Can you drink alcohol while on bystolic

When blood pressure dips too low, a person may feel dizzy or lightheaded, and might even faint.

Because alcohol compounds the blood-pressure reduction effects of ACE inhibitors, it’s best to avoid drinking while taking them, Elder said.

Cholesterol-lowering medications

Statins, such as Lipitor and Crestor, rank among the country’s top-selling drugs. About 32 million Americans are taking a statin, according to a Harvard Medical School publication.

“In general, it’s best to err on the side of drinking moderately if you’re on statins,” Qato said.

Moderate drinking means one drink a day for women and up to two daily for men, according to the U.S. government’s Dietary Guidelines for Americans.(One drink is considered 12 ounces of beer, 5 ounces of wine or 1.5 ounces of liquor.)

But Qato said a bigger concern is the people who take these cholesterol-lowering drugs and have a history of heavy drinking. That’s because liver damage is a potential side effect of statin treatment, and regular statin use combined with frequent bouts of heavy drinking can both take a toll on the liver.

Liver problems may not cause any noticeable symptoms, and may be detected only through a liver function test.

Diabetes medications

Slightly more than 70 percent of American adults with diabetes use an oral medication to treat it, according to the 2007-2009 National Health Interview Survey. About 26 million children and adults in the U.S. have diabetes, according to the CDC.

People who have diabetes should be aware that alcohol can cause low blood-sugar levels not only right after drinking, but also up to 24 hours afterward, Elder said. Because of this, she advised eating a snack before or while you’re drinking, to keep blood-sugar levels steady.

Some diabetes medications may not mix well with alcohol because they lower blood sugar and could lead to dangerous side effects.

One of these medications is metformin, which has been linked with a rare but potentially serious side effect when taken by someone who has been drinking excessively. It increases the risk of lactic acidosis, which causes a buildup of lactic acid in the blood and could lead to such symptoms as nausea and weakness.

Drugs used to treat diabetes, such as glimepiride, and other sulfonylurea drugs can also occasionally interact with alcohol and cause dizziness, nausea, flushing (redness of the face), and extremely low blood glucose levels, Elder said.

Gastroesophageal reflux and ulcer drugs

Though Elder said it may be OK to have one drink if you have heartburn, larger amounts of alcohol can relax the muscle between the stomach and the esophagus, increasing acid reflux. This could produce a burning sensation in the upper chest and a sour taste in the back of the mouth, she explained.

Although Elder said there’s not really any direct reaction between alcohol and proton pump inhibitors, which are the drugs commonly used to treat gastroesophageal reflux disease (GERD), drinking can make heartburn worse.

The holidays can be challenging for people with GERD because there’s often so much tempting food and alcohol. “It’s hard to tell whether it’s eating or drinking that is causing reflux symptoms to flare up,” Elder said.

Alcohol can irritate and erode the lining of the stomach and esophagus, and also increase the amount of stomach acid produced, thus worsening acid reflux as well as ulcer symptoms.

Elder advised people with stomach ulcers to avoid alcohol because it can slow an ulcer’s ability to heal.

Painkillers

Drinking can be harmful when taking certain over-the-counter and prescription pain relievers because alcohol intensifies the effect of some pain medicines.

It’s generally safe to drink in small amounts if you’re taking acetaminophen (Tylenol), Qato said, but she warned that chronic drinking and acetaminophen use can cause liver damage.

Other over-the-counter pain remedies, such as aspirin and ibuprofen, are usually safe with moderate drinking, Qato said. But she cautioned that because aspirin and ibuprofen can increase stomach irritation, and so does alcohol, it’s best to refrain from heavy drinking if you take pain relievers on a regular basis in order to avoid the possibility of ulcers and stomach bleeding.

Drinking should be avoided when taking prescription pain medications, including opioids such as Vicodin and OxyContin. Alcohol can enhance the sedative side effects of these narcotics, thus increasing fatigue and causing blood pressure to drop. Combining alcohol and narcotics can also impair thinking and motor skills, and lead to breathing problems.

