Sacutril
Generic Name
Sacubitril
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sacutril 24 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Sacutril 24 mg tablet contains Sacubitril, an active component typically part of an Angiotensin Receptor-Neprilysin Inhibitor (ARNI) combination product with Valsartan. It is primarily used to treat chronic heart failure with reduced ejection fraction.
Uses & Indications
Dosage
Adults
Typically used as part of a combination product (Sacubitril/Valsartan). Initial dose of Sacubitril component is 24 mg twice daily, as part of Sacubitril/Valsartan 24 mg/26 mg. The dose may be up-titrated based on clinical response and tolerability, usually by doubling the dose every 2-4 weeks.
Elderly
No specific dose adjustment is required based solely on age, but caution is advised in elderly patients due to potential age-related renal impairment and increased sensitivity to hypotensive effects.
Renal_impairment
For severe renal impairment (eGFR <30 mL/min/1.73m²), consider a lower starting dose (e.g., Sacubitril/Valsartan 24 mg/26 mg once daily) and careful titration. No dose adjustment is needed for mild to moderate renal impairment.
How to Take
Take orally twice daily, with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Sacubitril inhibits neprilysin, an enzyme responsible for the degradation of natriuretic peptides. This inhibition leads to increased levels of endogenous natriuretic peptides (e.g., ANP, BNP), which exert vasodilatory, natriuretic, and diuretic effects, thereby reducing cardiac preload and afterload. It is always administered in combination with valsartan, an angiotensin receptor blocker.
Pharmacokinetics
Onset
Pharmacological effects observed within 1 hour.
Excretion
The active metabolite LBQ657 is primarily eliminated via urine (approximately 52-68%) and to a lesser extent via feces (approximately 13%).
Half life
The elimination half-life of the active metabolite LBQ657 is approximately 10-12 hours.
Absorption
Sacubitril is rapidly absorbed and converted to its active metabolite LBQ657. Peak plasma concentration of LBQ657 is reached within 2 hours.
Metabolism
Sacubitril is a prodrug, rapidly metabolized to the active neprilysin inhibitor LBQ657 by esterases. 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 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
NSAIDs
May reduce the hypotensive effect and worsen renal function in dehydrated patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor serum lithium levels.
Aliskiren
Contraindicated in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
ACE Inhibitors
Concomitant use is contraindicated due to increased risk of angioedema. A 36-hour washout period is required between discontinuing an ACE inhibitor and initiating sacubitril/valsartan.
Angiotensin Receptor Blockers (ARBs)
Not recommended due to the valsartan component and potential for excessive blood pressure lowering.
Potassium-sparing diuretics and Potassium Supplements
May lead to increased serum potassium and 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 available. The most likely symptoms of overdose would be profound hypotension and possibly hyperkalemia. Treatment should be symptomatic and supportive, including close monitoring of blood pressure and electrolyte levels. Intravenous fluids may be administered to support blood pressure.
Pregnancy & Lactation
Pregnancy: Use is contraindicated during pregnancy as it can cause fetal harm or death. If pregnancy is detected, discontinue sacubitril/valsartan as soon as possible. Lactation: Not recommended during breastfeeding due to potential risk to the nursing 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 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
NSAIDs
May reduce the hypotensive effect and worsen renal function in dehydrated patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor serum lithium levels.
Aliskiren
Contraindicated in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
ACE Inhibitors
Concomitant use is contraindicated due to increased risk of angioedema. A 36-hour washout period is required between discontinuing an ACE inhibitor and initiating sacubitril/valsartan.
Angiotensin Receptor Blockers (ARBs)
Not recommended due to the valsartan component and potential for excessive blood pressure lowering.
Potassium-sparing diuretics and Potassium Supplements
May lead to increased serum potassium and 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 available. The most likely symptoms of overdose would be profound hypotension and possibly hyperkalemia. Treatment should be symptomatic and supportive, including close monitoring of blood pressure and electrolyte levels. Intravenous fluids may be administered to support blood pressure.
Pregnancy & Lactation
Pregnancy: Use is contraindicated during pregnancy as it can cause fetal harm or death. If pregnancy is detected, discontinue sacubitril/valsartan as soon as possible. Lactation: Not recommended during breastfeeding due to potential risk to the nursing infant.
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 (Bangladesh)
Patent Status
Available as generic; original formulation may be patented
Clinical Trials
Extensive clinical trials, most notably PARADIGM-HF (for HFrEF) and PARAGON-HF (for HFpEF), have demonstrated the efficacy and safety of sacubitril/valsartan in reducing cardiovascular mortality and heart failure hospitalizations.
Lab Monitoring
- Serum potassium levels (before and periodically during treatment)
- Renal function (serum creatinine, eGFR) (before and periodically during treatment)
- Blood pressure monitoring regularly
Doctor Notes
- Ensure 36-hour washout period after ACE inhibitor discontinuation before initiating sacubitril/valsartan.
- Monitor renal function and serum potassium regularly, especially during dose titration.
- Educate patients on symptoms of angioedema and to seek immediate medical attention if they occur.
- Consider lower starting dose in patients with severe renal impairment or those who are not currently on an ACE inhibitor/ARB.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medicine suddenly without consulting your doctor.
- Report any signs of angioedema (e.g., swelling of face, lips, tongue, throat) immediately.
- Avoid potassium-rich foods or supplements unless advised by your doctor.
- Monitor your blood pressure regularly as instructed.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose (within 6 hours), skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or lightheadedness, especially at the start of treatment or when changing doses. Exercise caution when driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet low in sodium.
- Engage in regular, moderate exercise as recommended by your doctor.
- Limit alcohol consumption.
- Quit smoking.
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