Diltiazem Hydrochloride Extended-Release Tablets Interactions

Brand names: Diltiazem Hydrochloride

Route: Oral

Contraindications

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). • Patients who have demonstrated hypersensitivity to the drug. • Patients with acute myocardial infarction and pulmonary. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. ( 4 ) • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. ( 4 ) • Hypotension (less than 90 mm Hg systolic). ( 4 ) • Hypersensitivity to the drug. ( 4 ) • Acute myocardial infarction and pulmonary. ( 4 )

Pregnancy & Breastfeeding

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. An increased incidence of stillbirths was noted at diltiazem doses approximately 2 times the MRHD of Diltiazem Hydrochloride Extended-Release Tablets. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2- 4% and 15-20%, respectively. Data Animal Data Embryofetal development studies have been conducted with diltiazem in rats and rabbits. Daily oral administration of diltiazem at 0, 17.5, 35 or 70 mg/kg to pregnant rabbits during organogenesis (gestational day 6 to 18) resulted in embryo-fetal lethality at 35 mg/kg/day (approximately 1 time the MRHD of Diltiazem Hydrochloride Extended-Release Tablets, on a mg/m 2 basis) and higher, concurrent with maternal toxicity (reduced body weight gain). Daily oral administration of diltiazem at 0, 100, 200 and 400 mg/kg to pregnant rats during organogenesis (gestation day 9 to 14) resulted in embryo-fetal lethality at 200 mg/kg/day (approximately 4 times the MRHD of Diltiazem Hydrochloride Extended-Release Tablets, on a mg/m 2 basis) and higher. These doses, in some studies, were reported to cause increased incidence of skeletal malformations (e.g. malformations of

3 interactions on record