um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1)
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
Monotherapy
Fulvestrant Injection is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Combination Therapy
Fulvestrant Injection is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
1 INDICATIONS AND USAGE
Duloxetine is indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults and pediatric patients 13 years of age and older.
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 USP is 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 (1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)
Chronic musculoskeletal pain in adults (1)
INDICATIONS AND USAGE
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 cancer
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 arthritis	Post-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis
Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)
Dermatologic diseases
PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis
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 reactions
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 ophthalmia
Respiratory diseases
Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis
Hematologic disorders
Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia
Neoplastic diseases.
For palliative management of: Leukemias and lymphomas in adultsAcute leukemia of childhood
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.
Gastrointestinal diseases. To tide the patient over a critical period of the disease in:
Ulcerative colitisRegional enteritis
Nervous system. Acute exacerbations of multiple sclerosis
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
1 INDICATIONS & USAGE
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondaryhyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with:
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2).
1 INDICATIONS AND USAGE
AVODART 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.
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: AVODART is not approved for the prevention of prostate cancer. (1.3)
1.1 Monotherapy
AVODART (dutasteride) Soft Gelatin 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
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
AVODART is not approved for the prevention of prostate cancer.
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules 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 INDICATIONS AND USAGE
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after 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)
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] .
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
INDICATIONS AND USAGE
Malaria
Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria.
Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology).
Prior to prescribing hydroxychloroquine sulfate for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria).
Lupus Erythematosus
Hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1 INDICATIONS AND USAGE
Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist.
Aprepitant capsules are indicated
in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:
o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)
o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)
for prevention of postoperative nausea and vomiting (PONV) in adults (1.2)
Limitations of Use: (1.3)
Aprepitant has not been studied for treatment of established nausea and vomiting.
Chronic continuous administration of aprepitant is not recommended.
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.
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
1-receptor antagonist indicated for:
The relief of symptoms associated with perennial allergic rhinitis (
1.1)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (
1.2)
1.1 Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets
are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older.
1.2 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets
are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
1.4
Uncomplicated Skin and Skin Structure Infections
Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)].
INDICATIONS AND USAGE
OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
1 INDICATIONS AND USAGE
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Risperidone is an atypical antipsychotic agent indicated
for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term
treatment of acute manic or mixed episodes associated with Bipolar I Disorder in
adults (1.2)
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights;
this drug product is not labeled for use in pediatric patients with
schizophrenia or bipolar mania. (1.1, 1.2)
Treatment of irritability associated with autistic disorder in children and
adolescents aged 5-16 years (1.3)
1.1 Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of
schizophrenia [see Clinical Studies
(14.1)].
Adolescents
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights,
this drug product is not labeled for use in pediatric patients with
schizophrenia .Pediatric use information for the treatment of pediatric patients
with schizophrenia, 13 to 17 years of age, is approved for Janssen
Pharmaceuticals Corporations risperidone drug products.
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone tablets are indicated for the short-term treatment of acute manic
or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights,
this drug product is not labeled for use in pediatric patients with bipolar
mania. Pediatric use information for the treatment of pediatric patients with
bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals
Corporations risperidone drug products.
Combination Therapy
Adults
The combination of risperidone with lithium or valproate is indicated for the
short-term treatment of acute manic or mixed episodes associated with Bipolar I
Disorder [see Clinical Studies
(14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
Risperidone tablets are indicated for the treatment of irritability
associated with autistic disorder in children and adolescents aged 5-16 years,
including symptoms of aggression towards others, deliberate self-injuriousness,
temper tantrums, and quickly changing moods [see Clinical
Studies (14.4)].
1 INDICATIONS AND USAGE
ADVAIR HFA is indicated for treatment of asthma in adult and adolescent patients aged 12years and older. ADVAIR HFA 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 ICS and long-acting beta2-adrenergic agonist (LABA).
Limitations of Use
ADVAIR HFA is not indicated for the relief of acute bronchospasm.
ADVAIR HFA is a combination of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long-acting beta2adrenergic agonist (LABA), indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. (1)
Limitations of use: Not indicated for relief of acute bronchospasm. (1)
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS AND USAGE
Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES.)
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis,
Chlamydia trachomatis,
N. gonorrhoeae,
Candida albicans, and Herpes simplex virus should be ruled out.
1
INDICATIONS AND USAGE
QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (
14
)].
QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1)
1 INDICATIONS AND USAGE
SOGROYA is indicated for the:
Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
Replacement of endogenous GH in adults with growth hormone deficiency (GHD).
SOGROYA is a human growth hormone analog indicated for:
Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) (1).
Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (1).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS;
Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac potassium tablets are indicated:
for treatment of primary dysmenorrhea
for relief of mild to moderate pain
for relief of the signs and symptoms of osteoarthritis
for relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine Sublingual Tablets contain buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (
1)
Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1 INDICATIONS AND USAGE
SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14)].
Limitations of Use
The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. (1)
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. (1)
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only).
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance (1)