Every year, many severe — and sometimes fatal — overdoses are caused by mixing alcohol and narcotics, Qato said.

Sleeping pills

It’s generally recommended to steer clear of alcohol if you’re taking sleeping pills, said Qato.

Combining sleep aids, such as Lunesta or Ambien, with alcohol can be dangerous. Alcohol can increase the sedative effects of sleep medications, depressing parts of the brain and causing severe drowsiness and dizziness, which may increase the risk of falls, injuries and car accidents.

Heavy drinking while taking sleeping pills can reduce blood pressure to extremely low levels, and cause difficulty breathing.

Although drinking can make you feel tired, which is why some people use it as a nightcap, it can also disrupt normal sleep patterns and cause you to wake up more often during the night.

If you have a drink, try to wait at least six hours before taking sleeping pills in order to keep alcohol far away from your bedtime, Qato recommended.

Follow us @livescience, Facebook & Google+. Original article on LiveScience.

PMC

  • Benetos A, Rudnichi A, Safar M, et al. Pulse pressure and cardiovascular mortality in normotensive and hypertensive subjects. Hypertension. 1998;32:560–4.
  • Benetos A, Safar M, Rudnichi A, et al. Pulse pressure:a predictor of long-term cardiovascular mortality in a French male population. Hypertension. 1997;30:1410–5.
  • Blacher J, Guerin AP, Pannier B, et al. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999;99:2434–9.
  • Blacher J, Staessen J, Girerd X, et al. Pulse pressure not mean pressure determines cardiovascular risk in older hypertensive patients. Arch Int Med. 2000;160:1085–9.
  • Bonapace S, Rossi A, Cicoira M, et al. Aortic distensibility independently affects exercise tolerance in patients with dilated cardiomyopathy. Circulation. 2003;107:1603–8.
  • Boutouyrie P, Tropeano AI, Asmar R, et al. Aortic stiffness is an independent predictor of primary coronary events in hypertensive patients. Hypertension. 2002;39:10–5.
  • Bowman AJ, Chen CP-H, Ford GA. Nitric oxide mediated venodilator effects of nebivolol. Br J Clin Pharmacol. 1994;38:199–204.
  • Breithaupt-Grogler K, Leschinger M, Belz GG, Butzer R, Erb K, de Mey C, Sinn W. Influence of antihypertensive therapy with cilazapril and hydrochlorothiazide on the stiffness of the aorta. Cardiovasc Drugs Ther. 1996;10:49–57.
  • Brunner H, Cockcroft JR, Deanfield J, et al. Endothelial function and dysfunction. Part II: association with cardiovascular risk factors and diseases. A statement by the Working Group on Endothelins and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005;23:233–46.
  • Carlberg B, Samuelsson O, Lindholm LH. Atenolol in hypertension: is it a wise choice? Lancet. 2004;364:1684–9.
  • Chen CP-H, Ting C-T, Lin S-J, et al. Different effects of fosinipril and atenolol on wave reflection in hypertensive patients. Hypertension. 1995;25:1034–41.
  • Cleophas TJ, Agrawal R, Lichtenthal A, et al. Nationwide efficacy-safety study of nebivolol in mildly hypertensive patients. Am J Ther. 2006;13:192–7.
  • Cleophas TJ, Grabowsky I, Niemeyer MG, et al. Long-term efficacy of nebivolol monotherapy in patients with hypertension. Curr Ther Res. 2001;62:451–61.
  • Cockcroft JR, Chowienczyk PJ, Brett SE, et al. Nebivolol vasodilates human forearm vasculature: evidence for an L-arginine/NO-dependent mechanism. J Pharmacol Exp Ther. 1995;274:1067–71.
  • Cockcroft JR, Wilkinson IB, Webb DJ. The Trevor Howell Lecture: age, arterial stiffness and the endothelium. Ageing. 1997;26:53–60.
  • Cruickshank JM, Prichard BNC. Beta-blockers in clinical practice. Edinburgh: Churchill Livingstone; 1987.
