Ralozine SR 500 mg (Tablet (Sustained Release))

Unit Price: ৳ 16.00 (2 x 10: ৳ 320.00)
Strip Price: ৳ 160.00

Medicine Details

Category Details
Generic Ranolazine
Company Incepta pharmaceuticals ltd

Indications

  • Treatment of chronic angina
  • May be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers
  • Decreases angina episodes in patients with coronary artery disease on maximal doses of amlodipine
  • Prolongs the QT interval
  • Effect on angina rate or exercise tolerance may differ in women

Pharmacology

  • Anti-ischemic and anti-anginal effects
  • Does not depend upon reductions in heart rate or blood pressure
  • Inhibition of cardiac late sodium current (I_Na)
  • Inhibition of I_Kr prolongs the ventricular action potential
  • Absorption: C_max - 2-5 hours
  • Half-life: 6-22 hours
  • Approximately 62% bound to human plasma proteins
  • Metabolized mainly by CYP3A and to a lesser extent by CYP2D6
  • Metabolized rapidly and extensively in the liver and intestine
  • Approximately 75% of the dose excreted in urine and 25% in feces

Dosage & Administration

  • Initiate dosing at 500 mg twice daily
  • Increase to 1000 mg twice daily if needed
  • Swallow tablets whole; do not crush, break or chew
  • Maximum recommended daily dose is 1000 mg twice daily
  • Pediatric use: Safety and effectiveness not established

Interaction

  • Do not use with strong CYP 3A inhibitors
  • Limit maximum dose with moderate CYP 3A inhibitors
  • Do not use with inducers
  • May need to lower the dose with P-gp inhibitors
  • May need reduced doses of drugs transported by P-gp or metabolized by CYP2D6 when used together

Contraindications

  • With pre-existing QT prolongation
  • With hepatic impairment
  • Taking QT prolonging drugs
  • Taking potent and moderately potent CYP3A inhibitors

Side Effects

  • Bradycardia
  • Palpitations
  • Tinnitus
  • Vertigo
  • Abdominal pain
  • Dry mouth
  • Vomiting
  • Peripheral edema
  • Dyspnea
  • Hypotension
  • Orthostatic hypotension

Pregnancy & Lactation

  • Pregnancy Category C
  • No adequate studies on the effect on the developing fetus
  • No well-controlled studies in pregnant women
  • Use during pregnancy only if potential benefit justifies potential risk to the fetus
  • Not known whether excreted in human milk
  • Consideration should be made to discontinue nursing or the drug, taking into account the importance of the drug to the mother

Precautions & Warnings

  • Blocks QTc and prolongs the QTc interval in a dose-related manner
  • Clinical experience did not show increased risk of proarrhythmia or sudden death
  • Co-administration with digoxin increases plasma concentrations of digoxin
  • Caution should be exercised when co-administering with P-gp inhibitors

Overdose Effects

  • Dose-related increases in dizziness, nausea, and vomiting with high oral doses
  • Diplopia, paresthesia, confusion, and syncope with high intravenous exposure
  • General supportive measures and continuous ECG monitoring may be warranted in overdose
  • Unlikely to be effectively cleared by hemodialysis

Therapeutic Class

  • Other Anti-anginal & Anti-ischaemic drugs

Storage Conditions

  • Keep below 30°C temperature
  • Away from light & moisture
  • Keep out of the reach of children

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