Ranexa Dosage/Direction for Use

Patients should be given the Ranexa package leaflet and the Patient Alert Card and instructed to present their Patient Alert Card and medication list to their health care professional at each visit.
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 Pharmacology: Pharmacodynamics under Action).
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 Precautions and Interactions).
Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see Contraindications and Interactions).
Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions). Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions). Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Elderly: Dose titration in elderly patients should be exercised with caution (see Precautions). Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see Pharmacology: Pharmacokinetics under Actions). The incidence of adverse events was higher in the elderly (see Adverse Reactions).
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 Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III-IV) should be exercised with caution (see Precautions and Pharmacology: Pharmacokinetics under Actions).
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.