Ralozine SR

Ralozine SR500 mg

Tablet

Ranolazine

Incepta Pharmaceuticals Ltd.

Product Code : 14381
MRP 160.00
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Medicine overview

Indications of Ralozine SR 500 mg

Ralozine SR 500 mg is indicated for the treatment of chronic angina. Ralozine SR 500 mg may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. It has been shown to decrease angina episodes in patients with ... Read moreRalozine SR 500 mg is indicated for the treatment of chronic angina. Ralozine SR 500 mg may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. It has been shown to decrease angina episodes in patients with coronary artery disease on maximal doses of amlodipine. Because Ralozine SR 500 mg prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs.The effect on angina rate or exercise tolerance appeared to be smaller in women than men.

Theropeutic Class

Other Anti-anginal & Anti-ischaemic drugs

Pharmacology

Ralozine SR 500 mg has anti-ischemlc and antlanginal effects that do not depend upon reductions in heart rate or blood pressure.The exact mechanism of action of Ralozine SR 500 mg is unknown. Ralozine SR 500 mg at therapeutic levels can inhibit the cardiac late sodium current (INa). However, the relationship of this inhibition to angina symptoms is uncertain.The QT prolongation effect of Ralozine SR 500 mg on the surface electrocardiogram is the result of inhibition of IKr which prolongs the ventricular action potential.

Dosage & Administration of Ralozine SR 500 mg

Initiate Ralozine SR 500 mg dosing at 500 mg twice daily and increase to 1000 mg twice daily, if needed, based on clinical symptoms. Take Ralozine SR 500 mg with or without meals. Swallow Ralozine SR 500 mg tablets whole; do not crush, break or chew. The maximum recommended daily dose of Ralozine SR 500 mg is 1000 mg twice daily. If a dose of Ralozine SR 500 mg is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

Dosage of Ralozine SR 500 mg

Initiate Ralozine SR 500 mg dosing at 500 mg twice daily and increase to 1000 mg twice daily, if needed, based on clinical symptoms. Take Ralozine SR 500 mg with or without meals. Swallow Ralozine SR 500 mg tablets whole; do not crush, break or chew. The maximum recommended daily dose of Ralozine SR 500 mg is 1000 mg twice daily. If a dose of Ralozine SR 500 mg is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

Interaction of Ralozine SR 500 mg

CYP 3A Inhibitors: Do not use Ralozine SR 500 mg with strong CYP 3A inhibitors. With moderate CYP 3A inhibitors (e.g., diltiazem, verapamil, erythromycin) limit maximum dose of Ralozine SR 500 mg to 500 mg twice daily.CYP 3A Inducers: Do not use Ralozine SR 500 mg with inducers.P-gp Inhibitors (e.g., Cyclosporin): May need to lower the Ralozine SR 500 mg dose based on clinical dose.Drugs transported by P-gp or metabolized by CYP2D6 (eg., digoxin, TCA): May need reduced doses of these drugs when used with Ralozine SR 500 mg.

Contraindications

Ralozine SR 500 mg is contraindicated in patients: With pre-existing QT prolongation With hepatic impairment Taking QT prolonging drugs Taking potent and moderately potent CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, including diltiazem.

Side Effects of Ralozine SR 500 mg

Cardiac Disorders: bradycardia, palpitationsEar and Labyrinth Disorders: tinnitus, vertigoGastrointestinal Disorders: abdominal pain, dry mouth, vomitingGeneral Disorders and Administrative Site Adverse Events: peripheral edemaRespiratory, Thoracic, and Mediastinal Disorders: dyspneaVascular Disorders: hypotension, orthostatic hypotension

Pregnancy & Lactation

Pregnancy Category C. There are no adequate studies assessing the effect of Ralozine SR 500 mg on the developing fetus. There are no adequate well-controlled studies in pregnant women. Ralozine SR 500 mg should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus.lt is not known whether Ralozine SR 500 mg is excreted in human milk. Because of the potentiality for serious adverse reactions from Ralozine SR 500 mg in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Ralozine SR 500 mg, taking into account the importance of the drug to the mother.

Precautions & Warnings

Ralozine SR 500 mg blocks QTc and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death.Co-administration of Ralozine SR 500 mg with digoxin increases the plasma concentrations of digoxin by approximately 1.5-fold and the dose of digoxin may have to be reduced accordingly. The dose of other P-gp substrates may have to be reduced as well when Ralozine SR 500 mg Is co-admlnistered. Caution should be exercised when co-adminlstering Ralozine SR 500 mg with P-gp inhibitors such as ritonavir or cydosporine.

Overdose Effects of Ralozine SR 500 mg

Symptoms: Dizziness, nausea, vomiting, diplopia, lethargy, syncope, severe tremor, incoordination, dysplasia, hallucination. Management: Symptomatic and supportive treatment.

Storage Conditions

Store Ralozine SR 500 mg tablets at 25°C with excursion permitted to 15° to 30°C. Protect from light and moisture.

Use In Special Populations

Pediatric use: Safety and effectiveness in pediatric patients have not been established.Renal Impairment: Mild to moderate (CrCl 30-80 mL/min): Dose titration needed Severe (CrCl <30 mL/min): Contraindicated Hepatic Impairment: Mild: Dose titration needed Moderate to severe: Contraindicated

Drug Classes

Other Anti-anginal & Anti-ischaemic drugs

Mode Of Action

Ralozine SR 500 mg has anti-ischemlc and antlanginal effects that do not depend upon reductions in heart rate or blood pressure.The exact mechanism of action of Ralozine SR 500 mg is unknown. Ralozine SR 500 mg at therapeutic levels can inhibit the cardiac late sodium current (INa). However, the relationship of this inhibition to angina symptoms is uncertain.The QT prolongation effect of Ralozine SR 500 mg on the surface electrocardiogram is the result of inhibition of IKr which prolongs the ventricular action potential.

Pregnancy

Pregnancy Category C. There are no adequate studies assessing the effect of Ralozine SR 500 mg on the developing fetus. There are no adequate well-controlled studies in pregnant women. Ralozine SR 500 mg should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus.lt is not known whether Ralozine SR 500 mg is excreted in human milk. Because of the potentiality for serious adverse reactions from Ralozine SR 500 mg in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Ralozine SR 500 mg, taking into account the importance of the drug to the mother.

Pediatric Uses

Pediatric use: Safety and effectiveness in pediatric patients have not been established.Renal Impairment: Mild to moderate (CrCl 30-80 mL/min): Dose titration needed Severe (CrCl <30 mL/min): Contraindicated Hepatic Impairment: Mild: Dose titration needed Moderate to severe: Contraindicated
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.