Newsemia

• September 25, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: abdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisAllergic Reactions anaphylactoid or hypersensitivity reactionsalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationcontact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.convulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppresionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. To report SUSPECTED ADVERSE EVENTSrashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)thin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Sep 25, 2018 EST

• July 20, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: (listed alphabeticallyabdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationconvulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppressionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. Closerashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)The initial dosage of prednisone Tabletsthin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisunder each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactionsurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Jul 20, 2018 EST

• July 12, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: abdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisAllergic Reactions anaphylactoid or hypersensitivity reactionsalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationcontact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.convulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppresionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. To report SUSPECTED ADVERSE EVENTSrashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)thin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Jul 12, 2018 EST