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2,270,472,226
effect
(See INDICATIONS AND USAGE and WARNINGS.) Experience in over 1,400 patients with nifedipine immediate-release capsules in a noncomparative clinical trial has shown that concomitant administration of nifedipine and beta-blocking agents is usually well tolerated, but there have been occasional literature reports suggesting that the combination may increase the likelihood of congestive heart failure, severe hypotension, or exacerbation of angina.
Nifedipine
CONGESTIVE HEART FAILURE
2,270,469,148
effect
*Early clinical studies and incidence rates from early clinical experience with allopurinol suggested that these adverse reactions were found to occur at a rate of greater than 1%. The most frequent event observed was acute attacks of gout following the initiation of therapy. Analyses of current usage suggest that the incidence of these adverse reactions is now less than 1%. The explanation for this decrease has not been determined, but it may be due to following recommended usage (see ADVERSE REACTIONS introduction, INDICATIONS AND USAGE, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).
Allopurinol
GOUT
2,270,472,289
effect
*Early clinical studies and incidence rates from early clinical experience with allopurinol suggested that these adverse reactions were found to occur at a rate of greater than 1%. The most frequent event observed was acute attacks of gout following the initiation of therapy. Analyses of current usage suggest that the incidence of these adverse reactions is now less than 1%. The explanation for this decrease has not been determined, but it may be due to following recommended usage (see ADVERSE REACTIONS introduction, INDICATIONS AND USAGE, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).
Allopurinol
GOUT
2,259,533,372
indication_treatment
1 INDICATIONS AND USAGE 1.1 Hypertension ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. 1.2 Stable Coronary Artery Disease ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. Close
Perindopril
hypertension
2,259,533,358
indication_treatment
1 INDICATIONS AND USAGE 1.1 Hypertension Diovan퉌¬ (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See퉌æClinical Studies (14.2)]퉌æ 1.3 Post-Myocardial Infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [See퉌æClinical Studies (14.3)] Close
Valsartan
hypertension
2,259,533,362
indication_treatment
1 INDICATIONS AND USAGE 1.1 Hypertension Diovan퉌¬ (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See퉌æClinical Studies (14.2)]퉌æ 1.3 Post-Myocardial Infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [See퉌æClinical Studies (14.3)] Close
Valsartan
hypertension
2,259,533,373
indication_treatment
1 INDICATIONS AND USAGE 1.1 Hypertension ATACAND is indicated for the treatment of hypertension in adults and children 1 to < 17 years of age. It may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure ATACAND is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction í¢äóÁŒ_ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see CLINICAL STUDIES (14.2)]. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor. Close
Candesartan cilexetil
hypertension
2,259,533,409
indication_treatment
1 INDICATIONS AND USAGE 1.1 Hypothyroidism CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyroid-Stimulating Hormone(TSH) Suppression CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. 1.3 Thyroid Suppression Test CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use CYTOMEL is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4)]. CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Close
Liothyronine
thyroid cancer
2,259,533,342
indication_treatment
1 INDICATIONS AND USAGE 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.4 Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Close
Venlafaxine
panic disorder
2,259,533,330
indication_treatment
1 INDICATIONS AND USAGE 1.1 Ovarian Cancer DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma DOXIL, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Close
Epirubicin
ovarian cancer
2,259,533,331
indication_treatment
1 INDICATIONS AND USAGE 1.1 Ovarian Cancer DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma DOXIL, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Close
Doxorubicin
ovarian cancer
2,259,533,404
indication_treatment
1 INDICATIONS AND USAGE 1.1 Patient Selection Considerations Serum potassium levels should be measured before initiating INSPRA therapy, and INSPRA should not be prescribed if serum potassium is >5.5 mEq/L. [See CONTRAINDICATIONS (4)]. 1.2 Congestive Heart Failure Post-Myocardial Infarction INSPRA is indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction í¢äóÁŒ_40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI). 1.3 Hypertension INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents. Close
Eplerenone
hypertension
2,259,533,332
indication_treatment
1 INDICATIONS AND USAGE Isopto퉌¬ Carpine is indicated for the: 1.1 Reduction of Elevated Intraocular Pressuare (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension 1.2 Management of Acute Angle-Closure Glaucoma 1.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery 1.4 Induction of Miosis Close
Pilocarpine
hypertension
2,259,533,384
indication_treatment
1 INDICATIONS AND USAGE AZOPT퉌¬ (brinzolamide ophthalmic suspension) 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Close
Brinzolamide
hypertension
2,259,533,318
indication_symptomatic_relief
1 INDICATIONS AND USAGE Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Close
Flurbiprofen
rheumatoid arthritis
2,259,533,336
indication_treatment
1 INDICATIONS AND USAGE Latanoprost is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Close
Latanoprost
hypertension
2,259,536,667
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Alpha-Linolenic Acid
Diabetes Mellitus
2,259,536,841
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Icosapent
Diabetes Mellitus
2,259,536,907
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Icosapent
Diabetes Mellitus
2,259,536,974
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Doconexent
Diabetes Mellitus
2,265,783,227
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Alpha-Linolenic Acid
Diabetes Mellitus
2,265,783,663
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Icosapent
Diabetes Mellitus
2,265,783,776
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Icosapent
