um-ids/dailymed-annotations huggingface dataset:
Indications and Usage Section
1.1 Respiratory Tract Infections
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Please review the manufacturer's complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91
INDICATIONS AND USAGE
Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension
This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patients needs, therapy with the fixed combination may be more convenient than with the separate components.
1 INDICATIONS AND USAGE
Levetiracetam oral solution is indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patientsone monthof age and older with epilepsy (
1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (
1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (
1.3)
1.1 Partial Onset Seizures
Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE, GENERALOral/Body Cavity Use
OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.4 to 3 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.
Adults
OMNIPAQUE 350 is indicated in adults for arthrography and oral pass-thru examination of the gastrointestinal tract.
OMNIPAQUE 300 is indicated in adults for arthrography and hysterosalpingography. OMNIPAQUE diluted to concentrations from 6 mg Iodine/mL to 9 mg Iodine/mL administered orally in conjunction with
OMNIPAQUE
300
at
a
concentration
of
300
mg Iodine/mL
administered intravenously is indicated in adults for contrast enhanced computed tomography of the abdomen.
Pediatric Patients
OMNIPAQUE 300 is indicated in pediatric patients for examination of the gastrointestinal tract.
OMNIPAQUE diluted to concentrations from 50 mg Iodine/mL to 100 mg Iodine/mL is indicated in pediatric patients for voiding cystourethrography.
OMNIPAQUE diluted to concentrations from 9 mg Iodine/mL to 21 mg Iodine/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL administered intravenously are indicated in pediatric patients for use in contrast enhanced computed tomography of the abdomen.
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.
1 INDICATIONS AND USAGE
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablet is indicated for the treatment of hypertension.
Enalapril maleate tablet is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.
Heart Failure
Enalapril maleate tablet is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablet improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate tablet decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).
In using enalapril maleate 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 enalapril maleate tablet does not have a similar risk (see WARNINGS).
In considering use of enalapril maleate 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, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS,
Head and Neck Angioedema
).
INDICATIONS AND USAGE
Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions.
Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.
INDICATIONS AND USAGE
Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving Milrinone Lactate Injection should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
INDICATIONS AND USAGEIntrathecal
OMNIPAQUE 300 is indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography).
1
INDICATIONS & USAGE
Heparin Sodium Injection, USP is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;
Atrial fibrillation with embolization;
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
INDICATIONS
AND
USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine
HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and
Phenazopyridine
HCl should be
discontinued when symptoms
arecontrolled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is,however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See
DOSAGE AND ADMINISTRATION section.)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac sodium delayed-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. (1.1)
1.1 Hypertension
CARDENE I.V. (nicardipine hydrochloride) is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)].
1 INDICATIONSAND USAGE
Tamsulosin hydrochloride capsules USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see
Clinical Studies (
14)]. Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules USP are an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (
1)
Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension (
1)
1 INDICATIONS AND USAGE
Decitabine for Injectionis indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for Injectionis a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
1 INDICATIONS AND USAGE
Celecoxib capsules are indicated
Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [
see Clinical Studies (
14.1)
]
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [
see Clinical Studies (
14.2)
]
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [
see Clinical Studies (
14.3)
]
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [
see Clinical Studies (
14.4)
]
1.5 Acute Pain
For the management of acute pain in adults [
see Clinical Studies (
14.5)
]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see Clinical Studies (
14.5)
]
1 INDICATIONS AND USAGE
Tazarotene gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (
1.1)
Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (
1.2)
Limitations of Use
The safety of tazarotene gel use on more than 20% body surface area has not been established. (
1.3)
1.1 Plaque Psoriasis
Tazarotene gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.
1.2 Acne Vulgaris
Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.
The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.
1.3 Limitations of Use
The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne
[see Warnings and Precautions (
5.1) and Use in Specific Populations (
8.1)].
INDICATIONS AND USAGE
ADTHYZA (thyroid tablets, USP) are indicated:
As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS).
As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.
Hypertension
Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
INDICATIONS AND USAGE
Bleomycin for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents:
Squamous Cell Carcinoma:
Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin for injection is poorer in patients with previously irradiated head and neck cancer.
Lymphomas:
Hodgkin's disease, non-Hodgkin's lymphoma.
Testicular Carcinoma:
Embryonal cell, choriocarcinoma, and teratocarcinoma.
Bleomycin for injection has also been shown to be useful in the management of:
Malignant Pleural Effusion:
Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
1 INDICATIONS AND USAGE
Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1).
INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting or dissolving drugs
for intravenous, intramuscular or subcutaneous injection, according to
instructions of the manufacturer of the drug to be administered.
PURPOSE:
RX STRENGTH TOPICAL RETINOID FOR TREATMENT OF ACNE, SHAVING BUMPS, AND SPECIFIC BUMPY SKIN PROBLEMS. LEAVES SKIN SMOOTH, CLEAR AND NEW.
uSES: ACNE AND SPECIFIC SKIN CONDITIONS.
1 INDICATIONS AND USAGE
Sorafenib is a kinase inhibitor indicated for the treatment of
Unresectable hepatocellular carcinoma (1.1)
Advanced renal cell carcinoma (1.2)
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3)
1.1 Hepatocellular Carcinoma
Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
1.2 Renal Cell
Carcinoma
Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
1.3 Differentiated
Thyroid Carcinoma
Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
INDICATIONS FOR USE Hypertensa is intended for the clinical dietary management of the metabolic processes in patients with hypertension.
Indications and Directions
Indications: Topical anti-carie preparation
Directions:
Following prophylaxis treatment, fill 1/3 of tray with gel
Insert tray in the patient's mouth
Have patient bite down lightly for 60 seconds
Remove tray and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after the application
Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
1 INDICATIONS AND USAGE
FARXIGA (dapagliflozin) is indicated:
To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
FARXIGA is not recommended for patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
FARXIGA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective in this setting based upon its mechanism of action.
FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations.
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated:
To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. (1)
To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. (1)
To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. (1)
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of use:
Not for treatment of type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. (1)
Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. FARXIGA is not expected to be effective in these populations. (1)
1 INDICATIONS AND USAGE
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium Chloride is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (
1)