Sacubitril and Valsartan Oral

Sacubitril and valsartan is a medication combination known under US brand name Entresto. It is used to treat chronic heart failure.

Overview

Sacubitril is a blood pressure medication that works by increasing the levels of certain types of protein in the body that can dilate blood vessels. This can help lower blood pressure by reducing sodium levels in the body.

Valsartan is an angiotensin II receptor blocker which works by preventing the blood vessels from narrowing, which in turn improves blood flow and lowers blood pressure.

Sacubitril and valsartan combination are two drugs used together alongside other medicines to treat chronic heart failure in adults and reduce the number of hospital visits needed for associated heart problems. This medication is only available via prescription from your doctor and is available in the dosage form of tablet for oral consumption.

Conditions Treated

  • Chronic Heart Failure

Type of Medicine

  • Tablet for oral consumption

Side Effects

Along with its intended effects, the consumption of sacubitril and valsartan can produce some unwanted side effects. Inform your doctor or a healthcare professional urgently if you suffer from any of the following side effects while taking sacubitril/valsartan.

More common side effects:

  • Blurred vision
  • Difficult breathing
  • Confusion
  • Faintness, dizziness or lightheadedness when getting up suddenly from a sitting or lying position
  • Stomach or abdominal pain
  • Irregular heartbeat
  • Nervousness
  • Vomiting or nausea
  • Tingling or numbness in the feet, hands or lips
  • Heaviness or weakness of the legs
  • Sweating
  • Unusual weakness or tiredness

Less common side effects:

  • Decreased frequency or amount of urine
  • Loss of appetite
  • Increased thirst
  • Lower back or side pain
  • Bloody urine
  • Weight gain
  • Swelling of fingers, face, or lower legs

Rare side effects:

  • Large, hive-like swelling on the eyelids, face, lips, tongue, throat, legs, hands, feet, or sex organs

Some side effects usually don't require urgent attention. However, if you find the side effects are impacting your everyday life, then you should get in touch with a local pharmacist or your doctor for advice and information on ways to reduce or prevent the side effects.

  • Dizziness
  • Cough

Remember you can report all side effects to the FDA on 1-800-FDA-1088. You may experience side effects that are not on this list. If you experience anything abnormal, contact a healthcare professional for advice.

Dosage

The final dosage of any drug will depend on a variety of factors. These include your age, your height, and weight, the severity of your condition, your past medical history, current medications you are on and how to react to the first dose. This information is to be used only as a guide. Do not stop, start or change any doses without guidance from your doctor. The following information applies to the following strength(s) of sacubitril and valsartan, 24 to 26 mg; 97 to 103 mg and 49 to 51 mg.

Typical Adult Dose for Congestive Heart Failure

The initial dose is 49 mg of Sacubitril combined with 51 mg of valsartan given twice a day via oral consumption. The maintenance dose is typical, 97 mg of sacubitril and 103 mg of valsartan twice a day via oral consumption.

  • The maintenance dose should be increased to reach the target after two-four weeks depending on how well it is tolerated.
  • For patients not currently taking an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE), or for patients previously taking low doses of this medication, a starting dose of sacubitril 24 mg-valsartan 26 mg twice a day is recommended. The dose should be doubled every two to four weeks to reach the target maintenance dose depending on how well it is tolerated.
  • Take this medication by mouth with or without food as directed by your doctor. You should also aim to try and take the medication at the same time every day.

Missed Dose

If you miss a dose of sacubitril and valsartan, take it as soon as you remember. If it's near the time of your next scheduled dose then skip the dose you missed. Take your next dose at its scheduled time. Under no circumstances should you double doses.

Interactions

Interactions can happen between drugs that cause harmful side effects. It's therefore important that you inform your doctor or a healthcare professional of all the current drugs you are taking, as well as drugs you have taken in the past. This includes prescription, non-prescription drugs, vitamins and herbal remedies. It's also important you let your doctor know of any medical conditions you suffer/have suffered from and any that run in the family history.

Using this drug with any of the following medications is not recommended. Your doctor may change some of the other medications you take or alternatively decide not to treat you with this drug at all.

  • Aliskiren
  • Captopril
  • Benazepril
  • Enalapril
  • Fosinopril
  • Enalaprilat
  • Lisinopril
  • Moexipril
  • Quinapril
  • Perindopril
  • Ramipril
  • Zofenopril
  • Trandolapril

The use of this drug with any of the following medications isn't usually recommended, but in some circumstances, it may be required. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Captopril
  • Benazepril
  • Enalaprilat
  • Enalapril
  • Fosinopril
  • Lithium
  • Lisinopril
  • Moexipril
  • Quinapril
  • Perindopril
  • Ramipril
  • Trandolapril
  • Simeprevir
  • Trimethoprim

Using this drug with any of the following medications can cause an increased risk of some side effects. However, sometimes the use of both drugs may be the best treatment. but using both drugs may be the best treatment for you. If you are prescribed both medicines your doctor may alter the dose or change how often you use the medications.