Diabetes Mellitus
2,265,783,948
indication_treatment
1 INDICATIONS AND USAGE LOVAZA’äΠ(omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta’äξblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. Close
Doconexent
Diabetes Mellitus
2,259,533,311
indication_treatment
1 INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: í¢ä‰åŒ¢ Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults í¢ä‰åŒ¢ Narcolepsy Close
Dexmethylphenidate
narcolepsy
2,259,533,314
indication_treatment
1 INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: í¢ä‰åŒ¢ Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults í¢ä‰åŒ¢ Narcolepsy Close
Methylphenidate
narcolepsy
2,259,533,378
indication_treatment
1í¢ä‰å¨Íí¢ä‰å¨ÍINDICATIONS AND USAGE 1.1í¢ä‰å¨Íí¢ä‰å¨ÍHypertension MICARDIS is indicated for the treatment of hypertension.퉌æ It may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)]. 1.2í¢ä‰å¨Íí¢ä‰å¨ÍCardiovascular Risk Reduction MICARDIS is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage [see Clinical Studies (14.2)]. 퉌æMICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy) [see Clinical Studies (14.2)]. Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. Use of telmisartan with an ACE inhibitor is not recommended [see Warnings and Precautions (5.6)]. Close
Telmisartan
hypertension
2,259,533,357
indication_treatment
INDICATIONS AND USAGE Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics. Close
Isradipine
hypertension
2,259,533,369
indication_treatment
INDICATIONS AND USAGE Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics. Close
Isradipine
hypertension
2,259,533,368
indication_treatment
INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets, USP are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patientí¢ä‰åä‹¢s clinical condition allows퉌æ(see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Close
Metoprolol
hypertension
2,259,533,316
indication_treatment
INDICATIONS AND USAGE The intra-articular or soft tissue administration of Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis, or osteoarthritis. The intralesional administration of Kenalog-10 Injection is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Kenalog-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). Close
Triamcinolone
alopecia areata
2,259,533,385
indication_treatment
INDICATIONS AND USAGE Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets are indicated in the management of hypertension; they may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Close
Nadolol
hypertension
2,259,533,387
indication_treatment
INDICATIONS AND USAGE Edema Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. Close
Furosemide
hypertension
2,259,533,381
indication_treatment
INDICATIONS AND USAGE Hypertension AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Nephropathy in Type 2 Diabetic Patients AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY: Clinical Studies). Close
Irbesartan
hypertension
2,270,650,760
indication_treatment
INDICATIONS AND USAGE Hypertension AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Nephropathy in Type 2 Diabetic Patients AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY: Clinical Studies). Close
Irbesartan
hypertension
2,259,533,376
indication_treatment
INDICATIONS AND USAGE Hypertension Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or incombination with thiazide diuretics. In using quinapril hydrochloride, consideration should be given to the fact that another angiotensinconvertingenzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renalimpairment or collagen vascular disease. Available data are insufficient to show that quinaprilhydrochloride does not have a similar risk (see WARNINGS). Angioedema in black patients Black patients receiving ACE inhibitor monotherapy have beenreported to have a higher incidence of angioedema compared to non-blacks. It should also be notedthat in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in blackpatients than in non-blacks. Close
Quinapril
hypertension
2,259,533,397
indication_treatment
INDICATIONS AND USAGE Hypertension Trandolapril Tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Close
Trandolapril
hypertension
2,259,533,333
indication_treatment
INDICATIONS AND USAGE Hypertension: Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy: Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see PRECAUTIONS, Raceand CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race). Close
Losartan
hypertension
2,259,533,323
unrelated
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis is not recommended. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used only under medical supervision as described above. The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer) in the following populations has not been studied. The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer) excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. The safety and efficacy of using Ciclopirox Topical Solution, 8% (Nail Lacquer) daily for greater than 48 weeks have not been established. Close
Ciclopirox
epilepsy syndrome
2,259,533,335
indication_treatment
INDICATIONS AND USAGE BETAGAN퉌¬ ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension. Close
Levobunolol
hypertension
2,270,640,805
indication_treatment
INDICATIONS AND USAGE BETAGAN퉌¬ ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension. Close
Levobunolol
hypertension
2,270,471,797
effect
INDICATIONS AND USAGE Clindacin•P® is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS). Close
Clindamycin
DIARRHEA
2,259,533,370
indication_treatment
INDICATIONS AND USAGE Hypertension Lisinopril tablets are indicated for the treatment of hypertension. They may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril tablets does not have a similar risk. (See WARNINGS.)In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions). Close
Lisinopril
hypertension
2,259,533,319
indication_treatment
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated. While rebound rarely occurs, most patients will experience relapse with Neoral as with other therapies upon cessation of treatment. Close
Ciclosporin
rheumatoid arthritis
2,259,533,340
indication_symptomatic_relief
