Product Information
Registration Status: ActiveRANEXA PROLONGED-RELEASE TABLET 500mg is approved to be sold in Singapore with effective from 2015-06-10. It is marketed by A. MENARINI SINGAPORE PTE LTD, with the registration number of SIN14862P.
This product contains Ranolazine 500 mg in the form of TABLET, FILM-COATED, EXTENDED-RELEASE. It is approved for ORAL use.
This product is manufactured by MENARINI - VON HEYDEN GmbH in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Ranolazine is an antianginal medication. On January 31, 2006, ranolazine was approved for use in the United States by the FDA for the treatment of chronic angina.
Indication
For the treatment of chronic angina. It should be used in combination with amlodipine, beta-blockers or nitrates.
Mechanism of Action
The mechanism of action of ranolazine is unknown. It does not increase the rate-pressure product, a measure of myocardial work, at maximal exercise. In vitro studies suggest that ranolazine is a P-gp inhibitor. Ranolazine is believed to have its effects via altering the trans-cellular late sodium current. It is by altering the intracellular sodium level that ranolazine affects the sodium-dependent calcium channels during myocardial ischemia. Thus, ranolazine indirectly prevents the calcium overload that causes cardiac ischemia.
Pharmacokinetics
- Absorption
- Absorption is highly variable. After oral administration of ranolazine as a solution, 73% of the dose is systemically available as ranolazine or metabolites. The bioavailability of oral ranolazine relative to that from a solution is 76%.
- Distribution
- Metabolism
- Hepatic, metabolized mainly by CYP3A and to a lesser extent by CYP2D6. The pharmacologic activity of the metabolites has not been well characterized.
- Elimination
Toxicity
In the event of overdose, the expected symptoms would be dizziness, nausea/vomiting, diplopia, paresthesia, and confusion. Syncope with prolonged loss of consciousness may develop.
Active Ingredient/Synonyms
Ranolazine | Ranolazine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.