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

zydus pharmaceuticals (usa) inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). diclofenac sodium topical solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see warnings and precautions (5.7, 5.9)]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. risk summary use of nsaids, including diclofenac sodium topical solution, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids,

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

zydus pharmaceuticals (usa) inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam capsules, usp are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including

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

nivagen pharmaceuticals, inc - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 10 mg - piroxicam capsules usp is indicated: -   for relief of the signs and symptoms of osteoarthritis. -   for relief of the signs and symptoms of rheumatoid arthritis. piroxicam capsules usp is contraindicated in the following patients: -   known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7 , 5.9)] -   history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7 , 5.8)] -   in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam capsules usp, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosu

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

pd-rx pharmaceuticals, inc. - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam 20 mg - piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions ( 5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1)] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including piroxica

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

remedyrepack inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see warnings and precautions (5.7 , 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7 , 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks

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

physicians total care, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41) - alendronic acid 70 mg - fosamax® plus d is indicated for: for the treatment of osteoporosis, fosamax plus d increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). fosamax plus d alone should not be used to treat vitamin d deficiency. the safety and effectiveness of fosamax plus d for the treatment of osteoporosis are based on clinical data of four years duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see warnings and precautions (5.1)] - inability to stand or sit upright for at least 30 minutes [see dosage and administration (2.3), warnings and precautions (5.1)] - hypocalcemia [see warnings and precautions (5.2)] - hypersensitivity to any component of this product. hypersensitivity reactions including urticaria and angioedema have

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

pfizer laboratories div pfizer inc - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k), bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - neomycin 3.5 mg in 1 g - for the treatment of corticosteroid-responsive dermatoses with secondary infection. it has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment. (see warnings.) not for use in the eyes or in the external ear canal if the eardrum is perforated. this product is contraindicated in tuberculous, fungal, or viral (for example, herpes simplex or varicella zoster) lesions of the skin. this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

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

physicians total care, inc. - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 10 mg - rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for merck & co., inc.’s rizatriptan benzoate tablets. however, due to merck & co., inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. limitations of use rizatriptan benzoate is contraindicated in patients with: there are no adequate and well-controlled studies in pregnant women. rizatriptan benzoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a general reproductive study in rats, birth weights and pre- and post-weaning weight gain were reduced in the offspring of females treated prior to and during mating and throughout gestation and lactation with doses of 10 and 100 mg/kg/day. in a pre- and postnatal de

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

calvin scott & co., inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes melli

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

calvin scott & co., inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes melli