Sacutril
Generic Name
sacutril-97-mg-tablet
Manufacturer
Various (e.g., Novartis for Entresto, others for generics)
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sacutril 97 mg tablet | ৳ 120.00 | ৳ 1,200.00 |
Description
Overview of the medicine
Sacubitril is a neprilysin inhibitor, typically used in combination with valsartan (an angiotensin receptor blocker) to treat chronic heart failure with reduced ejection fraction in adults. It works by enhancing the body's protective neurohormonal systems while inhibiting harmful ones, leading to improved cardiovascular outcomes.
Uses & Indications
Dosage
Adults
Initial dose: 49 mg Sacubitril/51 mg Valsartan (total 100 mg) twice daily. Target maintenance dose: 97 mg Sacubitril/103 mg Valsartan (total 200 mg) twice daily, achieved by doubling the dose approximately every 2-4 weeks as tolerated.
Elderly
No specific dose adjustment based on age alone is required, but titration should be cautious.
Renal_impairment
Mild to moderate (eGFR 30-60 mL/min/1.73m²): Initial dose 24 mg Sacubitril/26 mg Valsartan (total 50 mg) twice daily. Severe (eGFR <30 mL/min/1.73m²): Not recommended or initiate at 24 mg Sacubitril/26 mg Valsartan (total 50 mg) twice daily with caution and close monitoring.
How to Take
Oral administration, typically twice daily. Can be taken with or without food. Swallow the tablet whole; do not crush or chew.
Mechanism of Action
Sacubitril inhibits neprilysin, an enzyme responsible for the degradation of beneficial natriuretic peptides (NPs). By inhibiting neprilysin, sacubitril increases the levels of NPs, leading to vasodilation, natriuresis, and diuresis. In combination with valsartan, it also blocks the AT1 receptor, countering the effects of angiotensin II, further reducing vasoconstriction and aldosterone release. This dual action reduces cardiac workload and improves myocardial function.
Pharmacokinetics
Onset
Clinical effects seen within hours, sustained over long-term treatment.
Excretion
Primarily renal (approx. 52-68% of LBQ657), with a smaller portion excreted in feces (approx. 37% of LBQ657).
Half life
LBQ657: approximately 9.9-10 hours.
Absorption
Sacubitril is a prodrug that is rapidly converted to its active metabolite, LBQ657, by esterases. Peak plasma concentration of LBQ657 is reached in about 2 hours. Bioavailability is approximately 60%.
Metabolism
Sacubitril is metabolized by esterases to LBQ657. LBQ657 is further metabolized to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to any component of the product.
- Concomitant use with ACE inhibitors (due to risk of angioedema); a washout period of at least 36 hours is required after discontinuing an ACE inhibitor.
- 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 carefully.
Aliskiren
Increased risk of hyperkalemia, hypotension, and renal impairment in patients with diabetes or renal impairment. Contraindicated.
ACE inhibitors
Increased risk of angioedema. Contraindicated.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Increased risk of renal impairment, especially in elderly or dehydrated patients. Monitor renal function.
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include profound hypotension. Treatment is symptomatic and supportive. Since it is highly protein-bound, hemodialysis is unlikely to be effective in removing sacubitril or LBQ657.
Pregnancy & Lactation
Pregnancy Category D. Use in pregnancy is contraindicated due to fetal toxicity and death. Discontinue as soon as pregnancy is detected. Lactation: Not recommended during breastfeeding due to potential serious adverse reactions in the breastfed infant.
Side Effects
Contraindications
- Hypersensitivity to any component of the product.
- Concomitant use with ACE inhibitors (due to risk of angioedema); a washout period of at least 36 hours is required after discontinuing an ACE inhibitor.
- 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 carefully.
Aliskiren
Increased risk of hyperkalemia, hypotension, and renal impairment in patients with diabetes or renal impairment. Contraindicated.
ACE inhibitors
Increased risk of angioedema. Contraindicated.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Increased risk of renal impairment, especially in elderly or dehydrated patients. Monitor renal function.
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia).
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Limited data on overdose. Symptoms may include profound hypotension. Treatment is symptomatic and supportive. Since it is highly protein-bound, hemodialysis is unlikely to be effective in removing sacubitril or LBQ657.
Pregnancy & Lactation
Pregnancy Category D. Use in pregnancy is contraindicated due to fetal toxicity and death. Discontinue as soon as pregnancy is detected. Lactation: Not recommended during breastfeeding due to potential serious adverse reactions in the breastfed infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA (as part of Sacubitril/Valsartan combination)
Patent Status
Under patent (for innovator drug, generics may exist in some regions)
Clinical Trials
Key trials include PARADIGM-HF, which demonstrated superiority of sacubitril/valsartan over enalapril in reducing cardiovascular death and heart failure hospitalizations. Subsequent trials like PARAGON-HF explored its role in HFpEF.
Lab Monitoring
- Serum potassium levels (regularly, especially in patients with renal impairment or on potassium-sparing diuretics).
- Renal function (e.g., serum creatinine, eGFR) periodically.
- Blood pressure monitoring.
Doctor Notes
- Ensure patient is hemodynamically stable before initiating treatment.
- Monitor potassium and renal function closely, especially during dose titration.
- Educate patients on symptoms of angioedema and the importance of immediate medical attention if it occurs.
- Not to be used concomitantly with ACE inhibitors due to increased angioedema risk.
- Consider lower starting dose for patients with moderate renal impairment or who are already on high doses of diuretics.
Patient Guidelines
- Take medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Avoid consuming potassium-rich foods or potassium supplements unless advised by your doctor.
- Report any swelling of the face, lips, tongue, or throat immediately to your doctor.
- Avoid driving or operating machinery until you know how this medicine affects you, as it may cause dizziness.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or lightheadedness, especially at the start of treatment or when changing doses. Patients should be cautioned about driving or operating machinery until they know how Sacubitril affects them.
Lifestyle Advice
- Maintain a healthy diet, low in sodium.
- Engage in regular, moderate exercise as advised by your doctor.
- Avoid smoking and excessive alcohol consumption.
- Monitor your blood pressure and heart rate regularly at home if recommended.
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International brand names for this medicine. Click a brand to search for detailed information.
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