Product Description

VYMADA 100 (SACUBITRIL AND VALSARTAN)

WHAT ARE SACUBITRIL AND VALSARTAN (VYMADA 100)?

• Sacubitril is a blood pressure medicine. It works by increasing the levels of certain proteins in the body that can dilate (widen) blood vessels.
• This helps lower blood pressure by reducing sodium levels. Valsartan is an angiotensin II receptor blocker (sometimes called an ARB).
• Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Sacubitril and valsartan is a combination medicine used in certain people with chronic heart failure.
• This medicine helps lower the risk of needing to be hospitalized when symptoms get worse and helps lower the risk of death from heart failure.
• Sacubitril and valsartan are usually given together with other blood pressure medications. Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SACUBITRIL AND VALSARTAN (VYMADA 100)?

Do not use it if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. If you have diabetes, do not use sacubitril and valsartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING SACUBITRIL AND VALSARTAN (VYMADA 100)?

• You should not use this medicine if you are allergic to sacubitril or valsartan (Diovan), or if you have ever had a severe allergic reaction to a blood pressure medication such as an ACE inhibitor (benazepril, captopril, lisinopril, ramipril, Lotensin, Vasotec, Prinivil, Accupril, Mavik, and others); or an ARB (candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, Atacand, Benicar, Cozaar, Exforge, Hyzaar, Micardis, and others).
• You should not take sacubitril and valsartan within 36 hours before or after you have taken an ACE inhibitor medication. If you have diabetes, do not use sacubitril and valsartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna). You may also need to avoid taking sacubitril and valsartan with aliskiren if you have kidney disease. To make sure sacubitril and valsartan are safe for you, tell your doctor if you have: liver disease; diabetes; if you are on a low-salt diet; or if you are dehydrated.
• Do not use it if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control. It is not known whether sacubitril and valsartan pass into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.

HOW SHOULD I TAKE SACUBITRIL AND VALSARTAN (VYMADA 100)?

• Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
• Do not take this medicine in larger or smaller amounts or for longer than recommended. You may take sacubitril and valsartan with or without food.
• Take the medicine at the same time each day. Your blood pressure will need to be checked often. Your kidney function may also need to be checked.
• Store this medicine in the original container at room temperature away from moisture and heat.
• Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

WHAT HAPPENS IF I MISS A DOSE FOR VYMADA 100 (SACUBITRIL AND VALSARTAN)?

• Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

WHAT SHOULD I AVOID WHILE TAKING SACUBITRIL AND VALSARTAN (VYMADA 100 )?

• Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
• Do not use potassium supplements or salt substitutes while you are taking sacubitril and valsartan unless your doctor has told you to.
• Drinking alcohol can further lower your blood pressure and may increase certain side effects of sacubitril and valsartan.

WHAT IS SIDE EFFECTS FOR SACUBITRIL AND VALSARTAN (VYMADA 100)?

• Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• You may be more likely to have an allergic reaction if you are African-American. Also, call your doctor at once if you have: a light-headed feeling, like you, might pass out; extreme tiredness; high potassium–slow heart rate, weak pulse, muscle weakness, tingly feeling; or kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.
• Common side effects may include dizziness; or cough.

WHAT IS DOSING INFORMATION  FOR SACUBITRIL AND VALSARTAN (VYMADA 100) ?

Usual Adult Dose for Congestive Heart Failure: Initial dose: Sacubitril 49 mg-Valsartan 51 mg orally twice a day. Maintenance dose: Sacubitril 97 mg-Valsartan 103 mg orally twice a day

Comments: -Increase to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily) after 2 to 4 weeks, as tolerated. -A starting dose of sacubitril 24 mg-valsartan 26 mg twice a day is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) and for patients previously taking low doses of these agents. Double the dose every 2 to 4 weeks to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily), as tolerated.
Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic New York Heart Association (NYHA) Class II to IV heart failure and reduced ejection fraction; usually administered in conjunction with other heart failure therapies or in place of an ACE inhibitor or other ARB.

WHAT OTHER DRUGS WILL AFFECT SACUBITRIL AND VALSARTAN (VYMADA 100)?

• Tell your doctor about all your current medicines and any you start or stop using, especially: aliskiren; lithium; any other heart or blood pressure medicines;
• a diuretic or “water pill“; medicine or mineral supplements that contain potassium; or NSAIDs (nonsteroidal anti-inflammatory drugs)–aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
• This list is not complete. Other drugs may interact with sacubitril and valsartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.