RANEXA PROLONGED-RELEASE TABLET 375 MG

MENARINI - VON HEYDEN GMBH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Oct 6, 2015
Approval ID: 3b9c8ecf04713251
Company: MENARINI - VON HEYDEN GMBH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 3b9c8ecf04713251
Drug Name: RANEXA PROLONGED-RELEASE TABLET 375 MG
Product Name: RANEXA PROLONGED-RELEASE TABLET 375 MG
Approval Number: SIN14861P
Approval Date: 2015-10-06
Registrant: A. MENARINI SINGAPORE PTE. LTD.
Licence Holder: A. MENARINI SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Dosage: 4.2 Posology and method of administration Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets. Adults: The recommended initial dose of Ranexa is 375 mg twice daily. After 2–4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient’s response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), down-titration of Ranexa to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued. Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30–80 ml/min) (see sections 4.4, 4.8, and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Elderly: Dose titration in elderly patients should be exercised with caution (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The incidence of adverse events was higher in the elderly (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Low weight: The incidence of adverse events was higher in patients with low weight (≤ 60 kg). Dose titration in patients with low weight should be exercised with caution (see sections 4.4, 4.8, and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III–IV) should be exercised with caution (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population The safety and efficacy of Ranexa in children below the age of 18 years have not been established. No data are available Method of administration Ranexa tablets should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without food.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Moderate or severe hepatic impairment (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
Atc Code: C01EB18
Atc Item Name: ranolazine
Pharma Manufacturer Name: A. MENARINI SINGAPORE PTE. LTD.

Active Ingredients

RANOLAZINE

375 mg

RANOLAZINE

375 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 6, 2015

Approval ID

3b9c8ecf04713251

Type

Therapeutic

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