Nadolol (Page 3 of 3)

Gastrointestinal

Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, anorexia, bloating, and flatulence have been reported in 1 to 5 of 1000 patients.

Miscellaneous

Each of the following has been reported in 1 to 5 of 1000 patients: rash; pruritus; headache; dry mouth, eyes, or skin; impotence or decreased libido; facial swelling; weight gain; slurred speech; cough; nasal stuffiness; sweating; tinnitus; blurred vision. Reversible alopecia has been reported infrequently.

The following adverse reactions have been reported in patients taking nadolol and/or other beta- adrenergic blocking agents, but no causal relationship to nadolol has been established.

Central Nervous System

Reversible mental depression progressing to catatonia; visual disturbances; hallucinations; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics.

Gastrointestinal

Mesenteric arterial thrombosis; ischemic colitis; elevated liver enzymes.

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.

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 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 TABLETS 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/1.73m2)	Dosage Interval (hours)
>50	24
31 to 50	24 to 36
10 to 30	24 to 48
<10	40 to 60

HOW SUPPLIED

20 mg tablets: White to off-white colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with ”N” on upper half of the breakline and “20” on lower half of the breakline on one side and plain on other sideand are supplied as :

NDC 68382-732-16 in bottle of 90 tablets

NDC 68382-732-01 in bottle of 100 tablets

NDC 68382-732-10 in bottle of 1000 tablets

NDC 68382-732-77 in cartons of 100 tablets (10 x 10 unit-dose)

40 mg tablets: Light yellow colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with “N” on upper half of the breakline and “40” on lower half of the breakline on one side and plain on the other side and are supplied as :

NDC 68382-733-16 in bottle of 90 tablets

NDC 68382-733-01 in bottle of 100 tablets

NDC 68382-733-10 in bottle of 1000 tablets

NDC 68382-733-77 in cartons of 100 tablets (10 x 10 unit-dose)

80 mg tablets: Light blue colored, spotted, round shaped, flat faced, beveled edge uncoated tablets debossed with “N” on upper half of the breakline and “80” on lower half of the breakline on one side and plain on the other side and are supplied as :

NDC 68382-734-16 in bottle of 90 tablets

NDC 68382-734-01 in bottle of 100 tablets

NDC 68382-734-10 in bottle of 1000 tablets

NDC 68382-734-77 in cartons of 100 tablets (10 x 10 unit-dose)

STORAGE

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

Avoid excessive heat. Protect from light. Keep bottle tightly closed.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This product’s package insert may have been updated. For current package insert, please visit www.zydususa.com

Manufactured by:

Cadila Healthcare Limited

Matoda, Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 08/17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-732-16

Nadolol tablets, 20 mg

Rx only

90 tablets

Zydus

NDC 68382-733-16

Nadolol tablets, 40 mg

Rx only

90 tablets

Zydus

NDC 68382-734-16

Nadolol tablets, 80 mg

Rx only

80 tablets

Zydus

NADOLOL nadolol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-733 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 CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 9mm Flavor Imprint Code N;40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-733-16 90 TABLET in 1 BOTTLE None 2 NDC:68382-733-01 100 TABLET in 1 BOTTLE None 3 NDC:68382-733-10 1000 TABLET in 1 BOTTLE None 4 NDC:68382-733-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-733-30) 4 NDC:68382-733-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-733-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207761 08/08/2017

NADOLOL nadolol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-734 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 CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color BLUE (BLUE) Score 2 pieces Shape ROUND (ROUND) Size 11mm Flavor Imprint Code N;80 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-734-16 90 TABLET in 1 BOTTLE None 2 NDC:68382-734-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-734-30) 2 NDC:68382-734-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-734-77) 3 NDC:68382-734-10 1000 TABLET in 1 BOTTLE None 4 NDC:68382-734-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207761 08/08/2017

NADOLOL nadolol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-732 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 CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE (OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code N;20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-732-16 90 TABLET in 1 BOTTLE None 2 NDC:68382-732-01 100 TABLET in 1 BOTTLE None 3 NDC:68382-732-10 1000 TABLET in 1 BOTTLE None 4 NDC:68382-732-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-732-30) 4 NDC:68382-732-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-732-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207761 08/08/2017

Labeler — Zydus Pharmaceuticals USA Inc. (156861945)

Registrant — Zydus Pharmaceuticals USA Inc. (156861945)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		863362789	ANALYSIS (68382-732), ANALYSIS (68382-733), ANALYSIS (68382-734), MANUFACTURE (68382-732), MANUFACTURE (68382-733), MANUFACTURE (68382-734)

Revised: 11/2022 Zydus Pharmaceuticals USA Inc.