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

remedyrepack inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that

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)

remedyrepack inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine, cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. for example, increased plasma concentrations of some of these drugs can lead to qt prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. (see precautions: drug interactions.) coadministration of ketoconazole tablets with lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions (see precautions: drug interactions). additionally, the following other drugs are contraindicated with ketoconazole tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine. (see precautions: drug interactions.) coadministration of ketoconazole tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. this may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. concomitant administration of ketoconazole tablets with oral triazolam, oral midazolam or alprazolam is contraindicated. (see precautions: drug interactions.) coadministration of cyp3a4 metabolized hmg-coa reductase inhibitors such as simvastatin, and lovastatin is contraindicated with ketoconazole tablets. (see precautions: drug interactions.) concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with ketoconazole tablets is contraindicated. (see precautions: drug interactions.) the use of ketoconazole tablets is contraindicated in patients with acute or chronic liver disease. ketoconazole tablets usp, 200 mg is contraindicated in patients who have shown hypersensitivity to the drug.

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

Malta - English - Medicines Authority

elpen pharmaceutical co. inc. 95 marathonos ave., 190 09 pikermi, attica, greece - film-coated tablet - sitagliptin 25 mg - drugs used in diabetes

Malta - English - Medicines Authority

elpen pharmaceutical co. inc. 95 marathonos ave., 190 09 pikermi, attica, greece - film-coated tablet - sitagliptin 50 mg - drugs used in diabetes

Malta - English - Medicines Authority

elpen pharmaceutical co. inc. 95 marathonos ave., 190 09 pikermi, attica, greece - film-coated tablet - sitagliptin 100 mg - drugs used in diabetes

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - enfuvirtide 108mg (includes overage 20%) - injection with diluent - 90 mg/ml - active: enfuvirtide 108mg (includes overage 20%) excipient: hydrochloric acid mannitol sodium carbonate sodium hydroxide water for injection - fuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of hiv-1 replication despite ongoing therapy. evidence to support this indication is based on surrogate endpoints (change in viral load and cd4 count) in controlled studies following 48 weeks of treatment (see clinical trials).