Nepitan
Generic Name
Sacubitril and Valsartan
Manufacturer
Generic Manufacturer (e.g., Square Pharmaceuticals, Incepta Pharmaceuticals, Renata Pharmaceuticals)
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nepitan 24 mg tablet | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Nepitan 24 mg tablet is a combination medication containing sacubitril and valsartan, indicated for the treatment of chronic heart failure with reduced ejection fraction in adult patients. It works to reduce the risk of cardiovascular death and hospitalization for heart failure.
Uses & Indications
Dosage
Adults
The recommended starting dose for Nepitan is 24 mg/26 mg (sacubitril 24 mg / valsartan 26 mg) orally twice daily. The dose should be doubled at 2-4 week intervals to a target maintenance dose of 97 mg/103 mg (sacubitril 97 mg / valsartan 103 mg) twice daily, as tolerated by the patient. For patients not currently taking an ACE inhibitor or ARB, or those on low doses, Nepitan 24 mg/26 mg twice daily can be considered as a starting dose.
Elderly
No specific dose adjustment is required based on age alone, but renal function should be assessed before initiation and monitored periodically.
Renal_impairment
For patients with moderate renal impairment (eGFR 30-60 mL/min/1.73 m²), the starting dose is Nepitan 24 mg/26 mg twice daily. Not recommended for severe renal impairment (eGFR < 30 mL/min/1.73 m²) due to limited data and increased risk of adverse effects.
How to Take
Take the tablet orally, twice daily, at approximately 12-hour intervals, with or without food. Swallow the tablet whole; do not crush, chew, or break it.
Mechanism of Action
Sacubitril is a neprilysin inhibitor that increases levels of natriuretic peptides, leading to vasodilation, natriuresis, and diuresis. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the effects of angiotensin II, resulting in vasodilation and reduced blood pressure. The combined action of these two components provides synergistic benefits in heart failure management.
Pharmacokinetics
Onset
Blood pressure lowering effects can be observed within 1 week. Clinical benefits in heart failure, such as reduction in cardiovascular death and hospitalisation, are observed over several weeks to months.
Excretion
Approximately 52-68% of sacubitril (as LBQ657) and 13% of valsartan are excreted in the urine. About 37-48% of sacubitril (as LBQ657) and 86% of valsartan are excreted in the feces.
Half life
The effective half-life of LBQ657 is approximately 10-13 hours, and for valsartan, it is approximately 9.9 hours.
Absorption
Sacubitril is a prodrug, rapidly converted to the active metabolite LBQ657 by esterases. Valsartan is well absorbed. Bioavailability of sacubitril (as LBQ657) is approximately 60% and valsartan is approximately 23%. Peak plasma concentrations of LBQ657 and valsartan are reached in 2 hours and 1.5 hours, respectively.
Metabolism
Sacubitril is metabolized to its active metabolite LBQ657. Valsartan is minimally metabolized, with only about 20% of the dose being metabolized.
Side Effects
Contraindications
- Hypersensitivity to sacubitril, valsartan, or any excipients of the tablet.
- Concomitant use with ACE inhibitors (a washout period of at least 36 hours is required after discontinuing an ACE inhibitor before initiating Nepitan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Pregnancy.
Drug Interactions
Lithium
Increased serum lithium concentrations and potential for toxicity. Monitor serum lithium levels.
Other ARBs
Do not co-administer with other angiotensin receptor blockers (ARBs).
Sildenafil
Potential for increased hypotensive effects due to additive blood pressure lowering effects.
ACE Inhibitors
Contraindicated due to increased risk of angioedema. A 36-hour washout period is required when switching.
Statins (e.g., simvastatin)
Potential for increased exposure to certain statins due to sacubitril's effect on OATP1B1/B3 transporters.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Increased risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
Potassium-Sparing Diuretics/Potassium Supplements
Increased risk of hyperkalemia. Monitor serum potassium levels.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep the tablets in their original packaging until use. Keep out of reach of children.
Overdose
Limited data are available on overdose in humans. Symptoms of overdose may include severe hypotension (low blood pressure) and potentially hyperkalemia. Treatment is symptomatic and supportive. It includes monitoring of blood pressure, potassium levels, and renal function. Hemodialysis is unlikely to remove the drug effectively due to high protein binding.
Pregnancy & Lactation
Pregnancy: Nepitan is contraindicated during pregnancy due to the risk of fetal injury and death. Women of childbearing potential should be advised about the risks and use effective contraception. Lactation: It is unknown whether sacubitril or valsartan passes into human breast milk. Due to the potential for serious adverse reactions in breastfed infants, Nepitan is not recommended during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to sacubitril, valsartan, or any excipients of the tablet.
