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Nebivolol Hydrochloride (Bystolic)

Trade Name : Bystolic

Cardinal Health

TABLET

Strength 5 mg/1

NEBIVOLOL HYDROCHLORIDE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nebivolol Hydrochloride (Bystolic) which is also known as Bystolic and Manufactured by Cardinal Health. It is available in strength of 5 mg/1 per ml. Read more

Nebivolol Hydrochloride (Bystolic) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressureu00a0n n BYSTOLIC may be used alone or in combination with other antihypertensive agents n n u00a0
  • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC.
  • Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programu2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
  • Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
  • Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
  • Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
  • BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment ofu00a0hypertension, to lower blood pressure.u00a0 Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ()
  • Can be taken with and without food. Individualize to the needs of the patient and monitor during up-titration. ()
  • u2022
  • 2.1
  • BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol.
  • BYSTOLIC tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with u201cu201d on one side and the number of mg (2 u00bd, 5, 10, or 20) on the other side.
  • Tablets: 2.5, 5, 10, 20 mg ()
  • BYSTOLIC is contraindicated in the following conditions:
  • No data
  • 6.1
  • To report SUSPECTED ADVERSE REACTIONS, Contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u2022
  • No data
  • No data
  • u2022
  • 8.2
  • u00a0
  • In clinical trials and worldwide postmarketing experience there were reports of BYSTOLIC overdose. The most common signs and symptoms associated with BYSTOLIC overdosage are bradycardia and hypotension. Other important adverse reactions reported with BYSTOLIC overdose include cardiac failure, dizziness, hypoglycemia, fatigue and vomiting. Other adverse reactions associated with u03b2-blocker overdose include bronchospasm and heart block.
  • The largest known ingestion of BYSTOLIC worldwide involved a patient who ingested up to 500 mg of BYSTOLIC along with several 100 mg tablets of acetylsalicylic acid in a suicide attempt. The patient experienced hyperhydrosis, pallor, depressed level of consciousness, hypokinesia, hypotension, sinus bradycardia, hypoglycemia, hypokalemia, respiratory failure and vomiting. The patient recovered.
  • Because of extensive drug binding to plasma proteins, hemodialysis is not expected to enhance nebivolol clearance.
  • If overdose occurs, provide general supportive and specific symptomatic treatment. Based on expected pharmacologic actions and recommendations for other u03b2-blockers, consider the following general measures, including stopping BYSTOLIC, when clinically warranted:
  • Bradycardia:
  • Hypotension:n- u00a0
  • Heart Block (second or third degree):n- u00a0
  • Congestive Heart Failure:
  • Bronchospasm:
  • Hypoglycemia:
  • Supportive measures should continue until clinical stability is achieved. The half-life of low doses of nebivolol is 12-19 hours.
  • Call the National Poison Control Center (800-222-1222) for the most current information on u03b2-blocker overdose treatment.
  • The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1u2019RS)-1,1u2019-[(2RS,2u2019SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2u2019-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivololu2019s molecular formula is (CHFNOu2022HCl) with the following structural formula:
  • 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.
  • Nebivolol is a u03b2-adrenergic receptor blocking agent. In extensive metabolizers (most of the population) and at doses less than or equal to 10 mg, nebivolol is preferentially u03b2 selective. In poor metabolizers and at higher doses, nebivolol inhibits both u03b2 - and u03b2 - adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, BYSTOLIC does not demonstrate u03b1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to u03b2-blocking activity.
  • In a two-year study of nebivolol in mice, a statistically significant increase in the incidence of testicular Leydig cell hyperplasia and adenomas was observed at 40 mg/kg/day (5 times the maximally recommended human dose of 40 mg on a mg/m basis). Similar findings were not reported in mice administered doses equal to approximately 0.3 or 1.2 times the maximum recommended human dose. No evidence of a tumorigenic effect was observed in a 24-month study in Wistar rats receiving doses of nebivolol 2.5, 10 and 40 mg/kg/day (equivalent to 0.6, 2.4, and 10 times the maximally recommended human dose). Co-administration of dihydrotestosterone reduced blood LH levels and prevented the Leydig cell hyperplasia, consistent with an indirect LH-mediated effect of nebivolol in mice and not thought to be clinically relevant in man.
  • A randomized, double-blind, placebo- and active-controlled, parallel-group study in healthy male volunteers was conducted to determine the effects of nebivolol on adrenal function, luteinizing hormone, and testosterone levels. This study demonstrated that 6 weeks of daily dosing with 10 mg of nebivolol had no significant effect on ACTH-stimulated mean serum cortisol AUC, serum LH, or serum total testosterone.
  • Effects on spermatogenesis were seen in male rats and mice at u2265 40 mg/kg/day (10 and 5 times the MRHD, respectively). For rats the effects on spermatogenesis were not reversed and may have worsened during a four week recovery period. The effects of nebivolol on sperm in mice, however, were partially reversible.
  • Mutagenesis: Nebivolol was not genotoxic when tested in a battery of assays (Ames, mouse lymphoma TK, human peripheral lymphocyte chromosome aberration, Drosophila melanogaster sex-linked recessive lethal, and mouse bone marrow micronucleus tests).
