Sacuva
Generic Name
Sacubitril and Valsartan
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sacuva 24 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Sacuva 24 mg tablet is a combination medicine containing Sacubitril and Valsartan, used to treat chronic heart failure with reduced ejection fraction in adults.
Uses & Indications
Dosage
Adults
Initial dose: One Sacuva 24 mg/26 mg tablet (sacubitril/valsartan) twice daily. The dose should be doubled at 2-4 week intervals to the target dose of 97 mg/103 mg twice daily, as tolerated.
Elderly
No specific dose adjustment is required based on age, but consider renal function and comorbidities.
Renal_impairment
Mild to moderate (eGFR ≥30 mL/min/1.73m²): No initial dose adjustment. Severe (eGFR <30 mL/min/1.73m²): Consider a lower starting dose (e.g., 24 mg/26 mg twice daily) or avoid.
How to Take
Take Sacuva orally, with or without food, usually twice daily. Swallow the tablet whole; do not crush or chew it.
Mechanism of Action
Sacubitril inhibits neprilysin, leading to increased levels of natriuretic peptides which cause vasodilation and natriuresis. Valsartan is an angiotensin II receptor blocker (ARB), which inhibits the renin-angiotensin-aldosterone system (RAAS), thereby reducing vasoconstriction and fluid retention.
Pharmacokinetics
Onset
Clinical benefits, such as improvement in heart failure symptoms, are typically observed within a few weeks.
Excretion
LBQ657 is primarily excreted in urine. Valsartan is primarily excreted in feces.
Half life
Sacubitril active metabolite (LBQ657): approximately 11.3 hours. Valsartan: approximately 9.9 hours.
Absorption
Rapidly absorbed. Sacubitril is rapidly converted to its active metabolite, LBQ657, by esterases. Valsartan has moderate absorption.
Metabolism
Sacubitril is a prodrug, activated to LBQ657 by esterases. Valsartan is minimally metabolized.
Side Effects
Contraindications
- Hypersensitivity to sacubitril, valsartan, or any component of the formulation.
- Concomitant use with ACE inhibitors (a 36-hour washout period is required when switching).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels closely.
Aliskiren
Contraindicated in patients with diabetes or renal impairment.
ACE inhibitors
Increased risk of angioedema. Contraindicated. A 36-hour washout period is required.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect and worsen renal function. Monitor renal function.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia. Monitor serum potassium.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include severe hypotension. Treatment is symptomatic and supportive. Sacubitril and its active metabolite (LBQ657), as well as valsartan, are not removed by hemodialysis to a significant extent.
Pregnancy & Lactation
Pregnancy Category D (FDA). Sacuva is contraindicated during pregnancy due to the risk of fetal harm or death. If pregnancy is detected, discontinue Sacuva as soon as possible. It is unknown whether Sacuva is excreted in human milk; therefore, breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to sacubitril, valsartan, or any component of the formulation.
- Concomitant use with ACE inhibitors (a 36-hour washout period is required when switching).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels closely.
Aliskiren
Contraindicated in patients with diabetes or renal impairment.
ACE inhibitors
Increased risk of angioedema. Contraindicated. A 36-hour washout period is required.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect and worsen renal function. Monitor renal function.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia. Monitor serum potassium.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include severe hypotension. Treatment is symptomatic and supportive. Sacubitril and its active metabolite (LBQ657), as well as valsartan, are not removed by hemodialysis to a significant extent.
Pregnancy & Lactation
Pregnancy Category D (FDA). Sacuva is contraindicated during pregnancy due to the risk of fetal harm or death. If pregnancy is detected, discontinue Sacuva as soon as possible. It is unknown whether Sacuva is excreted in human milk; therefore, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Generics available (after brand patent expiry)
Clinical Trials
The landmark PARADIGM-HF trial demonstrated that sacubitril/valsartan significantly reduced the primary endpoint of cardiovascular death or hospitalization for heart failure compared to enalapril in patients with chronic heart failure with reduced ejection fraction.
Lab Monitoring
- Monitor renal function (serum creatinine, eGFR) and serum potassium levels periodically, especially at initiation and after dose adjustments.
- Regularly monitor blood pressure.
Doctor Notes
- Crucial to ensure a minimum 36-hour washout period when transitioning from ACE inhibitors to Sacuva to prevent angioedema.
- Monitor patients for hypotension, hyperkalemia, and renal dysfunction, especially upon initiation and dose titration.
- Educate patients on symptoms of angioedema and the importance of immediate reporting.
Patient Guidelines
- Take Sacuva exactly as prescribed by your doctor; do not stop taking it without consulting them.
- Report any signs of angioedema (e.g., swelling of the face, lips, tongue, or throat) immediately to your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically advised by your doctor.
- Be aware of potential dizziness, especially when standing up from a sitting or lying position.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sacuva may cause dizziness or lightheadedness, especially at the start of treatment or when the dose is increased. Exercise caution when driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Follow a healthy lifestyle, including a balanced diet low in sodium and regular exercise, as advised by your healthcare provider.
- Manage other health conditions, such as diabetes and hypertension, to support heart health.
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