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trupharma llc - aminocaproic acid (unii: u6f3787206) (aminocaproic acid - unii:u6f3787206) - aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. in life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (see warnings .) aminocaproic acid should not be used when there is ev

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

trupharma llc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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

trupharma, llc - acetic acid (unii: q40q9n063p) (acetic acid - unii:q40q9n063p) - for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. hypersensitivity to acetic acid otic solution or any of the ingredients. perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal. safety and effectiveness in pediatric patients below the age of 3 years have not been established.

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

trupharma llc - clozapine (unii: j60ar2ikic) (clozapine - unii:j60ar2ikic) - versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. because of the risks of severe neutropenia and of seizure associated with its use, versacloz should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see warnings and precautions (5.1, 5.5) ] . the effectiveness of clozapine in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine and chlorpromazine in patients who had failed other antipsychotics [see  clinical studies (14.1)] . versacloz is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. suicidal behavior refers to actions by a patient that put him/herself at risk for death. the effectiven

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

trupharma llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (who group i) in adults to improve exercise ability and delay clinical worsening. the delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see clinical studies (14)]. studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with new york heart association (nyha) functional class ii-iii symptoms and idiopathic etiology (71%) or associated with connective tissue disease (ctd) (25%). limitation of use : adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see clinical studies (14)]. sildenafil tablets are contraindicated in patients with: -   concomitant use of organic nitrates in any form, either regularly or intermittently, because of the

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

trupharma, llc - apomorphine hydrochloride (unii: f39049y068) (apomorphine - unii:n21far7b4s) - apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced parkinson's disease. apomorphine hydrocloride inejction has been studied as an adjunct to other medications [see clinical studies (14)] . apomorphine hydrocloride is contraindicated in patients: - using concomitant drugs of the 5ht3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see drug interactions (7.1)] . there have been reports of profound hypotension and loss of consciousness when apomorphine hydrocloride was administered with ondansetron. - with hypersensitivity/allergic reaction to apomorphine or to any of the excipients of apomorphine hydrocloride, including a sulfite (i.e., sodium metabisulfite). angioedema or anaphylaxis may occur [see warnings and precautions (5.12)]. risk summary there are no adequate data on the developmenta

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

trupharma, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride oral solution is 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 oral solution is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [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 oral solution 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 mellitus in pregnancy [see clinical considerations] . no adverse developmental effects were o

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

trupharma llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil tablets are indicated for the treatment of erectile dysfunction. consistent with its known effects on the nitric oxide/cgmp pathway [ see  clinical pharmacology (12.1, 12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. after patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see dosage and administration (2.3), drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil tablets are contraindicated in patients

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

trupharma llc - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria). oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

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

trupharma, llc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. it is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see warnings ). the risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. the risk is dependent on the extent and location of the injury. the precise time of onset and the duration of the risk period are not known.