  • Cruickshank K, Riste L, Anderson SG, et al. Aortic pulse-wave velocity and its relationship to mortality in diabetes and glucose intolerance. An integrated index of vascular function? Circulation. 2002;106:2085–90.
  • Dawes M, Brett SE, Chowienczyk PJ, Mant TGK, et al. The vasodilator action of nebivolol in forearm vasculature of subjects with essential hypertension. J Clin Pharmacol. 1999;48:460–3.
  • De Cree J, Geukens H, Verhaegen H. Non-invasive cardiac haemodynamics of nebivolol. Clin Drug Investig. 1991;3(Suppl 1):25–30.
  • Dhakam Z, McEniery CM, Yasmin, et al. Atenolol and eprosartan:differential effects on central blood pressure and aortic pulse wave velocity. Am J Hypertens. 2006;19:214–9.
  • Dreary AJ, Schumann AL, Murfet H, et al. Influence of drugs and gender on the arterial pulse wave and natiuretic peptide secretion in untreated patients with essential hypertension. Clin Sci. 2002;103:493–9.
  • Erdogan D, Gullu H, Caliskan M, et al. Nebivolol improves coronary flow reserve in patients with idiopathic dilated Cardiomyopathy. Heart. 2007;93:319–24.
  • Fallois JV, Faulhaber H-D. Nebivolol, a third generation beta-blocker:the current treatment of arterial hypertension. Praxis. 2001;90:435–41.
  • Flather MD, Shibata MC, Coats AJ, et al. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS) Eur Heart J. 2005;26:215–25.
  • Fogari R, Zoppi A, Lazzari P, et al. Comparative effects of nebivolol and atenolol on blood pressure and insulin sensitivity in hypertensive patients with type II diabetes. J Hum Hypertens. 1997;11:753–7.
  • Gao Y, Nagao T, Bond RA, et al. Nebivolol induces endothelium-dependent relaxations of canine coronary arteries. J Cardiovasc Pharmacol. 1991;17:964–9.
  • Kamp O, Sieswerda GT, Visser CA. Comparison of effects on systolic and diastolic left ventricular function of nebivolol versus atenolol in patients with uncomplicated essential hypertension. Am J Cardiol. 2003;92:344–8.
  • Kannel WB, Wilson PW, Zhang TJ. The epidemiology of impaired glucose tolerance and hypertension. Am Heart J. 1991;121:1268–73.
  • Kass DA. Age-related changes in venticular-arterial coupling: pathophysiologic implications. Heart Fail Rev. 2002;7:51–62.
  • Kawaguchi M, Hay I, Fetics B, et al. Combined ventricular systolic and arterial stiffening in patients with heart failure and preserved ejection fraction: implications for systolic and diastolic reserve limitations. Circulation. 2003;107:714–720.
  • Kelly R, Daley J, Avolio A, et al. Arterial dilation and reduced wave reflection. Benefit of dilevalol in hypertension. Hypertension. 1989;14:14–21.
  • Kinlay S, Creager MA, Fukumoto M, et al. Endothelium-derived nitric oxide regulates arterial elasticity in human arteries in vivo. Hypertension. 2001;38:1049–53.
  • Lacourciere Y, Arnott W. Placebo-controlled comparison of the effects of nebivolol and low-dose hydrochlorothiazide as monotherapies and in combination on blood pressure and lipid profile in hypertensive patients. J Hum Hypertens. 1994;8:283–8.
  • Lacourciere Y, Poirier L, Lefebvre J. Comparative effects of a new cardioselective beta-blocker nebivolol and nifedipine sustained-release on 24-hour ambulatory blood pressure and plasma lipoproteins. J Clin Pharmacol. 1992;32:660–6.
  • Laurent S, Boutouyrie P, Asmar R, et al. Aortic stiffness is an independent predictor of all-cause and cardiovascular mortality in hypertensive patients. Hypertension. 2001;37:1236–41.
  • Lindholm LH, Carlberg B, Samuelsson O. Should beta-blockers remain first choice in the treatment of primary hypertension? A meta-analysis. Lancet. 2005;366:1545–53.
