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

biocomp pharma, inc. - prednisolone sodium phosphate (unii: iv021nxa9j) (prednisolone - unii:9phq9y1olm) - prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 ml) is indicated in the following conditions: 1. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. dermatologic diseases pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (stevens-johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephritic syndrome, without uremia. 4. 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. 5. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. hematologic disorders idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; diamond-blackfan anemia. 7. neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. nervous system acute exacerbations of multiple sclerosis. 9. ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. respiratory diseases symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “allergic states”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (copd), and pneumocystis carinii pneumonia (pcp) associated with hypoxemia occurring in an hiv (+) individual who is also under treatment with appropriate anti-pcp antibiotics. studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. 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; epicondylitis. for the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. miscellaneous tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents). systemic fungal infections. hypersensitivity to the drug or any of its components.

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

biocomp pharma, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - sulfacetamide sodium 100 mg in 1 ml - this product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). it also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease. general: nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. although rare, sensitivity to sodium sulfacetamide may occur. therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. if the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. patients should be carefully observed for possible local irritation or sensitization during long-term therapy. systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. particular caution should be employed if areas of denuded or abraded skin are involved. systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. information for patients: patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. the use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. avoid contact with eyes, lips and mucous membranes. drug interactions: this product is incompatible with silver preparations. carcinogenesis, mutagenesis and impairment of fertility: long-term animal studies for carcinogenic potential have not been performed on this product to date. studies on reproduction and fertility also have not been performed. chromosomal nondisjunction has been reported in the yeast, saccharomyces cerevisiae, following application of sodium sulfacetamide. the significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. pregnancy: category c. animal reproduction studies have not been conducted with this product. it is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. this product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. nursing mothers: it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. pediatric use: safety and effectiveness in children under the age of 12 years have not been established.

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

biocomp pharma, inc. - sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70), sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - this product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease. general: nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. although rare, sensitivity to sodium sulfacetamide may occur. therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. if the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. patients should be carefully observed for possible local irritation or sensitization during long-term therapy. systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hyp

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

biocomp pharma, inc. - carbinoxamine maleate (unii: 02o55696wh) (carbinoxamine - unii:982a7m02h5) - carbinoxamine maleate 4 mg - carbinoxamine maleate is effective for the symptomatic treatment of: seasonal and perennial allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angio-edema. dermatographism. as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. amelioration of the severity of allergic reactions to blood or plasma. carbinoxamine maleate is contraindicated in children younger than 2 years of age. carbinoxamine maleate is contraindicated in nursing mothers. carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (see drug interactions section).

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

biocomp pharma, inc. - sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70), sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - sulfur 40 mg in 1 g - this product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.

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

biocomp pharma, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - sulfacetamide sodium 100 mg in 1 g - this product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.

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

biocomp pharma, inc. - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - urea 400 mg in 1 g - for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

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

biocomp pharma, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - sulfacetamide sodium 100 mg in 1 ml - this product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). it also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.

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

biocomp pharma, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5) - sulfacetamide sodium 100 mg in 1 ml - this product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). it also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.

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

biocomp pharma, inc. - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - sulfacetamide sodium 100 mg in 1 g - this product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.