with dose (see UNDESIRABLE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) patients should be treated with the lowest effective dose of lurasidone. Pediatric Patients (13 – 17 years) The recommended starting dose of lurasidone is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. Lurasidone has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacodynamic effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The maximum recommended dose is 80 mg per day. The efficacy of lurasidone in the treatment of mania associated with bipolar disorder has not been established. Dose Modifications in Special Populations Renal Impairment After administration of a single dose of 40 mg to patients with mild, moderate and severe renal impairment, mean Cmax increased by 40%, 92%, and 54%, respectively and mean AUC(0–∞) increased by 53%, 91% and 2-times, respectively compared to healthy matched subjects. Caution should be exercised when starting lurasidone in patients with renal impairment. As the 20 mg tablet is not available in Singapore, it is not recommended that LURAMAX 40MG & 80MG be used in patients with moderate (creatinine clearance: 30 to <50 mL/min) or severe renal impairment (creatinine clearance <30 mL/min). Hepatic Impairment In a single-dose study of 20 mg, lurasidone mean AUC (0–last) was 1.5-times higher in subjects with mild hepatic impairment (Child-Pugh Class A), 1.7-times higher in subjects with moderate hepatic impairment (Child-Pugh class B) and 3-times higher in subjects with severe hepatic impairment (Child-Pugh Class C) compared to the values for healthy matched subjects. Mean Cmax was 1.3, 1.2, and 1.3-times higher for mild, moderate and severe hepatic impaired patients, respectively, compared to the values for healthy matched subjects. Caution should be exercised when starting lurasidone in patients with hepatic impairment. As the 20 mg tablet is not available in Singapore, it is not recommended that LURAMAX 40MG & 80MG be used in patients with moderate (Child-Pugh Score = 7 to 9) or severe hepatic impairment (Child-Pugh Score = 10 to 15). Dose Modifications Due to Drug Interactions Concomitant Use with CYP3A4 Inhibitors LURAMAX 40MG & 80MG should not be used in combination with a strong CYP3A4 inhibitor (e.g. ketoconazole) (see CONTRAINDICATIONS). If LURAMAX 40MG & 80MG is being prescribed and a moderate CYP3A4 inhibitor (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the LURAMAX 40MG & 80MG dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and LURAMAX 40MG & 80MG is added to therapy, the recommended starting dose of lurasidone is 20 mg per day, the maximum recommended dose of lurasidone is 80 mg/day. Grapefruit and grapefruit juice should be avoided in patients taking LURAMAX 40MG & 80MG, since these may inhibit CYP3A4 and alter LURAMAX 40MG & 80MG concentrations. Concomitant Use with CYP3A4 Inducers LURAMAX 40MG & 80MG should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) (see CONTRAINDICATIONS). If LURAMAX 40MG & 80MG is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the LURAMAX 40MG & 80MG dose after chronic treatment (7 days or more) with the CYP3A4 inducer. Method of administration Administration with food substantially increases the absorption of LURAMAX 40MG & 80MG. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3- fold. In the clinical studies, lurasidone was administered with food.
Route Of Administration: ORAL
Indication Info: INDICATIONS 2 LURAMAX 40MG & 80MG is indicated for: <ul> <li>Treatment of adult and adolescent patients age 13 to 17 years with schizophrenia.</li> <li>Monotherapy treatment of adult and pediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).</li> <li>Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).</li> </ul>
Contraindications: CONTRAINDICATIONS 2 <ul> <li>LURAMAX 40MG & 80MG is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation.</li> <li>LURAMAX 40MG & 80MG is contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, and voriconazole) and strong CYP3A4 inducers (e.g., rifampin, St. John’s wort, phenytoin, and carbamazepine).</li> </ul>

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 3, 2025

Approval ID

977caaaa28ec75d9

Type

Therapeutic

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