  • Lombardo RM, Reina C, Abrignani MG, et al. Effects of nebivolol versus carvedilol on left ventricular function in patients with chronic heart failure and reduced left ventricular systolic function. Am J CardiovascDrugs. 2006;6:259–63.
  • Mason RP. Nitric oxide mechanisms in the pathogenesis of global risk. J Clin Hypertens (Greenwich) 2006;8:31–8.
  • Mason RP, Kalinowski L, Jacob RF, et al. Nebivolol reduces nitroxidative stress and restores nitric oxide bioavailability in endothelium of black Americans. Circulation. 2005;112:3795–801.
  • Mazza A, Gil-Extremera B, Maldonato A, et al. Nebivolol vs amlodipine as first-line treatment of essential arterial hypertension in the elderly. Blood Press. 2002;11:182–8.
  • McEniery CM, Schmitt M, Qasem A, et al. Nebivolol increases arterial distensibility in vivo. Hypertension. 2004;44:305–10.
  • Meaume S, Benetos A, Henry OF, et al. Aortic pulse wave velocity predicts cardiovascular mortality in subjects. >70 years of age. Arterioscler Thromb Vasc Biol. 2001;21:2046–50.
  • Millar JA, Lever AF, Burke V. Pulse pressure as a risk factor for cardiovascular events in the MRC Mild Hypertension Trial. J Hypertens. 1999;17:1065–72.
  • Mitchell GF, Moye LA, Braunwald E, et al. Sphygomanometrically determined pulse pressure is a powerful independent predictor of recurrent events after myocardial infarction in patients with impaired left ventricular function. Circulation. 1997;96:4254–60.
  • Mitchell GF, Tardif JC, Arnold JM, et al. Pulsatile hemodynamics in congestive heart failure. Hypertension. 2001;38:1433–9.
  • Moncada S. Nitric oxide. J Hypertens Suppl. 1994;12:S35–S9.
  • Mottram PM, Haluska BA, Leano R, et al. Relation of arterial stiffness to diastolic dysfunction in hypertensive heart disease. Heart. 2005;91:1551–6.
  • NICE. Hypertension: Management of Hypertension in Adults in Primamry care – Partial update. NICE. 2006
  • O’Rourke MF, Kelly RP, Avolio AP, et al. Effects of arterial dilator agents on central systolic pressure and on left ventricular hydraulic load. Am J Cardiol. 1989;63:381–441.
  • Palatini P, Casiglia E, Julius S. High heart rate: a risk factor for cardiovascular death in elderly men. Arch Int Med. 1999;159:585–92.
  • Palmer RM, Ashton DS, Moncada S. Vascular endothelial cells synthesize nitric oxide from L-arginine. Nature. 1988;333:664–6.
  • Pedersen ME, Cockcroft JR. The latest generation of beta-blockers:new pharmacologic properties. Curr Hypertens Rep. 2006;8:279–86.
  • Redfield MM, Jacobsen SJ, Borlaug BA, et al. Age- and gender-related ventricular-vascular stiffening: a community-based study. Circulation. 2005;112:2254–62.
  • Resnick LM, Lester MH. Differential effects of antihypertensive drug therapy on arterial compliance. Am J Hypertens. 2002;15:1096–100.
  • Ritter JM. Nebivolol: endothelium-mediated vasodilating effect. J Cardiovasc Pharmacol. 2001;38(Suppl 3):S13–S16.
  • Robertson JIS, Ball SG. Hypertension for the clinician. London: W.B. Saunders; 1994.
  • Schmitt M, Avolio A, Qasem A, et al. Basal NO locally modulates human iliac artery function in vivo. Hypertension. 2005;46:227–31.
  • Shibata M, Flather M, Wang W. Systematic review of the impact of beta blockers on mortality and hospital admissions in heart failure. Eur J Heart Failure. 2001;3:351–7.
  • Staessen J, Wang J-G, Thijs L. Cardiovascular prevention and blood pressure reduction: a quantitative overview updated until March 2003. Hypertension. 2003;21:1055–76.
  • Steiner SS, Friedhoff AJ, Wilson BL, et al. Antihypertensive therapy and quality of life: comparison of atenolol, enalapril and propanolol. J Hum Hypertens. 1990;4:217–25.
  • Stoleru L, Wijns W, van Eyll C, et al. Effects of d-nebivolol and l-nebivolol on left ventricular systolic and diastolic function: comparison with dl-nebivolol and atenolol. J Cardiovasc Pharmacol. 1993;22:183–90.
