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ANZIPRO is a brand name for Ranolazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ranolazine 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 is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Adults:
The recommended initial dose of ranolazine is 375 mg twice daily. 1). g. dizziness, nausea, or vomiting), down titration of ranolazine 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 in children below the age of 18 years have not been established. No data are available Method of administration Anzipro 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 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.
The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
The frequency of adverse reactions is based on the following categories:
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 Very rare <1/10,000, not known cannot be estimated from the available data V e r y c o m m o n Com mon Unc omm on Rare Not kno wn (can not be esti mate d from avail able data) Metabo lism Anor exia, Hypon atremi and nutritio n disorder s: decr ease d appe tite, dehy drati on.
a.
Psychia tric disorder s:
Anxi ety, inso mnia , conf usio nal state, hallu cinat ion. Disori entatio n.
Nervou s system disorder s:
Dizzi ness, heada che. Leth argy, sync ope, hypo aesth esia, som nole nce, trem or, post ural dizzi ness, para esthe sia. Amnes ia, depres sed level of consci ousnes s, loss of consci ousnes s, coordi nation abnor mal, gait disturb ance, paros mia.
Myo clon us.
Eye disorder s:
Blur red visio n, visu al distu rban ce, diplo pia Ear and labyrint h disorder s: Verti go, tinni tus Impair ed hearin g.
Vascula r disorder s:
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 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 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).
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Hot flush , hypo tensi on. Periph eral coldne ss, orthost atic hypote nsion.
Respira tory, thoracic , and mediast inal disorder s:
Dys pnoe a, coug h, epist axis Throat tightne ss.
Gastroi ntestina l disorder s:
Const ipatio n, vomit ing, nause a. Abd omin al pain, dry mout h, dysp epsia , flatu lenc e, stom ach disc omf ort. Pancre atitis, erosive duode nitis, oral hypoae sthesia .
Skin and subcuta neous tissue disorder s:
Pruri tus, hype rhidr osis. Angio edema, allergi c dermat itis, urticari a, cold sweat, rash. Muscul oskeleta l and Pain in extre connect ive tissue disorder s: mity, mus cle cram p, joint swel ling, mus cular wea knes s Renal and urinary disorder s: Dys uria, hae matu ria, chro matu ria.
Acute renal failure, urinary retenti on.
Reprod uctive system and breast disorder :
Erectil e dysfun ction.
General disorder s and adminis tration site conditio ns:
Asthe nia. Fatig ue, perip heral oede ma.
Investig ations:
Incre ased bloo d creat inine , incre ased bloo d urea, prol onge d QT corre cted Elevat ed levels of hepatic enzym e. inter val, incre ased plate let or whit e bloo d cell coun t, decr ease d weig ht. The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
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 (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. 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.