- Concomitant use with ACE inhibitors (a washout period of at least 36 hours is required after discontinuing an ACE inhibitor before initiating Nepitan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Pregnancy.
Drug Interactions
Lithium
Increased serum lithium concentrations and potential for toxicity. Monitor serum lithium levels.
Other ARBs
Do not co-administer with other angiotensin receptor blockers (ARBs).
Sildenafil
Potential for increased hypotensive effects due to additive blood pressure lowering effects.
ACE Inhibitors
Contraindicated due to increased risk of angioedema. A 36-hour washout period is required when switching.
Statins (e.g., simvastatin)
Potential for increased exposure to certain statins due to sacubitril's effect on OATP1B1/B3 transporters.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Increased risk of renal impairment, especially in elderly, volume-depleted, or renally impaired patients.
Potassium-Sparing Diuretics/Potassium Supplements
Increased risk of hyperkalemia. Monitor serum potassium levels.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep the tablets in their original packaging until use. Keep out of reach of children.
Overdose
Limited data are available on overdose in humans. Symptoms of overdose may include severe hypotension (low blood pressure) and potentially hyperkalemia. Treatment is symptomatic and supportive. It includes monitoring of blood pressure, potassium levels, and renal function. Hemodialysis is unlikely to remove the drug effectively due to high protein binding.
Pregnancy & Lactation
Pregnancy: Nepitan is contraindicated during pregnancy due to the risk of fetal injury and death. Women of childbearing potential should be advised about the risks and use effective contraception. Lactation: It is unknown whether sacubitril or valsartan passes into human breast milk. Due to the potential for serious adverse reactions in breastfed infants, Nepitan is not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on the manufacturer's specifications and storage conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved (e.g., FDA in USA, DGDA in Bangladesh for local brands)
Patent Status
Patented (original drug by Novartis, generics available post-patent expiry or under license)
Clinical Trials
The pivotal clinical trial supporting the use of sacubitril/valsartan (the active ingredients in Nepitan) for heart failure with reduced ejection fraction was the PARADIGM-HF trial. This trial demonstrated superiority over enalapril in reducing cardiovascular mortality and heart failure hospitalizations.
Lab Monitoring
- Serum potassium levels (especially at initiation, dose escalation, and in patients with renal impairment).
- Renal function (serum creatinine and estimated Glomerular Filtration Rate - eGFR, particularly in patients with pre-existing renal impairment or during dose adjustments).
- Blood pressure monitoring regularly, especially after dose changes.
Doctor Notes
- Crucially advise patients regarding the mandatory 36-hour washout period when transitioning from an ACE inhibitor to Nepitan to mitigate angioedema risk.
- Monitor serum potassium and renal function (eGFR, creatinine) meticulously at baseline, 1-2 weeks post-initiation/dose escalation, and then periodically as clinically indicated.
- Educate patients thoroughly on the symptoms of angioedema and the necessity for immediate medical attention if they occur. Emphasize that angioedema can occur at any time during treatment.
- Counsel on adherence to the twice-daily dosing schedule and the importance of not discontinuing the medication without physician consultation.
- Evaluate for symptomatic hypotension and adjust concomitant antihypertensive medications if necessary, particularly during titration.
Patient Guidelines
- Take Nepitan exactly as prescribed by your doctor, usually twice daily, approximately 12 hours apart.
- Do not stop taking Nepitan without consulting your doctor, even if you feel better, as this can worsen your heart failure.
- Ensure a 36-hour washout period if you are switching from an ACE inhibitor to Nepitan to avoid the risk of angioedema.
- Immediately report any signs of angioedema (e.g., swelling of the face, lips, tongue, or throat) to your doctor.
- Monitor your blood pressure and follow dietary restrictions (e.g., low sodium, controlled potassium intake) as advised by your healthcare provider.
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 of the 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
Nepitan may cause dizziness, lightheadedness, or fatigue, especially at the start of treatment or during dose escalation. If you experience these symptoms, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Adopt a heart-healthy diet that is low in sodium and saturated fats, and rich in fruits, vegetables, and whole grains.
- Engage in regular, moderate exercise as advised by your doctor to improve cardiovascular health.
- Monitor your weight daily and report any sudden or significant increase (e.g., >2 kg in a few days) to your doctor, as this may indicate fluid retention.
- Avoid excessive alcohol consumption and smoking, as these can negatively impact heart health.
- Manage stress through relaxation techniques or other coping strategies.
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Global Brand Names
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