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wockhardt usa llc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection, usp is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration ( 2.1)] . nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c there are no adequate and well-controlled studies of nicardipine use in pregnant women. however, limited human data in pregnant women with preeclampsia or pre-term labor are available. in animal studies, no embryotoxicity occurred in rats with oral doses 8 times the maximum recommended human dose (mrhd) based on body surface area (mg/

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

wockhardt limited - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits (see "dosage and administration") nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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

epic pharma, llc - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 20 mg - nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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

puracap laboratories llc dba blu pharmaceuticals - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 20 mg - nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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

mylan pharmaceuticals inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 20 mg - nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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

pharmaforce, inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. for prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits (see dosage and administration). nicardipine hydrochloride injection is contraindicated in patients with known hypersensitivity to the drug. nicardipine hydrochloride injection is also contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

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

american regent, inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection, usp is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.  for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.1)] . nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload.  reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c there are no adequate and well-controlled studies of nicardipine use in pregnant women. however, limited human data in pregnant women with preeclampsia or pre-term labor are available. in animal studies, no embryotoxicity occurred in rats with oral doses 8 times the maximum recommended human dose (mrhd) based on body surface area (mg/m2 ), but did occur in rabbits with oral doses

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

west-ward pharmaceuticals corp - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.6)]. do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c. there are no adequate and well-controlled studies of nicardipine use in pregnant women. there are limited human data in pregnant women with pre-eclampsia and preterm labor. in animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproduction studies conducted in rats and rabbits, increased embryolethality oc

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

hikma pharmaceuticals usa inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 25 mg in 10 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.6)]. do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. there are no adequate and well-controlled studies of nicardipine use in pregnant women. there are limited human data in pregnant women with pre-eclampsia and preterm labor. in animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproduction studies conducted in rats and rabbits, increased embryolethality occurred when nicardipine was administered intravenously at doses equivalent to human intravenous doses of 1.6 (rats) and 0.32 mg/kg/day (rabbits). increased embryolethality was also observed when nicardipine was administered orally to pregnant rabbits at a dose equivalent to a human oral dose of about 48 mg/kg/day (a dose 24 times the maximum recommended human oral dose and one associated with marked maternal body weight gain suppression). at a lower oral dose, equivalent to a human dose of about 32 mg/kg/day (16 times the maximum recommended human oral dose), in a different strain of rabbit, there were no adverse effects on the fetus, though there was increased maternal mortality. there was no evidence of embryolethality or teratogenicity when pregnant rats were administered nicardipine orally at a dose equivalent to a human oral dose of about 16 mg/kg/day (8 times the mrhd); however, dystocia, reduced birth weight, reduced neonatal survival and reduced neonatal weight gain were reported [see nonclinical toxicology (13.3)] . nicardipine is minimally excreted into human milk. among 18 infants exposed to nicardipine through breast milk in the postpartum period, calculated daily infant dose was less than 0.3 mcg and there were no adverse events observed. it is recommended that women who wish to breastfeed should not be given this drug. in a study of 11 women who received oral nicardipine 4 days to 14 days postpartum, 4 women received immediate-release nicardipine 40 to 80 mg daily, 6 women received sustained-release nicardipine 100 mg to 150 mg daily, and one woman received intravenous nicardipine 120 mg daily. the peak milk concentration was 7.3 mcg/l (range 1.9 to 18.8), and the mean milk concentration was 4.4 mcg/l (range 1.3  to 13.8). infants received an average of 0.073% of the weight-adjusted maternal oral dose and 0.14% of the weight-adjusted maternal intravenous dose. in another study of seven women who received intravenous nicardipine for an average of 1.9 days in the immediate postpartum period as therapy for pre-eclampsia, 34 milk samples were obtained at unspecified times and nicardipine was undetectable (less than 5 mcg/l) in 82% of the samples. four women who received 1 to 6.5 mg/hour of nicardipine had 6 milk samples with detectable nicardipine levels (range 5.1 to 18.5 mcg/l). the highest concentration of 18.5 mcg/l was found in a woman who received 5.5 mg/hour of nicardipine. the estimated maximum dose in a breastfed infant was less than 0.3 mcg daily or 0.015% to 0.004% of the therapeutic dose in a 1 kg infant. safety and efficacy in patients under the age of 18 have not been established. the steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (greater than 65 years) and young healthy adults. clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and concomitant disease of other drug therapy.

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

carilion materials management - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 30 mg - nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. nicardipine hydrochloride capsules are indicated for the treatment of hypertension. nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. in administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see dosage and administration). nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.