قرص زینارو 500 میلی گرم-رانولازین XINARO 500 MG Tablet-RANOLAZINE

What is Xinaro?
Xinaro® antianginal Extended-release tablet with the generic name Ranolazine

Product Information
Xinaro® extended-release oral tablet with the generic name Ranolazine is used to treat chronic angina (chest pain). This medicine reduces the frequency of angina (chest pain) and nitroglycerin consumption in patients without significantly affecting blood pressure and heart rate. Xinaro® can be used in patients with chronic angina along with medicines such as beta-blockers, nitrates, calcium channel blockers, antiplatelets, etc.

What is Xinaro®’s mechanism of action?
Ranolazine exerts antianginal and anti-ischemic effects without changing hemodynamic parameters (heart rate or blood pressure). At therapeutic levels, ranolazine reduces intracellular sodium concentrations in ischemic cardiac myocytes, thereby reducing intracellular calcium. Decreased intracellular calcium reduces ventricular tension and myocardial oxygen consumption.

What are the indications of Xinaro®?
Xinaro® is indicated for the treatment of chronic angina.

What are the dosage forms of Xinaro®?
Extended-release tablets: 500 & 1000 mg

How is the administration of Xinaro®?
Administer with or without meals. Swallow the tablet whole; do not crush, break, or chew.

Does Xinaro® need to adjust the dose in renal failure?
Creatinine Clearance (CrCl) >80 mL/minute:
No dosage adjustment is necessary.
CrCl >30 to 80 mL/minute: 
No dosage adjustment is necessary; however, there is significant interpatient variability in pharmacokinetics; use with caution, especially in patients with CrCl <50 mL/minute.
CrCl ≤30 mL/minute:
Use with extreme caution; acute kidney injury and other adverse effects (e.g., neurologic) have been observed in some patients with severe kidney impairment.
Maximum dose: 500 mg twice daily.

Does Xinaro® need to adjust the dose in liver failure?
No dosage adjustment is necessary. Use is contraindicated with hepatic cirrhosis.

Who should not use Xinaro® (Ranolazine)? (Contraindications)
•    Patients with Hepatic cirrhosis.
•    Current users of strong CYP3A inhibitors such as Clarithromycin and Ketoconazole.
•    Current users of CYP3A inducers such as Rifampin and Carbamazepine.

Is it safe to use Xinaro® during pregnancy or breastfeeding?
•    There are no available data on Xinaro® use in pregnant women.
•    It is not known if Ranolazine is present in breast milk. The decision to breastfeed during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother.

What drugs does Xinaro® interact with?
Avoid use of Xinaro® with the following medicines (category X):
•    Alcohol: May increase the serum concentration of Ranolazine.
•    CYP3A4 Inducers (Moderate & Strong): May decrease the serum concentration of Ranolazine (such as Carbamazepine and Rifampin).
•    CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ranolazin (such as Itraconazole and Ketoconazole).

Combination use of Xinaro® with the following medicine requires therapy modification (category D):
•    CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Ranolazine. 
Management: Limit the Ranolazine dose to a maximum of 500 mg twice daily in patients concurrently receiving moderate CYP3A4 inhibitors. Monitor for increased Ranolazine effects and toxicities during concomitant use (such as diltiazem and verapamil).

•    Digoxin: Ranolazine may increase the serum concentration of Digoxin. 
Management: Measure digoxin serum concentrations before initiating treatment with Ranolazine. Reduce digoxin concentrations by reducing the digoxin dose by 30% to 50% or modifying the dosing frequency.

•    Metformin: Ranolazine may increase the serum concentration of metformin. Management: Limit the metformin dose to a maximum of 1,700 mg per day when used together with Ranolazine 1,000 mg twice daily. Monitor patients for metformin toxicities, including lactic acidosis, and carefully weigh the risks and benefits of this combination.

What precautions and warnings does Xinaro® (Ranolazine) have when using it?

QT Interval Prolongation
•    May cause a dose-dependent increase in QT interval. Use with caution in patients who are at risk of QT prolongation. Some experts avoid use in patients with preexisting QT interval prolongation or in patients taking other drugs that prolong the QT interval.

Renal Failure
•    Acute renal failure has been observed in some patients with severe renal impairment (Creatinine Clearance < 30 mL/min) while taking Ranolazine. If acute renal failure develops (e.g., a marked increase in serum creatinine associated with an increase in Blood Urea Nitrogen [BUN]), discontinue Ranolazine.

Frequently Asked Questions (FAQs)

What should you do if you miss a dose?
If a dose of Xinaro® is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

Does Xinaro decrease Blood Pressure?
Xinaro® does not have any significant effect on BP (Blood Pressure) or heart rate.

What should you avoid while taking Xinaro®?
Avoid drinking alcohol. Drinking alcohol with Xinaro® can cause side effects. Grapefruit may interact with Ranolazine and lead to unwanted side effects. Limit your consumption of grapefruit and grapefruit products. If you regularly use grapefruit, consult your doctor to adjust the ranolazine dose.

How should you keep/store your Xinaro® tablets?
Store below 30°C. Protect it from light and moisture and keep it out of reach for children.