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Ranolazine extended-release tablets
RANEXA™
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FDA Approval: |
January 2006 |
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Indication: |
Chronic angina - reserve for cases where other antianginals have been
inadequate |
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Pharmacology: |
Antianginal and anti-ischemic agent |
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Usual Dose: |
Initial: 500 mg orally twice a day |
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Contraindications: |
Existing QT prolongation
Concurrent use of QT prolonging drugs
Potent and moderate
CYP450 3A inhibitors
Liver impairment (Child-Pugh A, B, C) |
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Warnings: |
Ranolazine may prolong QT interval Monitor ECG at baseline and
during treatment
Do not exceed doses of 1000 mg twice daily
Avoid use in patients with severe renal impairment
Monitor blood pressure in patients with severe renal impairment
May reversibly elevate serum creatinine
Not to be used for treatment of an acute anginal episode
Patients should be cautioned against driving, etc., if
lightheadedness or dizziness, occur
Patients should notify physician if syncope or palpitations occur
Tablets should not be crushed, broken, or chewed
Nursing mothers should stop breastfeeding or discontinue the drug
Safety and efficacy not established in pediatric patients
Patients
≥ 75 years had a higher incidence
of side effects |
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Pregnancy Category: |
C |
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Side Effects: |
Dizziness, headache, constipation, nausea, asthenia Syncope,
palpitations
Tinnitus, vertigo
Abdominal pain, vomiting, dry mouth
Peripheral edema, dyspnea
Bradycardia, hypotension, tremor, blurry vision, hypoesthesia,
hematuria
Transient eosinophilia, decreased hematocrit |
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Drug Interactions: |
CYP3A4 inhibitors (eg, diltiazem, grapefruit, HIV protease
inhibitors, ketoconazole, macrolide antibiotics, verapamil) QT
interval prolonging drugs (Class I or III antiarrhythmics, eg,
quinidine, dofetilide, sotalol; erythromycin, antipsychotics, eg,
thioridazine, ziprasidone)
P-gp inhibitors (eg, ritonavir, cyclosporine)
P-gp substrates (eg, digoxin)
CYP450 2D6 substrates (eg, tricyclic antidepressants,
antipsychotics)
Paroxetine
Simvastatin |
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