Vymada 100 (box)

VYMADA 100 (BOX) by NOVARTIS INDIA LIMITED

VYMADA 100 is a prescription medication manufactured by Novartis India Limited, primarily used in the management of chronic heart failure. It is an angiotensin receptor-neprilysin inhibitor (ARNI) that works by a dual mechanism to improve cardiovascular outcomes.

Composition

VYMADA 100 mg contains a combination of two active ingredients:

• Sacubitril: 49 mg
• Valsartan: 51 mg

These are present as a sacubitril-valsartan sodium salt complex.

Uses

VYMADA 100 is prescribed for:

• Heart Failure Treatment: It is used to treat chronic heart failure in adults and children above one year of age, particularly to reduce the risk of cardiovascular death and hospitalization. It helps the heart pump blood more efficiently by relaxing and widening blood vessels.
• Hypertension Management: In some cases, it may also be used to manage hypertension (high blood pressure) and provide cardiovascular protection.

Dosage and Administration

VYMADA 100 mg tablets are for oral administration and can be taken with or without food. It is recommended to take the tablet at the same time each day to maintain consistent blood levels and maximize benefits. Do not chew, crush, or break the tablet; swallow it whole with water.

The recommended starting dose is typically 100 mg (one tablet) twice daily. The dose may be doubled at 2-4 week intervals to a target dose of 200 mg (two tablets) twice daily, as tolerated by the patient, under the guidance of a healthcare professional. A lower starting dose of 50 mg twice daily may be considered for patients with systolic blood pressure (SBP) between 100 and 110 mmHg, or those not previously on ACE inhibitors or ARBs.

Side Effects

Common side effects may include:

• Dizziness, lightheadedness, or fainting
• Cough
• Nausea, stomach pain, or diarrhea
• Weakness or unusual tiredness
• Low blood pressure (hypotension)
• High potassium levels in the blood (hyperkalemia)

Serious side effects, though less common, require immediate medical attention:

• Angioedema (swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing)
• Severe allergic reactions
• Kidney problems or impaired renal function

Precautions

• Allergies: Do not take VYMADA 100 if you are allergic to sacubitril, valsartan, or any of its components.
• ACE Inhibitors/ARBs: VYMADA 100 should not be taken with Angiotensin-Converting Enzyme (ACE) inhibitors. A washout period of at least 36 hours is required after discontinuing an ACE inhibitor before starting VYMADA, and vice-versa, due to the risk of angioedema. It should also not be co-administered with another ARB-containing product.
• Aliskiren: Avoid concomitant use with aliskiren, especially in patients with diabetes or kidney impairment (eGFR <60 ml/min/1.73 m²).
• Pregnancy and Breastfeeding: VYMADA 100 is not recommended during pregnancy as it can harm the unborn baby, especially after the first 3 months. Breastfeeding is also not recommended during treatment.
• Kidney and Liver Disease: Use with caution in patients with kidney or liver diseases; dose adjustment may be necessary, and regular monitoring is advised.
• Diabetes: Patients with diabetes should closely monitor their blood sugar levels.
• Orthostatic Hypotension: VYMADA can cause dizziness or lightheadedness due to low blood pressure, especially when standing up. Patients should rise slowly and carefully.
• Potassium Levels: This medicine may increase potassium levels. Avoid potassium supplements and potassium-rich foods unless advised by a doctor.
• Driving/Operating Machinery: VYMADA may cause dizziness or tiredness; exercise caution when driving or operating heavy machinery.

Storage

Store VYMADA 100 mg tablets in a cool and dry place, away from direct sunlight. The ideal storage temperature is between 10ºC to 25ºC or below 30ºC. Keep the medication in its original package to protect it from moisture. Keep it out of the sight and reach of children and pets.

VYMADA 100 (Sacubitril/Valsartan) is a combination medicine primarily used to treat chronic heart failure in adults. It works to improve the heart's pumping efficiency and reduce the risk of hospitalization and cardiovascular death associated with heart failure.

