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

parke-davis div of pfizer inc - ethosuximide (unii: 5seh9x1d1d) (ethosuximide - unii:5seh9x1d1d) - ethosuximide 250 mg in 5 ml - zarontin is indicated for the control of absence (petit mal) epilepsy. ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

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

parke-davis div of pfizer inc - ethosuximide (unii: 5seh9x1d1d) (ethosuximide - unii:5seh9x1d1d) - ethosuximide 250 mg - zarontin is indicated for the control of absence (petit mal) epilepsy.

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

parke-davis div of pfizer inc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - neurontin® is indicated for: neurontin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as neurontin, during pregnancy. encourage women who are taking neurontin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of neurontin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data]. in the u.s. general population, the estimated background

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - phenytoin sodium, quantity: 30 mg - capsule, hard - excipient ingredients: magnesium stearate; purified talc; gelatin; carbon black; titanium dioxide; lactose monohydrate; maize starch; sucrose - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - phenytoin sodium, quantity: 100 mg - capsule, hard - excipient ingredients: gelatin; magnesium stearate; erythrosine; purified talc; titanium dioxide; sunset yellow fcf; carbon black; lactose monohydrate; maize starch; sucrose - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration).

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

parke-davis div of pfizer inc - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - lopid (gemfibrozil tablets, usp) is indicated as adjunctive therapy to diet for: in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (greater than 46.4 mg/dl), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see table i). the initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. physical exercise can be an important ancillary measure, and has been associated with rises in hdl-cholesterol. diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. in such cases, discontinuation of estrogen therapy may obv

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

parke-davis div of pfizer inc - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - lipitor is indicated: discontinue lipitor when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. lipitor decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, lipitor 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 lipitor 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/m2 ). 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 2-4% and 15-20%, respectively. 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. 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/m2). 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. 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 lipitor, 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 lipitor [see use in specific populations (8.1), clinical pharmacology (12.1)] . 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 lipitor as an adjunct to diet to reduce ldl-c have been established pediatric patients 10 years of age and older with hefh. use of lipitor 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 lipitor 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 lipitor 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 lipitor 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 lipitor-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 lipitor-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 lipitor 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 lipitor, 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 lipitor are markedly increased. cmax and auc are each 4-fold greater in patients with childs-pugh a disease. cmax and auc are approximately 16-fold and 11-fold increased, respectively, in patients with childs-pugh b disease. lipitor is contraindicated in patients with acute liver failure or decompensated cirrhosis [see contraindications (4)] .

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

parke-davis div of pfizer inc - quinapril hydrochloride (unii: 33067b3n2m) (quinaprilat - unii:34ssx5lde5) - quinapril 5 mg - accupril is 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. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with accupril. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pres

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

parke-davis div of pfizer inc - quinapril hydrochloride (unii: 33067b3n2m) (quinaprilat - unii:34ssx5lde5), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - quinapril 10 mg - accuretic is 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. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with accuretic. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pr

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

parke-davis div of pfizer inc - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 0.3 mg - nitrostat is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. do not use nitrostat in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use nitrostat in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. concomitant use can cause hypotension. nitrostat is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). nitrostat may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury). nitrostat is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. nitrostat is contraindicated in patients with acute circulatory failure or shock. risk summary limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. in animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [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 2–4% and 15–20%, respectively. data animal data no embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 80 and 240 mg/kg/day, respectively, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day from gestation day 7–17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6–18. risk summary sublingual nitroglycerin has not been studied in lactating women. it is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. the safety and effectiveness of nitroglycerin in pediatric patients have not been established. clinical studies of nitrostat 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 of concomitant disease or other drug therapy.