BOX WARNING Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal
Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.
|
| |
NADOLOL SUMMARY
NADOLOL TABLETS, USP 20 mg, 40 mg and 80 mg
Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent.
Nadolol Tablets are indicated for the following:
Angina Pectoris: Nadolol Tablets are indicated for the long-term management of patients with angina pectoris.
Hypertension: Nadolol Tablets are indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
|
NEWS HIGHLIGHTS
Published Studies Related to Nadolol
Nadolol plus isosorbide mononitrate alone or associated with band ligation in the prevention of recurrent bleeding: a multicentre randomised controlled trial. [2009.08] CONCLUSIONS: Adding EBL to pharmacological treatment did not reduce recurrent bleeding, the need for rescue therapy, or mortality, and was associated with more adverse events. Furthermore, associating EBL to drug therapy did not reduce the high rebleeding risk of HVPG non-responders. ISRCTN26221020.
Clinical trial: a randomized controlled study on prevention of variceal rebleeding comparing nadolol + ligation vs. hepatic venous pressure gradient-guided pharmacological therapy. [2009.02.15] BACKGROUND: Hepatic venous pressure gradient (HVPG) monitoring of therapy to prevent variceal rebleeding provides strong prognostic information. Treatment of nonresponders to beta-blockers +/- nitrates has not been clarified. AIM: To assess the value of HVPG-guided therapy using nadolol + prazosin in nonresponders to nadolol + isosorbide-5-mononitrate (ISMN) compared with a control group treated with nadolol + ligation... CONCLUSIONS: In patients treated to prevent variceal rebleeding, the association of nadolol and prazosin effectively rescued nonresponders to nadolol and ISMN, improving the haemodynamic response observed in controls receiving nadolol and endoscopic variceal ligation. Our results also suggest that ligation may rescue nonresponders.
Comparison of endoscopic variceal ligation and nadolol plus isosorbide-5-mononitrate in the prevention of first variceal bleeding in cirrhotic patients. [2006.10] BACKGROUND: Both drug therapy and banding ligation are widely used in the prevention of first variceal bleeding. This study compared the efficacy and safety of band ligation vs. combination of beta-blocker and nitrate for the prevention of first bleeding in patients with cirrhosis and high-risk esophageal varices... CONCLUSION: Our preliminary results suggest that endoscopic variceal ligation is similar to the combination of nadolol plus ISMN with regard to effectiveness and safety in the prevention of first variceal bleeding in patients with cirrhosis.
Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligation plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial. [2006.08.15] BACKGROUND: After variceal bleeding, cirrhotic patients should receive secondary prophylaxis. AIM: To compare nadolol plus 5-isosorbide mononitrate (5-ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death... CONCLUSION: This trial suggests no superiority of endoscopic band ligation over nadolol plus 5-ISMN mononitrate for the prevention of rebleeding in cirrhotic patients.
Evaluation of endoscopic variceal ligation (EVL) versus propanolol plus isosorbide mononitrate/nadolol (ISMN) in the prevention of variceal rebleeding: comparison of cirrhotic and noncirrhotic patients. [2005.08] Both EVL and drug therapy are effective in the prevention of variceal rebleeding. Comparisons between the two modalities are few, and only in cirrhotics... However, in view of the small number of NCPH patients, further studies are needed before this can be stated conclusively.
Clinical Trials Related to Nadolol
Secondary Prophylaxis After Variceal Bleeding in Non-Responders [Completed]
Controlled and randomized study comparing combined treatment (nadolol and endoscopic
ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to
hemodynamic response, in the prevention of esofagic verices rebleeding.
Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's
nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets
following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting
conditions.
Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's
nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets
following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fed conditions.
Oral Nadolol for the Treatment of Adults With Mild Asthma [Recruiting]
The purpose of this study is to confirm previous observations in asthmatics that chronic
nadolol treatment reduces asthmatic airway hyper-responsiveness.
Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding [Recruiting]
Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal
injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic
treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized
combination of GVO and BB can further decrease the rebleeding rate.
|
|
|
|
Page last updated: 2009-10-20
|