Ranexa Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
YES
Mechanism of Action
Ranexa Indications
Indications
Ranexa Dosage and Administration
Adult
Children
Renal Impairment
A pharmacokinetic study of Ranexa in patients with severe renal impairment (CrCL <30 mL/min) was stopped when 2 out of 4 patients developed acute renal failure after receiving Ranexa 500 mg twice daily for 5 days (lead-in phase) followed by 1000 mg twice a day (1 dose in one patient and 11 doses in the other). Increases in creatinine, BUN, and potassium were observed in 3 patients during the 500 mg lead-in phase. One patient required hemodialysis, while the other 2 patients improved upon drug discontinuation. Monitor renal function periodically in patients with moderate to severe renal impairment. Discontinue Ranexa if acute renal failure develops.
Hepatic Impairment
Ranexa is contraindicated in patients with liver cirrhosis. In a clinical study, the Cmax of ranolazine was increased 30% in cirrhotic patients with mild (Child-Pugh Class A) hepatic impairment, but increased 80% in cirrhotic patients with moderate (Child-Pugh Class B) hepatic impairment compared to those without hepatic impairment. This increase was not enough to account for the 3-fold increase in QT prolongation seen in cirrhotic patients with mild to moderate hepatic impairment.
Other Modifications
Use in Patients with Heart Failure
- Heart failure (NYHA Class I to IV) had no significant effect on ranolazine pharmacokinetics.
- Ranexa had minimal effects on heart rate and blood pressure in patients with angina and heart failure NYHA Class I to IV.
- No dose adjustment of Ranexa is required in patients with heart failure.
Use in Patients with Diabetes Mellitus
- Data from a population pharmacokinetic evaluation of angina patients and healthy subjects showed no effect of diabetes on ranolazine pharmacokinetics. No dose adjustment is required in patients with diabetes.
- Ranexa produces small reductions in HbA1c in patients with diabetes, the clinical significance of which is unknown.
- Ranexa should not be considered a treatment for diabetes.
Ranexa Contraindications
Contraindications
Ranexa Boxed Warnings
Not Applicable
Ranexa Warnings/Precautions
Warnings/Precautions
Ranexa Pharmacokinetics
Absorption
After oral administration of Ranexa, peak plasma concentrations of ranolazine are reached between 2 and 5 hours. After oral administration of 14C-ranolazine as a solution, 73% of the dose is systemically available as ranolazine or metabolites. The bioavailability of ranolazine from Ranexa tablets relative to that from a solution of ranolazine is 76%.
Distribution
Plasma protein bound: ~62%.
Elimination
Following a single oral dose of ranolazine solution, ~75% of the dose is excreted in urine and 25% in feces. Half-life: range 6–22 hours.
Ranexa Interactions
Interactions
Ranexa Adverse Reactions
Adverse Reactions
Ranexa Clinical Trials
Ranexa Note
Not Applicable
Ranexa Patient Counseling
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