Entresto

The usual starting dose of sacubitril - valsartan is 1 tablet of 49 mg sacubitril and 51 mg valsartan taken twice a day. Based on the effectiveness of the medication, your doctor will gradually increase the dose to 1 tablet of 97 mg sacubitril and 103 mg valsartan taken 2 times a day.

Entresto may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Entresto exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your 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. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Entresto at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause an increase of potassium in your blood. Periodic blood collection may be needed to evaluate its actual effect.; rarely it may affect your kidneys, causing symptoms such as a decrease in urine volume and unusual tiredness - if you experience any of these symptoms, seek medical assistance immediately; it may cause a cough; it may lower your blood pressure, which could cause weakness and/or dizziness. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

24 mg/26 mg
Each violet-white, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "LZ" on the other, contains 24.3 mg of sacubitril and 25.7 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

49 mg/51 mg
Each pale yellow, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "L1" on the other, contains 48.6 mg of sacubitril and 51.4 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide yellow (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

97 mg/103 mg
Each light pink, ovaloid, biconvex, film-coated tablet, with bevelled edges, unscored, debossed with "NVR" on one side and "L11" on the other, contains 97.2 mg of sacubitril and 102.8 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

Do not take Entresto if you:

• are allergic to sacubitril, valsartan, or any ingredients of the medication
• are experiencing or have recently experienced dizziness or lightheadedness caused by Low Blood Pressure
• are taking any medication containing an angiotensin-converting enzyme inhibitor (ACEI)
• have had angioedema (swelling of the face and throat) after taking an ACE inhibitor or angiotensin II receptor blocker (ARB)
• have Diabetes and are taking the medication Aliskiren
• have moderate-to-severe Kidney Disease and are taking the medication aliskiren
• have a history of hereditary angioedema or angioedema that appears to occur without a cause
• are or may become pregnant

There may be an interaction between sacubitril - valsartan and any of the following:

• Aldesleukin
• aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• amifostine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• other angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• barbiturates (e.g., Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bortezomib
• brimonidine
• Bromocriptine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Cyclosporine
• dexmethylphenidate
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Duloxetine
• drospirenone
• Eltrombopag
• Eplerenone
• Guanfacine
• Gemfibrozil
• Heparin
• Hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir)
• herbs that affect blood pressure (e.g., cayenne, ginger, ephedra, ginseng (American) licorice, black cohosh, goldenseal)
• Hydralazine
• iron sucrose
• levodopa
• lithium
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Methylphenidate
• Minoxidil
• Morphine
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Obinutuzumab
• Pentoxifylline
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• potassium supplements
• Pramipexole
• quinine
• Rasagiline
• Ropinirole
• Rotigotine
• salt substitutes that contain potassium
• Selegiline
• sodium phosphates
• Tacrolimus
• Teriflunomide
• thalidomide
• tolcapone
• Tolvaptan
• tretinoin
• Trimethoprim
• Warfarin
• Yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Entresto. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Entresto.

Angioedema: Angioedema is a condition where the deeper layers of the skin around the eyes and lips swell. It can be life-threatening if the swelling is severe enough to cause the throat or tongue to swell and block the airways. The risk of developing angioedema with Entresto increases if it is taken with other ARBs (angiotensin receptor blockers) or any medications in the family of angiotensin-converting enzyme inhibitors (ACEIs).

This condition has been associated with ARBs such as valsartan and may occur with Entresto. If you have experienced angioedema in the past with ACEIs or ARBs, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Low blood pressure: Sacubitril - valsartan may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the first few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because Entresto can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods. If you have heart disease (e.g., heart failure, Heart Attack) or are taking medications that lower blood pressure, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Kidney problems: Valsartan can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe Congestive Heart Failure).

The use of aliskiren with Entresto may further increase risk of kidney problems for people already at risk for this problem. If you have reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed. If you have reduced kidney function, you may require lower doses of Entresto.

Entresto should not be taken by people with severely decreased kidney function.

Liver problems: Liver disease or reduced liver function may cause Entresto to build up in the body, causing side effects. People with reduced liver function may need a lower-than-normal dose of valsartan; therefore, it may be necessary to use the components of the combination product separately. If you have reduced liver function or liver disease, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed. Entresto is not recommended for people with severe liver impairment.

Entresto may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Potassium levels: Increases in blood levels of potassium occur for some people who take sacubitril - valsartan. Potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

If you have diabetes, severely reduced kidney function, or a high potassium intake in your diet, discuss with your doctor how Entresto may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entresto, and whether any special monitoring is needed.

Pregnancy: Valsartan may cause severe harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking Entresto, stop taking it immediately and call your doctor. It is important to use effective birth control while taking Entresto and for 1 week after the last dose.

Breast-feeding: It is not known if sacubitril - valsartan passes into breast milk. If you are a breast-feeding mother and are taking Entresto, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Entresto have not been established for children.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. You should take this medication at approximately the same time each day. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food.