  • Tzemos N, Lim PO, MacDonald TM. Nebivolol reverses endothelial dysfunction in essential hypertension. Circulation. 2001;104:511–14.
  • Uhlir O, Fejifusa M, Havranek K. Nebivolol versus metoprolol in the treatment of hypertension. Clin Drug Investig. 1991;3(Suppl 1):107–10.
  • Van Bortel LM, Bulpitt CJ, Fici F. Quality of life and antihypertensive effect with nebivolol and losartan. Am J Hypertens. 2005;18:1060–6.
  • Van Bortel LMAB, Breed JGS, Joosten J, et al. Nebivolol in hypertension: a double-blind placebo-controlled multicenter study assessing its antihypertensive efficacy and impact on quality of life. J Cardiovasc Pharmacol. 1993;21:856–62.
  • Van Bortel LMAB, de Hoon JNJM, Kool MJ, et al. Pharmacological properties of nebivolol in man. Eur J Clin Pharmacol. 1997;51:379–84.
  • Van Bortel LMAB, Kool MJ, Boudier HA, et al. Effects of antihypertensive agents on local arterial distensibility and compliance. Hypertension. 1995;26:531–4.
  • Van Bortel LMAB, Van Baak MA. Exercise tolerance with nebivolol and atenolol. Cardiovasc Drugs Ther. 1992;6:239–47.
  • Van de Water A, Janssens WJ, Van Nueten L, et al. Pharmacological and hemodynamic profile of nebivolol, a chemically novel, potent and selective beta1-adrenergic antagonist. J Cardiovasc Pharmacol. 1988;11:552–63.
  • Van Merode T, Van Bortel LMAB, Smeets FA. Verapamil and nebivolol improve carotid artery distensibility in hypertensive patients. J Hypertens. 1989;(Suppl 7):S262–S3.
  • Van Nueten L, De Cree J. Nebivolol: a comparison of the effects of dl-nebivolol, d-nebivolol, l-nebivolol, atenolol, and placebo on exercise-induced increases in heart rate and systolic blood pressure. Cardiovasc Drugs Therap. 1998;12:339–44.
  • Van Nueten L, Dupont AG, Vertommen C, et al. A dose-response trial of nebivolol in essential hypertension. J Hum Hypertens. 1997a;11:139–44.
  • Van Nueten L, Lacourciere Y, Vyssoulis G, et al. Nebivolol versus nifedipine in the treatment of essential hypertension: a double-blind randomised comparative trial. Am J Therap. 1998a;5:237–43.
  • Van Nueten L, Schelling A, Vertommen C, et al. Nebivolol versus enalapril in the treatment of essential hypertension:a double-blind randomised trial. J Hum Hypertens. 1997b;11:813–19.
  • Van Nueten L, Taylor FR, Robertson JI. Nebivolol vs atenolol and placebo in essential hypertension: a double-blind randomised trial. J Hum Hypertens. 1998b;12:135–40.
  • Van Nueten L, Taylor FR, Robertson JIS. Nebivolol versus atenolol and placebo in essential hypertension: a double-blind randomised trial. J Hum Hypertens. 1998c;12:135–40.
  • van Popele NM, Mattace-Raso FU, Vliegenthart R, et al. Aortic stiffness is associated with atherosclerosis of the coronary arteries in older adults: the Rotterdam Study. J Hypertens. 2006;24:2371–6.
  • WHO-ISH. Hypertension guidelines. J Hypertens. 1999;17:151–83.
  • Wilkinson IB, Franklin SS, Cockcroft JR. Nitric oxide and the regulation of large artery stiffness: from physiology to pharmacology. Hypertension. 2004;44:112–6.
  • Wilkinson IB, McEniery CM, Cockcroft JR. Atenolol and cardiovascular risk: an issue close to the heart. Lancet. 2006;367:627–9.
  • Wilkinson IB, Qasem A, McEniery CM, et al. Nitric oxide regulates local arterial distensibility in vivo. Circulation. 2002;105:213–7.
  • Williams B, Lacy PS, Thom SM, et al. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006;113:1213–25.
  • Yambe M, Tomiyama H, Hirayama Y, et al. Arterial stiffening as a possible risk factor for both atherosclerosis and diastolic heart failure. Hypertens Res. 2004;27:625–31.

