Ranexa雷諾嗪

Ranexa

ranolazine

Manufacturer:

A. Menarini

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Ranolazine
Indications/Uses
Add-on therapy for the symptomatic treatment of adult patients w/ stable angina pectoris who are inadequately controlled or intolerant to 1st-line antianginal therapies (eg, β-blockers &/or Ca antagonists).
Dosage/Direction for Use
Adult Initially 375 mg bd. After 2-4 wk, the dose should be titrated to 500 mg bd, & according to patient's response, further titrated to a max 750 mg bd.
Administration
May be taken with or without food: Swallow whole, do not break/chew/crush.
Contraindications
Hypersensitivity. Severe renal impairment (CrCl <30 mL/min); moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, posaconazole, HIV PIs, clarithromycin, telithromycin, nefazodone). Concomitant administration of class Ia (eg, quinidine) or class III (eg, dofetilide, sotalol) antiarrhythmics other than amiodarone.
Special Precautions
Patients w/ low body wt (≤60 kg); moderate to severe CHF (NYHA Class III-IV); mild hepatic impairment; mild to moderate renal impairment (CrCl 30-80 mL/min); elderly; poor CYP2D6 metabolisers. QT prolongation. Concomitant administration of moderate CYP3A4 inhibitors; P-gp inhibitors; CYP3A4 inducers. May affect ability to drive & operate machinery. Pregnancy & lactation. 750 mg tab: Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Azo colouring agent E102 may cause allergic reactions.
Adverse Reactions
Dizziness, headache; constipation, vomiting, nausea; asthenia.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, posaconazole, HIV PIs, clarithromycin, telithromycin, nefazodone, grapefruit, diltiazem, erythromycin, fluconazole); P-gp inhibitors (eg, ciclosporin, verapamil); CYP2D6 inhibitors (eg, paroxetine). Decreased steady-state conc w/ CYP3A4 inducers (eg, rifampicin, phenytoin, phenobarb, carbamazepine, St. John's wort). Increased plasma conc of P-gp substrates; sensitive CYP3A4 substrates (eg, simvastatin, lovastatin) & CYP3A4 substrates w/ a narrow therapeutic range (eg, ciclosporin, tacrolimus, sirolimus, everolimus); metoprolol or other CYP2D6 substrates (eg, propafenone & flecainide or, to a lesser extent, TCAs & antipsychotics); digoxin; atorvastatin. Increased plasma exposure of metformin (OCT2 substrate). Caution during co-administration w/ CYP2B6 substrates (eg, bupropion, efavirenz, cyclophosphamide).
MIMS Class
ATC Classification
C01EB18 - ranolazine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Ranexa PR tab 500 mg
Packing/Price
60's
Form
Ranexa PR tab 375 mg
Packing/Price
60's
Form
Ranexa PR tab 750 mg
Packing/Price
60's
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