Nadolol (Page 3 of 3)

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 (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/1.73m2)

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 are supplied as:

20 mg tablets: Yellow, round, biconvex tablets debossed “347” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.

Supplied in bottles of 100s (NDC 68001-317-00)

40 mg tablets: Yellow, round, biconvex tablets debossed “348” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.

Supplied in bottles of 100s (NDC 68001-318-00)

80 mg tablets: Yellow, round, biconvex tablets debossed “349” on one side and ‘I’ on the left side of the bisect and ‘G’ on the right side of bisect on other.

Supplied in bottles of 100s (NDC 68001-319-00)

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

For BluePoint Laboratories

Revised: 12/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-317-00 Rx ONLY

Nadolol Tablets, USP

20 mg

BluePoint LABORATORIES 100 Tablets

Nadolol 20mg 100ct label Rev 01-17
(click image for full-size original)

Package/Label Display Panel

NDC 68001-318-00 Rx ONLY

Nadolol Tablets, USP

40 mg

BluePoint LABORATORIES 100 Tablets

Nadolol 40mg 100ct label Rev 01-17
(click image for full-size original)

Package/Label Display Panel

NDC 68001-319-00 Rx ONLY

Nadolol Tablets, USP

80 mg

BluePoint LABORATORIES 100 Tablets

Nadolol 80mg 100ct label Rev 01-17
(click image for full-size original)
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-317
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
D&C YELLOW NO. 10
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code IG;347
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-317-00 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203455 02/23/2016
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-318
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
D&C YELLOW NO. 10
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code IG;348
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-318-00 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203455 02/23/2016
NADOLOL
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-319
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
D&C YELLOW NO. 10
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code IG;349
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-319-00 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203455 02/23/2016
Labeler — BluePoint Laboratories (985523874)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 165104469 ANALYSIS (68001-317), ANALYSIS (68001-318), ANALYSIS (68001-319), MANUFACTURE (68001-317), MANUFACTURE (68001-318), MANUFACTURE (68001-319)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 080334903 ANALYSIS (68001-317), ANALYSIS (68001-318), ANALYSIS (68001-319), pack (68001-317), pack (68001-318), pack (68001-319)

Revised: 12/2018 BluePoint Laboratories

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