AMERIGEN Announces Tentative Approval of Generic Bystolic®

LYNDHURST, N.J., April 17, 2015 /PRNewswire/ — Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Bystolic® (Nebivolol HCl 2.5, 5, 10 and 20mg instant release tablets). Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Bystolic® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.

Forest Laboratories markets Bystolic® in the U.S. for the treatment of hypertension, to lower blood pressure. U.S. sales of Bystolic® were approximately $793 million for the 12 months ended December 31st 2014, according to IMS Health.

Pursuant to a 2013 settlement agreement with Forest Laboratories, and subject to FDA final approval of its ANDA, Amerigen may launch its generic product on the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Amerigen receives final FDA approval of its ANDA, or earlier under certain circumstances.

About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group’s Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA’s with the US FDA and the Chinese CFDA. Amerigen’s focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen’s products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

SOURCE Amerigen Pharmaceuticals

Bystolic (Nebivolol Hydrochloride)

  • tell your doctor if you have a slow heart rate, heart or liver disease, or heart failure. Your doctor may tell you not to take nebivolol.
  • tell your doctor if you have or have ever had asthma or other lung diseases, diabetes, hyperthyroidism (an overactive thyroid gland), problems with blood circulation, kidney disease, severe allergies, or pheochromocytoma (a tumor that develops on a gland near the kidneys and may cause high blood pressure and fast heart rate).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking nebivolol, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nebivolol.
  • you should know that nebivolol may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that if you have allergic reactions to different substances, your reactions may be worse while you are using nebivolol, and your allergic reactions may not respond to the usual doses of injectable epinephrine.
  • Bystolic

    Generic Name: nebivolol (ne BIV oh lol)
    Brand Names: Bystolic

    Medically reviewed by Sanjai Sinha, MD Last updated on Mar 4, 2019.

    • Overview
    • Side Effects
    • Dosage
    • Professional
    • Interactions
    • More

    What is Bystolic?

    Bystolic (nebivolol) belongs to a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

    Bystolic is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

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

    Important information

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

    Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    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.

    Before taking this medicine

    To make sure you can safely take Bystolic, tell your doctor if you have any of these other conditions:

    • severe liver disease; or

    • a heart problem such as heart block, sick sinus syndrome, slow heart rate, or heart failure.

    If you have any of these other conditions, you may need a Bystolic dose adjustment or special tests:

    • asthma, bronchitis, emphysema;

    • liver or kidney disease;

    • diabetes;

    • a thyroid disorder;

    • a history of allergies;

    • problems with circulation (such as Raynaud’s syndrome);

    • pheochromocytoma (tumor of the adrenal gland); or

    • if you have recently had a heart attack.

    FDA pregnancy category C. It is not known whether Bystolic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Bystolic. It is not known whether nebivolol passes into breast milk or if it could harm a nursing baby. Do not use Bystolic without telling your doctor if you are breast-feeding a baby.

    How should I take Bystolic?

    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.

    What happens if I miss a dose?

    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.

    What happens if I overdose?

    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.

    What should I avoid?

    Bystolic may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Bystolic side effects

    Get emergency medical help if you have any of these signs of an allergic reaction to Bystolic: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

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

    What other drugs will affect Bystolic?

    Tell your doctor about all other medicines you use, especially:

    This list is not complete and other drugs may interact with Bystolic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Further information

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Bystolic only for the indication prescribed.

    Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

    Copyright 1996-2020 Cerner Multum, Inc. Version: 4.01.

    Medical Disclaimer

    More about Bystolic (nebivolol)

    • Side Effects
    • During Pregnancy or Breastfeeding
    • Dosage Information
    • Drug Images
    • Drug Interactions
    • Compare Alternatives
    • Support Group
    • Pricing & Coupons
    • En Español
    • 192 Reviews
    • Drug class: cardioselective beta blockers
    • FDA Approval History

    Consumer resources

    • Bystolic
    • Bystolic (Advanced Reading)

    Professional resources

    • Bystolic (AHFS Monograph)
    • … +1 more

    Related treatment guides

    • High Blood Pressure
    • Mitral Valve Prolapse

    Bystolic Tablets

    SIDE EFFECTS

    Clinical Studies Experience

    BYSTOLIC has been evaluated for safety in patients with hypertension and in patients with heart failure. The observed adverse reaction profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.

    The data described below reflect worldwide clinical trial exposure to BYSTOLIC in 6545 patients, including 5038 patients treated for hypertension and the remaining 1507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received BYSTOLIC for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 patients for more than one year.

    HYPERTENSION

    In placebo-controlled clinical trials comparing BYSTOLIC with placebo, discontinuation of therapy due to adverse reactions was reported in 2.8% of patients treated with nebivolol and 2.2% of patients given placebo. The most common adverse reactions that led to discontinuation of BYSTOLIC were headache (0.4%), nausea (0.2%) and bradycardia (0.2%).

    Table 1 lists treatment-emergent adverse reactions that were reported in three 12-week, placebo-controlled monotherapy trials involving 1597 hypertensive patients treated with either 5 mg, 10 mg, or 20-40 mg of BYSTOLIC and 205 patients given placebo and for which the rate of occurrence was at least 1% of patients treated with nebivolol and greater than the rate for those treated with placebo in at least one dose group.

    Table 1: Treatment-Emergent Adverse Reactions with an Incidence (over 6 weeks) ≥ 1% in BYSTOLIC-Treated Patients and at a Higher Frequency than Placebo-Treated Patients

    System Organ Class -Preferred Term Placebo
    (n = 205) (%)
    Nebivolol 5 mg
    (n = 459) (%)
    Nebivolol 10 mg
    (n = 461) (%)
    Nebivolol 20-40 mg
    (n = 677) (%)
    Cardiac Disorders
    Bradycardia 0 0 0 1
    Gastrointestinal Disorders
    Diarrhea 2 2 2 3
    Nausea 0 1 3 2
    General Disorders
    Fatigue 1 2 2 5
    Chest pain 0 0 1 1
    Peripheral edema 0 1 1 1
    Nervous System Disorders
    Headache 6 9 6 7
    Dizziness 2 2 3
    Psychiatric Disorders
    Insomnia 0 1 1 1
    Respiratory Disorders
    Dyspnea 0 0 1 1
    Skin and subcutaneous Tissue Disorders
    Rash 0 0 1 1

    Listed below are other reported adverse reactions with an incidence of at least 1% in the more than 4300 patients treated with BYSTOLIC in controlled or open-label trials except for those already appearing in Table 1, terms too general to be informative, minor symptoms, or adverse reactions unlikely to be attributable to drug because they are common in the population. These adverse reactions were in most cases observed at a similar frequency in placebo-treated patients in the controlled studies.

    Body as a Whole: asthenia.

    Gastrointestinal System Disorders: abdominal pain

    Metabolic and Nutritional Disorders: hypercholesterolemia

    Nervous System Disorders: paraesthesia

    Laboratory Abnormalities

    In controlled monotherapy trials of hypertensive patients, BYSTOLIC was associated with an increase in BUN, uric acid, triglycerides and a decrease in HDL cholesterol and platelet count.