  • The antihypertensive effectiveness of BYSTOLIC as monotherapy has been demonstrated in three randomized, double-blind, multi-center, placebo-controlled trials at doses ranging from 1.25 to 40 mg for 12 weeks (Studies 1, 2, and 3). A fourth placebo-controlled trial demonstrated additional antihypertensive effects of BYSTOLIC at doses ranging from 5 to 20 mg when administered concomitantly with up to two other antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics) in patients with inadequate blood pressure control.
  • The three monotherapy trials included a total of 2016 patients (1811 BYSTOLIC, 205 placebo) with mild to moderate hypertension who had baseline diastolic blood pressures (DBP) of 95 to 109 mmHg. Patients received either BYSTOLIC or placebo once daily for twelve weeks. Two of these monotherapy trials (Studies 1 and 2) studied 1716 patients in the general hypertensive population with a mean age of 54 years, 55% males, 26% non-Caucasians, 7% diabetics and 6% genotyped as PMs. The third monotherapy trial (Study 3) studied 300 Black patients with a mean age of 51 years, 45% males, 14% diabetics, and 3% as PMs.
  • Placebo-subtracted blood pressure reductions by dose for each study are presented in Table 2. Most studies showed increasing response to doses above 5 mg.
  • * p<0.05 based on pair-wise comparison vs. placebo
  • Study 4 enrolled 669 patients with a mean age of 54 years, 55% males, 54% Caucasians, 29% Blacks, 15% Hispanics, 1% Asians, 14% diabetics, and 5% PMs. BYSTOLIC, 5 mg to 20 mg, administered once daily concomitantly with stable doses of up to two other antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics) resulted in significant additional antihypertensive effects over placebo compared to baseline blood pressure.
  • Effectiveness was similar in subgroups analyzed by age and sex. Effectiveness was established in Blacks, but as monotherapy the magnitude of effect was somewhat less than in Caucasians.
  • The blood pressure lowering effect of BYSTOLIC was seen within two weeks of treatment and was maintained over the 24-hour dosing interval.
  • There are no trials of BYSTOLIC demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits. u00a0
  • BYSTOLIC is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol.
  • BYSTOLIC tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with u201cu201d on one side and the number of mg (2 u00bd, 5, 10, or 20) on the other side. BYSTOLIC tablets are supplied in the following strengths and package configurations:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) n
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • See FDA-approved patient labeling (n- ).
  • Advise patients to take BYSTOLIC regularly and continuously, as directed. BYSTOLIC can be taken with or without food. If a dose is missed, take the next scheduled dose only (without doubling it). Do not interrupt or discontinue BYSTOLIC without consulting the physician.
  • Patients should know how they react to this medicine before they operate automobiles, use machinery, or engage in other tasks requiring alertness.
  • Advise patients to consult a physician if any difficulty in breathing occurs, or if they develop signs or symptoms of worsening congestive heart failure such as weight gain or increasing shortness of breath, or excessive bradycardia.
  • Caution patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, that u03b2-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • Distributed by:
  • Cardinal Health
  • Dublin, OH 43017
  • Licensed from Mylan Laboratories, Inc.
  • Actidose-Aqua is a registered trademark of Paddock Laboratories, LLC
  • Bystolic is a registered trademark of Allergan Sales, LLC.
  • Patented. See www.allergan.com/patents
  • u00a9 2019u00a0Allergan. All rights reserved.
  • v 2.1USPI1402
  • PATIENT INFORMATION
  • BYSTOLICn n- (bi-STOL-ik)
  • (nebivolol) Tablets
  • Read the Patient Information that comes with BYSTOLIC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about BYSTOLIC, ask your doctor or pharmacist.
  • WHAT IS BYSTOLIC?
  • BYSTOLIC is a kind of prescription medicine called a u201cbeta-blockeru201d. BYSTOLIC treats:
  • BYSTOLIC can lower blood pressure when used by itself and with other medicines.u00a0u00a0
  • BYSTOLIC is not approved for children less than 18 years of age.
  • WHO SHOULD NOT TAKE BYSTOLIC?
  • Do not take BYSTOLIC if you:
  • WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING BYSTOLIC?
  • Tell your doctor about all of your medical problems, including if you:
  • u00a0
  • Tell your doctor about all the medicines you take
  • Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.
  • HOW SHOULD I TAKE BYSTOLIC?
  • WHAT ARE POSSIBLE SIDE EFFECTS OF BYSTOLIC?
  • Tell your doctor if you have any side effects that bother you or donu2019t go away.
  • HOW SHOULD I STORE BYSTOLIC?
  • GENERAL INFORMATION ABOUT BYSTOLIC
  • Doctors sometimes prescribe medicines for conditions not included in the patient information leaflets.
  • This leaflet summarizes the most important information about BYSTOLIC. For more information:
  • WHAT IS IN BYSTOLIC?
  • Active Ingredient:
  • Inactive Ingredients:
  • 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.
  • Rev. June 2019
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • Distributed By:
  • Cardinal Health
  • Dublin, OH 43017
  • L70850520
  • L70890420
  • L70881118A
  • Licensed from Mylan Laboratories, Inc.
  • Actidose-Aqua is a registered trademark of Paddock Laboratories, LLC
  • BYSTOLIC is a registered trademark of Allergan Sales, LLC.
  • Patented. See www.allergan.com/patents
  • u00a9 2019u00a0Allergan. All rights reserved.
  • V2.1PPI1402
  • Bystolicu00ae (nebivolol) tablets
  • 5 mg
  • Contains Approximately 1710 Tablets
  • Bystolicu00ae (nebivolol) tablets
  • 10 mg
  • Contains Approximately 1710 Tablets
  • Bystolicu00ae (nebivolol) tablets
  • 20 mg
  • Contains Approximately 1710 Tablets

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