Rangina 1000 mg

Ranolazine Extended release

Each tablet contains:
Ranolazine 1000 mg

Size: 30

Item Form: ER Tablet

Flavor: None

Drug class:

Antianginal agents

General information:

Administer with or without meals.
Swallow tablet whole; do not crush, break, or chew.
Limit the use of grapefruit juice and grapefruit-containing products.
Ranolazine may cause side effects such as dizziness, blurred vision, that may affect your ability to drive or use machines. If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Missed dose: if a dose is missed, it should be taken at the next scheduled time; the next dose should not be doubled

Mechanism of Action:

Ranolazine exerts antianginal and anti-ischemic effect without changing hemodynamic parameters (heart rate or blood pressure).

At therapeutic level ranolazine inhibit the late phase of the inward sodium channel in ischemic cardiac myocytes during cardiac repolarization, reducing intracellular sodium concentration and thereby reducing calcium influx via Na-Ca exchange.

Decreased intracellular calcium reduces ventricular tension and myocardial oxygen consumption.

It is thought that ranolazine produces myocardial relaxation and reduces anginal symptoms through this mechanism, although this is uncertain.

At higher concentrations ranolazine inhibits the rapid delayed rectifier potassium current, prolonging the ventricular action potential duration and subsequent prolongation of the QT interval.

Indications and Dosage:

Adult:

Chronic angina

Initial dosage: 500 mg twice daily
Maximum dose: 1000 mg twice daily

Contraindications:

Hypersensitivity to the active substance or to any of the excipients.
Concomitant use with strong CYP3A inhibitors or CYP3A inducers; liver cirrhosis

Pregnancy:

Adverse events were observed in animal reproduction studies.

You should not take ranolazine if you are pregnant unless your doctor has advised you to do so.

Lactation:

It is not known if ranolazine is excreted in breast milk.

The decision to breast-feed during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

Warnings/Precautions:

Altered cardiac conduction: Use with caution in cirrhotic patients, use of other QT- prolonging drugs, potassium-channel variant, family history of long QT syndrome, family history of congenital long QT syndrome, or acquired prolonged QT.
Ranolazine will not relieve an acute angina episode and has not demonstrated benefit in acute coronary syndrome.
Monitor renal function periodically in patients with moderate to severe renal impairment.
Use with caution in patients older than 75 years; they may experience more adverse events (including serious adverse events) and drug discontinuations due to adverse events.
Safety and efficacy have not been established in adolescents and Children

Interactions:

Antifungal Agents (Azole Derivatives, systemic), Aripiprazol, Atorvastatin,lovastatin, Simvastatin, Bosutinib, brentuximab vedotin, Calcium channel blockers ( nondihydropyridine), colchicine, conivaptan, CYP3A4 Inducers( moderate), CYP3A4 Inducers( strong), CYP3A4 Inhibitors( moderate), CYP3A4 Inhibitors (strong),Dabigatran etexilate, Dasatinib, Deferasirox, Digoxin, Doxorubicin ( conventional),Edoxaban, Everolimus, Flibanserin, Fosaprepitant, Fusidic Acid (Systemic), Highest Risk QTC-Prolonging agents, Moderate Risk QTC-Prolonging agents, Hydrocodone, Idelalisib, Ivacaftor, Ledipasvir, Lomitapide, Luliconazole, Metformin, Naloxegol, Nimodipine, Osimertinib, Palbociclibe, Pazopanib, p-glycoprotein/ABCB1 inducers, p-glycoprotein/ABCB1 inhibitors, p-glycoprotein/ABCB1 substrates, pimozide, prucalopride, Rifampin, Rifaximin, Silodosin, Siltuximab, Simeprevir, St john’s wort, Stiripentol, Tacrolimus ( systemic), Tocilizumab, Topotecan, Venetoclax, Vincristine ( Liposomal).

Adverse reactions:

Cardiovascular: bradycardia, hypotension, orthostatic hypotension, palpitations, peripheral edema, prolonged Q-T interval on ECG (> 500 msec ) , syncope Central nervous system: confusion, dizziness (may be dose related), headache, vertigo.
Dermatologic: hyperhidrosis
Gastrointestinal: abdominal pain, anorexia, constipation, nausea, vomiting, xerostomia.
Genitourinary: hematuria
Neuromuscular & Skeletal: weakness
Ophthalmic: blurred vision
Otic: Tinnitus
Respiratory: dyspnea

Over dosage:

If you accidentally take too many Ranolazine tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once.

If you cannot contact your doctor, go to the nearest accident and emergency department.

Packaging:

Store at controlled room temperature, below 30°C.

References: 1.Drugs facts and comparisons 2017 2.PDR