Bystolic Tablets

DRUG DESCRIPTION

The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4•HCl) with the following structural formula:

BYSTOLIC® (nebivolol) Structural Formula Illustration

SRRR - or d-nebivolol hydrochloride


RSSS - or l-nebivolol hydrochloride
MW: 441.90 g/mol

Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene.

BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.

What are the possible side effects of nebivolol (Bystolic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • slow or uneven heartbeats; or
  • numbness or cold feeling in your hands and feet.

Less serious side effects may include:

  • headache;
  • tired...

Read All Potential Side Effects and See Pictures of Bystolic Tablets »

What are the precautions when taking nebivolol tablets (Bystolic Tablets)?

Before taking nebivolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of severe allergic reactions (e.g., anaphylaxis), blood circulation problems (e.g., Raynaud's disease), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), diabetes, heart problems (e.g., slow or irregular heartbeat, heart failure), kidney disease, liver disease, mental/mood disorders (e.g., depression), a certain muscle disease (myasthenia gravis), overactive thyroid (hyperthyroidism), a...

Read All Potential Precautions of Bystolic Tablets »


Bystolic Tablets Consumer (continued)

SIDE EFFECTS: Headache, dizziness, tiredness, nausea, slow heartbeat, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you notice any of the following unlikely but serious side effects: swelling ankles/feet, severe tiredness, unexplained/sudden weight gain, symptoms of asthma (e.g., feeling of tightness in the chest, shortness of breath, cough, wheezing).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nebivolol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of severe allergic reactions (e.g., anaphylaxis), blood circulation problems (e.g., Raynaud's disease), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), diabetes, heart problems (e.g., slow or irregular heartbeat, heart failure), kidney disease, liver disease, mental/mood disorders (e.g., depression), a certain muscle disease (myasthenia gravis), overactive thyroid (hyperthyroidism), a certain type of tumor (pheochromocytoma).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this medication may mask the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness or sweating are unaffected by this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. However, similar drugs pass into breast milk and may have undesirable effects on a nursing infant (e.g., slow heartbeat). Discuss the risks and benefits with your doctor before breast-feeding.


Bystolic Tablets Patient Information Including Side Effects

Brand Names: Bystolic

Generic Name: nebivolol (Pronunciation: ne BIV oh lol)

  • What is nebivolol (Bystolic Tablets)?
  • What are the possible side effects of nebivolol (Bystolic Tablets)?
  • What is the most important information I should know about nebivolol (Bystolic Tablets)?
  • What should I discuss with my healthcare provider before taking nebivolol (Bystolic Tablets)?
  • How should I take nebivolol (Bystolic Tablets)?
  • What happens if I miss a dose (Bystolic Tablets)?
  • What happens if I overdose (Bystolic Tablets)?
  • What should I avoid while taking nebivolol (Bystolic Tablets)?
  • What other drugs will affect nebivolol (Bystolic Tablets)?
  • Where can I get more information?

What is nebivolol (Bystolic Tablets)?

Nebivolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Nebivolol is used to treat hypertension (high blood pressure).

Nebivolol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nebivolol (Bystolic Tablets)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • slow or uneven heartbeats; or
  • numbness or cold feeling in your hands and feet.

Less serious side effects may include:

  • headache;
  • tired feeling;
  • nausea, stomach pain;
  • diarrhea; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nebivolol (Bystolic Tablets)?

Do not skip doses or stop taking nebivolol 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.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using nebivolol. You may need to stop using the medicine for a short time.

Nebivolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Nebivolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

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