Nebicard Tablet 5mg10 tablets
Nebicard 2.5 tablet: Pink, round tablet. Each tablet contains Nebivolol Hydrochloride INN equivalent to Nebivolol 2.5mg. Nebicard
5 Tablet: Pink, shield shaped tablet, scored on one side. Each tablet contains Nebivolol Hydrochloride INN equivalent to Nebivolol
Nebicard Prescribing Information
Nebivolol is a ß adrenergic receptor blocking agent. Nebivolol inhibits both ß1 and ß2-adrenergic receptors. Nebivolol lacks
intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant
doses, Nebicard does not demonstrate ß1-adrenergic receptor blockade activity. Various metabolites, including glucuronides,
contribute to beta-blocking activity.
Mode of Action of Nebicard involved include: (1) decreased heart rate, (2) decreased myocardial contractility, (3) diminution of
tonic sympathetic outflow to the periphery from cerebral vasomotor centers, (4) suppression of resin activity and (5) vasodilation
and decreased peripheral vascular resistance.
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 b blocking activity.
Absorption and Distribution
Absorption of Nebicard is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4
hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebicard may be administered without
regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is
independent of nebivolol concentrations.
Metabolism and Excretion
Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and
oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and
44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebicard (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy
adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol. Warfarin: Administration of
Nebicard (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin
following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of
warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy
adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been
performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Indications and Usage for Nebicard
Treatment of essential hypertension.
Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Nebicard is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock,
decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment
(Child-Pugh >B), and in patients who are hypersensitive to any component of this product. Warnings
Abrupt Cessation of Therapy
Patients with coronary artery disease treated with Nebicard should be advised against abrupt discontinuation of therapy. Severe
exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with
coronary artery disease following the abrupt discontinuation of therapy with b-blockers. Myocardial infarction and ventricular
arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery
disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other ß-blockers, when
discontinuation of Nebicard is planned, patients should be carefully observed and advised to minimize physical activity. Nebicard
should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is
recommended that Nebicard be promptly reinstituted, at least temporarily.
Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and
ß-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have
compensated congestive heart failure, Nebicard should be administered cautiously. If heart failure worsens, discontinuation of
Nebicard should be considered.
Angina and Acute Myocardial Infarction
Nebicard was not studied in patients with angina pectoris or who had a recent MI.
In general, patients with bronchospastc diseases should not receive ß-blockers.
Anesthesia and Major Surgery
If Nebicard is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress
myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If ß-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 ß-blocking effects of Nebicard can be reversed by ß-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
Diabetes and Hypoglycemia
ß-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective ß-blockers may potentiate
insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects.
Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be
advised about these possibilities and nebivolol should be used with caution.
ß-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of ß-blockers may be followed by an
exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease
ß-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution
should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers
Because of significant negative inotropic and chronotropic effects in patients treated with ß-blockers and calcium channel
blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG
and blood pressure should be monitored.
Impaired Renal Function
Nebicard should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebicard has
not been studied in patients receiving dialysis.
Impaired Hepatic Function
Nebicard should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebicard
has not been studied in patients with severe hepatic impairment, Nebicard is contraindicated in this population.
Risk of Anaphylactic Reactions
While taking ß-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive
to repeated challenge either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of
epinephrine used to treat allergic reactions.
Nebicard should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists
(particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazerm] classes), or antiarrhythmic agents, such as
disopyramide, are used concurrently. Both digitalis glycosides and ß-blockers slow atrioventricular conduction and decrease heart
rate. Concomitant use can increase the risk of bradycardia.
Nebicard should not be combined with other ß-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or
guanethidine, should be closely monitored, because the added ß-blocking action of Nebicard may produce excessive reduction of
sympathetic activity. In patients who are receiving Nebicard and clonidine, Nebicard should be discontinued for several days
before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebicard is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine,
Headache, nausea and bradycardia.
Nebicard Dosage and Administration
The dose of Nebicard should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5
mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction
in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be
Nebicard 2.5 tablet: Carton containing 30 tablet in Alu-Alu blister pack.
Nebicard 5 Tablet: Carton containing 30 tablet in Alu-Alu blister pack.
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