VALCUDER 100MG TABLETS

Name: VALCUDER 100MG TABLETS
Brand: ELDER GENERIC
SKU: 95025
Price: 697.50 INR
Availability: InStock

Manufactured By ELDER GENERIC

Composition VALSARTAN 51MG SACUBITRIL 49MG

RS 697.50

MRP RS 775.00

(10% OFF)

Includes all taxes

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( 14`s )

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Information about VALCUDER 100MG TABLETS

Description:

Valcuder 100mg Tablet Valcuder 100mg Tablet is a fixed dose combination of Sacubitril 49mg and Valsartan 51mg manufactured by Elder Generic and classified as an ARNI Angiotensin Receptor Neprilysin Inhibitor a landmark drug class in the treatment of chronic heart failure with reduced ejection fraction HFrEF It works through a dual mechanism Sacubitril inhibits neprilysin an enzyme that degrades natriuretic peptides increasing beneficial natriuretic peptide levels to promote vasodilation natriuresis and cardioprotection while Valsartan simultaneously blocks the angiotensin II type 1 AT1 receptor to reduce vasoconstriction sodium retention and cardiac remodelling Available from Shabbir Medical Hall at the best price in India this genuine prescription tablet is available online with fast delivery nationwide BENEFITS Valcuder 100mg Tablet has demonstrated landmark clinical evidence from the PARADIGM HF trial which showed that Sacubitril Valsartan reduced cardiovascular death and hospitalisation for heart failure by 20 compared to enalapril in patients with HFrEF It is now recommended by international cardiology guidelines ESC ACC AHA as a first line therapy for HFrEF replacing ACE inhibitors in patients who can tolerate it Benefits include improved symptoms functional capacity quality of life and survival in chronic heart failure patients USAGE OVERVIEW Valcuder 100mg Tablet is taken orally typically twice daily every 12 hours with or without food as prescribed by the treating cardiologist The starting dose titration schedule and target maintenance dose depend on the patient 39 s prior therapy ACE inhibitor or ARB dose blood pressure renal function and potassium levels A 36 hour washout period is mandatory before switching from an ACE inhibitor to prevent angioedema Regular monitoring of blood pressure renal function and serum potassium is essential throughout therapy SAFETY OVERVIEW The most significant risks are symptomatic hypotension low blood pressure hyperkalaemia high potassium and renal impairment particularly when combined with other renin angiotensin system agents Angioedema risk is elevated if switched from an ACE inhibitor without the mandatory 36 hour washout This medicine requires a valid prescription from a registered cardiologist

Uses / Indications:

PRIMARY USES Chronic Heart Failure with Reduced Ejection Fraction HFrEF treatment of symptomatic chronic heart failure NYHA Class II IV in adult patients with left ventricular ejection fraction LVEF 40 to reduce cardiovascular death and hospitalisation for heart failure Replacement of ACE Inhibitor or ARB Therapy Sacubitril Valsartan replaces ACE inhibitors e g enalapril ramipril or ARBs e g losartan valsartan in patients who are already stabilised on and tolerating these agents ADDITIONAL USES Heart Failure with Mildly Reduced Ejection Fraction HFmrEF LVEF 41 49 increasingly used based on expanding clinical evidence and guideline updates Heart Failure with Preserved Ejection Fraction HFpEF some guideline support especially in women and patients with lower normal EF specialist decision Post MI Heart Failure early initiation of Sacubitril Valsartan post acute myocardial infarction with reduced EF as per cardiologist protocol Hypertension off label Valsartan component provides antihypertensive benefit not a primary indication for this combination WHO IS THIS FOR Adult patients with established HFrEF EF 40 currently on ACE inhibitor or ARB therapy who remain symptomatic Patients newly diagnosed with HFrEF as first line RAAS therapy per latest ESC 2021 and ACC AHA 2022 guidelines Patients hospitalised for acute decompensated heart failure stabilised prior to discharge in hospital initiation

Interactions / Warnings:

