Bystolic

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• slow heart rate
• dizziness or fainting
• shakiness
• sweating
• confusion
• nervousness, irritability, or sudden changes in behavior or mood
• headache
• numbness or tingling around the mouth
• weakness
• pale skin
• sudden hunger
• clumsy or jerky movements
• difficulty breathing
• seizures
• tiredness
• vomiting

Bystolic is a prescription medicine that is used to treat high blood pressure. Bystolic is in a class of medications called beta blockers and works by relaxing blood vessels and slowing heart rate to decrease blood pressure. 

Bystolic is part of the drug class:

• Beta blocking agents, selective

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bystolic falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

For most people, the recommended starting dose is 5 mg once daily, with or without food, alone or in combination with other medicines. If necessary, the dose can be increased at 2-week intervals up to 40 mg. 

Absorption

Bioavailability

Absolute bioavailability not determined.1

Following oral administration, mean peak plasma concentrations occur within approximately 1.5–4 hours.1

Food

Food does not alter pharmacokinetics; however, may slightly reduce nebivolol glucuronides.1

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.1

Plasma Protein Binding

Approximately 98% (mainly albumin).1

Elimination

Metabolism

Undergoes first-pass metabolism in the liver mainly via glucuronidation of the parent drug and, to a lesser extent, via N-dealkylation and oxidation by CYP2D6.1 2 7 11

Elimination Route

Excreted in urine (38%) and feces (44%), principally as metabolites;1 <0.5% eliminated in urine and feces as unchanged drug.7 11

Half-life

12 hours for d-nebivolol.1

Special Populations

Poor CYP2D6 metabolizers: Eliminated in urine (67%) and feces (13%), principally as metabolites.1 7 Half-life is 19 hours.1

Decreased clearance in patients with moderate hepatic impairment (Child-Pugh class B) or with severe renal impairment (Clcr <30 mL/minute).1 7

• Importance of taking nebivolol exactly as prescribed.1

• Importance of not interrupting or discontinuing therapy without consulting a clinician;1 patients should temporarily limit physical activity when discontinuing therapy.1

• If a dose is missed, importance of patient taking only the next scheduled dose (i.e., the next dose should not be doubled).1

• Importance of avoiding some activities (e.g., driving, operating machinery) until effects on the patient are known.1

• Importance of warning patients receiving insulin or oral hypoglycemic agents and those subject to spontaneous hypoglycemia that β-blockers can mask some symptoms of hypoglycemia (e.g., tachycardia).1

• Importance of immediately informing clinician at the first sign or symptom (e.g., weight gain, shortness of breath) of CHF.1

• Importance of patients informing their anesthesiologist or dentist about nebivolol therapy before undergoing major surgery.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Bystolic® (nebivolol) tablets

5 mg

Contains Approximately 3600 Tablets

Take Bystolic exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take Bystolic at the same time every day. You may take the medication with or without food.

Do not skip doses or stop taking Bystolic without first talking to your doctor. Stopping suddenly may make your condition worse or cause other serious heart problems such as severe chest pain or heart attack. You may need to use less and less before you stop the medication completely.

Your blood pressure will need to be checked often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using Bystolic.

Bystolic is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Keep using Bystolic as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store Bystolic at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out.

Applies to nebivolol: oral tablet

Along with its needed effects, nebivolol (the active ingredient contained in Bystolic) 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 while taking nebivolol:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain or discomfort
• difficult or labored breathing
• lightheadedness, dizziness, or fainting
• rapid weight gain
• shortness of breath
• slow or irregular heartbeat
• tightness in the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• wheezing

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

• 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 of nebivolol 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:

• Mild headache

• Diarrhea
• rash
• sleeplessness
• trouble sleeping
• unable to sleep