NADOLOL

Brand and Other Names:

Classes: Nonselective; Beta-adrenergic receptor antagonist

Brief Description: Nadolol is an oral beta-adrenergic receptor antagonist similar to propranolol.

However, Nadolol is is renally eliminated and possesses a low degree of lipid solubility and has

the longest plasma half-life of all the beta-blockers. Nadolol was approved by the FDA in

December 1989.

ADMINISTRATION

 General Administration Information: For storage information, see the specific product

information within the How Supplied section.

 Route-Specific Administration: N/A

 Oral Administration: Administer nadolol without regard to meals.

DOSAGE & USES

 Angina Pectoris (Long-term Management):

ADULTS: 40 mg PO once daily; increase as needed by 40-80 mg/day q 3-7 days.

Maximum dose is 240 mg/day.

 Hypertension (either alone or in combination):

ADULTS: 40 mg PO once daily; increase as needed by 40-80 mg/day q 2-14 days.

Maximum dose is 240-320 mg/day.

 Ventricular Tachycardia Prophylaxis:

 Maintenance doses of 40 to 240 mg/day PO, single or divided doses for ventricular

ectopy and ventricular tachycardia.

160 mg/day or less for arrhythmia suppression.

 Heart rate control for patients with atrial fibrillation:

ADULTS: 10 to 240 mg PO daily.

 Paroxysmal Supraventricular Tachycardia (PSVT) Prophylaxis:

ADULTS: 80 mg PO daily. Doses up to 240 mg/day

ADOLESCENTS & CHILDREN: 0.5 to 2.5 mg/kg PO once daily (median 1 mg/kg once

daily). Maximum dose is 2.5 mg/kg/day.

 Migraine Prophylaxis:

ADULTS: 80 mg PO daily. Doses up to 240 mg/day.

 Tremor:

LITHIUM-INDUCED TREMOR: doses of 120 to 240 mg/day PO

ADULTS: Doses of 20 to 40 mg PO once daily

 Anxiety:

Doses of 20 to 40 mg PO, given 2 hours prior to the anxiety-producing event.

 Patients with Renal Impairment:

CrCl > 50 ml/min: no dosage adjustment needed.

CrCl 31 to 50 ml/min: extend dosage interval to 24 to 36 hours.

CrCl 10 to 30 ml/min: extend dosage interval to 24 to 48 hours.

CrCl < 10 ml/min: extend dosage interval to 40 to 60 hours.

 Patients with Hepatic Impairment:

No dosage adjustments are necessary.

  Intermittent hemodialysis:

Nadolol is hemodialyzable. A supplemental dose of up to 40 mg may be given following

hemodialysis.

 OTHER INDICATIONS & USES

- Portal hypertension* and/or variceal bleeding prophylaxis* in patients with

esophageal varices*

ADVERSE EFFECTS

 1-10%

Symptomatic bradycardia (2%)

Sinus bradycardia and hypotension (1%)

Dizziness (2%)

Fatigue (2%).

Peripheral vasoconstriction (2%)

 <1%

behavioral changes

disorientation, drowsiness or sedation

dysarthria (slurred speech)

hallucinations

headache

short-term memory loss and visual impairment (0.1-0.6%)

bronchospasm (0.1%)

Cough (0.1-0.6%)
 Sexual Dysfunction (0.1-0.6%)

Nasal Congestion (0.1-0.6%)

pruritus, rash, skin hyperpigmentation, dermatitis (0.1-0.6%)

Weight gain, indigestion, N&V, Abdominal pain (0.1-0.6%)

 Frequency Not Defined

agranulocytosis, thrombotic and non-thrombotic thrombocytopenic purpura (TTP),

hypertriglyceridemia, Facial swelling, Palpitations

CONTRAINDICATIONS:

 Severe bradycardia

 Sick sinus syndrome

 Acute systolic congestive heart failure

 Prinzmetal's angina

 Hypotension

 Peripheral vascular disease

 Hypersensitivity

 Pulmonary disease

WARNING:

 Beta-blockers should not be used as first-line therapy for the treatment of hypertension,

as several comparative clinical trials have shown beta blockers to be inferior to ACE
 inhibitors, angiotensin-receptor blockers, or calcium channel blockers for preventing both

stroke and coronary artery disease complications.