THE 36 HOUR ACE INHIBITOR WASHOUT CRITICAL WARNING Before starting Valcuder 100mg Tablet there MUST be a minimum 36 hour gap after the last dose of any ACE inhibitor This is because both neprilysin inhibition sacubitril and ACE inhibition increase bradykinin concurrent use causes a dangerous potentially fatal risk of angioedema Document the washout period in the patient 39 s medical record before prescribing BLOOD PRESSURE MONITORING Check blood pressure at baseline at 1 2 weeks after initiation and after each dose increase If systolic BP 100 mmHg consider dose reduction or temporary discontinuation Advise patients to rise slowly from sitting lying to avoid postural hypotension RENAL FUNCTION ELECTROLYTE MONITORING Monitor serum creatinine eGFR and serum potassium at baseline 1 2 weeks after initiation after each dose increase every 3 6 months on stable therapy If serum creatinine rises 50 above baseline or K 5 5 mmol L halve the dose if K 6 0 mmol L STOP and reassess RENAL ARTERY STENOSIS Use with extreme caution in patients with bilateral renal artery stenosis high risk of acute renal failure CONTRAINDICATIONS ABSOLUTE Concurrent use with ACE inhibitors within 36 hours concurrent use with aliskiren in diabetic patients pregnancy all trimesters severe hepatic impairment Child Pugh C known hypersensitivity to sacubitril valsartan or any excipient prior history of angioedema related to ACE inhibitor or ARB therapy DRIVING MACHINERY Dizziness and hypotension may impair driving ability particularly at treatment initiation or after dose increase advise caution

Pregnancy interaction:

PREGNANCY SAFETY CONTRAINDICATED Valcuder 100mg Tablet is CONTRAINDICATED in pregnancy both Sacubitril and Valsartan as an ARB are teratogenic Drugs affecting the renin angiotensin system ARBs ACE inhibitors ARNIs can cause foetal renal toxicity oligohydramnios limb deformities skull hypoplasia and neonatal death particularly during the 2nd and 3rd trimesters Women of childbearing potential MUST use effective contraception during treatment If pregnancy is detected during treatment discontinue Valcuder IMMEDIATELY and consult the cardiologist for alternative heart failure therapy that is safe in pregnancy BREASTFEEDING Valcuder 100mg Tablet is NOT recommended during breastfeeding It is unknown whether sacubitril or valsartan is excreted in human breast milk Given the potential risk to the nursing infant a decision should be made to discontinue breastfeeding or discontinue the drug based on the importance of therapy to the mother FERTILITY No clinical data on effects on human fertility Animal studies showed no effects on fertility at clinical doses

Expert advice:

PHARMACIST BEST PRACTICES 1 VERIFY THE 36 HOUR ACE INHIBITOR WASHOUT EVERY TIME Before dispensing Valcuder 100mg Tablets to any patient who was previously on an ACE inhibitor enalapril ramipril lisinopril perindopril captopril etc verify with the patient and check their prescription record to confirm that at least 36 hours have elapsed since the last ACE inhibitor dose This is the most critical safety check with this drug missed washout can cause life threatening angioedema of the airway Document this check If in doubt contact the prescribing cardiologist before dispensing 2 EDUCATE PATIENTS ON POSTURAL HYPOTENSION Rise slowly from sitting or lying positions sit at the edge of the bed for 1 2 minutes before standing Avoid standing for prolonged periods in heat Maintain adequate fluid intake but within any fluid restriction set by the cardiologist Monitor blood pressure at home if a home BP device is available Report persistent dizziness lightheadedness or fainting to their cardiologist immediately 3 COUNSEL ON ANGIOEDEMA RECOGNITION RED FLAG EMERGENCY Angioedema swelling of the face lips tongue or throat is a rare but potentially life threatening reaction Every patient starting Valcuder must be counselled to stop the tablet immediately if any facial swelling lip tingling or throat tightness develops Call emergency services 108 112 and go to the nearest A E immediately NOT attempt to manage at home with antihistamines alone Inform all healthcare providers of their angioedema history 4 COUNSEL ON TITRATION DO NOT SELF ADJUST DOSE Dose titration from 50mg 100mg 200mg twice daily must ONLY occur under cardiologist supervision and after confirmation of tolerated blood pressure acceptable renal function eGFR and normal potassium levels Many patients are started at the lower dose and titrated over 6 12 weeks Patients must NOT self increase the dose based on perceived benefit dose changes require a clinical review and blood test confirmation 5 ADVISE ON CONCURRENT MEDICATIONS POTASSIUM NSAIDs Patients on Valcuder must avoid potassium supplements potassium containing salt substitutes and potassium sparing diuretics unless specifically prescribed by their cardiologist and monitored with regular serum potassium testing They must avoid regular use of NSAIDs ibuprofen diclofenac naproxen as these impair renal function and can worsen heart failure Direct patients to paracetamol for analgesia instead MONITORING ADVICE Blood Pressure At baseline 1 2 weeks post initiation after each dose increase then every 3 6 months Serum Creatinine eGFR Baseline 1 2 weeks after each dose increase then every 3 6 months Serum Potassium Same schedule as above target K 4 0 5 0 mmol L action if K 5 5 mmol L Serum Sodium Baseline and periodic monitoring hyponatraemia can occur Body Weight Daily self monitoring at home same time same clothing weight gain 2 kg in 2 days signals fluid retention Symptoms Monitor for oedema ankle swelling dyspnoea orthopnoea key HF decompensation signs NYHA Class Reassess functional class at each clinic visit Echocardiography Repeat echo at 3 6 months to assess response LVEF left ventricular dimensions COMPLIANCE TIPS Take Valcuder at the same time every day twice daily dosing every 12 hours is critical for maintaining therapeutic drug levels Use a pill organiser or phone alarm to avoid missed doses in elderly patients Never stop Valcuder suddenly without cardiologist advice abrupt discontinuation can cause acute cardiac decompensation Carry a medication card listing all heart medicines particularly when attending other healthcare providers emergency dentist surgeon Keep a symptom diary record BP readings weight and any new symptoms to share at clinic visits SAFETY TIPS This medicine MUST NOT be used without a valid prescription from a registered cardiologist or physician Do NOT take Valcuder with an ACE inhibitor this is a life threatening combination Inform all doctors dentists and surgeons that you are on Sacubitril Valsartan before any procedure or new prescription Women of childbearing potential must use effective contraception throughout therapy this drug is teratogenic

