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

prasco laboratories - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. amlodipine amlodipine 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 amlodipine. 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, evaluatio

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

prasco laboratories - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u), vilanterol trifenatate (unii: 40aho2c6dg) (vilanterol - unii:028lzy775b) - fluticasone furoate/vilanterol ellipta 100/25 mcg is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. fluticasone furoate/vilanterol ellipta 100/25 mcg is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. fluticasone furoate/vilanterol ellipta 100/25 mcg once daily is the only strength indicated for the treatment of copd. important limitation of use fluticasone furoate/vilanterol ellipta is not indicated for the relief of acute bronchospasm fluticasone furoate/vilanterol ellipta is indicated for the once-daily treatment of asthma in patients aged 18 years and older. fluticasone furoate/vilanterol ellipta should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2

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

prasco laboratories - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate hfa is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. limitations of use fluticasone propionate hfa is not indicated for the relief of acute bronchospasm. fluticasone propionate hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate hfa in pregnant women. there are clinical considerations with the use of fluticasone propionate hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations in rats, mice, and rabbits, was observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (mrhdid) on a mcg/m2 basis. (see data.) however, fluticasone propionate administered via inhalation to rats decreased fetal body weight but did not induce terat

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

prasco laboratories - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin calcium nasal ointment is indicated for the eradication of nasal colonization with methicillin‑resistant staphylococcus aureus (mrsa) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of mrsa infection during institutional outbreaks of infections with this microorganism. mupirocin calcium nasal ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin calcium nasal ointment. pregnancy category b. there are no adequate and well-controlled studies of mupirocin calcium nasal ointment (contains equivalent of 2% mupirocin free acid) in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and ra

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

prasco laboratories - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - tafluprost ophthalmic solution 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on cmax . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposu

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

prasco laboratories - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate and salmeterol hfa is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. fluticasone propionate and salmeterol hfa should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). limitations of use fluticasone propionate and salmeterol hfa is not indicated for the relief of acute bronchospasm. fluticasone propionate and salmeterol hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate and salmeterol hfa or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of fluticasone propionate and salmeterol hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of cortic

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

prasco laboratories - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤ 40%) (hfref) after an acute myocardial infarction (mi). eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv 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, e

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

prasco laboratories - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride 225 mg - propafenone hydrochloride extended-release (sr) capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: propafenone hydrochloride extended-release (sr) capsules are contraindicated in the following circumstances:   risk summary there are no studies of propafenone hydrochloride extended-release (sr) capsules in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride extended-release (sr) capsules in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was

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

prasco laboratories - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (estradiol - unii:4ti98z838e) - kit - 0.1 mg - cesia® (desogestrel/ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and implants, depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - cerebral vascular or coronary artery disease (current or history) - valvular heart disease with thrombogenic complications - severe hypertension - diabetes with vascular involvement - headaches with focal neurological symptoms - major surgery w

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

prasco laboratories - levalbuterol hydrochloride (unii: wdq1526qjm) (levalbuterol - unii:edn2nbh5ss) - levalbuterol 0.31 mg in 3 ml - levalbuterol hcl inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. levalbuterol hcl inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see warnings and precautions (5.6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol hcl inhalation solution, during pregnancy. to enroll in mothertobaby pregnancy studies' asthma & pregnancy study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma. risk summary there are no adequate and well-controlled studies of levalbuterol hcl inhalation solution in pregnant women. there are clinical con