INDICATIONS AND USAGE Osteoarthritis, Rheumatoid Arthritis and Acute Painful Shoulder: Salicylates are considered the base therapy of choice in the arthritides; and choline magnesium trisalicylate preparation is indicated for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and other arthritides. Choline Magnesium Trisalicylate Liquid is indicated in the long-term management of these diseases and especially in the acute flare of rheumatoid arthritis. Choline Magnesium Trisalicylate Liquid is also indicated for the treatment of acute painful shoulder. Choline Magnesium Trisalicylate Liquid is effective and generally well tolerated, and is logical choice whenever salicylate treatment is indicated. It is particularly suitable when a once-a-day or b.i.d. dosage regimen is important to patient compliance; when gastrointestinal intolerance to aspirin is encountered; when gastrointestinal microbleeding or hematologic effects of aspirin are considered a patient hazard; and when interference (or the risk of interference) with normal platelet function by aspirin or by propionic acid derivatives is considered to be clinically undesirable. Use of Choline Magnesium Trisalicylate Liquid is appropriate when a liquid dosage form is preferred, as in the elderly patient. The efficacy of Choline Magnesium Trisalicylate Liquid has not been studied in those patients who are designated by the American Rheumatism Association as belonging inFunctional Class IV (incapacitated, largely or wholly bedridden or confined to a wheelchair, with little or no self-care). Analgesic and Antipyretic Action: Choline Magnesium Trisalicylate Liquid is also indicated for the relief of mild to moderate pain and for antipyresis. Pediatric Use In children, Choline Magnesium Trisalicylate Liquid is indicated for conditions requiring anti-inflammatory or analgesic action-such as juvenile rheumatoid arthritis and other appropriate conditions. Close
Magnesium salicylate
rheumatoid arthritis
2,270,469,149
effect
INDICATIONS AND USAGE AMICAR 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.) Close
Aminocaproic Acid
ABRUPTIO PLACENTAE
2,259,533,403
indication_treatment
INDICATIONS AND USAGE Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes. Close
Amiloride
hypertension
2,259,531,489
indication_symptomatic_relief
INDICATIONS AND USAGE Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Close
Betamethasone
corticosteroid-responsive dermatoses
2,259,531,566
indication_symptomatic_relief
INDICATIONS AND USAGE Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Close
Betamethasone
corticosteroid-responsive dermatoses
2,259,531,595
indication_symptomatic_relief
INDICATIONS AND USAGE Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Close
Betamethasone
corticosteroid-responsive dermatoses
2,259,531,738
indication_symptomatic_relief
INDICATIONS AND USAGE Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Close
Betamethasone
corticosteroid-responsive dermatoses
2,259,533,351
indication_treatment
INDICATIONS AND USAGE Benazepril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Close
Benazepril
hypertension
2,259,533,400
indication_treatment
INDICATIONS AND USAGE Benazepril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Close
Benazepril
hypertension
2,259,533,354
indication_treatment
INDICATIONS AND USAGE BENICAR퉌¬ is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Close
Olmesartan
hypertension
2,259,533,391
indication_treatment
INDICATIONS AND USAGE BENICAR퉌¬ is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Close
Olmesartan
hypertension
2,259,533,364
indication_treatment
INDICATIONS AND USAGE Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics. Close
Betaxolol
hypertension
2,259,533,338
indication_treatment
INDICATIONS AND USAGE Betimol퉌¬ is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Close
Timolol
hypertension
2,259,533,389
indication_treatment
INDICATIONS AND USAGE Bisoprolol is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents. Close
Bisoprolol
hypertension
2,259,533,388
indication_treatment
INDICATIONS AND USAGE CARDENE SR is indicated for the treatment of hypertension. CARDENE SR may be used alone or in combination with other anti-hypertensive drugs. Close
Nicardipine
hypertension
2,259,531,490
indication_symptomatic_relief
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis** 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5. Acute gouty arthritis Close
Sulindac
Osteoarthritis
2,259,533,406
indication_treatment
INDICATIONS AND USAGE Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms. Close
Lenalidomide
anemia
2,259,536,378
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,379
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,476
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,477
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION). It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,380
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Tablets, USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets, USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,381
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Tablets, USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets, USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,478
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Tablets, USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets, USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only. Close
Clemastine
Pruritus
2,259,536,479
indication_symptomatic_relief
INDICATIONS AND USAGE Clemastine Fumarate Tablets, USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets, USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only. Close
Clemastine
Pruritus
2,259,533,349
indication_treatment
INDICATIONS AND USAGE Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents. Close
Clonidine
hypertension
2,259,533,401
indication_treatment
INDICATIONS AND USAGE Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents. Close
Clonidine
hypertension
2,259,536,373
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,536,471
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,536,472
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,533,356
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
hypertension
2,259,533,363
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
hypertension
2,259,536,375
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,536,376
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,536,473
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,536,474
indication_treatment
