Bystolic

1 What is Bystolic?

Brand: Bystolic

Generic: Nebivolol

Nebivolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Nebivolol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

2 What to Know Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 Population

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

Geriatric Population

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

Pregnancy:Category C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Drug Interactions

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 this medicine, 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 this medicine 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.

  • Amiodarone
  • Clonidine Crizotinib
  • Diltiazem Dronedarone
  • Fenoldopam Fingolimod
  • Lacosamide
  • Panobinostat Paroxetine
  • Rivastigmine
  • Verapamil

Using this medicine 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 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 Fluoxetine Flurbiprofen
  • Glimepiride Glipizide Glyburide
  • Ibuprofen Ibuprofen
  • Lysine
  • 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
  • Oxaprozin Oxyphenbutazone
  • Parecoxib Phenoxybenzamine Phentolamine Phenylbutazone Piketoprofen Pioglitazone Piroxicam Pramlintide 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

Other Interactions

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 this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (severe chest pain)—May provoke chest pain if stopped too quickly.
  • Peripheral vascular disease (clogged blood vessels)—Use with caution. May make this condition worse.
  • Bradycardia (slow heartbeat), severe
  • Cardiogenic shock (shock caused by heart attack)
  • Heart block
  • Heart failure
  • Liver disease, severe
  • Lung disease (e.g., bronchitis, emphysema)
  • Sick-sinus syndrome (heart rhythm problem), without a pacemaker—Should not be used in patients with these conditions.
  • Diabetes
  • Hyperthyroidism (overactive thyroid)
  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.
  • Kidney disease, severe
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Pheochromocytoma (adrenal gland tumor)—Use an alpha-blocker medicine before taking this medicine.
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3 Proper Usage

Diet

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Regular Follow up

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.
You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For high blood pressure:

  • Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose if needed.
  • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

4 Precautions to Take

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Discontinuing Medication

Do not interrupt or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

Blood Sugar

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

Surgery and Dental procedures

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Medical Tests

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Driving, Use of Machinery

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking nebivolol.

Other Medicines

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.

5 Potential 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:

Less common:

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Absence of or decrease in body movement
  • Anxiety
  • Blue lips, fingernails, or skin
  • Blurred vision
  • Chills
  • Cold sweats
  • Coma
  • Confusion
  • Cool, pale skin
  • Cough
  • Decreased urine output
  • Depression
  • Dilated neck veins
  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • Dry mouth
  • Extreme fatigue
  • Fast heartbeat
  • Headache
  • Increased hunger
  • Increased sweating
  • Increased thirst
  • Irregular, fast or slow, or shallow breathing
  • Loss of appetite
  • Mood changes
  • Muscle pain or cramps
  • Nausea or vomiting
  • Nervousness
  • Nightmares
  • Noisy breathing
  • Numbness in the hands, feet, or lips
  • Seizures
  • Shakiness
  • Slurred speech
  • Troubled breathing
  • Vomiting
  • Weight gain

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:

  • Mild headache

Less common:

  • Diarrhea
  • Rash
  • Sleeplessness
  • Trouble sleeping
  • Unable to sleep

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.

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