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remedyrepack inc. - atorvastatin calcium propylene glycol solvate (unii: yrz789owmi) (atorvastatin - unii:a0jwa85v8f) - atorvastatin calcium tablets are indicated: - to reduce the risk of: myocardial infarction (mi), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (chd) but without clinically evident chd mi and stroke in adults with type 2 diabetes mellitus with multiple risk factors for chd but without clinically evident chd non-fatal mi, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident chd - myocardial infarction (mi), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (chd) but without clinically evident chd - mi and stroke in adults with type 2 diabetes mellitus with multiple risk factors for chd but without clinically evident chd - non-fatal mi, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident chd - as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c) in: adults with primary hyperlipidemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - adults with primary hyperlipidemia. - adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies, or alone if such treatments are unavailable, to reduce ldl-c in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia hypertriglyceridemia - primary dysbetalipoproteinemia - hypertriglyceridemia - acute liver failure or decompensated cirrhosis [see warnings and precautions ( 5.3)] - hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, stevens-johnson syndrome, and toxic epidermal necrolysis, have been reported [see adverse reactions ( 6.2)] . risk summary discontinue atorvastatin calcium when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology ( 12.1)]. in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients.   available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data). in animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 80 mg, based on body surface area (mg/m 2 ). in rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the mrhd (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.   animal data atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively. atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. these doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the mrhd based on surface area (mg/m 2 ). in rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. at the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. in a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed. pup body weight was decreased through postnatal day 21 at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day. pup development was delayed (rotorod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). these doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the mrhd, based on auc. atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. risk summary there is no information about the presence of atorvastatin in human milk,  the effects of the drug on the breastfed infant or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. studies in rats have shown that atorvastatin and/or its metabolites are present in the breast milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data). statins, including atorvastatin calcium, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium  [see use in specific populations ( 8.1), clinical pharmacology ( 12.1)]. data following a single oral administration of 10 mg/kg of radioactive atorvastatin to lactating rats, the concentration of total radioactivity was determined. atorvastatin and/or its metabolites were measured in the breast milk and pup plasma at a 2:1 ratio (milk: plasma). the safety and effectiveness of atorvastatin calcium as an adjunct to diet to reduce ldl-c have been established pediatric patients 10 years of age and older with hefh. use of atorvastatin calcium for this indication is based on a double-blind, placebo-controlled clinical trial in 187 pediatric patients 10 years of age and older with hefh. in this limited controlled trial, there was no significant effect on growth or sexual maturation in the boys or girls, or on menstrual cycle length in girls.   the safety and effectiveness of atorvastatin calcium as an adjunct to other ldl-c-lowering therapies to reduce ldl-c have been established pediatric patients 10 years of age and older with hofh. use of atorvastatin calcium for this indication is based on a trial without a concurrent control group in 8 pediatric patients 10 years of age and older with hofh [see clinical studies ( 14)].   the safety and effectiveness of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with hefh or hofh, or in pediatric patients with other types of hyperlipidemia (other than hefh or hofh). of the total number of atorvastatin calcium tablets-treated patients in clinical trials, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. no overall differences in safety or effectiveness were observed between these patients and younger patients.   advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets-associated myopathy and rhabdomyolysis. dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving atorvastatin calcium tablets for the increased risk of myopathy [see warnings and precautions ( 5.1) and clinical pharmacology ( 12.3)]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. renal impairment does not affect the plasma concentrations of atorvastatin, therefore there is no dosage adjustment in patients with renal impairment [see warnings and precautions ( 5.1) and clinical pharmacology ( 12.3)]. in patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin are markedly increased. c max and auc are each 4-fold greater in patients with childs-pugh a disease. c max and auc are approximately 16-fold and 11-fold increased, respectively, in patients with childs-pugh b disease. atorvastatin calcium tablets are contraindicated in patients with acute liver failure or decompensated cirrhosis [see contraindications ( 4)].

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taro pharmaceuticals u.s.a., inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate 0.5 mg in 1 g - halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. halobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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zydus lifesciences limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 6 and 21 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memant

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conopco inc. d/b/a unilever - aluminum zirconium tetrachlorohydrex gly (unii: 8o386558je) (aluminum zirconium tetrachlorohydrex gly - unii:8o386558je) - purpose antiperspirant uses reduces underarm wetness

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merck sharp & dohme corp. - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r), pseudoephedrine sulfate (unii: y9dl7qpe6b) (pseudoephedrine - unii:7cuc9ddi9f) - desloratadine 2.5 mg - clarinex-d® 12 hour extended release tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. clarinex-d 12 hour extended release tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see clinical pharmacology (12)]. clarinex-d 12 hour extended release tablets are contraindicated in: - patients with hypersensitivity to any of its ingredients, or to loratadine [see warnings and precautions (5.4) and adverse reactions (6.2)] - patients with narrow-angle glaucoma - patients with urinary retention - patients receiving monoamine oxidase (mao) inhibitor therapy or within fourteen (14) days of stopping such treatment [see drug interactions (7.1)] - patients with severe hypertension or severe coronary artery disease risk summary the limited available data with clarinex-d 12 hour in pregnant wom

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seroyal usa - passiflora incarnata flowering top (unii: clf5yfs11o) (passiflora incarnata flowering top - unii:clf5yfs11o), ipomoea purga root (unii: 4udo46ybk2) (ipomoea purga root - unii:4udo46ybk2), arabica coffee bean (unii: 3sw678mx72) (arabica coffee bean - unii:3sw678mx72), magnesium (unii: i38zp9992a) (magnesium - unii:i38zp9992a), palladium (unii: 5twq1v240m) (palladium - unii:5twq1v240m), tellurium (unii: nqa0o090zj) (tellurium - unii:nqa0o090zj), phosphoric acid (unii: e4ga8884nn) (phosphoric acid - uni - passiflora incarnata flowering top 3 [hp_x] in 30 ml - uses for the temporary relief of symptoms associated with irregular sleep patterns ordinary restlessness uses for the temporary relief of symptoms associated with irregular sleep patterns ordinary restlessness directions to be taken ten minutes away from food. invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. hold contents for about 20 seconds and swallow. to promote drop flow, invert bottle and shake before each use. dosage frequency may be increased up to six times daily depending on the severity of symptoms. adults and adolescents (12 years and older) take 10 drops three times daily or as recommended by your healthcare practitioner. children (under 12 years) take under the direction of your healthcare practitioner.

