Sacuval 100 Tab

SACUVAL 100 TAB

SACUVAL 100 TAB by ALKEM LABORATORIES LTD. is a medication primarily used for the management of chronic heart failure. It is a combination drug that works to improve heart function and reduce the risk of associated complications.

• Name:

  • Brand Name: SACUVAL 100 TAB
  • Common Name: Sacubitril and Valsartan
  • Manufacturer: Alkem Laboratories Ltd.

• Composition:

  • Each tablet contains:
    • Sacubitril: 49 mg
    • Valsartan: 51 mg
  • SACUVAL 100 belongs to a class of medicines known as Angiotensin Receptor Neprilysin Inhibitors (ARNIs). Sacubitril inhibits neprilysin, an enzyme that breaks down beneficial natriuretic peptides, while Valsartan is an angiotensin II receptor blocker (ARB). Together, these components relax blood vessels, promote sodium and water excretion, and reduce the workload on the heart.

• Uses:

  • SACUVAL 100 is primarily prescribed for the treatment of chronic heart failure in adults, particularly heart failure with reduced ejection fraction (HFrEF).
  • It is used to reduce the risk of cardiovascular death and hospitalization in patients with chronic heart failure.
  • The medication also helps alleviate symptoms associated with heart failure such as shortness of breath, fatigue, and swelling in the feet and ankles.

• Dosage and Administration:

  • SACUVAL 100 should be taken exactly as prescribed by a healthcare professional.
  • Swallow the tablet whole with a glass of water; do not chew, crush, or break it.
  • It can be taken with or without food.
  • For optimal benefits, it is recommended to take the medicine at the same time each day.
  • The dosage and duration of treatment are determined by the physician based on the patient's medical condition, age, body weight, and response to the medication. Do not exceed the prescribed dose.
  • If a dose is missed, take it as soon as remembered, unless it is almost time for the next scheduled dose. Do not double the dose to compensate for a missed one.

• Side Effects:

  • Common Side Effects: Low blood pressure (hypotension), dizziness, increased potassium levels (hyperkalemia), cough, nausea, diarrhea, weakness, fatigue, headache, and impaired renal function. To minimize dizziness, rise slowly from a sitting or lying position.
  • Serious Side Effects: In rare cases, angioedema (swelling of the face, lips, tongue, throat, or extremities) can occur, requiring immediate medical attention. Seek immediate medical attention if you experience severe dizziness, difficulty breathing, swelling, or chest pain.

• Precautions:

  • SACUVAL 100 is contraindicated during pregnancy and breastfeeding, as it may cause harm to the unborn baby or infant.
  • Do not take SACUVAL 100 with ACE inhibitors (e.g., captopril, enalapril). A washout period of at least 36 hours is required before or after taking an ACE inhibitor.
  • Exercise caution in patients with kidney or liver problems; dose adjustments may be necessary. It is contraindicated in severe liver disease.
  • Avoid if there is a known allergy to sacubitril, valsartan, or any other ingredients.
  • Limit alcohol consumption as it may intensify side effects such as dizziness or fatigue.
  • Avoid potassium-rich foods and supplements unless advised by your doctor, due to the risk of hyperkalemia.
  • Regular monitoring of blood pressure, kidney function, and potassium levels is recommended during treatment.
  • This medicine may cause dizziness, so avoid driving or operating heavy machinery if you feel dizzy.
  • It is not suitable for use in children and adolescents under 18 years of age and should be used with caution in elderly patients.
  • Inform your doctor about all other medications you are taking, including other ARBs, Aliskiren, NSAIDs, potassium-sparing diuretics, potassium supplements, sildenafil, heparin, and warfarin, as drug interactions may occur.

• Storage:

  • Store SACUVAL 100 at room temperature, ideally below 30°C.
  • Keep the medication away from moisture and direct sunlight.
  • Store in the original package to protect it from light.
  • Keep out of the sight and reach of children.

SACUVAL 100 Tablet is a combination medicine containing Sacubitril (49mg) and Valsartan (51mg). It belongs to a class of medications called Angiotensin Receptor Neprilysin Inhibitors (ARNIs).

What is SACUVAL 100 Tablet used for?

SACUVAL 100 Tablet is primarily used to treat chronic heart failure in adults, specifically in patients with reduced ejection fraction (New York Heart Association Class II-IV). It helps to reduce the risk of cardiovascular death and hospitalization associated with heart failure. The medication also aims to improve symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles, thereby enhancing the overall quality of life for individuals with heart failure.

How does SACUVAL 100 Tablet work?

