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BYSTOLIC is a brand name for Nebivolol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BYSTOLIC® (nebivolol tablets) is indicated for: The treatment of mild to moderate essential hypertension. BYSTOLIC may be used alone or concomitantly with thiazide diuretics or angiotensin converting enzyme (ACE) inhibitors. See 9 DRUG INTERACTIONS, 4.2 Recommended Dose and Dosage Adjustment and 14 CLINICAL TRIALS.…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment For most patients, the recommended starting dose is 5 mg once daily, with or without food. For patients requiring further reduction in blood pressure, the dose can be increased at two-week intervals up to 20 mg once daily.
Concomitant use of ACE inhibitors: When BYSTOLIC is to be co-administered with an ACE inhibitor, the lowest dose of the added agent should be employed initially and if needed, can be then increased at two-week intervals up to the maximum recommended dose.
4 Drug-Drug Interactions . 5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients receiving dialysis and is therefore not recommended for use in this patient population. 3 Pharmacokinetics . 5 mg once daily; titrate up slowly if needed.
BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore is contraindicated in that population. 3 Pharmacokinetics . Geriatric Patients: No dose adjustments are usually necessary for elderly patients. CYP2D6 Polymorphism: No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers.
The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers. 3 Pharmacokinetics. 4 Administration Once-daily dosing has shown to sustain efficacy over 24 hours. A more frequent dosing regimen is unlikely to be beneficial.
BYSTOLIC tablets can be taken with or without food. 5 Missed Dose If patients miss a dose, they should wait until their next scheduled dose. Patients should not double their dose. BYSTOLIC should be taken once approximately every 24 hours.
BYSTOLIC (nebivolol) Page 6 of 39
1 Adverse Reaction Overview BYSTOLIC has been evaluated for safety in more than 7,100 patients with hypertension with a clinical trial exposure to BYSTOLIC in approximately 5,400 patients. Patients received BYSTOLIC for up to 36 months, with over 1,000 patients treated for at least 6 months, and approximately 500 patients for more than one year.
1%). BYSTOLIC was well tolerated and adverse events have generally been mild to moderate in intensity. 0% of patients given placebo (4/205). 1%) for patients who received BYSTOLIC. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction BYSTOLIC (nebivolol) Page 12 of 39 information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
25 mg to 40 mg, and 205 patients were given placebo. The median exposure to treatment in these three trials was 85-days. 3 Less Common Clinical Trial Adverse Reactions Adverse events reported in the placebo-controlled studies with incidence rates of less than <1% and at a higher frequency than placebo-treated patients are listed below: Blood and Lymphatic System Disorders: anemia; leukopenia; lymphadenopathy Cardiac Disorders: myocardial infarction; myocardial ischemia; angina pectoris; atrioventricular block first degree; cardiac failure congestive; extrasystoles; tachycardia; withdrawal arrhythmia BYSTOLIC (nebivolol) Page 14 of 39 Ear And Labyrinth Disorders: deafness; ear pain; hearing impaired; vertigo Eye Disorders: conjunctival haemorrhage; conjunctivitis; eye pain; glaucoma; vision disturbances Gastrointestinal Disorders: abdominal pain; flatulence; gastro-oesophageal reflux disease; oral mucosal lesions; toothache; vomiting General Disorders and Administration Site Conditions: influenza-like illness; pyrexia; weakness Immune System Disorders: hypersensitivity Infections and Infestations: fungal infection; gastroenteritis; hepatitis; localized infection; lower respiratory tract infection Investigations: alanine aminotransferase increased; aspartate aminotransferase increased; blood alkaline phosphatase increased; blood glucose increased; blood uric acid increased; cardiac murmur; haematocrit/hemoglobin decreased; high density lipoprotein decreased; […]
3 Pharmacokinetics . 5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore is contraindicated in that population. 3 Pharmacokinetics . Geriatric Patients: No dose adjustments are usually necessary for elderly patients.
CYP2D6 Polymorphism: No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers. The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers. 3 Pharmacokinetics.
4 Administration Once-daily dosing has shown to sustain efficacy over 24 hours. A more frequent dosing regimen is unlikely to be beneficial. BYSTOLIC tablets can be taken with or without food. 5 Missed Dose If patients miss a dose, they should wait until their next scheduled dose.
Patients should not double their dose. BYSTOLIC should be taken once approximately every 24 hours.
BYSTOLIC (nebivolol) Page 6 of 39 5 OVERDOSAGE Symptoms:
In clinical trials and worldwide post-marketing 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 heart 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 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.
BYSTOLIC is contraindicated in patients with: Hypersensitivities to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
Severe bradycardia (generally <50 bpm prior to start of therapy) Cardiogenic shock Decompensated cardiac failure Second or third degree atrioventricular (AV) block Sick sinus syndrome or sinoatrial block Severe hepatic impairment (Child-Pugh Score >B) Severe peripheral arterial circulatory disorders The rare hereditary conditions of Galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption BYSTOLIC (nebivolol) Page 5 of 39
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment:
Because of extensive drug binding to plasma proteins, hemodialysis is not expected to enhance nebivolol clearance. Administration of activated charcoal is not recommended as it has no effect on the pharmacokinetics of BYSTOLIC. 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, when clinically warranted: Bradycardia: Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously.
Under some circumstances, transthoracic or transvenous pacemaker placement may be necessary. Hypotension: Administer IV fluids and vasopressors. Intravenous glucagon may be useful. Heart Block (second or third degree): Monitor and treat with isoproterenol infusion.
Under some circumstances, transthoracic or transvenous pacemaker placement may be necessary. Congestive Heart Failure: Initiate therapy with digitalis glycoside and diuretics. In certain cases, consider the use of inotropic and vasodilating agents.
Bronchospasm: Administer bronchodilator therapy such as a short-acting inhaled β2- agonist and/or aminophylline. Hypoglycemia: Administer IV glucose. Repeated doses of IV glucose or possibly glucagon may be required. Supportive measures should continue until clinical stability is achieved.
For management of a suspected drug overdose, contact your regional poison control centre. 5, 5 and 10 mg) or 90 tablets (20 mg). 5, 5, 10, or 20) on the other side. 5 mg tablet is light blue, the 5 mg tablet is beige, the 10 mg tablet is pinkish-purple, and the 20 mg tablet is light blue.
4 Drug-Drug Interactions ]. The dose of BYSTOLIC may need to be reduced. Cardiovascular Abrupt Cessation of Therapy Do not abruptly discontinue BYSTOLIC therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers.
Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of angina pectoris. Caution patients without overt coronary artery disease against interruption or abrupt discontinuation of therapy.
As with other β-blockers, when discontinuation of BYSTOLIC is planned, the dosage should be gradually reduced over a period of about two weeks and the patient should be carefully observed and advised to limit physical activity to a minimum.
The same frequency of administration should be maintained. 5 mg, 5 mg, 10 mg and 20 mg Colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake (10 mg and 20 mg only), 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) Page 8 of 39 and under closer observation. If the angina worsens or acute coronary insufficiency develops, re-start BYSTOLIC promptly, at least […]