es (14.1)]. The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.
3 DOSAGE FORMS AND STRENGTHS
INNOPRAN XL Extended-Release Capsules are supplied as capsules containing either 80 mg, or 120 mg of propranolol hydrochloride imprinted with “InnoPran XL”. In addition, the 80 mg strength is a gray/white capsule imprinted with “80” and 2 segmented bands, while the 120 mg strength is a gray/off-white capsule imprinted with “120” and 3 segmented bands.
4 CONTRAINDICATIONS
INNOPRAN XL is contraindicated in patients with:
Cardiogenic shock or decompensated heart failure
Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place
Bronchial asthma
Known hypersensitivity (e.g., anaphylactic reaction) to propranolol hydrochloride or any of the components of INNOPRAN XL
5 WARNINGS AND PRECAUTIONS
5.1 Cardiac Ischemia after Abrupt Discontinuation
Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred.
When discontinuing chronically administered INNOPRAN XL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1-2 weeks and monitor the patients. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without physician’s advice.
Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of INNOPRAN XL therapy even in patients treated only for hypertension.
5.2 Cardiac Failure
Beta-blockers, like INNOPRAN XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of INNOPRAN XL or to discontinue it.
5.3 Maintain During Major Surgery
Chronically administered beta-blocking therapy, including INNOPRAN XL, should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
5.4 Masked Signs of Hypoglycemia
Beta-blockers, like INNOPRAN XL, may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
5.5 Thyrotoxicosis
INNOPRAN XL may mask clinical signs of hyperthyroidism, such as tachycardia. Avoid abrupt withdrawal of beta-blockade, which may precipitate a thyroid storm.
5.6 Bradycardia
Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of INNOPRAN XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving INNOPRAN XL. If severe bradycardia develops, reduce o |
