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APO-NADOLOL is a brand name for Nadolol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Angina: APO-NADOLOL (nadolol) is indicated for prophylaxis of angina pectoris. Hypertension: APO-NADOLOL is indicated in patients with mild or moderate hypertension. APO-NADOLOL is usually used in combination with other drugs, particularly a thiazide diuretic. However, it may be tried alone as an initial agent in…
Verbatim from this product's HC label. Tap a section to expand.
It is recommended that APO-NADOLOL (nadolol) be administered as a single daily dose. APO- NADOLOL may be administered without regard to meals since the presence of food in the gastrointestinal tract does not affect the rate or extent of nadolol absorption.
APO-NADOLOL dosage must always be adjusted to the individual needs of the patient, in accordance with the following guidelines: Angina Pectoris: APO-NADOLOL treatment should be initiated with doses of 80 mg daily. If an adequate response is not observed after one week, dosage may be increased by 80 mg increments at weekly intervals, until a satisfactory response is achieved.
The maximum recommended daily dose is 240 mg. Patients stabilized on 80 mg daily might be tried on 40 mg daily as this dose has been found to be effective in some cases. The value and safety of doses above 240 mg daily in angina pectoris have not been established.
Hypertension:
APO-NADOLOL treatment should be initiated with doses of 80 mg daily. If an adequate response is not observed after one week, dosage may be increased by 80 mg increments at weekly intervals, until a satisfactory response is achieved.
The maximum recommended daily dose is 320 mg, although most patients respond to 240 mg or less. The value and safety of doses above 320 mg daily have not been established.
AVAILABILITY Page 14 of 31 40 mg tablets:
Round, white, biconvex tablets, engraved N40 below bisect, other side plain. Available in bottles of 100, 500 and 1000 tablets. 80 mg tablets: Round, white, biconvex tablets, engraved N80 below bisect, other side plain. Available in bottles of 100, 500 and 1000 tablets.
160 mg tablets: Blue, capsule-shaped, biconvex tablets, engraved bisect and 160 on the right, other side plain. Available in bottles of 100, 500 and 1000 tablets. Store tightly closed, at room temperature. 41 Chemical Name: 2,3-cis-1,2,3,4-tetrahydro-5-(2-hydroxy-3-(tert-butylamino)propoxy)-2,3- naphthalenediol.
0).
Pharmacokinetics:
The principle details of the human pharmacokinetics of nadolol may be found under ACTIONS. Mean minimum serum concentrations at steady state were approximately 28, 70, and 131 ng/mL at doses of 80, 160 and 240 mg daily, respectively.
Allergic rhinitis, bronchospasm (including bronchial asthma), or severe chronic obstructive pulmonary disease (see PRECAUTIONS). Sinus bradycardia. Second and third degree A-V block. Right ventricular failure secondary to pulmonary hypertension.
Congestive heart failure (see WARNINGS). Cardiogenic shock. g. ether. Hypersensitivity to nadolol.
WARNINGS Cardiac Failure:
Special cautions should be exercised when administering APO-NADOLOL (nadolol) to patients with a history of heart failure. Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with beta blockade always carries a potential hazard of further depressing myocardial contractility and precipitating cardiac failure.
In patients without a history of cardiac failure, continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of impending cardiac failure during APO-NADOLOL therapy, patients should be fully digitalized, and/or given a diuretic, and the response observed closely.
Nadolol acts selectively without blocking the inotropic action of digitalis on the heart muscle. Page 6 of 31 However, the positive inotropic action of digitalis may be reduced by the negative inotropic effect of nadolol when the two drugs are used concomitantly.
The effects of nadolol and digitalis are additive in depressing A-V conduction. If cardiac failure continues despite adequate digitalization and diuretic therapy APO-NADOLOL therapy should be discontinued (see WARNING below).
Abrupt Cessation of Therapy with APO-NADOLOL:
Patients with angina should be warned against abrupt discontinuation of APO-NADOLOL. There have been reports of severe exacerbation of angina, and of myocardial infarction or ventricular arrhythmias occurring in patients with angina pectoris, following abrupt discontinuation of beta- blocker therapy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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After intravenous administration 73% of the dose was excreted via the kidneys and about 23% via the gastrointestinal tract, the latter of biliary origin. In dog studies, the highest concentrations of nadolol were present in the kidneys, lungs and heart.
Effects on the Cardiovascular System:
Animal studies in vitro and in vivo showed nadolol to be an antagonist of the beta-stimulatory effects of catecholamines and to consistently block isoproterenol-induced tachycardia and vasodepression in anesthetized dogs and cats, as well as in unanesthetized monkeys and spontaneously hypertensive rats.
Nadolol possesses no significant intrinsic sympathomimetic or membrane-stabilizing (quinidine- like) activities. Page 16 of 31 In human studies, nadolol has been shown to inhibit the effects of both isoproterenol- and exercise- induced tachycardia at doses as low as 10 mg.
