um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa Staphylococcus aureus, and Streptococcus pneumoniae.
INDICATIONS AND USAGE
Dipyridamole Tablets, USP are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
INDICATIONS AND USAGE
Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).
1 INDICATIONS AND USAGE
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1)
USES:
EXTREME SKIN DISCOLORATION AND DARK SPOTS.
1 INDICATIONSAND USAGE
Dutasteride capsules is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride capsulesin combination with the alpha adrenergic antagonist, tamsulosin,are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: Dutasteride capsulesare not approved for the prevention of prostate cancer. (1.3)
1.1 Monotherapy
Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination With Alpha Adrenergic Antagonist
Dutasteride capsules in combination with the alpha adrenergic antagonist, tamsulosin, are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
Dutasteride capsules are not approved for the prevention of prostate cancer.
1 INDICATIONSAND USAGE
Tizanidine hydrochloride capsulesareindicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
Tizanidine hydrochloride capsulesare a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis.
INDICATIONS AND USAGE
Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.
INDICATIONS AND USAGE
For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.For use in temporary treatment of opioid dependence in patients unable to take oral medication.Outpatient maintenance and outpatient detoxification treatment may be provided only by opioid treatment programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of hospitalization, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
NOTE: INJECTABLE METHADONE PRODUCTS ARE NOT APPROVED FOR THE OUTPATIENT TREATMENT OF OPIOID DEPENDENCE. IN THIS PATIENT POPULATION, PARENTERAL METHADONE IS TO BE USED ONLY FOR PATIENTS UNABLE TO TAKE ORAL MEDICATION, SUCH AS HOSPITALIZED PATIENTS.
1 INDICATIONS AND USAGE
Everolimus Tablets are kinase inhibitor indicated for the treatment of:
Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1)
Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5)
1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer
Everolimus Tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.
1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma
Everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.
1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
Everolimus tabletsare indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.
1. INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients who weigh
60 kg (1.3)
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
LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Limitations of Use
LEVEMIR is not recommended for the treatment of diabetic ketoacidosis.
LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus (1).
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis.
INDICATIONS AND USAGE
Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
INDICATIONS AND USAGE
Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
(see
WARNINGS: Cardiovascular Thrombotic Events,
Gastrointestinal Bleeding, Ulceration, and Perforation
).
Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses
(see
WARNINGS: Addiction, Abuse, and Misuse
),
reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions (5.2)]. ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV Patient Care Program. To enroll, call 1-877-772-9390.
ZYPREXA RELPREVV is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.(1.1)
Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults.(14.1)
1.1 Schizophrenia
ZYPREXA RELPREVV is indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults [see Clinical Studies (14.1)].
INDICATIONS AND USAGE
MSC123D - For collection of up to 210 mL of umbilical cord blood. Use aseptic technique.
1 INDICATIONS AND USAGE
Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 6 years of age and older [see Microbiology (12.4)
and Clinical Studies (14)].
Additional pediatric use information is approved for Janssen Products, LPs INTELENCE (etravirine) tablets. However, due to Janssen Products, LPs marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older. (1)
INDICATIONS AND USAGE
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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)4. Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia7. Respiratory diseases Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8. Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9. Neoplastic diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood10. Edematous states. To induce a diuresis or remission of proteinuria in the nephritic 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 colitisRegional enteritis12. Nervous system. Acute exacerbations of multiple sclerosis13. MiscellaneousTuberculous meningitis with sub-arachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
INDICATIONS AND USAGE
P32 sodium phosphate is indicated for the treatment of polycythemia vera and is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. It may also be used in the palliative treatment of selected patients with multiple areas of skeletal metastases
Mechanism of Action
Radioactive phosphorous concentrates to a very high degree in rapidly proliferating tissues
INDICATIONS AND USAGE
Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1 INDICATIONS AND USAGE
FOSAMAX PLUS D is indicated for:
FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for:
Treatment of osteoporosis in postmenopausal women (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. (1.3)
The optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis.
1.1 Treatment of Osteoporosis in Postmenopausal Women
For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
1.2 Treatment to Increase Bone Mass in Men with Osteoporosis
1.3 Important Limitations of Use
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.
The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
1 INDICATIONS AND USAGE
Enoxaparin sodium injection is a low molecular weight heparin [LMWH] indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (1.3)
Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (1.4)
1.1 Prophylaxis of Deep Vein Thrombosis
Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see
Clinical Studies (14.1)
]
in patients undergoing hip replacement surgery, during and following hospitalization
in patients undergoing knee replacement surgery
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
1.2 Treatment of Acute Deep Vein Thrombosis
Enoxaparin sodium injection is indicated for:
the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin sodium injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Indomethacin extended-release capsules have been found effective in active stages of the following:
1.Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2.Moderate to severe ankylosing spondylitis. 3.Moderate to severe osteoarthritis. 4.Acute painful shoulder (bursitis and/or tendinitis).
Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.
Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See
PRECAUTIONS,Drug Interactions
).
INDICATIONS AND USAGE
Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the
Squamous Cell Carcinoma
Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer.
Lymphomas
Hodgkin's disease, non-Hodgkin's lymphoma.
Testicular Carcinoma
Embryonal cell, choriocarcinoma, and teratocarcinoma.
Bleomycin for Injection, USP has also been shown to be useful in the management of:
Malignant Pleural Effusion
Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are 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 anadjunct 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.
INDICATIONS & USAGE
Selegiline hydrochloride capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.
Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving
levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
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INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for: - Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
- Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2 )
- Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
- Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)