um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
INDICATIONS AND USAGE:
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and the severity of adverse reactions associated with the recommended doses (see
WARNINGS,
PRECAUTIONS,
DOSAGE AND ADMINISTRATION,
and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see
DOSAGE AND ADMINISTRATION, Pharmaceutical Information for Ketorolac Tromethamine Injection
).
Indications & Usage
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following:
1.
Mild to moderate pain
2.
Osteoarthritis
3.
Rheumatoid arthritis
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders(previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children 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.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of 1 or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
1.8 Plague
Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to
Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see
CLINICAL STUDIES(
14.3)].
1 INDICATIONS AND USAGE
Paricalcitol capsules is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD) (1.2).
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
INDICATIONS
Sulfacetamide sodium and sulfur wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Ranolazine extended-release tablets are indicated for the treatment of chronic angina.
Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. (
1)
1INDICATIONS AND USAGE
SCEMBLIX is indicated for the treatment of adult patients with:
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).
Ph+ CML in CP with the T315I mutation.
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with:
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). (1)
Ph+ CML in CP with the T315I mutation. (1)
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older (
1.3).
1.1 Asthma
Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1
Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2
Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3
Limitations of Use
Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see Microbiology (12.4)].
Oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].
1 INDICATIONS & USAGE
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1)
1 INDICATIONS AND USAGE
Previfem (norgestimate and ethinyl estradiol tablets), are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraceptive
Previfem (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)].
INDICATIONS AND USAGE
Verapamil Hydrochloride Injection, USP is indicated for the following:
Rapid conversion to sinus rhythm of
paroxysmal supraventricular tachycardias, including those associated with
accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine
[L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers
(e.g., Valsalva maneuver) should be attempted prior to verapamil
hydrochloride administration.
Temporary control of rapid ventricular
rate in atrial flutter or atrial fibrillation except when the atrial
flutter and/or atrial fibrillation are associated with accessory bypass
tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L)
syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride.
Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole - see
CONTRAINDICATIONS and
WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation
facilities , including D.C.-cardioversion capability (see
ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.
1 INDICATIONS AND USAGE
Doxorubicin hydrochloride (HCl) is an anthracycline topoisomerase II inhibitor indicated:
as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. (1.1)
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma. (1.2)
1.1 Adjuvant Breast Cancer
Doxorubicin HCl is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)].
1.2 Other Cancers
Doxorubicin HCl is indicated for the treatment of:
acute lymphoblastic leukemia
acute myeloblastic leukemia
Hodgkin lymphoma
non-Hodgkin lymphoma (NHL)
metastatic breast cancer
metastatic Wilms' tumor
metastatic neuroblastoma
metastatic soft tissue sarcoma
metastatic bone sarcoma
metastatic ovarian carcinoma
metastatic transitional cell bladder carcinoma
metastatic thyroid carcinoma
metastatic gastric carcinoma
metastatic bronchogenic carcinoma
1 INDICATIONS AND USAGE
Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to:
reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1).
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1).
Limitations of Use (1.3):
Do not use for treatment oftype 1 diabetes or for diabetic ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V dyslipidemias.
improve glycemic control in adults with type 2 diabetes mellitus (1.2).
1.1
Primary Hyperlipidemia
Colesevelam hydrochloride for oral suspension is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
Colesevelam hydrochloride for oral suspension is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.
1.2 Type 2 Diabetes
Mellitus
Colesevelam hydrochloride for oral suspension is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.3 Limitations of Use
Colesevelam hydrochloride for oral suspension should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
Colesevelam hydrochloride for oral suspension has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
Hypertension:Captopril tablets, USP are indicated for the treatment of hypertension.
In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see
WARNINGS
).
Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
Heart Failure: Captopril tablets, USP are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.
Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets, USP are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.
Diabetic Nephropathy: Captopril tablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of captopril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS: Head and Neck Angioedema and Intestinal Angioedema
).
INDICATIONS AND USAGE
Sedative
AnticonvulsantFor the treatment of generalized and partial seizures.
INDICATIONS AND USAGE
Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
INDICATIONS AND USAGE
Amphetamine sulfate tablets, USP 5 mg and 10 mg 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 children with 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 the 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 not be warranted.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see
CLINICAL PHARMACOLOGY
) should be weighed against possible risks inherent in use of the drug, such as those described below.
1 INDICATIONS AND USAGE
Tetrabenazine tablets are indicatedforthetreatment of chorea associatedwith Huntingtons disease.
Tetrabenazineis avesicular monoaminetransporter 2(VMAT) inhibitor indicatedfor thetreatmentof choreaassociatedwith Huntingtonsdisease.(1)