  • Aceclofenac
  • Amtolmetin Guacil
  • Acemetacin
  • Bromfenac
  • Celecoxib
  • Bufexamac
  • Clonixin
  • Choline Salicylate
  • Dexibuprofen
  • Diflunisal
  • Dexketoprofen
  • Diclofenac
  • Droxicam
  • Dipyrone
  • Etodolac
  • Felbinac
  • Etofenamate
  • Etoricoxib
  • Feprazone
  • Fenoprofen
  • Fepradinol
  • Floctafenine
  • Flurbiprofen
  • Flufenamic Acid
  • Ibuprofen
  • Ketoprofen
  • Indomethacin
  • Ketorolac
  • Lumiracoxib
  • Lornoxicam
  • Loxoprofen
  • Meloxicam
  • Meclofenamate
  • Mefenamic Acid
  • Morniflumate
  • Naproxen
  • Nabumetone
  • Niflumic Acid
  • Nepafenac
  • Nimesulide
  • Oxaprozin
  • Nimesulide Beta-Cyclodextrin
  • Oxyphenbutazone
  • Piketoprofen
  • Parecoxib
  • Phenylbutazone
  • Piroxicam
  • Proglumetacin
  • Proquazone
  • Propionic Acid
  • Propyphenazone
  • Salicylic Acid
  • Rofecoxib
  • Salsalate
  • Sodium Salicylate
  • Tenoxicam
  • Sulindac
  • Tiaprofenic Acid
  • Tolmetin
  • Tolfenamic Acid
  • Valdecoxib

Other medical conditions that can cause intreactions

If you suffer from other medical conditions, they could interact with the effectiveness of these drugs. Ensure you inform your doctor or healthcare professional of any other health problems you suffer from, including:

  • Kidney disease (severe or otherwise)
  • Liver disease (moderate or otherwise) - caution should be exercised as the effects of this medication could be increased due to the slow removal of the medication from the body.
  • The medication should not be used in those suffering from a severe liver disease.
  • Angioedema caused by ARB therapy or ACE inhibitor
  • Patients who suffer from T2 diabetes who are also taking aliskiren (Tekturna®). These medication combinations should not be used.

Warnings

Allergies

Before you take this product, you should inform your pharmacist or doctor if you are allergic to either sacubitril or valsartan, or to other ARBs (such as losartan, candesartan), or to ACE inhibitors (such as ramipril, quinapril). You should also inform them if you have any other allergies including, allergies to animals, foods, dyes, preservatives etc. This drug may contain inactive ingredients which could increase your chance of having an allergic reaction or cause other problems. For more details, you should speak with your local pharmacist or doctor.

You should not take sacubitril and valsartan within a thirty-six hour period before or after you have taken any ACE inhibitors.

Use of medication in the pediatric population

Studies have not taken place regarding the relationship of age to the effects of valsartan and sacubitril combination on the pediatric population. Therefore efficacy and safety have not been established.

Use of medication in the geriatric population

Studies that have been performed to date have not indicated a geriatric-specific problem that could limit the useful nature of this drug combination in the older population.

Use of drug combination in pregnancy and breastfeeding

Do not use this drug combination if you are pregnant. Stop using the medication immediately and inform your doctor urgently if you become pregnant whilst taking this medication. Sacubitril and valsartan can cause death or injury to an unborn baby if you take the medicine during your second or third trimester. Use an effective form of birth control to keep prevent you from falling pregnant.

Since there have been no adequate studies in women for determining infant risk when using this drug whilst breastfeeding, it is unknown if this drug passes into breast milk. You should discuss with your doctor and weigh the potential benefits and the potential risks before you begin taking this medication whilst breastfeeding.

  • This drug combination can make you feel dizzy, lightheaded or faint, especially when you get up suddenly from a sitting or lying position or if you have consumed a diuretic (water pill). If you begin to feel dizzy, take a moment, sit down and rest, so you don't faint. Then sit for a few moments before standing to prevent the dizziness from returning.
  • The use of marijuana and alcohol can make you dizzier. Don't use machinery, drive or do anything that requires you to be alert until you can do it safely. You should limit your intake of alcohol. Speak with your doctor or healthcare professional if you are using marijuana.
  • This product can increase your levels of potassium. Before using salt substitutes or potassium supplements that contain potassium, consult a pharmacist or doctor. Don't take any other medications unless they have been prescribed by your doctor and discussed with your doctor. This includes the use of prescription, non-prescription, vitamins and herbal remedies.

Storage

This medication needs to be stored at 77°F (25°C); excursions permitted between 59°F and 86°F (15°C/ 30°C). This medication should also be protected from moisture, so needs to be stored in a dry place away from damp.

Summary

When used correctly, sacubitril and valsartan combination is successful in treating chronic heart failure. It's extremely important that your doctor or healthcare professional continually monitors you or your child's progress whilst taking this medication via regular visits. This is to ensure that the medication is working as it should be and to test for any unwanted side effects. These can be visited via simple urine and blood tastes taken regularly. To limit interactions, you should inform your doctor of any medication you are currently taken or if you are currently suffering from any other medical problems. This drug cannot be taken if you are pregnant and if you fall pregnant whilst taking this drug, it's vital that you inform your doctor immediately. Since it's unknown whether this drug passes into breast milk, you will have to weigh up the risks and benefits alongside your doctor and come to a decision.

 

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Last Reviewed:
January 31, 2018
Last Updated:
January 27, 2018