Here are some frequently asked questions about VYMADA 100:

What is VYMADA 100 used for?

VYMADA 100 is primarily used to treat chronic heart failure in adult patients with reduced ejection fraction (NYHA Class II-IV). It helps manage symptoms such as breathlessness, fatigue, and fluid retention, improving the heart's function and reducing the risk of cardiovascular death and hospitalization. It may also be used in the management of hypertension (high blood pressure).

How does VYMADA 100 work?

VYMADA 100 is an Angiotensin Receptor Neprilysin Inhibitor (ARNI) containing two active ingredients: Sacubitril and Valsartan. Sacubitril inhibits the enzyme neprilysin, which breaks down beneficial peptides that help relax blood vessels, excrete sodium, and increase urine production, thereby reducing the heart's workload. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the effects of angiotensin II, a hormone that constricts blood vessels and raises blood pressure. Together, they relax and widen blood vessels, making it easier for the heart to pump blood, reduce fluid retention, and improve overall heart function.

What is the usual dosage of VYMADA 100?

The recommended starting dose for VYMADA is typically 100 mg twice daily. The dose is usually doubled at 2-4 weeks to a target dose of 200 mg twice daily, as tolerated by the patient. Your doctor will determine the exact starting dose and subsequent adjustments based on your condition and response to treatment. It can be taken with or without food, preferably at the same time each day.

What are the possible side effects of VYMADA 100?

Common side effects of VYMADA 100 include dizziness, lightheadedness, low blood pressure (hypotension), cough, nausea, diarrhea, fatigue, weakness, headache, stomach pain, and high potassium levels in the blood (hyperkalemia). Serious side effects can include angioedema (swelling of the face, lips, tongue, or throat) and kidney problems. If you experience severe or persistent side effects, or signs of an allergic reaction like angioedema, seek immediate medical attention.

Is VYMADA 100 safe during pregnancy or breastfeeding?

VYMADA 100 is not recommended during pregnancy, especially after the first three months, as it can cause serious harm to the unborn baby. Women who could become pregnant should use effective contraception while taking this medicine. It is also not recommended for use during breastfeeding, as it may pass into breast milk and harm the baby. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can VYMADA 100 be taken with other medications?

VYMADA 100 should not be taken with ACE inhibitors or other Angiotensin Receptor Blockers (ARBs) due to an increased risk of angioedema and other adverse effects. There must be at least a 36-hour gap between discontinuing an ACE inhibitor and starting VYMADA, and vice-versa. Concomitant use with aliskiren-containing products is also contraindicated in patients with diabetes or renal impairment. Using VYMADA with potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium can increase blood potassium levels. NSAIDs may increase the risk of worsening kidney function. Always inform your doctor about all medications, herbal preparations, and supplements you are currently taking to avoid potential drug interactions.

What precautions should be taken?

Several precautions should be taken while on VYMADA 100:

• Angioedema: VYMADA is contraindicated in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy, or with hereditary or idiopathic angioedema.
• Blood Pressure: Treatment should not be initiated if systolic blood pressure (SBP) is below 100 mmHg. Patients should rise slowly from a sitting or lying position to reduce dizziness from low blood pressure.
• Kidney/Liver Disease: Use with caution in patients with kidney or liver diseases, and dose adjustments may be necessary. Regular monitoring of kidney function is recommended.
• Potassium Levels: VYMADA can increase potassium levels in the blood (hyperkalemia). Avoid potassium supplements and potassium-rich foods unless advised by your doctor. Regular monitoring of serum potassium is recommended.
• Diabetes: Caution is advised in diabetic patients due to the risk of altered blood sugar levels; close monitoring is recommended.
• Alcohol: Avoid alcohol consumption as it may increase dizziness.

What happens if a dose is missed?

If you miss a dose of VYMADA 100, 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 the missed one.

How should it be stored?

Store VYMADA 100 tablets in a cool and dry place, preferably below 30°C (86°F). Keep the medication in its original package to protect it from moisture and away from direct sunlight. Keep it out of the sight and reach of children and pets.