um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Methylprednisolone Tablets are indicated in the following conditions:
1. 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 hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
Psoriatic arthritis
Epicondylitis
Acute gouty arthritis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Serum sickness
Contact dermatitis
Bronchial asthma
Atopic dermatitis
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Keratitis
Optic neuritis
Allergic conjunctivitis
Chorioretinitis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. 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.
11.Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets, USP areindicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of 40% (with or without symptomatic heart failure) [see Clinical Studies 14.2)].
1.3 Hypertension
Carvedilol tablets, USP are indicated for the management of essential hypertension [see Clinical tudies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
1 INDICATIONS AND USAGE
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (
1.1
1.5)
In combination for treatment of
H. pylori infection and duodenal ulcer disease. (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus species. (- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus
influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Escherichia coli, Proteus mirabilis, or
Enterococcus
faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H.
influenzae.
1.5
Helicobacter pylori Infection
Triple therapy for
Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for
H. pylori with lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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
Benign Prostatic Hyperplasia (BPH)
Doxazosin tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin tablets may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin tablet monotherapy. Doxazosin tablets provide rapid improvement in symptoms and urinary flow rate in 66% to 71% of patients. Sustained improvements with doxazosin tablets were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.
Hypertension
Doxazosin tablets are also indicated for the treatment of hypertension. Doxazosin tablets may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.
1 INDICATIONS AND USAGE
Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Limitations of Use
Therapy with megestrol acetate oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.
Megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss.
Megestrol acetate oral suspension is a progestin indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) (1).
INDICATIONS AND USAGE
Pentoxifylline Extended-Release Tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline Extended-Release Tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL)are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)
1.1 Major Depressive Disorder
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
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
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
1 INDICATIONS AND USAGE
HETLIOZ is a melatonin receptor agonist.
HETLIOZ capsules are indicated for the treatment of:
Non-24-Hour Sleep-Wake Disorder (Non-24) in adults (1)
Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in
patients 16 years of age and older (1)
HETLIOZ LQ oral suspension is indicated for the treatment of:
Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age (1)
1.1	Non-24-Hour Sleep-Wake Disorder (Non-24)
HETLIOZ capsules are indicated for the treatment of Non-24 in adults.
1.2	Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)
HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.
INDICATIONS:
Folitin-Z
TM
is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occurs together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
INDICATIONS AND USAGE
Sedative
Anticonvulsant
For the treatment of generalized and partial seizures.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets, USP are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets, USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
INDICATIONS AND USAGE
Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
INDICATIONS AND USAGE
Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) 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 the empiric selection of therapy.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see
CLINICAL STUDIES
). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (
1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (
1)
Diabetic peripheral neuropathic pain (DPNP) in adults (
1)
Fibromyalgia (FM) in adults (
1)
Chronic musculoskeletal pain in adults (
1)
1 INDICATIONS AND USAGE
Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. (1)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
BENDEKA injection is an alkylating drug indicated for treatment of patients with:
Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1)
Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2)
1.1 Chronic Lymphocytic Leukemia (CLL)
BENDEKA is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
1.2 Non-Hodgkin Lymphoma (NHL)
BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
1 INDICATIONS AND USAGE
DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)].
Important Limitations of Use
Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.5)].
DUETACT is a thiazolidinedione and a sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and glimepiride is appropriate. (1)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
INDICATIONS AND USAGE
Ranitidine Tablets, USP is indicated in:
1. Short-term treatment of active duodenal ulcer. Most patients
heal within 4 weeks. Studies available to date have not assessed the safety of
ranitidine in uncomplicated duodenal ulcer for periods of more than 8
weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced
dosage after healing of acute ulcers. No placebo-controlled comparative studies
have been carried out for periods of longer than 1 year.
3. The treatment of pathological hypersecretory conditions (e.g.,
Zollinger-Ellison syndrome and systemic mastocytosis).
4. Short-term treatment of active, benign gastric ulcer. Most
patients heal within 6 weeks and the usefulness of further treatment has not
been demonstrated.
Studies available to date have not assessed the safety of
ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6
weeks.
5. Maintenance therapy for gastric ulcer patients at reduced
dosage after healing of acute ulcers. Placebo-controlled studies have been
carried out for 1 year.
6. Treatment of GERD. Symptomatic relief commonly occurs within
24 hours after starting therapy with Ranitidine Tablets, USP 150 mg
b.i.d.
7. Treatment of endoscopically diagnosed erosive esophagitis.
Symptomatic relief of heartburn commonly occurs within 24 hours of therapy
initiation with Ranitidine Tablets, USP 150 mg q.i.d.
8. Maintenance of healing of erosive esophagitis.
Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients
with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states;
GERD; and erosive esophagitis.
1 INDICATIONS AND USAGE
Estarylla (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraceptive
Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)].
1 INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
mild to
severe chronic heart failure (
1.1)
left
ventricular dysfunction following myocardial infarction in clinically
stable patients(
1.2)
hypertension(
1.3)
1.1 Heart Failure
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [
see Drug Interactions (
7.4) and Clinical Studies (
14.1)
].
1.2 Left Ventricular Dysfunction following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [
see
Clinical Studies (
14.2)
].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [
see
Clinical Studies (
14.3,
14.4)]
. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [
see Drug Interactions (
7.2)]
.
1 INDICATIONS AND USAGE
Terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.
Terbinafine hydrochloride tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). (1)
INDICATIONS AND USAGE
Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.