OUR PRODUCTS
Each extended-release, film-coated tablet contains 375, 500 or 750 ranolazine.
- Hypersensitivity to the active substance or to any of the excipients
- Severe renal impairment (creatinine clearance less than 30 ml/min)
- Moderate or severe hepatic impairment
- Coadministration of strong CYP3A4 inhibitors (eg itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
- Concomitant administration of class Ia (eg quinidine) or class III (eg dofetilide, sotalol) antiarrhythmics other than amiodarone.
- CYP3A4 or P-gp Inhibitors: Ranolazine is a substrate for the CYP3A4 enzyme, so CYP3A4 inhibitors increase the plasma concentrations of ranolazine.
- Diltiazem: increases the plasma concentrations of ranolazine. Dose titration is recommended for concomitant use.
- Cyclosporine and verapamil: they are strong inhibitors of P-gp, and ranolazine is a basic substrate for it. Therefore, the plasma concentrations of ranolazine increase with concomitant use.
- CYP3A4 Inducers: Initiation of treatment with Razox should be avoided while CYP3A4 inducers are administered (eg, rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's wort)
- CYP2D6 inhibitors: ranolazine is partially metabolized by CYP2D6; Therefore, inhibitors of this enzyme may increase plasma ranolazine concentrations
- Digoxin: A 1.5-fold increase in digoxin plasma concentrations has been reported when ranolazine and digoxin were taken together. Therefore, digoxin levels should be monitored after initiation and termination of treatment.
- In adults, Razox is used as an add-on to the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant of first-line antianginal therapies (eg beta-blockers and/or calcium antagonists).
- Dosage:
- Adults: The recommended starting dose of Razox is 375 mg twice daily. After 2-4 weeks, the dose should be titrated to 500 mg twice daily and, according to patient response, the maximum recommended dose of 750 mg twice daily titrated.
- If the patient experiences treatment-related adverse events (eg, dizziness, nausea, or vomiting), a reduction in titration of Razox to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued.
- Concomitant therapy with CYP3A4 inhibitors and P-glycoprotein (P-gp): Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (eg diltiazem, fluconazole, erythromycin) or P-gp inhibitors (eg verapamil, cyclosporine) that nullifies the efficacy of concomitant administration. Strong CYP3A4 Inhibitors
- Renal impairment: Careful titration of the dose is recommended in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml/min). Razox is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
- Hepatic insufficiency: Dose titration is recommended with caution in patients with mild hepatic impairment. Razox is contraindicated in patients with moderate or severe hepatic impairment.
- Elderly: Caution should be exercised in dose titration in elderly patients. The elderly may have increased exposure to ranolazine due to age-related decreases 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). Caution should be exercised when titrating the dose in underweight patients.
- Congestive Heart Failure (CHF): Caution should be exercised when dose titration is used in patients with moderate to severe congestive heart failure.
- Children's population: The safety and effectiveness of razox have not been established in children younger than 18 years of age.
Undesirable effects in patients receiving Radox are generally mild to moderate in severity and often develop within the first two weeks of treatment. They range from dehydration, loss of appetite, hyponatremia, anxiety and insomnia, dizziness and headache, lethargy, blurred vision, ringing in the ears .......etc.
RAZOX 375 MG EX.R F.CTABLETS.......
RAZOX 500 MG EX.R F.CTABLETS.......
RAZOX 750 MG EX.R F.CTABLETS.......
A carton box containing 2 blisters, each one contains 10 ex.r f.c tablets.