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Molecule

Ranolazine

Anti-anginal
Available on requestCardiology
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Ranolazine is an anti-anginal indicated for the treatment of chronic angina. It is available as extended-release tablets and granules for oral use. MedsAcross supplies Ranolazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anti-anginal, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A Inhibitors, Organic Cation Transporter 2 Inhibitors, P-Glycoprotein Inhibitors
ATC classification
C01EB18 Ranolazine · Heart rhythm and heart failure medicines, subgroup C01E, subgroup C01EB
US FDA first approval
27 January 2006
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Extended-release tablet, Granules
Identifiers
UNII A6IEZ5M406RxCUI 35829CAS 95635-55-5DrugBank DB00243Q907104

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina.

Source: US FDA prescribing information

How it works

The mechanism of action of ranolazine's antianginal effects has not been determined. Ranolazine has anti-ischemic and antianginal effects that do not depend upon reductions in heart rate or blood pressure. It does not affect the rate-pressure product, a measure of myocardial work, at maximal exercise. Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (I Na ). However, the relationship of this inhibition to angina symptoms is uncertain. The QT prolongation effect of ranolazine on the surface electrocardiogram is the result of inhibition of I Kr which prolongs the ventricular action potential.

Source: US FDA prescribing information

Dosing overview

500 mg orally twice daily and increase to 1000 mg orally twice daily, based on clinical symptoms Dosing Information Initiate ASPRUZYO Sprinkle dosing at 500 mg orally twice daily and increase to 1000 mg orally twice daily, as needed, based on clinical symptoms. The maximum recommended daily dose of ASPRUZYO Sprinkle is 1000 mg twice daily. If a dose of ASPRUZYO Sprinkle is missed, take the prescribed dose at the next scheduled time, do not double the next dose. Directions for use with soft food (e.g., applesauce and yogurt) Sprinkle granules on one tablespoonful of soft food and consume immediately. Do not crush or chew the granules. Direction for nasogastric and gastric tube administration Nasogastric (NG) tube: Add the content of a sachet to a plastic catheter tip syringe and add 50 mL of water. Gently shake the syringe for approximately 15 seconds.

Source: US FDA prescribing information

Contraindications

ASPRUZYO Sprinkle is contraindicated in patients: Taking strong inhibitors of CYP3A Taking inducers of CYP3A With liver cirrhosis Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir). CYP3A inducers (e.g., rifampin, phenobarbital, St. John's wort). Liver cirrhosis

Source: US FDA prescribing information

Warnings and precautions

QT interval prolongation: Can occur with ranolazine. Little information available on high doses, long exposure, use with QT interval‑ prolonging drugs, potassium channel variants causing prolonged QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation. Renal failure: Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL <60 mL/min). If acute renal failure develops, discontinue ASPRUZYO Sprinkle.

Source: US FDA prescribing information

Side effects

Most common adverse reactions (> 4% and more common than with placebo) are dizziness, headache, constipation, nausea.

Source: US FDA prescribing information

Interactions

Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ASPRUZYO Sprinkle to 500 mg twice daily. P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. Titrate ASPRUZYO Sprinkle based on clinical response. CYP3A substrates: Limit simvastatin to 20 mg when used with ASPRUZYO Sprinkle. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ASPRUZYO Sprinkle. OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ASPRUZYO Sprinkle 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses. Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ASPRUZYO Sprinkle.

Source: US FDA prescribing information

Storage

Store ASPRUZYO Sprinkle at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Ranolazine, sorted by availability.

MedicineManufacturerRegisterAvailability
Ranolazine 500 mg extended-release tabletOralGeneric name—US FDAAvailable on request
Ranolazine 1000 mg extended-release tabletOralGeneric name—US FDAAvailable on request
Aspruzyo Sprinkle 1000 mg granulesOralSun Pharmaceutical IndustriesIndiaUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Indian manufacturers are highlighted.

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 January 2006Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Ranolazine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Ranolazine available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Ranolazine and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.

What brand names does Ranolazine have?

The catalogue lists 1 brand names for Ranolazine, including Aspruzyo Sprinkle.

Is Ranolazine approved by the US FDA?

Yes. The US FDA first approved Ranolazine on 27 January 2006, according to Drugs@FDA.

Is Ranolazine authorised in the European Union?

Yes. Ranolazine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Ranolazine need cold chain shipping?

No listed presentation of Ranolazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Ranolazine in?

Ranolazine is classified under ATC code C01EB18 (Ranolazine).

References

  1. ASPRUZYO SPRINKLE prescribing information (Sun Pharmaceutical Industries). U.S. National Library of Medicine, DailyMed. Retrieved 29 January 2025
  2. Ranexa (previously Latixa): European public assessment report (EPAR). European Medicines Agency. Retrieved 10 April 2024

Request Ranolazine for export supply

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