 Abrupt withdrawal of beta-blockers in a patient with hyperthyroidism can precipitate

thyroid storm.

 Avoid driving or operating machinery until the drug response is known.

 May exacerbate conditions such as psoriasis.

 Nadolol may potentiate muscle weakness and double vision in patients with myasthenia

gravis.

 Abrupt discontinuation of any beta-adrenergic-blocking agent, including nadolol, can

result in the development of myocardial ischemia, myocardial infarction, ventricular

arrhythmias, or severe hypertension, particularly in patients with preexisting cardiac

disease.

 Abrupt discontinuation of hypertensive patients may cause withdrawal symptoms

including headache, diaphoresis, palpitations, sinus tachycardia, tremor, and

hypertension.

CAUTION:

 Consideration should be given to the type of surgery (e.g., cardiac vs. noncardiac),

anesthetic strategy, and coexisting health conditions when using beta blockers.

 Nadolol should be used with caution in patients with hyperthyroidism or thyrotoxicosis

because beta-blockers can mask tachycardia.

 Nadolol should be used with caution in patients with cerebrovascular insufficiency

(cerebrovascular disease) or stroke because of potential effects of beta-blockade on blood

pressure and pulse.

  Nadolol should be used with caution in patients with poorly controlled diabetes mellitus,

particularly brittle diabetes.

 Beta-blockers can mask signs of hypoglycemia, especially tachycardia, palpitations, and

tremors.

 Nadolol should be used with caution in patients with major depression.

PREGNANCY & LACTATION:

 Pregnancy Category: C

 Lactation: Nadolol should not be used during breast-feeding. Nadolol is excreted into

breast milk (4.6 times higher than maternal serum levels). Neonates whose mothers

received nodalol may show adverse effects.

INTERACTIONS

DRUGS SEVERITY SUMMARY

Acetaminophen; Aspirin, Moderate May result in loss of
ASA; Caffeine antihypertensive activity, due
to renal prostaglandin
inhibition, and may decreased
renal blood flow (salt & water
retention).
Acetaminophen; Caffeine; Moderate May result in loss of
Magnesium Salicylate; antihypertensive activity, due
Phenyltoloxamine to renal prostaglandin
inhibition, and may decreased
renal blood flow (salt & water
retention).
Acetaminophen; Caffeine; Moderate May result in loss of
Phenyltoloxamine; antihypertensive activity, due
Salicylamide to renal prostaglandin
inhibition, and may decreased
renal blood flow (salt & water
retention).
Adenosine Moderate Additive effects are possible
when used in combination
with adenosine: (1) Additive
 inhibition of AV conduction;
(2) Additive negative
inotropic effects could lead to
overt heart failure.
Albiglutide Moderate May potentiate insulin-
induced hypoglycemia and a
delay in recovery of blood
glucose to normal levels
Aldesleukin, IL-2 Moderate May potentiate the
hypotension.
Alemtuzumab Moderate May cause hypotension.
Alfentanil Moderate May cause bradycardia.
Alfuzosin Moderate May cause hypotension.
Reduction of blood pressure
and heart rate were also
reported.
Aliskiren; Amlodipine Moderate Hypotension and impaired
cardiac performance can
occur.
Aliskiren; Amlodipine; Moderate Hypotension and impaired
Hydrochlorothiazide, HCTZ cardiac performance can
occur.
Alogliptin; Metformin Moderate May hide symptoms of
hypoglycemia. It may also
potentiate insulin-induced
hypoglycemia and a delay in
recovery of blood glucose to
normal levels; thus, may have
negative effects on glycemic
control.
Alpha-blockers Moderate Orthostatic hypotension may
be more likely to occur.
Alpha-glucosidase Inhibitors Moderate May hide symptoms of
hypoglycemia. It may also
potentiate insulin-induced
hypoglycemia and a delay in
recovery of blood glucose to
normal levels; thus, may have
negative effects on glycemic
control.