um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
EMGALITY is a calcitonin-gene related peptide antagonist indicated in adults for the:
preventive treatment of migraine. (1.1)
treatment of episodic cluster headache. (1.2)
1.1 Migraine
EMGALITY is indicated for the preventive treatment of migraine in adults.
1.2 Episodic Cluster Headache
EMGALITY is indicated for the treatment of episodic cluster headache in adults.
INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
MAXZIDE (triamterene and hydrochlorothiazide) is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
MAXZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).
MAXZIDE may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since MAXZIDE (triamterene and hydrochlorothiazide) may enhance the actions of these drugs, dosage adjustments may be necessary.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
1 INDICATIONS AND USAGE
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the:
Treatment
of adults and pediatric patients with acute lymphoblastic leukemia (ALL)
as part of a combination chemotherapy
maintenance regimen (
1.1)
Treatment
of adults with mycosis fungoides (
1.1)
Treatment
of adults with relapsed or refractory non-Hodgkin lymphoma as part of a
metronomic combination regimen (
1.1)
Treatment
of adults with rheumatoid arthritis (
1.2)
Treatment
of pediatric patients with polyarticular juvenile idiopathic arthritis
(pJIA) (
1.3)
Treatment
of adults with severe psoriasis (
1.4)
1.1 Neoplastic Diseases
Methotrexate tablets are indicated for the:
treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen
treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen
1.2 Rheumatoid Arthritis
Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.
1.3 Polyarticular Juvenile Idiopathic Arthritis
Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.4 Psoriasis
Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
1. INDICATIONS AND USAGE
Bicalutamide Tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide Tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)].
Bicalutamide Tablets, USP 50 mg are an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide Tablets, USP 150 mg daily are not approved for use alone or with other treatments. (1)
INDICATIONS AND USAGE
Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
1 INDICATIONS AND USAGE
Allopurinol for injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.
Allopurinol for injection is a xanthine oxidase inhibitor indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. (1)
INDICATIONSAND USAGE
Trientine hydrochloride is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride and penicillamine cannot be considered interchangeable. Trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil 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.
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
UPPER RESPIRATORY TRACT
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains). (See CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to -lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific -lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing -lactamase inhibitors.
Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
LOWER RESPIRATORY TRACT
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
SKIN AND SKIN STRUCTURE
Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.
1 INDICATIONS AND USAGE
DIFFERIN Lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older.
DIFFERIN Lotion is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older.. (1)
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 is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1).
1 INDICATIONS AND USAGE
TUDORZA PRESSAIR (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)
INDICATIONS AND USAGE
When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows:
Allergic states
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Dermatologic diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases
To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
Hematologic disorders
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous
Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Neoplastic diseases
For the palliative management of leukemias and lymphomas.
Nervous System
Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.
Ophthalmic diseases
Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases
To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases
Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
1.1 Bronchospasm
VENTOLIN HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients aged 4 years and older.
1
INDICATIONS AND USAGE
Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
Epinephrine injection, USP auto-injector is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.
Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (1)
1 INDICATIONS AND USAGE
XANAX is indicated for the:
acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults.
XANAX is a benzodiazepine indicated for the:
Acute treatment of generalized anxiety disorder in adults. (1)
Treatment of panic disorder with or without agoraphobia in adults. (1)
INDICATIONS & USAGE
Herpes Zoster Infections:
Acyclovir capsulesis indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes:
Acyclovir capsules is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox:
Acyclovir capsules is indicated for the treatment of chickenpox (varicella).
INDICATIONS & USAGE SECTION
Terbinafine tablets, USP 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.
INDICATIONS AND USAGE
Famotidine tablets are indicated in:
1. . Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
Short term treatment of active duodenal ulcer
2.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3. . Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
Short term treatment of active benign gastric ulcer
4. Famotidine is indicated for short term treatment of patients with symptoms of GERD (see ).
Short term treatment of gastroesophageal reflux disease (GERD).
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see ).
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
5. ) (see ).
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
1 INDICATIONS AND USAGE
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.
Temsirolimus injection is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)
1 INDICATIONS AND USAGE
Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of testosterone gel 1.62% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established [see
Use in Specific Populations (8.4)
].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see
Indications and Usage (1)
, and
Clinical Pharmacology (12.3)
].
Testosterone gel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use:
Safety and efficacy of testosterone gel 1.62% in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established. (1, 8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1,12.3)
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Pregabalin is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
INDICATIONS AND USAGE
Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
1 INDICATIONSAND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablet is an HMG Co-A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1)Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.
Alfuzosin
hydrochloride extended-release tablets are not indicated for use in the pediatric population.
1 INDICATIONS AND USAGE
Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)].
Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (NSAID)ibuprofen and the histamine H2-receptorantagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. (1)