Nebivolol and valsartan

Nebivolol and Valsartan is part of the drug class:

• Beta blocking agents, selective, and other antihypertensives

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 the missed dose.

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 nebivolol and valsartan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nebivolol 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 nebivolol 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 nebivolol 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 nebivolol 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 nebivolol 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

Using nebivolol 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
• Bupropion
• Captopril
• Cinacalcet
• Clonidine
• Crizotinib
• Diltiazem
• Doxepin
• Dronedarone
• Duloxetine
• Enalapril
• Enalaprilat
• Fenoldopam
• Fingolimod
• Fluoxetine
• Fosinopril
• Lacosamide
• Lisinopril
• Lithium
• Moclobemide
• Moexipril
• Panobinostat
• Paroxetine
• Perindopril
• Quinapril
• Quinidine
• Quinine
• Ramipril
• Rivastigmine
• Rolapitant
• Sertraline
• Simeprevir
• Terbinafine
• Trandolapril
• Trimethoprim
• Verapamil

Using nebivolol 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.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Amiodarone
• Amtolmetin Guacil
• Arbutamine
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cimetidine
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Mibefradil
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sildenafil
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

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 nebivolol and valsartan. Make sure you tell your doctor if you have any other medical problems, especially:

• Anaphylactic reaction (severe), history of—May increase risk for repeated anaphylactic reactions.

• Bradycardia (slow heartbeat), severe or
• Cardiogenic shock (shock caused by heart attack) or
• Heart block or
• Heart failure, decompensated or
• Liver disease, severe or
• Patients with diabetes who are taking aliskiren or
• Sick sinus syndrome (type of abnormal heart rhythm), without a pacemaker—Should not be used in patients with these conditions.

• Coronary artery disease or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart failure or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Lung disease (eg, asthma, bronchitis, emphysema) or
• Peripheral vascular disease (clogged blood vessels) or
• Pheochromocytoma (adrenal gland tumor)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the symptoms of these diseases, such as a fast heartbeat.

• Tell all of your health care providers that you take nebivolol and valsartan. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• It may take several weeks to see the full effects.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with nebivolol and valsartan.
• Talk with your doctor before you drink alcohol.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Do not stop taking this medicine all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop nebivolol and valsartan as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
• This medicine may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking this medicine all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Dizziness or passing out.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Stomach pain.

• Byvalson

Mild impairment (Child-Pugh class A): No initial dosage adjustment required.

Moderate impairment (Child-Pugh class B): Not recommended as initial treatment.

Severe impairment (Child-Pugh class C): Use is contraindicated.

When pregnancy is detected, discontinue nebivolol/valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

More frequently reported side effects include: increased serum potassium. See below for a comprehensive list of adverse effects.

-Mild or moderate renal impairment: No adjustment recommended.
-Moderate and severe renal impairment (CrCl 60 mL/min or less): Data not available
-This drug combination is not recommended as initial treatment in patients with severe renal impairment, because the recommended starting dose of nebivolol in this population, 2.5 mg once daily, is lower than the dose of nebivolol contained in the combination formulation.