Ranozin

Strengths

Ranozin 375, Ranozin 500, Ranozin 750, Ranozin 1000

Dosage Form

Sustained Release Film Coated Tablets

Composition

Ranozin 375
Each S.R.F.C. tablet contains:
Ranolazine 375 mg

Ranozin 750
Each S.R.F.C. tablet contains:
Ranolazine 750 mg

Ranozin 1000
Each S.R.F.C. tablet contains:
Ranolazine 1000 mg

Packaging

Ranozin 375: 30 S.R.F.C. Tablets
Ranozin 500: 30 S.R.F.C. Tablets
Ranozin 750: 30 S.R.F.C. Tablets
Ranozin 1000: 30 S.R.F.C. Tablets

Indications

Ranolazine 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).

Dosage and Administration

Adults:
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 the dose should be titrated to 750 mg twice daily and further to the maximum recommended daily dose 1000 mg twice daily, as needed, based on clinical symptoms.
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, cyclosporine). Limit the maximum dose of ranolazine to 500 mg twice daily. Concomitant administration of potent CYP3A4 inhibitors is contraindicated.
Renal impairment: 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).
Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic. Ranolazine is contraindicated in patients with moderate or severe hepatic impairment.
Elderly: 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
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.
Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III–IV) should be exercised with caution.
Children: The safety and efficacy of Ranolazine in children below the age of 18 years have not been established. No data are available.
Method of administration:
Ranolazine tablets should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without food.
If a dose of Ranolazine is missed, take the prescribed dose at the next scheduled time; do not double the next dose.