    Postmarketing Experience

    The following adverse reactions have been identified from spontaneous reports of BYSTOLIC received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to BYSTOLIC. Adverse reactions common in the population have generally been omitted. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to BYSTOLIC exposure: abnormal hepatic function (including increased AST, ALT and bilirubin), acute pulmonary edema, acute renal failure, atrioventricular block (both second and third degree), bronchospasm, erectile dysfunction, hypersensitivity (including urticaria, allergic vasculitis and rare reports of angioedema), hypotension, myocardial infarction, pruritus, psoriasis, Raynaud’s phenomenon, peripheral ischemia/claudication, somnolence, syncope, thrombocytopenia, various rashes and skin disorders, vertigo, and vomiting.

    Read the entire FDA prescribing information for Bystolic Tablets (Nebivolol Tablets)

    what is BYSTOLIC?

    What should I tell my healthcare provider before taking BYSTOLIC?

    Before starting BYSTOLIC, tell your healthcare provider about all of your medical conditions, including if you:

    • Have asthma or other lung problems (such as bronchitis or emphysema)
    • Have problems with blood flow in your feet and legs (peripheral vascular disease). BYSTOLIC can make symptoms of blood flow problems worse.
    • Have diabetes and take medicine to control blood sugar
    • Have thyroid problems
    • Have liver or kidney problems
    • Have had allergic reactions to medications or have allergies
    • Have a condition called pheochromocytoma (rare adrenal gland tumor)
    • Are pregnant or trying to become pregnant. It is not known if BYSTOLIC is safe for your unborn baby. Talk with your doctor about the best way to treat your high blood pressure while you are pregnant.
    • Are breastfeeding. It is not known if BYSTOLIC passes into your breast milk. You should not breastfeed while using BYSTOLIC.
    • Are scheduled for surgery and will be given anesthetic agents
    • Have had acute angina (symptoms include chest pain or discomfort) or an MI (heart attack) as BYSTOLIC has not been studied in patients with these conditions.

    Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking or plan to take any prescription or over-the-counter medications, vitamins, or herbal products, including:

    • Certain CYP2D6 inhibitors (such as some antiarrhythmics like quinidine or propafenone or certain antidepressants such as fluoxetine or paroxetine, etc).
    • Other beta blockers
    • Digitalis
    • Certain calcium channel blockers (such as verapamil and diltiazem)
    • Antiarrhythmic agents (such as disopyramide)

    What are the possible side effects of BYSTOLIC?

    The most common side effects people taking BYSTOLIC report are headache, fatigue (tiredness), dizziness (if you feel dizzy, sit or lie down and tell your doctor right away), diarrhea, nausea, insomnia (difficulty falling or staying asleep), chest pain, bradycardia (slow heartbeat), dyspnea (shortness of breath), rash, and peripheral edema (leg swelling due to fluid retention). Other possible side effects include masking (hiding) the symptoms of low blood sugar and hyperthyroidism (overactive thyroid), especially a fast heartbeat. Tell your doctor if you gain weight or have trouble breathing while taking BYSTOLIC.

    This is not a complete list of side effects. Tell your doctor if you have any side effects that bother you or don’t go away.

    What other information do I need to know about taking BYSTOLIC?

    • Do not stop taking BYSTOLIC suddenly. You could have chest pain or a heart attack. If your doctor decides that you should stop taking BYSTOLIC, he or she will lower your dose slowly and over time.
    • Take BYSTOLIC every day exactly as your doctor tells you. Your doctor will tell you how much BYSTOLIC to take and how often. Your doctor may start with a low dose and raise it over time.
    • Do not stop taking BYSTOLIC or change your dose without talking with your doctor.
    • BYSTOLIC can be taken with or without food.
    • If you miss a dose, take your dose as soon as you remember, unless it is close to the time to take your next dose. Do not take 2 doses at the same time. Take your next dose at the usual time.
    • If you take too much BYSTOLIC, call your doctor or poison control center right away.

    What is BYSTOLIC?

    BYSTOLIC is a prescription medicine that belongs to a group of medicines called “beta blockers.” BYSTOLIC is used, often with other medicines, to treat adults with high blood pressure (hypertension). BYSTOLIC is not approved for use in children under 18 years of age.

    What is High Blood Pressure (Hypertension)?

    Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

    High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. BYSTOLIC tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

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