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RANOLAZINE ELARA is a brand name for Ranolazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ranolazine Elara is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Ranolazine Elara is available as 375 mg, 500 mg, and 750 mg prolonged- release tablets. Adults The recommended initial dose of Ranolazine Elara is 375 mg twice daily. 1). g. dizziness, nausea, or vomiting), down-titration of Ranolazine Elara to 500 mg or 375 mg twice daily may be required.
If symptoms do not resolve after dose reduction, treatment should be discontinued. g. g. 5). 5). 2). 2). 2). 2). 4). 2). 8). Low weight The incidence of adverse events was higher in patients with low weight (≤ 60 kg). 2). 2). Paediatric population The safety and efficacy of Ranolazine Elara in children below the age of 18 years have not been established.
No data are available Method of administration Ranolazine Elara tablets should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without food.
Undesirable effects in patients receiving Ranolazine Elara are generally mild to moderate in severity and often develop within the first 2 weeks of treatment. These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranolazine Elara.
The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
FrequencyBody system, organ class Common Uncommon Rare Not known Metabolism and nutrition disorders Anorexia, decreased appetite, dehydration Hyponatremia Psychiatric disorders Anxiety, insomnia, confusional state, hallucination Disorientation Nervous system disorders Dizziness, headache Lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paresthesia Amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia Myoclonus Eye disorders Blurred vision, visual disturbance, diplopia Ear and labyrinth disorders Vertigo, tinnitus Impaired hearing Vascular disorders Hot flush, hypotension Peripheral coldness, orthostatic hypotension Respiratory, thoracic, and mediastinal disorders Dyspnoea, cough, epistaxis Throat tightness Gastrointestinal disorders Constipation, vomiting, nausea Abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort Pancreatitis, erosive duodenitis, oral hypoaesthesia Skin and subcutaneous tissue disorders Pruritus, hyperhydrosis Angioedema, allergic dermatitis, urticaria, cold sweat, rash Musculoskeletal and connective tissue disorders Pain in extremity, muscle cramp, joint swelling, muscular weakness Renal and urinary disorders Dysuria, haematuria, chromaturia Acute renal failure, urinary retention Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Asthenia Fatigue, peripheral oedema Investigations Increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight Elevated levels of hepatic enzyme The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
5). 5). 2). 2). 2). 2). 2). In patients with a combination of these factors, additional exposure increases are expected. Dose- dependent side effects are likely to occur. If Ranolazine Elara is used in patients with a combination of several of these factors, monitoring of adverse events should be frequent, the dose reduced, and treatment discontinued, if needed.
2). The above precautions are based on the risk in a CYP2D6 PM patient, and are needed when the CYP2D6 status is unknown. There is a lower need for precautions in patients with CYP2D6 EM status. g. by genotyping) or is previously known to be EM, Ranolazine Elara can be used with caution in these patients when they have a combination of several of the above risk factors.
QT prolongation: ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. 4 msec per 1000 ng/ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
5 also).
Drug-drug interactions:
Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. 5). 2).
Azo colouring agent E102:
This medicinal product contains the azo colouring agent E102 which may cause allergic reactions.
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially 'sodium-free'.
1. 2). 2). g. 5). g. g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ranolazine in United Kingdom.
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In this long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events.
1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks. 0% in placebo). 5%). Elderly, renal impairment, and low weight In general, adverse events occurred more frequently among elderly patients and patients with renal impairment; however, the types of events in these subgroups were similar to those observed in the general population.
Of the most commonly reported, the following events occurred more often with Ranolazine Elara (placebo-corrected frequencies) in elderly (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).
In patients with mild or moderate renal impairment (creatinine clearance ≥ 30– 80 ml/min) compared to those with normal renal function (creatinine clearance > 80 ml/min), the most commonly reported events and their placebo-corrected frequencies included: constipation (8% versus 4%), dizziness (7% versus 5%), and nausea (4% versus 2%).
In general, the type and frequency of adverse events reported in patients with low body weight (≤ 60 kg) were similar to those of patients with higher weight (> 60 kg); however, the placebo-corrected frequencies of the following common adverse events were higher in low body weight than heavier patients: nausea (14% versus 2%), vomiting (6% versus 1%), and hypotension (4% versus 2%).
Laboratory findings Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranolazine Elara. There was no renal toxicity related to these findings.
A renal function study in healthy volunteers demonstrated a reduction in creatinine clearance with no change in glomerular filtration rate consistent with inhibition of renal tubular secretion of creatinine. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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