Nadolol (Page 3 of 3)
OVERDOSAGE
Nadolol can be removed from the general circulation by hemodialysis.
In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol.
Excessive Bradycardia
Administer atropine (0.25 to 1 mg). If there is no response to vagal blockade, administer isoproterenol cautiously.
Cardiac Failure
Administer a digitalis glycoside and diuretic. It has been reported that glucagon may also be useful in this situation.
Hypotension
Administer vasopressors, e.g., epinephrine or norepinephrine. (There is evidence that epinephrine may be the drug of choice.)
Bronchospasm
Administer a beta2 -stimulating agent and/or a theophylline derivative.
DOSAGE AND ADMINISTRATION
DOSAGE MUST BE INDIVIDUALIZED. NADOLOL MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.
Angina Pectoris
The usual initial dose is 40 mg nadolol once daily. Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 160 or 240 mg administered once daily may be needed.
The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS).
Hypertension
The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy. Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 240 or 320 mg administered once daily may be needed.
Dosage Adjustment in Renal Failure
Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended:
Creatinine Clearance (mL/min/1.73 m2) | Dosage Interval (hours) |
---|---|
>50 | 24 |
31 to 50 | 24 to 36 |
10 to 30 | 24 to 48 |
<10 | 40 to 60 |
HOW SUPPLIED
Nadolol Tablets USP, 20 mg are light blue colored, round, uncoated mottled tablets with scoreline on one side and ‘NA’ and ‘20’ debossed on other side. They are supplied as follows:
Bottles of 100 NDC 59651-589-01
Nadolol Tablets USP, 40 mg are light blue colored, round, biconvex, uncoated mottled tablets with scoreline separating ‘NA’ and ‘40’ debossed on one side and plain on other side. They are supplied as follows:
Bottles of 100 NDC 59651-251-01
Nadolol Tablets USP, 80 mg are light blue colored, round, biconvex, uncoated mottled tablets with scoreline separating ‘NA’ and ‘80’ debossed on one side and plain on other side. They are supplied as follows:
Bottles of 100 NDC 59651-252-01
STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Keep container tightly closed.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 01/2024
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 20 mg (100 Tablets Bottle)
NDC 59651-589-01
Rx only
Nadolo Tablets, USP
20 mg
AUROBINDO 100 Tablets
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 40 mg (100 Tablets Bottle)
NDC 59651-251-01
Rx only
Nadolo Tablets, USP
40 mg
AUROBINDO 100 Tablets
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg (100 Tablets Bottle)
NDC 59651-252-01
Rx only
Nadolo Tablets, USP
80 mg
AUROBINDO 100 Tablets
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Labeler — Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Aurobindo Pharma Limited | 918917642 | ANALYSIS (59651-251), ANALYSIS (59651-252), ANALYSIS (59651-589), MANUFACTURE (59651-251), MANUFACTURE (59651-252), MANUFACTURE (59651-589) |
Revised: 01/2024 Aurobindo Pharma Limited
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