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Bystolic osage, side effects, warnings, interactions, indications, and medication usage

Bystolic (Nebivolol hydrochloride)

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• 83 % of our Members who reviewed Bystolic (Nebivolol hydrochloride) had a positive experience with Bystolic (Nebivolol hydrochloride)
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Bystolic Information

Brand Name	Bystolic
Company Name	Physicians Total Care, Inc.

Bystolic (Nebivolol hydrochloride) . Dosage Forms And Strengths

Bystolic (Nebivolol hydrochloride) is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol.

Bystolic (Nebivolol hydrochloride) tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with “” on one side and the number of mg (2 ½, 5, 10, or 20) on the other side.

Bystolic (Nebivolol hydrochloride) . Contraindications

Bystolic (Nebivolol hydrochloride) is contraindicated in the following conditions:

Bystolic (Nebivolol hydrochloride) . Warnings And Precautions

Because beta-blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on beta-blockers should generally continue treatment throughout the perioperative period. If Bystolic (Nebivolol hydrochloride) is to be continued perioperatively, monitor patients closely when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

The β-blocking effects of Bystolic (Nebivolol hydrochloride) can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with β-blockers.

Bystolic (Nebivolol hydrochloride) . Adverse Reactions

Bystolic (Nebivolol hydrochloride) 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 (Nebivolol hydrochloride) 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 (Nebivolol hydrochloride) for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 patients for more than one year.

Bystolic (Nebivolol hydrochloride) . Use In Specific Populations

Nebivolol caused prolonged gestation and dystocia at doses ≥ 5 mg/kg in rats (1.2 times the MRHD). These effects were associated with increased fetal deaths and stillborn pups, and decreased birth weight, live litter size and pup survival rate, events that occurred only when nebivolol was given during the perinatal period (late gestation, parturition and lactation).

No studies of nebivolol were conducted in pregnant women. Use Bystolic (Nebivolol hydrochloride) during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Studies in rats have shown that nebivolol or its metabolites cross the placental barrier and are excreted in breast milk. It is not known whether this drug is excreted in human milk.

Because of the potential for β-blockers to produce serious adverse reactions in nursing infants, especially bradycardia, Bystolic (Nebivolol hydrochloride) is not recommended during nursing.

Bystolic (Nebivolol hydrochloride) . Overdosage

In clinical trials and worldwide postmarketing experience there were reports of Bystolic (Nebivolol hydrochloride) overdose. The most common signs and symptoms associated with Bystolic (Nebivolol hydrochloride) overdosage are bradycardia and hypotension. Other important adverse reactions reported with Bystolic (Nebivolol hydrochloride) overdose include cardiac failure, dizziness, hypoglycemia, fatigue and vomiting. Other adverse reactions associated with β-blocker overdose include bronchospasm and heart block.

The largest known ingestion of Bystolic (Nebivolol hydrochloride) worldwide involved a patient who ingested up to 500 mg of Bystolic (Nebivolol hydrochloride) 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 β-blockers, consider the following general measures, including stopping Bystolic (Nebivolol hydrochloride) , when clinically warranted:

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 β-blocker overdose treatment.

Bystolic (Nebivolol hydrochloride) . Description

The chemical name for the active ingredient in Bystolic (Nebivolol hydrochloride) (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 (CHFNO•HCl) with the following structural formula:

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 (Nebivolol hydrochloride) as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, Bystolic (Nebivolol hydrochloride) 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.

Bystolic (Nebivolol hydrochloride) . Clinical Pharmacology

Nebivolol is a β-adrenergic receptor blocking agent. In extensive metabolizers (most of the population) and at doses less than or equal to 10 mg, nebivolol is preferentially β selective. In poor metabolizers and at higher doses, nebivolol inhibits both β - and β - adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Bystolic (Nebivolol hydrochloride) does not demonstrate α-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to β-blocking activity.

Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6. The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers. This has less importance than usual, however, because the metabolites, including the hydroxyl metabolite and glucuronides (the predominant circulating metabolites), contribute to β-blocking activity.

Plasma levels of d–nebivolol increase in proportion to dose in EMs and PMs for doses up to 20mg. Exposure to l-nebivolol is higher than to d-nebivolol but l-nebivolol contributes little to the drug's activity as d-nebivolol's beta receptor affinity is > 1000-fold higher than l-nebivolol. For the same dose, PMs attain a 5-fold higher Cmax and 10-fold higher AUC of d-nebivolol than do EMs. d-Nebivolol accumulates about 1.5-fold with repeated once-daily dosing in EMs.

Bystolic (Nebivolol hydrochloride) . How Supplied/storage And Handling

Bystolic (Nebivolol hydrochloride) is available as tablets for oral administration containing nebivolol hydrochloride equivalent to 5, 10 mg of nebivolol.

Bystolic (Nebivolol hydrochloride) tablets are triangular-shaped, biconvex, unscored, differentiated by color and are engraved with “” on one side and the number of mg (5 or 10) on the other side. Bystolic (Nebivolol hydrochloride) tablets are supplied in the following strengths and package configurations:

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Bystolic (Nebivolol hydrochloride) Patient Counseling Information

See FDA-Approved Patient Labeling ().

Advise patients to take Bystolic (Nebivolol hydrochloride) regularly and continuously, as directed. Bystolic (Nebivolol hydrochloride) 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 (Nebivolol hydrochloride) 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 β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.

Bystolic (Nebivolol hydrochloride)