INDICATIONS AND USAGE DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. Close
Torasemide
Edema
2,259,533,313
indication_treatment
INDICATIONS AND USAGE Dextroamphetamine Sulfate Tablets USP are indicated for: Narcolepsy. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Close
Amphetamine
narcolepsy
2,259,533,312
indication_treatment
INDICATIONS AND USAGE Dextroamphetamine sulfate tablets, USP퉌æare indicated for: Narcolepsy. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Close
Dextroamphetamine
narcolepsy
2,270,629,496
indication_treatment
INDICATIONS AND USAGE Dextroamphetamine sulfate tablets, USP퉌æare indicated for: Narcolepsy. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Close
Dextroamphetamine
narcolepsy
2,259,533,321
indication_treatment
INDICATIONS AND USAGE Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information. Close
Diazepam
epilepsy syndrome
2,259,533,328
indication_treatment
INDICATIONS AND USAGE Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information. Close
Diazepam
epilepsy syndrome
2,259,533,361
indication_treatment
INDICATIONS AND USAGE Diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Evidence to support the use of diazepam rectal gel was adduced in two controlled trials (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES subsection) that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information. Close
Diazepam
epilepsy syndrome
2,259,533,350
indication_treatment
INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-release Capsules, USP (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics. Close
Diltiazem
hypertension
2,259,533,393
indication_treatment
INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-release Capsules, USP (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics. Close
Diltiazem
hypertension
2,259,533,334
indication_treatment
INDICATIONS AND USAGE Dorzolamide HCl Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Close
Dorzolamide
hypertension
2,259,533,343
indication_treatment
INDICATIONS AND USAGE Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis Dermatologic Diseases:PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia Respiratory Diseases:Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis Hematologic Disorders:Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia Neoplastic Diseases: For palliative management of:Leukemia and lymphomas in adultsAcute leukemia of childhood Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases: To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis Miscellaneous:Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement Diagnostic testing of adrenocortical hyperfunction. Close
Dexamethasone
anemia
2,259,533,346
indication_treatment
INDICATIONS AND USAGE Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis Dermatologic Diseases:PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia Respiratory Diseases:Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis Hematologic Disorders:Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia Neoplastic Diseases: For palliative management of:Leukemia and lymphomas in adultsAcute leukemia of childhood Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases: To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis Miscellaneous:Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement Diagnostic testing of adrenocortical hyperfunction. Close
Betamethasone
rheumatoid arthritis
2,259,533,347
indication_treatment
INDICATIONS AND USAGE Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis Dermatologic Diseases:PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia Respiratory Diseases:Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis Hematologic Disorders:Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia Neoplastic Diseases: For palliative management of:Leukemia and lymphomas in adultsAcute leukemia of childhood Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases: To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis Miscellaneous:Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement Diagnostic testing of adrenocortical hyperfunction. Close
Dexamethasone
rheumatoid arthritis
2,259,531,491
indication_symptomatic_relief
INDICATIONS AND USAGE Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. Close
Epinephrine
Serum Sickness
2,259,533,375
indication_treatment
INDICATIONS AND USAGE Eprosartan mesylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensives such as diuretics and calcium channel blockers. Close
Eprosartan
hypertension
2,259,533,320
indication_treatment
INDICATIONS AND USAGE Felbamate is not indicated as a first line antiepileptic treatment (see Warnings). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, Felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Close
Felbamate
epilepsy syndrome
2,259,533,324
indication_treatment
INDICATIONS AND USAGE Felbamate is not indicated as a first line antiepileptic treatment (see Warnings). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, Felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Close
Felbamate
epilepsy syndrome
2,259,533,360
indication_treatment
INDICATIONS AND USAGE Felbamate is not indicated as a first line antiepileptic treatment (see Warnings). Felbamate is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, Felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Close
Felbamate
epilepsy syndrome
2,259,533,380
indication_treatment
INDICATIONS AND USAGE Felodipine is indicated for the treatment of hypertension. Felodipine may be used alone or concomitantly with other antihypertensive agents. Close
Felodipine
hypertension
2,259,531,666
indication_symptomatic_relief
INDICATIONS AND USAGE Fluticasone Propionate Nasal Spray, USP, is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Fluticasone Propionate Nasal Spray, USP, in children below 4 years of age have not been adequately established. Close
Fluticasone propionate
Nonallergic rhinitis
2,259,533,371
indication_treatment
INDICATIONS AND USAGE For the treatment of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of the lower dose of a diuretic, which may be sufficient without leading to hypokalemia. For the prevention of hypokalemia in patients who would be at particular risk if hyperkalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted supplementation with potassium salts may be indicated. Close
Potassium chloride
hypertension

