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 -- 20 mg (100 Tablets Bottle)
(click image for full-size original)

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 -- 40 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg (100 Tablets Bottle)

NDC 59651-252-01
Rx only
Nadolo Tablets, USP
80 mg
AUROBINDO 100 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 80 mg (100 Tablets Bottle)
(click image for full-size original)
NADOLOL nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-589
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
STARCH, CORN
FD&C BLUE NO. 2
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 112
POVIDONE K90
Product Characteristics
Color BLUE (Light Blue) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code NA;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-589-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201893 06/07/2022
NADOLOL nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
STARCH, CORN
FD&C BLUE NO. 2
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 112
POVIDONE K90
Product Characteristics
Color BLUE (Light Blue) Score 2 pieces
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code NA;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-251-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201893 10/29/2021
NADOLOL nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-252
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
STARCH, CORN
FD&C BLUE NO. 2
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 112
POVIDONE K90
Product Characteristics
Color BLUE (Light Blue) Score 2 pieces
Shape ROUND (Biconvex) Size 11mm
Flavor Imprint Code NA;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-252-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201893 10/29/2021
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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