Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - prednisone (unii: vb0r961hzt) (prednisone - unii:vb0r961hzt) - prednisone 5 mg - prednisone tablets, usp are indicated in the following conditions: endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus er

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - anastrozole 1 mg

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 2 mg - perindopril erbumine is indicated for the treatment of patients with essential hypertension. perindopril erbumine may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. perindopril erbumine can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. perindopril erbumine is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. perindopril erbumine is also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with perindopril erbumine in patients with diabetes [see drug interactions (7.8) ]. perindopril erbumine is contraindicated in combination with neprilysin inhibitor (e.g., sacubitril).

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron .25 mg in 2 ml - palonosetron hydrochloride (hcl) injection is indicated for: •     moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses •     highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses palonosetron hcl injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see adverse reactions (6.2)] . r i sk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl to rats and rabbits during organogenesis at doses up to 1894 and 3789 times the recommended human intravenous dose, respectively [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  in the u.s. general popula

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 40 mg in 1 ml - megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). history of hypersensitivity to megestrol acetate or any component of the formulation. known or suspected pregnancy.

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride tablets are indicated for the prevention of: granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.6)]. do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c. there are no adequate and well-controlled studies of nicardipine use in pregnant women. there are limited human data in pregnant women with pre-eclampsia and preterm labor. in animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproduction studies conducted in rats and rabbits, increased embryolethality oc

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection, usp is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin sodium injection, usp can also be substituted, short-term, for oral phenytoin. fosphenytoin sodium injection, usp should be used only when oral phenytoin administration is not possible [see dosage and administration (2.4) and warnings and precautions (5.2) ]. fosphenytoin sodium injection is contraindicated in patients with: - a history of hypersensitivity to fosphenytoin sodium injection or its inactive ingredients, or to phenytoin or other hydantoins [see warnings and precautions (5.6)] . - sinus bradycardia, sino-atrial block, second and third degree a-v block, or adams-stokes syndrome because of the effect of parenteral phenytoin or fosphenytoin sodium injection on ventricular automaticity. - a history of prior acute hepatotoxicity attributable to fosphenytoin sodium injection or phenytoin [see warnings and pr

Estados Unidos - inglés - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole is indicated for the treatment of parkinson’s disease. ropinirole is indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (mrhd) for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [se