Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride tablets, usp are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - have not been tolerated or are not expected to be tolerated. - have not provided adequate analgesia or are not expected to provide adequate analgesia. tramadol hydrochloride tablets, usp is contraindicated for: -   all children younger than 12 years of age [see warnings and precautions (5.4)]. -   post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4)]. tramadol hydrochloride t

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - bisoprolol fumarate (unii: ur59kn573l) (bisoprolol - unii:y41js2nl6u) - bisoprolol fumarate tablets are indicated in the management of hypertension. it may be used alone or in combination with other antihypertensive agents. bisoprolol fumarate tablets are contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree av block and marked sinus bradycardia.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma llc - triamterene (unii: ws821z52lq) (triamterene - unii:ws821z52lq) - triamterene capsules usp is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. triamterene capsules usp may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. it also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. usage in pregnancy. the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. diuretics are indicated in pregnancy (however, see precautions below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. there is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. if this edema produces discomfort, increased recumbency will often provide relief. in rare instances, this edema may cause extreme discomfort which is not relieved by rest. in these cases, a short course of diuretics may provide relief and may be appropriate. anuria. severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. severe hepatic disease. hypersensitivity to the drug or any of its components. triamterene capsules usp should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with triamterene. triamterene should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. two deaths have been reported in patients receiving concomitant spironolactone and triamterene or dyazide®. although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma llc - ethacrynic acid (unii: m5dp350vzv) (ethacrynic acid - unii:m5dp350vzv) - ethacrynic acid tablets usp, are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. - treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. - short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. - short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. - intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable. all diuretics, including ethacrynic acid, are contraindicated in anuria. if increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued. in a few patients this diuretic has produced severe, watery diarrhea. if this occurs, it should be discontinued and not used again. until further experience in infants is accumulated, therapy with oral and parenteral ethacrynic acid is contraindicated. hypersensitivity to any component of this product.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride tablets, usp are indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride tablets, usp can cause marked elevation of supine blood pressure (bp>200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine hydrochloride tablets, usp effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride tablets, usp principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, usp. after initiation of treatment, midodrine hydrochloride tablets, usp should be continued

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - oxazepam (unii: 6gow6dwn2a) (oxazepam - unii:6gow6dwn2a) -       oxazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. anxiety associated with depression is also responsive to oxazepam therapy. this product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients. alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy. the effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. history of previous hypersensitivity reaction to oxazepam. oxazepam is not indicated in psychoses. an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide,

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic ef

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma llc - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride capsules usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride capsules for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the y

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - chlorzoxazone (unii: h0de420u8g) (chlorzoxazone - unii:h0de420u8g) - chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. chlorzoxazone does not directly relax tense skeletal muscles in man. chlorzoxazone is contraindicated in patients with known intolerance to the drug.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

trupharma, llc - acetazolamide (unii: o3fx965v0i) (acetazolamide - unii:o3fx965v0i) - for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. acetazolamide tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. hypersensitivity to acetazolamide or any excipients in the formulation. since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and i