Nadolol (Page 3 of 3)

Hematologic

Agranulocytosis; thrombocytopenic or nonthrombocytopenic purpura.

Allergic

Fever combined with aching and sore throat; laryngospasm; respiratory distress.

Miscellaneous

Pemphigoid rash; hypertensive reaction in patients with pheochromocytoma; sleep disturbances; Peyronie’s disease.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with nadolol.

To report SUSPECTED ADVERSE REACTIONS, contact US WorldMeds at 1-866-916-0581 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 1.0 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 levarterenol. (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 TABLET MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.

Angina Pectoris

The usual initial dose is 40 mg nadolol tablet 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 tablet 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/1.73m2)
Dosage Interval
(hours)
>50 24
31–50 24–36
10–30 24–48
<10 40–60

HOW SUPPLIED

Nadolol Tablets USP

20 mg tablets in bottles of 100 (NDC 59762–0810–1), 40 mg tablets in bottles of 100 (NDC 59762–0811–1) and 80 mg tablets in bottles of 100 (NDC 59762–0812–1).

All tablets are scored (bisect bar) and easy to break. Tablet identification numbers: 20 mg, 232 ; 40 mg, 207 ; and 80 mg, 241.

STORAGE

Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.

logo

LAB-0717-3.0

February 2020

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

NDC 59762-0810-1
100 Tablets

GREENSTONE ® BRAND

nadolol tablets, USP

20 mg

Rx only

PRINCIPAL DISPLAY PANEL -- 20 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 59762-0811-1
100 Tablets

GREENSTONE ® BRAND

nadolol tablets, USP

40 mg

Rx only

PRINCIPAL DISPLAY PANEL -- 40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 59762-0812-1
100 Tablets

GREENSTONE ® BRAND

nadolol tablets, USP

80 mg

Rx only

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 20 mg
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code KPI;232;Corgard;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-0810-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA018063 04/28/2014
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0811
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 40 mg
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code KPI;207;Corgard;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-0811-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA018063 04/28/2014
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0812
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NADOLOL (NADOLOL) NADOLOL 80 mg
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code KPI;241;Corgard;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-0812-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA018063 04/28/2014
Labeler — Greenstone LLC (825560733)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
UPM Pharmaceuticals, Inc 081301372 ANALYSIS (59762-0810), ANALYSIS (59762-0811), ANALYSIS (59762-0812), MANUFACTURE (59762-0810), MANUFACTURE (59762-0811), MANUFACTURE (59762-0812), PACK (59762-0810), PACK (59762-0811), PACK (59762-0812), LABEL (59762-0810), LABEL (59762-0811), LABEL (59762-0812)

Revised: 07/2021 Greenstone LLC

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