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sacubitril and valsartan (Oral route)

sak-UE-bi-tril, val-SAR-tan

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system may cause fetal injury or death. Discontinue use immediately if pregnancy is detected .

Commonly used brand name(s)

In the U.S.

  • Entresto

Available Dosage Forms:

  • Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Angiotensin II Receptor Antagonist

Uses For sacubitril and valsartan

Sacubitril and valsartan combination is used together with other medicines to treat chronic heart failure in adults and cut down on the number of hospital visits for heart problems.

sacubitril and valsartan is available only with your doctor's prescription.

Before Using sacubitril and valsartan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sacubitril and valsartan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sacubitril and valsartan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sacubitril and valsartan combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sacubitril and valsartan combination in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sacubitril and valsartan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sacubitril and valsartan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

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

Using sacubitril and valsartan with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Using sacubitril and valsartan with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sacubitril and valsartan. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angioedema caused by ACE inhibitor or ARB therapy, history of or
  • Patients with diabetes who are also taking aliskiren (Tekturna®)—Should not be used in patients with these conditions.
  • Kidney disease, severe or
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of sacubitril and valsartan

Take sacubitril and valsartan exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

sacubitril and valsartan comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

Tell your doctor if you have ever had any unusual or allergic reaction to sacubitril and valsartan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

  • For oral dosage form (tablets):
    • For heart failure:
      • Adults— At first, one tablet two times a day. Your doctor may increase your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of sacubitril and valsartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sacubitril and valsartan

It is very important that your doctor check your or your child's progress at regular visits to make sure that sacubitril and valsartan is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using sacubitril and valsartan while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using sacubitril and valsartan, tell your doctor right away.

Do not take sacubitril and valsartan for at least 36 hours before or after you take an ACE inhibitor medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to sacubitril and valsartan before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

sacubitril and valsartan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain
  • blurred vision
  • confusion
  • difficult breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular heartbeat
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • sweating
  • unusual tiredness or weakness
  • weakness or heaviness of the legs
Less common
  • Bloody urine
  • decreased frequency or amount of urine
  • increased thirst
  • loss of appetite
  • lower back or side pain
  • swelling of the face, fingers, or lower legs
  • weight gain
Rare
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough
  • dizziness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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