Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate .5 mg in 1 g - halobetasol propionate ointment 0.05% is a super-high potency corticosteroid indictated 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.

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - benicar hct (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure.  benicar hct is not indicated for the initial therapy of hypertension [see dosage and administration (2) ] . 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 benicar hct. 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,

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 80 mg in 1 ml - (to understand fully the indication for this product, please read the entire indications and usage section of the labeling.) ciclopirox topical solution, 8%, (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum . the comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.      • no studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.     • ciclopirox topical solution, 8%, (nail lacquer),

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 50 mg - carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). indomethacin is indicated in active stages of the following: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendonitis). - acute gouty arthritis. indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see description ). indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic like reactions to nsaids have been reported in such patients (see warnings - anaphylactoid reactions, and precautions - preexisting asthma

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - griseofulvin (unii: 32hrv3e3d5) (griseofulvin - unii:32hrv3e3d5) - griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:     tinea corporis     tinea pedis     tinea cruris     tinea barbae     tinea capitis tinea unguium when caused by one or more of the following species of fungi:  epidermophyton floccosum  microsporum audouinii  microsporum canis  microsporum gypseum  trichophyton crateriform  trichophyton gallinae  trichophyton interdigitalis  trichophyton megnini  trichophyton mentagrophytes  trichophyton rubrum  trichophyton schoenleini  trichophyton sulphureum  trichophyton tonsurans  trichophyton verrucosum note: prior to therapy, a dermatophyte should be identified as responsible for the infection. prior to initiating treatment, appropriate specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. griseofulvin is not effective in the following: bacterial infections coccidioidomycosis candidiasis (moniliasis) north american blastomycosis histoplasmosis cryptococcosis (torulosis) actinomycosis tinea versicolor sporotrichosis nocardiosis chromoblastomycosis the use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone. griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. griseofulvin may cause fetal harm when administered to a pregnant woman. two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also precautions, drug interactions ). if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of griseofulvin. note: the maximum recommended human dose (mrhd) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. if higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. for example, if a 1000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2. griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4x the maximum recommended human dose (mrhd) based on body surface area (bsa)]. griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1000 mg/week. there are reports of teratogenicity in a golden retriever when doses of 750 mg/day [1.2x the mrhd based on bsa] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9x the mrhd based on bsa] for intervals from one week up to the entire gestation period. teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40x the mrhd based on bsa] for 2 consecutive days at various stages of the pregnancy.

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 ml - fluocinolone acetonide topical solution, usp 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (hpa) axis suppression and cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenal (hpa) axis suppression, cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. adm

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - triamcinolone acetonide (unii: f446c597ka) (triamcinolone acetonide - unii:f446c597ka) - triamcinolone acetonide 5 mg in 1 g - triamcinolone acetonide ointment, usp 0.5% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hpa axis suppression and cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. hpa axis suppression, cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. administration of topical corticosteroids to children should be li

Spojené státy - angličtina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - nystatin cream, usp is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans and other susceptible candida species. this cream is not indicated for systemic, oral, intravaginal or ophthalmic use. nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components. safety and effectiveness have been established in the pediatric population from birth to 16 years. (see dosage and administration. ) clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Spojené státy - angličtina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - nystatin cream, usp is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans and other susceptible candida species. this cream is not indicated for systemic, oral, intravaginal or ophthalmic use. nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components. safety and effectiveness have been established in the pediatric population from birth to 16 years. (see dosage and administration. ) clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Spojené státy - angličtina - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. none. risk summary there are no available data on dapsone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at the maximum recommended human dose (mrhd) of dapsone gel, 5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognize