um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for:
Treatment of asthma in patients 6 years of age and older. (1.1)
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2)
Important limitations:
Not indicated for the relief of acute bronchospasm. (1.1, 1.2)
1.1 Treatment of Asthma
BREYNA is indicated for the treatment of asthma in patients 6 years of age and older.
BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).
Important Limitations of Use:
BREYNA is NOT indicated for the relief of acute bronchospasm.
1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease
BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
BREYNA 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD. BREYNA 160 mcg/4.5mcg is the only strength indicated for the treatment of COPD.
Important Limitations of Use:
BREYNA is NOT indicated for the relief of acute bronchospasm.
1 INDICATIONS AND USAGE
SPY AGENT GREEN is an optical imaging agent indicated for use with a fluorescence imaging device for:
Visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries including general minimally invasive surgical procedures in adults and pediatric patients one month of age and older. (1.1)
Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older. (1.2)
Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer. (1.3)
Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with breast cancer. (1.4)
1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion
SPY AGENT GREEN is indicated for fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients aged 1 month and older.
1.2 Visualization of Extrahepatic Biliary Ducts
SPY AGENT GREEN is indicated for fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older.
1.3	Lymphatic Mapping of Cervical and Uterine Cancer
SPY AGENT GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer for which this procedure is a component of intraoperative management.
1.4	Lymphatic Mapping of Breast Cancer
SPY AGENT GREEN is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.
INDICATIONS
Vitamin A injection is effective for the treatment of vitamin A deficiency.
The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the "Malabsorption Syndrome" with accompanying steatorrhea.
Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population.
Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.
INDICATIONS AND USAGE
Sodium ChlorideInjection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered.
Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters.
INDICATIONS & USAGE SECTION
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.3 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
1.4 Panic Disorder
Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1 INDICATIONS AND USAGE
Gabapentin capsules 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 capsulesare 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)
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.
INDICATIONS AND USAGE
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
INDICATIONS AND USAGE:
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
INDICATIONS
PAREMYD Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD provides clinically significant mydriasis with partial cycloplegia.
INDICATIONS AND USAGE
Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
INDICATIONS AND USAGE:
Folic acid is effective in the treatment of megaloblastic anemias due to deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
1 INDICATIONS AND USAGE
Epirubicin Hydrochloride Injection is an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer (
1).
Epirubicin Hydrochloride Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [
see Clinical Studies (14.1)]
.
Intramuscular
Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use 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 and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, 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 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, temporal arteritis, 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, polymyositis, and systemic lupus erythematosus.
Intra-Articular
The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
INDICATIONS AND USAGE
Desonide lotion is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
INDICATIONS AND USAGE
Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
1 INDICATIONSAND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloridecarbonic anhydrase inhibitor and timolol maleate a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
1 INDICATIONS AND USAGE
ZOLEDRONIC ACID Injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. ( 1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.( 1.2)
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12mg/dL [3.0mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL+0.8 (4.0 g/dL - patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets are indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days
INDICATIONS AND USAGE
Asthma
FORADIL AEROLIZER is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.
Long-acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death (see WARNINGS). Use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Pediatric and Adolescent Patients
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients (see WARNINGS). For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
Exercise-Induced Bronchospasm
FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 5 years of age and older, when administered on an occasional, as-needed basis.
Use of FORADIL AEROLIZER as a single agent for the prevention of exercise-induced bronchospasm may be clinically indicated in patients who do not have persistent asthma.
In patients with persistent asthma, use of FORADIL AEROLIZER for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.
Chronic Obstructive Pulmonary Disease
FORADIL AEROLIZER is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema.
Shigellosis:
For the treatment of enteritis caused by susceptible strains of Shigella flexneriand Shigella sonnei when antibacterial therapy is indicated.
1 INDICATIONS AND USAGE
FROVA is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with FROVA, reconsider the diagnosis of migraine before FROVA is administered to treat any subsequent attacks.
FROVA is not indicated for the prevention of migraine attacks.
Safety and effectiveness of FROVA have not been established for cluster headache.
FROVA is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
Indications and Usage: Nestabs is indicated
for use in improving the nutritional status of women throughout
pregnancy and in the postnatal period for both lactating and
nonlactating mothers. Nestabs is also beneficial in improving the
nutritional status of women prior to conception.
1 INDICATIONS AND USAGE
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of:
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 for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures patients12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients6 years of age and older with idiopathic generalized epilepsy.
1
INDICATIONS AND USAGE
Entecavir Tablets USP are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (
1)
1 INDICATIONS AND USAGE
ENTYVIO is indicated in adults for the treatment of:
moderately to severely active ulcerative colitis.
moderately to severely active Crohn's disease.
ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of:
moderately to severely active ulcerative colitis. (1)
moderately to severely active Crohn's disease. (1)
1. Indications and Usage
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets 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 (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets 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 are indicated for maintenance of healing of EE 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 are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE
Meperidine is indicated for the relief of moderate to severe pain.