Ranolazine ER

Class
Antianginal agents
Subclass
Late sodium current inhibitors
Substance name
Ranolazine ER
Brand names
Ranexa®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Stable angina
Start at: 500 mg PO BID
Maintenance: 500-1,000 mg PO BID
Maximum: 2,000 mg per day
AFPharmacological cardioversionOff-label
1,500 mg PO once
Administered in combination with intravenously amiodarone.
Indications for use
Labeled indications
Adults
Treatment of stable angina
Off-label indications
Adults
Treatment of AF (pharmacological cardioversion)
Safety risks
Contraindications
Hypersensitivity to ranolazine or its components
Liver cirrhosis
Concomitant use of CYP3A4 inducers
Concomitant use of potent CYP3A4 inhibitors
Warnings and precautions
AKI
Use caution in patients with severe renal impairment. Discontinue ranolazine if acute renal failure develops.
Increased serum ranolazine levels
Use caution in patients taking moderate CYP3A4 inhibitors or with the use of grapefruit juice. Maximal dose of 500 mg BID.
Prolonged QT interval
Use caution in all patients, especially with known QT prolongation, congenital long QT syndrome, or taking other QT-prolonging drugs.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
Use with caution.
Renal replacement therapy
Continuous renal replacement
Avoid use as much as possible.
Intermittent hemodialysis
Avoid use as much as possible.
Peritoneal dialysis
Avoid use as much as possible.
Hepatic impairment
Any severity
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
Bradycardia, diaphoresis, hypotension, orthostatic hypotension, peripheral edema, abdominal pain, asthenia, blurred vision, confusion, constipation, dizziness, dry mouth, dyspepsia, dyspnea, headache, hematuria, loss of appetite, nausea, palpitations, syncope, tinnitus, vertigo, vomiting
Uncommon < 1%
Angioedema, ↓ WBC count, ↓ blood glucose, ↓ platelet count, ↑ BUN, ↑ blood eosinophil count, pancytopenia, pulmonary fibrosis, renal failure, hypoesthesia, paresthesia, tremor, urine discoloration
Unknown frequency
Myoclonus, ↑QT interval, dysuria, hallucinations, pruritus, skin rash, urinary retention
Interactions
Drug(s)
Check Interactions
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