Diltiazem Hydrochloride Extended-release Tablets

1 INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-Release Tablets is a nondihydropyridine calcium channel blocker indicated for: • treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1 ) • improving exercise tolerance in patients with chronic stable angina. ( 1.2 ) 1.1 Hypertension Diltiazem Hydrochloride Extended-Release Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail, in other sections: • Bradycardia and AV block [see Warnings and Precautions ( 5.1 )] • Heart failure [see Warnings and Precautions ( 5.2 )] • Acute hepatic injury [see Warnings and Precautions ( 5.3 )] • Severe skin reactions [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (>2%) are lower limb edema, sinus congestion and rash in patients treated for hypertension, and lower limb edema, headache, dizziness, fatigue, bradycardia, first-degree AV block and cough in patients treated for angina. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary The available data from the published literature over decades of use with diltiazem during pregnancy have not identified a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in rats and rabbits, administration of diltiazem to pregnant animals during organogenesis at oral doses approximately 1 and 4 times the Maximum Recommended Human Dose (MRHD) of Diltiazem Hydrochloride Extended-Release Tablets produced embryofetal deaths and increased incidence of skeletal abnormalities.

5 WARNINGS AND PRECAUTIONS • Bradycardia, second- or third-degree AV block: Monitor heart rate and rhythm. ( 5.1 ) • Heart failure: Monitor for signs and symptoms. ( 5.2 ) • Increased liver enzymes and acute hepatic injury. ( 5.3 ) • Severe skin reactions. ( 5.4 ) 5.1 Bradycardia or AV Block Diltiazem Hydrochloride Extended-Release Tablets may cause abnormally slow heart rates or second- or third-degree AV block. Patients with sick sinus syndrome are at increased risk of bradycardia. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem [see Adverse Reactions (6) ] . 4 CONTRAINDICATIONS Diltiazem Hydrochloride Extended-Release Tablets are contraindicated in: • Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Patients with hypotension (less than 90 mm Hg systolic).