Razine Dosage/Direction for Use

Ranolazine tablets should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without meals.
Posology: 375 mg tablet: The recommended initial dose of Ranolazine 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. If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), down-titration of Ranolazine to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued.
500 mg tablet: Initiate Ranolazine dosing at 500 mg twice daily and increase to 1 g twice daily, as needed, based on clinical symptoms. The maximum recommended daily dose of Ranolazine is 1 g twice daily. If a dose of Ranolazine is missed, take the prescribed dose at the next scheduled time; do not double the next dose. Or as prescribed by the physician.
Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: 375 mg tablet: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, and erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin). Concomitant administration of potent CYP3A4 inhibitors is contraindicated.
Dose Modification: 500 mg tablet: Dose adjustments may be needed when Ranolazine is taken in combination with certain other drugs. Limit the maximum dose of Ranolazine to 500 mg twice daily in patients on diltiazem, verapamil, and other moderate CYP3A inhibitors. Down-titrate Ranolazine based on clinical response in patients concomitantly treated with P-gp inhibitors, such as cyclosporine.
Geriatric Use: 375 mg tablet: Dose titration in elderly patients should be exercised with caution. Elderly may have increased Ranolazine exposure due to age-related decrease in renal function. The incidence of adverse events was higher in the elderly.
500 mg tablet: In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease, or other drug therapy.
Pediatric Use: 375 mg tablet: The safety and efficacy of Ranolazine in children below the age of 18 years have not been established. Ranolazine is not recommended in patients below the age of 18 years.
500 mg tablet: Safety and effectiveness have not been established in pediatric patients.
Low weight: 375 mg tablet: 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.
Patients with Renal Impairment: 375 mg tablet: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 mL/min). Ranolazine is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min).
500 mg tablet: In patients with varying degrees of renal impairment, Ranolazine plasma levels increased up to 50%. The pharmacokinetics of Ranolazine has not been assessed in patients on dialysis.
Patients with Hepatic Impairment: 375 mg tablet: Careful dose titration is recommended in patients with mild hepatic impairment. Ranolazine is contraindicated in patients with moderate or severe hepatic impairment.
500 mg tablet: Ranolazine is contraindicated in patients with clinically significant hepatic impairment. Plasma concentrations of Ranolazine were increased by 30% in patients with mild (Child-Pugh Class A) and by 60% in patients with moderate (Child-Pugh Class B) hepatic impairment. This was not enough to account for the 3-fold increase in QT prolongation seen in patients with mild to severe hepatic impairment.
Patients with Heart Failure: 375 mg tablet: Dose titration in patients with moderate to severe CHF (NYHA Class III-IV) should be exercised with caution.
500 mg tablet: Heart failure (NYHA Class I to IV) had no significant effect on Ranolazine pharmacokinetics. Ranolazine had minimal effects on heart rate and blood pressure in patients with angina and heart failure NYHA Class I to IV. No dose adjustment of Ranolazine is required in patients with heart failure.
Patients with Diabetes Mellitus: 500 mg tablet: A population pharmacokinetic evaluation of data from angina patients and healthy subjects showed no effect of diabetes on Ranolazine pharmacokinetics. No dose adjustment is required in patients with diabetes. Ranolazine produces small reductions in HbA1c in patients with diabetes, the clinical significance of which is unknown. Ranolazine should not be considered a treatment for diabetes.