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hf acquisition co llc, dba healthfirst - esmolol hydrochloride (unii: v05260lc8d) (esmolol - unii:mdy902uxsr) - 1.1 supraventricular tachycardia or noncompensatory sinus tachycardia esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. esmolol hydrochloride injection is intended for short-term use. 1.2 intraoperative and postoperative tachycardia and hypertension esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. use of esmolol hydrochloride injection to prevent such events is not recommended. esmolol hydrochloride injection is contraindicated in patients with: • severe sinus bradycardia: may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions ( 5-5.2)]. • heart block greater than first degree: second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions ( 5-5.2)]. • sick sinus syndrome: may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see warnings and precautions ( 5-5.2)]. • decompensated heart failure: may worsen heart failure. • cardiogenic shock: may precipitate further cardiovascular collapse and cause cardiac arrest. • iv administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and esmolol hydrochloride injection in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving esmolol hydrochloride injection and intravenous verapamil. • pulmonary hypertension: may precipitate cardiorespiratory compromise. • hypersensitivity reactions, including anaphylaxis, to esmolol or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible). 8.1 pregnancy pregnancy category c esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). there are no adequate and well-controlled studies in pregnant women. esmolol hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. teratogenicity studies in rats at intravenous dosages of esmolol hydrochloride up to 3000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. in rabbits, intravenous dosages up to 1000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions. 8.2 labor and delivery although there are no adequate and well-controlled studies in pregnant women, use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. esmolol hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 nursing mothers it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from esmolol hydrochloride injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 pediatric use the safety and effectiveness of esmolol hydrochloride injection in pediatric patients have not been established. 8.5 geriatric use clinical studies of esmolol hydrochloride injection did not include sufficient numbers of subjects aged 65 and over to determine whether they responded 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 usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy. 8.6 hepatic impairment no special precautions are necessary in patients with hepatic impairment because esmolol hydrochloride injection is metabolized by red-blood cell esterases [see clinical pharmacology ( 12-12.3)]. 8.7 renal impairment no dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours. there is no information on the tolerability of maintenance infusions of esmolol using rates in excess of 150 mcg/kg or maintained longer than 4 hours [see clinical pharmacology ( 12-12.3)].

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deseret biologicals, inc. - dibasic potassium phosphate (unii: ci71s98n1z) (phosphate ion - unii:nk08v8k8hr), ambergris (unii: xtc0d02p6c) (ambergris - unii:xtc0d02p6c), cocoa (unii: d9108tz9kg) (cocoa - unii:d9108tz9kg), phosphoric acid (unii: e4ga8884nn) (phosphoric acid - unii:e4ga8884nn), arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw), oyster shell calcium carbonate, crude (unii: 2e32821g6i) (oyster shell calcium carbonate, crude - unii:2e32821g6i), sus scrofa cerebrum (unii: 4gb5dqr532) (sus scrofa cerebrum - unii:4gb5dqr532), sus scrofa adrenal gland (unii: 398iyq16yv) (sus scrofa adrenal gland - unii:398iyq16yv), lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66), aconitum napellus (unii: u0nq8555jd) (aconitum napellus - unii:u0nq8555jd), argemone mexicana (unii: 6x68976407) (argemone mexicana - unii:6x68976407), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), cicuta virosa root (unii: yea9p21s8n) (cicuta virosa root - unii:yea9p21s8n), hyoscyamus niger (unii: 4wrk2153h3) (hyoscyamus niger - unii:4wrk2153h3), strychnos ignatii seed (unii: 1nm3m2487k) (strychnos ignatii seed - unii:1nm3m2487k), lilium lancifolium whole flowering (unii: x67z2963pi) (lilium lancifolium whole flowering - unii:x67z2963pi), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), lycosa tarantula (unii: 86m454l2tt) (lycosa tarantula - unii:86m454l2tt), datura stramonium (unii: g6w4f0v8z3) (datura stramonium - unii:g6w4f0v8z3), androctonus australis venom (unii: 25imq489aw) (androctonus australis venom - unii:25imq489aw) - for the temporary relief of symptoms of stress such as terror, horror, post traumatic stress, fight or flight response, recurring nightmares, difficulty sleeping, difficulty concentrating, restlessness, and easy irritability.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration. for the temporary relief of symptoms of stress such as terror, horror, post traumatic stress, fight or flight response, recurring nightmares, difficulty sleeping, difficulty concentrating, restlessness, and easy irritability.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

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greer laboratories, inc. - ambrosia confertiflora pollen (unii: 63tbj590bl) (ambrosia confertiflora pollen - unii:63tbj590bl) - non-standardized allergenic extracts are indicated for: - skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens. - immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific ige antibodies. food extracts have not been proven safe or effective in allergen immunotherapy. non-standardized allergenic extracts are contraindicated in patients with: - severe, unstable or uncontrolled asthma - history of any severe systemic or local allergic reaction to an allergen extract 8.1 pregnancy risk summary all pregnancies have a risk of birth defect, loss, or 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 to 4% and 15 to 20%, respectively. there are no human or animal data to establish the presence or absence of non-standardized

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bryant ranch prepack - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin