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

cosette pharmaceuticals, inc. - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - effient ® is indicated to reduce the rate of thrombotic cv events (including stent thrombosis) in patients with acute coronary syndrome (acs) who are to be managed with percutaneous coronary intervention (pci) as follows: - patients with unstable angina (ua) or non-st-elevation myocardial infarction (nstemi). - patients with st-elevation myocardial infarction (stemi) when managed with primary or delayed pci. effient has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (mi), or nonfatal stroke compared to clopidogrel. the difference between treatments was driven predominantly by mi, with no difference on strokes and little difference on cv death [see clinical studies (14)] . effient is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ich) [see warnings and precautions (5.1) and

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

cosette pharmaceuticals, inc. - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - citalopram tablets, usp are indicated for the treatment of depression. the efficacy of citalopram tablets, usp in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category ofmajor depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. the antidepressant action of citalopram tablets, usp in hospitalized depressed patients has not been adequately studied.

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

cosette pharmaceuticals, inc. - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - acyclovir ointment usp 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation. clinical studies of acyclovir ointment 5% 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. systemic absorption of acyclovir after topical administration is minimal (see clinical pharmacology). safety and effectiveness in pediatric patients have not been established.

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

cosette pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). note for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginaldischarge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains cluecells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent  lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. other pathogens commonly associated with vulvovaginitis, e.g., trichomonas vaginalis, chlamydia trachomatis, n. gonorrhoeae, candida albicans , and herpes simplex virus should be ruled out. metronidazole vaginal gel is contraindicated i

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

cosette pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 12.5 mg - promethazine hcl suppositories, usp are useful for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of postoperative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hcl suppositories are contraindicated for use in pediatric patients less than two years of age. promethazine hcl suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. promethazine hcl suppositories are contraindicated for use in pediatric patients less than two years of age (see warnings-black box warning and use in pediatric patients). promethazine hcl suppositories should be used with caution in pediatric patients 2 years of age and older (see warnings – use in pediatric patients ). clinical studies of promethazine formulations 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. sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hcl suppositories and observed closely.

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

cosette pharmaceuticals, inc. - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician. desonide cream, 0.5% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. safety and effectiveness in pediatric patients have not been established. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. hpa axis suppression, cushing’s syndrome, linear growth retardation

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

cosette pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 ml - topical corticosteroids are 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. 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. administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.

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

cosette pharmaceuticals, inc. - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - nystatin 100000 [usp'u] in 1 g - 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.

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

cosette pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hcl suppositories, usp are useful for: perennial and seasonal allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. amelioration of allergic reactions to blood or plasma. dermographism. anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. preoperative, postoperative, or obstetric sedation. prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. therapy adjunctive to meperidine or other analgesics for control of postoperative pain. sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. active and prophylactic treatment of motion sickness. antiemetic therapy in postoperative patients. promethazine hcl suppositories are contraindicated for use in pediatric patients less than two years of age. promethazine hcl suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. promethazine hcl suppositories are contraindicated for use in pediatric patients less than two years of age (see warnings-black box warning and use in pediatric patients). promethazine hcl suppositories should be used with caution in pediatric patients 2 years of age and older (see warnings – use in pediatric patients ). clinical studies of promethazine hcl formulations 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. sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hcl suppositories and observed closely.

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

cosette pharmaceuticals, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - topical corticosteroids are 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. 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. administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.