Nepitan
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 |
|---|---|---|
| nepitan 49 mg tablet | ৳ 85.00 | ৳ 850.00 |
Description
Overview of the medicine
Nepitan 49 mg tablet is a combination medicine containing Sacubitril and Valsartan. It is used to treat chronic heart failure in adults with reduced ejection fraction. It works by enhancing the protective neurohormonal systems and simultaneously inhibiting the harmful effects of the renin-angiotensin-aldosterone system.
Uses & Indications
Dosage
Adults
Starting dose: 49 mg sacubitril/51 mg valsartan twice daily. Target maintenance dose: 97 mg sacubitril/103 mg valsartan twice daily, if tolerated. Dose should be doubled approximately every 2-4 weeks to reach the target dose.
Elderly
No specific dose adjustment is required based on age alone, but caution is advised due to potential for greater sensitivity.
Renal_impairment
Mild to moderate renal impairment: No initial dose adjustment. Severe renal impairment (eGFR <30 mL/min/1.73m²): Consider starting at 24 mg sacubitril/26 mg valsartan twice daily.
How to Take
Take orally, with or without food, usually twice daily. 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, leading to increased levels of these beneficial peptides. Valsartan is an angiotensin II receptor blocker (ARB) that antagonizes the effects of angiotensin II, including vasoconstriction and aldosterone secretion, thereby reducing blood pressure and fluid retention.
Pharmacokinetics
Onset
Clinical effects observed within days to weeks of initiation.
Excretion
Mainly excreted in urine and feces, with active metabolite of sacubitril primarily renal and valsartan primarily fecal.
Half life
Active metabolite of sacubitril (LBQ657): approximately 9.9-10.4 hours. Valsartan: approximately 9.9 hours.
Absorption
Sacubitril is a prodrug, rapidly converted to its active metabolite LBQ657. Valsartan is well absorbed. Bioavailability: Sacubitril (active metabolite) approximately 60%, Valsartan approximately 23%. Peak plasma concentrations achieved within 0.5-2 hours for sacubitril and 1.5-4 hours for valsartan.
Metabolism
Sacubitril is rapidly metabolized by esterases to LBQ657. Valsartan is minimally metabolized.
Side Effects
Contraindications
- Hypersensitivity to Sacubitril or Valsartan or any excipients.
- Concomitant use with ACE inhibitors (discontinue ACE inhibitor at least 36 hours before starting Nepitan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Hereditary or idiopathic angioedema.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Pregnancy.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor serum lithium levels.
Aliskiren
Avoid use in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
ACE Inhibitors
Contraindicated due to increased risk of angioedema. A washout period of 36 hours is required.
NSAIDs (Non-steroidal anti-inflammatory drugs)
May reduce the antihypertensive effect and worsen renal function, especially in elderly or dehydrated patients.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
May lead to increased serum potassium and hyperkalemia.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include marked hypotension (low blood pressure) and possibly hyperkalemia. Treatment is symptomatic and supportive, including intravenous fluid administration for hypotension.
Pregnancy & Lactation
Contraindicated during pregnancy due to fetal toxicity. Not recommended during lactation as it is unknown if components are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Sacubitril or Valsartan or any excipients.
- Concomitant use with ACE inhibitors (discontinue ACE inhibitor at least 36 hours before starting Nepitan).
- History of angioedema related to previous ACE inhibitor or ARB therapy.
- Hereditary or idiopathic angioedema.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Pregnancy.
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity have been reported. Monitor serum lithium levels.
Aliskiren
Avoid use in patients with diabetes or renal impairment (eGFR <60 mL/min/1.73m²).
ACE Inhibitors
Contraindicated due to increased risk of angioedema. A washout period of 36 hours is required.
NSAIDs (Non-steroidal anti-inflammatory drugs)
May reduce the antihypertensive effect and worsen renal function, especially in elderly or dehydrated patients.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
May lead to increased serum potassium and hyperkalemia.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include marked hypotension (low blood pressure) and possibly hyperkalemia. Treatment is symptomatic and supportive, including intravenous fluid administration for hypotension.
Pregnancy & Lactation
Contraindicated during pregnancy due to fetal toxicity. 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 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA (2015) and DGDA
Patent Status
Under patent (for originator, generics may exist)
Clinical Trials
The efficacy and safety of Sacubitril/Valsartan were primarily demonstrated in the PARADIGM-HF trial, which showed superiority over enalapril in reducing cardiovascular mortality and heart failure hospitalization in patients with chronic heart failure and reduced ejection fraction.
Lab Monitoring
- Serum potassium levels (before treatment and periodically during treatment)
- Renal function (e.g., serum creatinine, eGFR - before treatment and periodically during treatment)
- Blood pressure (regular monitoring)
Doctor Notes
- Ensure patient is stable on an ACE inhibitor or ARB before switching to Nepitan, and adhere to the 36-hour washout period for ACE inhibitors.
- Closely monitor blood pressure, renal function, and potassium levels, especially during initiation and dose titration.
- Educate patients on symptoms of angioedema and the need for immediate medical attention if it occurs.
- Not recommended for use in patients with NYHA Class IV heart failure requiring intravenous inotropes.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Nepitan without consulting your doctor.
- If you experience any signs of angioedema (swelling of face, lips, tongue), seek immediate medical attention.
- Report any symptoms of dizziness or lightheadedness, especially when standing up.
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 resume your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Nepitan may cause dizziness or lightheadedness, especially during the initial treatment period. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Follow a heart-healthy diet low in sodium and saturated fats.
- Engage in regular, moderate exercise as advised by your doctor.
- Avoid smoking and excessive alcohol consumption.
- Monitor your weight and report any sudden increases.
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