United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine 500 mg - ranexa is indicated for the treatment of chronic angina. ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranexa is contraindicated in patients: - taking strong inhibitors of cyp3a [see drug interactions (7.1)] - taking inducers of cyp3a [see drug interactions (7.1)] - with clinically significant hepatic impairment [see use in specific populations (8.6)] pregnancy category c in animal studies, ranolazine at exposures 1.5 (rabbit) to 2 (rat) times the usual human exposure caused maternal toxicity and misshapen sternebrae and reduced ossification in offspring. these doses in rats and rabbits were associated with an increased maternal mortality rate [see reproductive toxicology studies (13.3)] . there are no adequate well-controlled studies in pregnant women. ranexa should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine 500 mg - ranexa® is indicated for the treatment of chronic angina. ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranexa is contraindicated in patients: - taking strong inhibitors of cyp3a [see drug interactions (7.1)] - taking inducers of cyp3a [see drug interactions (7.1)] - with liver cirrhosis [see use in specific populations (8.6)] risk summary there are no available data on ranexa use in pregnant women to inform any drug-associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. in rats, de

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine extended-release tablets are indicated for the treatment of chronic angina. ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranolazine is contraindicated in patients: risk summary there are no available data on ranolazine use in pregnant women to inform any drug-associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. in rats, decreased fetal weight and reduced ossification were observed at doses (corresponding to 4-fold the auc for the mrhd)

United States - English - NLM (National Library of Medicine)

carilion materials management - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine 500 mg - ranexa® is indicated for the treatment of chronic angina. ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranexa is contraindicated in patients: - taking strong inhibitors of cyp3a [see drug interactions (7.1)] - taking inducers of cyp3a [see drug interactions (7.1)] - with liver cirrhosis [see use in specific populations (8.6)] risk summary there are no available data on ranexa use in pregnant women to inform any drug-associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. in rats, de

United States - English - NLM (National Library of Medicine)

slate run pharmaceuticals - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine extended-release tablets are indicated for the treatment of chronic angina. ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranolazine extended-release tablets are contraindicated in patients: risk summary there are no available data on ranolazine extended-release tablets use in pregnant women to inform any drug-associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. in rats, decreased fetal weight and reduced ossification were observed at doses (

United States - English - NLM (National Library of Medicine)

cardinal health - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine 500 mg

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - aspruzyo sprinkle is indicated for the treatment of chronic angina. aspruzyo sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers. aspruzyo sprinkle is contraindicated in patients: risk summary there are no available data on ranolazine use in pregnant women to inform any drug‑associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data). in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. in rats, decreased fetal weight and reduced ossification were observed at doses (corresponding to 4-fold the auc for the mrhd) that caused maternal weight l

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ranolazine - modified-release tablet - 375mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ranolazine - modified-release tablet - 500mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - ranolazine - modified-release tablet - 750mg