um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1.1, 1.3) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. (1.2)
1.1 Heart Failure in Adults
Digoxin Oral Solution USP is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
1.2 Heart Failure in Pediatric Patients
Digoxin is indicated to increase myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults
Digoxin Oral Solution USP is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation. Digoxin should not be used for the treatment of multifocal atrial tachycardia.
1 INDICATIONS AND USAGE
Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
Epoprostenol sodium is a prostanoid vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablet, (XL) is an aminoketone antidepressant, indicated for
treatment of major depressive disorder (MDD) (1.1)
prevention of seasonal affective disorder (SAD) (1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see
Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see
Clinical Studies (14.2)].
INDICATIONS AND USAGE:
Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
1 INDICATIONS AND USAGE
Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)].
Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) (1).
1 INDICATIONS AND USAGE
DHIVY is indicated for the treatment of Parkinsons disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
DHIVY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinsons disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
1 INDICATIONS AND USAGE
Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride orally disintegrating tablets, USP are 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
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
For the treatment of urinary tract infections due to susceptible strains of the following organisms: species, species, and . It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Urinary Tract Infections:
Escherichia coli, Klebsiella
Enterobacter
Morganella morganii, Proteus mirabilis
Proteus vulgaris
For the treatment of acute otitis media in pediatric patients due to susceptible strains of or when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Otitis Media:
Streptococcus pneumoniae
Haemophilus influenzae
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of or when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.
Acute Exacerbations of Chronic Bronchitis in Adults:
Streptococcus pneumoniae
Haemophilus influenzae
For the treatment of enteritis caused by susceptible strains of and when antibacterial therapy is indicated.
Shigellosis:
Shigella flexneri
Shigella sonnei
For the treatment of documented pneumonia and for prophylaxis against pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing pneumonia.
Pneumocystis jiroveci Pneumonia:
Pneumocystis jiroveci
P. jiroveci
P. jiroveci
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic
Traveler's Diarrhea in Adults:
E. coli.
INDICATIONS
NEONATAL 19 is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia,
hydrOXYzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. HydrOXYzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydrOXYzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1. INDICATIONS AND USAGE
Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension ( )
1.1
Coronary Artery Disease ( )
1.2
Chronic Stable Angina
Vasospastic Angina (Prinzmetals or Variant Angina)
Angiographically Documented Coronary Artery
Disease in patients without heart failure or an ejection fraction < 40%
1.1. Hypertension
Amlodipine besylate tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
1.2. Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine besylate tablets, USP are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets, USP may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetals or Variant Angina)
Amlodipine besylate tablets, USP are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets, USP may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, USP are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
INDICATIONS:
Estradiol is indicated in the treatment of:
1. Estrogen deficiency in Hysterectomized Women.
(There is no evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause, and they should not be used to treat these conditions.)
2. Atrophic vaginitis.
3. Kraurosis vulvae.
4. Female hypogonadism.
5. Female castration.
6. Primary ovarian failure.
7. Breast cancer (for palliation only) in approximately selected women and men with metastatic disease.
8. Postpartum breast engorgement- Althoughestrogens have been widely used for the prevention of postpatum breast engorgement, controlled studies hve demonstrated that the incidence of significapainful engorgementin patients not receiving such hormonal therapy is low and usually responsive to appropriate analgesic or other supportive therapy. Consequently, the benefit to be derived from estrogen therapy for this indication must be carefully weighed against the potential increased risk or puerperal thromboembolism associated with the use of large doses of estrogen.
20,22
ESTRADIOL HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURIG PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).
1 INDICATIONS AND USAGE
Doxercalciferol
capsules are indicated for the treatment of secondary hyperparathyroidism
in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and
adult patients with CKD on dialysis.
Doxercalciferol Capsules is a synthetic vitamin D2 analog:
Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. (1)
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
1 INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for: Adjuvant Colon Cancer (1.1)
Patients with Dukes C colon cancer Metastatic Colorectal Cancer (1.1)
First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred Metastatic Breast Cancer (1.2)
In combination with docetaxel after failure of prioranthracycline-containing therapy
As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
1.1 Colorectal Cancer
Capecitabine tablets USP is indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent capecitabine in the adjuvant treatment of Dukes C colon cancer.
Capecitabine tablets USP are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with capecitabine tablets monotherapy. Use of capecitabine tablets USP instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
1.2 Breast Cancer
Capecitabine tablets USP in combination with docetaxel are indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Capecitabine tablets monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
1 INDICATIONS AND USAGE
Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. in adults and pediatric patients 4 years of age or older.
1 INDICATIONS AND USAGE
Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.
Alprazolam XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. (1)
Indications and Usage Section
Metformin hydrochloride extended - release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONSAND USAGE
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Meropenem for Injection, USP is a penem antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) Complicated intra-abdominal infections (adult and pediatric patients). (1.2) Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection, USP and other antibacterial drugs, Meropenem for Injection, USP should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1 ComplicatedSkin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection, USP is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis,
Bacteroides fragilis, and Peptostreptococcus species.
1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients)
Meropenem for Injection, USP is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection, USP is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae,
Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.
Meropenem for Injection, USP has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection, USP and other antibacterial drugs, Meropenem for Injection, USP should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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.
INDICATIONS AND USAGE
Levothyroxine sodium is used for the following indications:
As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Hypothyroidism
In the treatment or prevention of various types of euthyroid goiters (see and ), including thyroid nodules (see and ), subacute or chronic lymphocytic thyroiditis (Hashimotos thyroiditis), multinodular goiter (see and ) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Pituitary TSH Suppression
WARNINGS
PRECAUTIONS
WARNINGS
PRECAUTIONS
WARNINGS
PRECAUTIONS
Indications and Usage
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (
14.1)
].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1).
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1).
1 INDICATIONS & USAGE
Gabapentin Capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin Capsules are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy(1)
INDICATIONSAND USAGE
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.