SACUVAL 100 Tablet works through a dual mechanism involving its two active ingredients: sacubitril and valsartan. Sacubitril is a neprilysin inhibitor that prevents the breakdown of natural substances called natriuretic peptides. These peptides help relax and widen blood vessels, promote the excretion of sodium and water, and reduce the strain on the heart, thus improving heart function. Valsartan is an angiotensin receptor blocker (ARB) that works by blocking the action of angiotensin II, a hormone that causes blood vessels to narrow and promotes salt and water retention. By blocking angiotensin II, valsartan relaxes blood vessels, lowers blood pressure, and decreases the workload on the heart. Together, these actions make it easier for the heart to pump blood throughout the body and help manage heart failure symptoms.

What is the usual dosage of SACUVAL 100 Tablet?

The dosage of SACUVAL 100 Tablet is determined by a healthcare professional, based on the patient's age, body weight, and medical condition. It is typically taken as one tablet once or twice daily. The tablet should be swallowed whole with a glass of water and not crushed or chewed. It can be taken with or without food, but maintaining a consistent routine by taking it at the same time each day is recommended for maximum benefit. It is important not to exceed the prescribed dose without consulting your doctor.

What are the possible side effects of SACUVAL 100 Tablet?

Common side effects of SACUVAL 100 Tablet may include low blood pressure (hypotension), dizziness, increased potassium levels in the blood (hyperkalemia), cough, headache, tiredness, nausea, and weakness. Some individuals may also experience diarrhea, decreased red blood cell count (anemia), or a decrease in renal function. In rare cases, angioedema (swelling of the face, lips, tongue, or throat) can occur, which requires immediate medical attention. It's advisable to rise slowly from sitting or lying positions to minimize dizziness due to low blood pressure. If any side effects worsen or become severe, a doctor should be consulted immediately.

Is SACUVAL 100 Tablet safe during pregnancy or breastfeeding?

SACUVAL 100 Tablet is generally not recommended during pregnancy, especially after the first three months, as it can cause serious harm to the developing baby, including potential damage to the baby's kidneys and lungs. If you are pregnant or planning to become pregnant, it is crucial to inform your doctor, who may prescribe a safer alternative.

For breastfeeding women, SACUVAL 100 Tablet is also generally not recommended. While some studies suggest minimal transfer of sacubitril/valsartan into human milk, the long-term effects on breastfed infants are not fully known, and there's a small potential risk of lowering the baby's blood pressure. A doctor should be consulted to discuss the risks and benefits and determine the best course of action.

Can SACUVAL 100 Tablet be taken with other medications?

SACUVAL 100 Tablet can interact with several medications, and it's crucial to inform your doctor about all medicines, supplements, and herbal products you are taking. Key interactions include:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril): Concurrent use can increase the risk of angioedema. A washout period of at least 36 hours is required when switching between an ACE inhibitor and SACUVAL 100 Tablet.
• Aliskiren: Combining with aliskiren (for high blood pressure) can increase the risk of kidney problems and high potassium levels, especially in diabetic patients or those with impaired kidney function.
• Potassium supplements or potassium-sparing diuretics (e.g., spironolactone): These can increase the risk of hyperkalemia.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAIDs may reduce the effectiveness of SACUVAL 100 Tablet and potentially worsen kidney function.
• Lithium: SACUVAL 100 Tablet may increase lithium levels in the blood, which can be harmful.
• Other blood pressure-lowering medications: Taking with other antihypertensives might lead to a further reduction in blood pressure.
• Atorvastatin: Used to lower high cholesterol levels.
• Sildenafil: Used for erectile dysfunction or lung hypertension.
• Heparin, Warfarin: Used to manage blood clots.

What precautions should be taken with SACUVAL 100 Tablet?

Several precautions should be taken while on SACUVAL 100 Tablet:

• Allergies: Do not take if you are allergic to sacubitril, valsartan, or any other ingredients in the tablet.
• Kidney and Liver Disease: Use with caution if you have kidney or liver problems. Dose adjustments may be necessary, and it is contraindicated in severe liver disease. Regular monitoring of kidney function is recommended.
• Angioedema History: Avoid if you have a history of angioedema.
• Blood Pressure: SACUVAL 100 Tablet can cause dizziness or tiredness due to low blood pressure. Avoid driving or operating heavy machinery until you know how the medicine affects you. Rise slowly from sitting or lying positions.
• Potassium Levels: Monitor potassium intake, as high-potassium foods or supplements can increase potassium levels in the blood.
• Hydration: Maintain adequate hydration.
• Alcohol: Limit or avoid alcohol consumption as it may intensify side effects like dizziness or fatigue.
• Children and Elderly: It is not suitable for use in children and adolescents under 18 years of age. Use with caution in elderly patients (65 years and above) as they may be more sensitive to its effects.

What happens if a dose is missed?

If you miss a dose of SACUVAL 100 Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

How should SACUVAL 100 Tablet be stored?

SACUVAL 100 Tablet should be stored in a closed container at room temperature, ideally below 30°C, and kept away from direct sunlight and moisture. Ensure it is kept out of the sight and reach of children. Always check the expiry date before use.