Sacuva
Generic Name
Sacubitril and Valsartan
Manufacturer
MediCorp Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sacuva 49 mg tablet | ৳ 75.00 | ৳ 750.00 |
Description
Overview of the medicine
Sacuva-49-mg-tablet contains Sacubitril and Valsartan, a combination medication known as an Angiotensin Receptor Neprilysin Inhibitor (ARNI). It is used to treat chronic heart failure with reduced ejection fraction in adults, helping to reduce the risk of cardiovascular death and hospitalizations.
Uses & Indications
Dosage
Adults
Recommended starting dose is 49 mg sacubitril/51 mg valsartan orally twice daily. The dose should be doubled after 2-4 weeks to the target maintenance dose of 97 mg sacubitril/103 mg valsartan twice daily, as tolerated.
Elderly
No specific dose adjustment required based on age alone, but clinical status should be considered.
Renal_impairment
Mild-to-moderate (eGFR 30-60 mL/min/1.73 m2): No initial dose adjustment. Severe (eGFR <30 mL/min/1.73 m2): Consider starting at 24 mg sacubitril/26 mg valsartan twice daily.
How to Take
Administer orally, twice daily, with or without food.
Mechanism of Action
Sacubitril inhibits neprilysin, an enzyme that degrades natriuretic peptides, leading to increased levels of these peptides. Natriuretic peptides promote natriuresis, diuresis, and vasodilation. Valsartan blocks the angiotensin II type 1 (AT1) receptor, inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. The combined action reduces cardiovascular stress.
Pharmacokinetics
Onset
Clinical benefits are typically observed over weeks to months, blood pressure reduction within hours.
Excretion
Primarily through urine (52-68% for LBQ657, ~13% for Valsartan) and feces (37-48% for LBQ657, ~86% for Valsartan).
Half life
LBQ657: ~10-13 hours; Valsartan: ~9-10 hours.
Absorption
Sacubitril is a prodrug, rapidly converted to the active metabolite LBQ657. Valsartan is also absorbed. Peak plasma concentration for LBQ657 is ~2 hours, for Valsartan ~1.5 hours.
Metabolism
Sacubitril is metabolized to LBQ657 by esterases. LBQ657 is further metabolized to inactive metabolites. Valsartan is minimally metabolized.
Side Effects
Contraindications
- Hypersensitivity to any component of the medication.
- Concomitant use with ACE inhibitors (must be discontinued for at least 36 hours before starting Sacubitril/Valsartan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with aliskiren in patients with diabetes.
- Severe hepatic impairment.
Drug Interactions
NSAIDs
May lead to worsening renal function and reduced antihypertensive effect.
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Contraindicated in patients with diabetes due to increased risk of hyperkalemia, renal dysfunction, and hypotension.
ACE Inhibitors
Concomitant use is contraindicated due to increased risk of angioedema. A washout period of 36 hours is required.
Potassium-Sparing Diuretics/Potassium Supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C (86°F). Protect from moisture. Keep out of reach of children.
Overdose
Limited data on overdose. The most likely symptom is marked hypotension. Treatment should be symptomatic and supportive, including intravenous fluid administration for hypotension.
Pregnancy & Lactation
Contraindicated during pregnancy due to fetal toxicity. Women of childbearing potential should use effective contraception. Not recommended during lactation as it is unknown if components are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to any component of the medication.
- Concomitant use with ACE inhibitors (must be discontinued for at least 36 hours before starting Sacubitril/Valsartan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use with aliskiren in patients with diabetes.
- Severe hepatic impairment.
Drug Interactions
NSAIDs
May lead to worsening renal function and reduced antihypertensive effect.
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Contraindicated in patients with diabetes due to increased risk of hyperkalemia, renal dysfunction, and hypotension.
ACE Inhibitors
Concomitant use is contraindicated due to increased risk of angioedema. A washout period of 36 hours is required.
Potassium-Sparing Diuretics/Potassium Supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C (86°F). Protect from moisture. Keep out of reach of children.
Overdose
Limited data on overdose. The most likely symptom is marked hypotension. Treatment should be symptomatic and supportive, including intravenous fluid administration for hypotension.
Pregnancy & Lactation
Contraindicated during pregnancy due to fetal toxicity. Women of childbearing potential should use effective contraception. Not recommended during lactation as it is unknown if components are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Available in pharmacies and hospitals
Approval Status
FDA and DGDA Approved
Patent Status
Patented (original formulation)
Clinical Trials
Sacubitril/Valsartan's efficacy and safety were primarily established in large-scale clinical trials such as PARADIGM-HF (in HFrEF) and PARAGON-HF (in HFpEF, though not FDA approved for this indication).
Lab Monitoring
- Monitor blood pressure regularly.
- Monitor renal function (creatinine, eGFR) periodically.
- Monitor serum potassium levels periodically.
Doctor Notes
- Prioritize patient education on symptoms of angioedema and the 36-hour washout period when switching from ACE inhibitors.
- Closely monitor renal function and potassium, especially in patients with pre-existing renal impairment or those on potassium-sparing diuretics.
Patient Guidelines
- Take exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.
- Avoid potassium supplements or salt substitutes containing potassium without consulting your doctor.
- Be aware of symptoms of angioedema (swelling of face, lips, tongue, throat) and seek immediate medical attention if they occur.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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 when starting treatment or increasing the dose. Exercise caution when driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in sodium.
- Engage in regular, moderate physical activity as advised by your doctor.
- Avoid smoking and excessive alcohol consumption.
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