Maximum inhibition was seen at 60-90 minutes and 3-8 hours respectively. Significant inhibition of exercise induced increases in double product (heart rate x blood pressure) persisted for at least 26 hours following single oral doses of 40-160 mg.
3-10 ug/kg of nadolol to normotensive male volunteers produced reductions in peripheral plasma renin activity. A similar effect was also seen in hypertensive patients. A study of the effects of nadolol on human cardiac electrophysiology and hemodynamics showed that nadolol reduces cardiac output without affecting stroke volume.
Studies involving guinea pig atria, papillary muscle of cats, anesthetized. dogs, and unanesthetized atherosclerotic rabbits indicated that nadolol produces little direct myocardial depression in doses much greater than those required to produce complete beta-blockade.
1 to 10 mg/kg (cats) produced decreases in heart rate from 15 to 30% and 23 to 45% respectively. In studies to determine the effect of intravenous nadolol on excitability, refractoriness, and conduction velocity of both atrial and ventricular tissue in anesthetized dogs, nadolol produced prolongation of ventricular refractoriness and depression of conduction through the A-V node.
0 mg/kg nadolol prevented ECG changes caused by coronary artery occlusion. Exacerbation of these changes by isoproterenol were similarly prevented. Page 17 of 31 Results from human studies have shown that nadolol possesses some anti-arrhythmic activity.
5%) in mean PAH clearance (effective renal plasma flow) and a 21% decrease in mean renovascular resistance after 16 weeks of combination therapy. Significant reduction in blood pressure and heart rate occurred. No significant changes were observed in plasma volume, serum creatinine or creatinine clearance.
Similar findings were reported following intravenous doses of nadolol to both hypertensive and normal subjects fed a low sodium diet.
Effects of Respiratory Function:
Studies of the effects of intravenous doses of nadolol on bronchial-airway resistance and on histamine- induced bronchial constriction in anesthetized cats indicated that nadolol increased bronchial-airway resistance. Histamine-induced increases of bronchial-airway […]
The last two complications may occur with or without preceding exacerbation of angina pectoris. Therefore, when discontinuation of APO-NADOLOL is planned in patients with angina pectoris, the dosage should be gradually reduced over a period of about 2 weeks and the patient should be carefully observed.
The same frequency of administration should be maintained. In situations of greater urgency, APO-NADOLOL therapy should be discontinued stepwise and under conditions of closer observation. If angina markedly worsens or acute coronary insufficiency develops, it is recommended that treatment with APO-NADOLOL be reinstituted promptly, at least temporarily.
Various skin rashes and conjunctival xerosis have been reported with beta-blockers including nadolol. A severe syndrome (oculo-muco-cutaneous syndrome) whose signs include conjunctivitis sicca and psoriasiform rashes, otitis and sclerosing serositis has occurred with the chronic use of one beta-adrenergic-blocking agent (practolol).
This syndrome has not been observed with nadolol or any other such agent. However, physicians should be alert to the possibility of such reactions and should discontinue treatment in the event that they occur. Page 7 of 31 Severe sinus bradycardia due to unopposed vagal activity occurs in approximately 3% of patients following administration of nadolol.
In such cases, dosage should be reduced or the use of intravenous atroine could be considered; if no improvement is seen, intravenous isoproterenol should be consideredIn patients with thyrotoxicosis, nadolol may give a false impression of improvement by diminishing peripheral manifestations of hyperthyroidism without improving thyroid function; therefore, abrupt withdrawal may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm.
, chronic bronchitis, emphysema) since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta receptors. There may be increased difficulty in treating an allergic type reaction in patients on beta-blockers.
In these patients, the reaction may be more severe due to pharmacologic effects of the beta-blockers and problems with fluid changes. Epinephrine should be administered with caution since it may not have its usual effects in the treatment of anaphylaxis.
On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other those doses can be associated with excessive alpha-adrenergic stimulation with consequent hypertension, reflex bradycardia and heart block and possible potentiation of bronchospasm.
Alternatives to the use of large doses of epinephrine include vigorous supportive care such as fluids and the use of beta-agonists including parenteral salbutamol or isoproterenol to overcome bronchospasm and norepinephrine to overcome hypotension.
APO-NADOLOL should be administered with caution to patients subject to spontaneous Page 8 of 31 hypoglycemia, or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic blockers may mask the premonitory signs and symptoms of acute hypoglycemia.
As beta-blockade also reduces the release of insulin in response to hyperglycemia, it may be necessary to adjust the dosage of anti-diabetic drugs. APO-NADOLOL dosage should be individually adjusted when used concomitantly with other antihypertensive agents (see DOSAGE AND ADMINISTRATION).
Patients receiving catecholamine-depleting drugs, such as reserpine and guanethidine, should be closely monitored if APO-NADOLOL is administered concomitantly. The added catecholamine blocking action of nadolol may produce an excessive reduction of the resting sympathetic nervous activity.
Concomitant use of fingolimod with beta blockers may potentiate bradycardic effects and is not […]