Dataset Card for OptimAL

Dataset Summary

OptimAL Dataset Summary:

The dataset in this repository is relevant to drug discovery and clinical decision support. The authors of the dataset reported on the combination of weak supervision (i.e., programmatic labeling and crowdsourcing) and deep learning methods for relation extraction from DailyMed text to create a higher quality drug-disease relation dataset. The generated drug-disease relation data showed a high overlap with DrugCentral, a manually curated dataset. Using this dataset, they constructed a machine learning model to classify relations between drugs and diseases from text into four categories; treatment, symptomatic relief, contradiction, and effect.

The data that is available in this repository is the OptimALBaselineDataset: https://github.com/MaastrichtU-IDS/OptimAL/blob/master/data/OptimALBaselineDataset.csv

Languages

The language in the dataset is English.

Dataset Structure

Dataset Instances

An example of 'train' looks as follows:

{
  "_unit_id": 2270472226,
  "Worker Answer": "effect",
  "context": "(See INDICATIONS AND USAGE and WARNINGS.)  Experience in over 1,400 patients with nifedipine immediate-release capsules in a noncomparative clinical trial has shown that concomitant administration of nifedipine and beta-blocking agents is usually well tolerated, but there have been occasional literature reports suggesting that the combination may increase the likelihood of congestive heart failure, severe hypotension, or exacerbation of angina.",
  "drug_name": "Nifedipine",
  "disease_name": "CONGESTIVE HEART FAILURE"
}

Data Fields

  • _unit_id: the unique identifier for this data entry, an int64 feature.
  • Worker Answer: the answer or classification provided by the worker based on the context, a string feature.
  • context: the text providing the scenario or situation where the drug and disease interaction is mentioned, a string feature.
  • drug_name: the name of the drug discussed in the context, a string feature.
  • disease_name: the name of the disease discussed in relation to the drug within the context, a string feature.

Citation

BibTeX:

@article{SHINGJERGJI2021103902,
title = {Relation extraction from DailyMed structured product labels by optimally combining crowd, experts and machines},
journal = {Journal of Biomedical Informatics},
volume = {122},
pages = {103902},
year = {2021},
issn = {1532-0464},
doi = {https://doi.org/10.1016/j.jbi.2021.103902},
url = {https://www.sciencedirect.com/science/article/pii/S1532046421002318},
author = {Krist Shingjergji and Remzi Celebi and Jan Scholtes and Michel Dumontier},
keywords = {Drug-disease relation classification, Drug indications, Drug data quality, Drug repositioning, Weak supervision, Programmatic labeling, Crowdsourcing, Human-in-the-loop, Machine learning},
}

APA:

  • Shingjergji, K., Celebi, R., Scholtes, J., & Dumontier, M. (2021). Relation extraction from DailyMed structured product labels by optimally combining crowd, experts and machines. Journal of Biomedical Informatics, 122, 103902. https://doi.org/10.1016/j.jbi.2021.103902

Dataset Card Authors

@phucdev

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