Side Effects:

COMMON SIDE EFFECTS 1 in 10 people Hypotension low blood pressure dizziness lightheadedness especially on standing most common particularly at treatment initiation or after dose increase Hyperkalaemia high potassium especially in patients with renal impairment or on potassium sparing diuretics or potassium supplements Renal Impairment rising serum creatinine reduced urine output monitor renal function at baseline 1 2 weeks after initiation and after each dose increase Cough less frequent than with ACE inhibitors as valsartan is an ARB not an ACEi but may still occur Dizziness headache Fatigue Nausea SERIOUS SIDE EFFECTS contact your doctor immediately Angioedema sudden swelling of the face lips tongue throat potentially life threatening airway obstruction Risk is higher in Patients with prior history of angioedema Black African American patients Those who did not observe the 36 hour ACE inhibitor washout SEEK EMERGENCY CARE IMMEDIATELY Symptomatic Hypotension syncope fainting severe dizziness may require dose reduction or temporary discontinuation Severe Hyperkalaemia K 6 0 mmol L cardiac arrhythmia risk monitor potassium regularly Acute Kidney Injury significant rise in serum creatinine renal failure in high risk patients bilateral renal artery stenosis EMERGENCY SIGNS SEEK IMMEDIATE MEDICAL HELP Swelling of face lips tongue or throat angioedema call emergency services Sudden severe drop in blood pressure fainting Significantly reduced urine output Irregular heartbeat or palpitations may indicate hyperkalaemia

How to use:

DOSAGE GUIDANCE always as directed by your cardiologist STARTING DOSE Patients currently on a moderate to high dose ACE inhibitor or ARB e g enalapril 10mg day or equivalent start with Sacubitril Valsartan 100mg 49 51mg twice daily Patients on a low dose ACE inhibitor or ARB or ACE inhibitor ARB naive start with Sacubitril Valsartan 50mg 24 26mg twice daily Patients with severe renal impairment eGFR

How it works:

OVERVIEW Valcuder 100mg Tablet contains two active components with complementary and synergistic mechanisms of action COMPONENT 1 SACUBITRIL Neprilysin Inhibitor NEPi Sacubitril is a prodrug it is converted in the body to its active metabolite LBQ657 sacubitrilat LBQ657 inhibits neprilysin neutral endopeptidase NEP an enzyme that normally degrades natriuretic peptides ANP BNP CNP bradykinin and adrenomedullin By inhibiting neprilysin sacubitril increases circulating levels of natriuretic peptides which produce Vasodilation reducing afterload and preload on the failing heart Natriuresis and diuresis reducing fluid overload oedema and congestion Inhibition of the renin angiotensin aldosterone system RAAS Anti fibrotic and anti hypertrophic effects on the myocardium cardiac remodelling reversal COMPONENT 2 VALSARTAN Angiotensin Receptor Blocker ARB Valsartan selectively blocks the angiotensin II type 1 AT1 receptor Prevents angiotensin II from causing Vasoconstriction which would increase cardiac workload Aldosterone secretion which promotes sodium and water retention Sympathetic nervous system activation Cardiac and vascular fibrosis and remodelling WHY VALSARTAN IS PAIRED NOT AN ACE INHIBITOR Neprilysin inhibition alone would increase bradykinin levels since bradykinin is also a neprilysin substrate ACE inhibitors also raise bradykinin combining both would risk dangerous angioedema ARBs like valsartan block RAAS without raising bradykinin making this a safe combination CLINICAL EVIDENCE PARADIGM HF Trial Sacubitril Valsartan reduced the composite endpoint of CV death HF hospitalisation by 20 vs enalapril CV death alone reduced by 20 all cause mortality reduced by 16 Improved NYHA functional class quality of life KCCQ scores and 6 minute walk distance

Faq for medicine:

1 How does Valcuder 100mg Tablet help reduce heart failure hospitalizations Valcuder 100mg Tablets contain Sacubitril 49mg and Valsartan 51mg working together as an ARNI to reduce hospitalizations due to heart failure Sacubitril inhibits neprilysin increasing beneficial natriuretic peptides that promote cardiac unloading and sodium excretion Valsartan blocks angiotensin II Combined in Valcuder 100mg these mechanisms significantly reduce worsening heart failure episodes and related emergency admissions in HFrEF patients 2 What is the target maintenance dose of Valcuder for chronic heart failure The target maintenance dose of Sacubitril Valsartan is 200mg twice daily Sacubitril 97mg Valsartan 103mg but many patients are stabilized on Valcuder 100mg Tablets twice daily Titration from 50mg to 100mg and then to 200mg occurs every 2 4 weeks as tolerated Valcuder 100mg is often the optimal maintenance dose for patients who cannot tolerate the maximum 200mg strength due to blood pressure or tolerability concerns 3 Can Valcuder 100mg Tablets be used together with beta blockers for heart failure Yes Valcuder 100mg Tablets are typically prescribed alongside beta blockers e g carvedilol metoprolol bisoprolol as part of guideline directed medical therapy GDMT for HFrEF This combination provides synergistic neurohormonal blockade reducing cardiac remodeling and improving survival outcomes Valcuder 100mg and beta blockers are both cornerstone therapies in modern heart failure management and can be safely co administered with appropriate monitoring 4 What are the signs of hyperkalemia to watch for with Valcuder 100mg Tablets Patients on Valcuder 100mg Tablets may develop hyperkalemia high potassium due to Valsartan s inhibition of aldosterone Symptoms include muscle weakness numbness irregular heartbeat and in severe cases cardiac arrhythmias Serum potassium should be regularly monitored especially in patients with kidney impairment diabetes or those on potassium sparing diuretics Dietary potassium restriction and dose adjustment of Valcuder may be required 5 Is Valcuder 100mg Tablet safe for patients with a low blood pressure baseline Valcuder 100mg Tablets may cause hypotension making them challenging in patients with already low blood pressure Initiation is typically deferred if systolic blood pressure is below 100 mmHg Dose escalation should be cautious If symptomatic hypotension occurs reducing or temporarily stopping concurrent diuretics may allow continued Valcuder use Risk benefit assessment by a cardiologist is essential before prescribing Valcuder 100mg in borderline hypotensive patients 6 How does Valcuder 100mg improve cardiac function over time Valcuder 100mg Tablets promote cardiac reverse remodeling in HFrEF patients by consistently reducing ventricular wall stress decreasing cardiac fibrosis and improving left ventricular ejection fraction over months of therapy This functional improvement is reflected in rising LVEF reduced ventricular dimensions and improved exercise capacity Long term Valcuder 100mg therapy has been associated with sustained improvement in cardiac structure and hemodynamic function

Medicine interaction:

CONTRAINDICATED COMBINATIONS ACE Inhibitors ramipril enalapril lisinopril perindopril ABSOLUTE CONTRAINDICATION concurrent use with Sacubitril Valsartan causes dangerous angioedema risk Mandatory 36 hour washout from last ACE inhibitor dose required before starting Valcuder Aliskiren direct renin inhibitor CONTRAINDICATED in patients with diabetes mellitus or renal impairment eGFR 100mg may reduce antihypertensive efficacy and increase risk of renal impairment avoid regular use Loop Diuretics furosemide torsemide Thiazide Diuretics increased hypotension risk reduce diuretic dose before initiating Valcuder monitor blood pressure closely Lithium ARB component valsartan may increase lithium toxicity monitor lithium levels if used concurrently Statins atorvastatin rosuvastatin no clinically significant interaction safe to use concurrently Beta Blockers carvedilol metoprolol bisoprolol additive hypotension possible standard co therapy in HFrEF monitor BP Phosphodiesterase 5 inhibitors sildenafil tadalafil additive hypotension use with extreme caution in heart failure patients SUPPLEMENT INTERACTIONS Avoid potassium rich herbal preparations noni aloe vera in large doses hyperkalaemia risk Always inform your cardiologist and pharmacist of all medications herbal products and supplements