um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Anastrozole tablets are an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (1.1)
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets (1.3)
1.1 Adjuvant Treatment
Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2 First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3 Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
1 INDICATIONS AND USAGE
Aripiprazole Orally Disintegrating Tablets, USPare indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
1 INDICATIONS AND USAGE
Lamotrigine tablet is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.
Epilepsymonotherapy in patients aged 16 years and older:
Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.
(1.1)
Bipolar Disorder : Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patientsaged 2 years and older:
partial seizures
primary generalized tonic-clonic (PGTC) seizures
generalized seizures of Lennox-Gastaut syndrome
Monotherapy
Lamotrigine tablets are indicated for conversion to monotherapy in adults (16 years of age) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine tablets are have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression,mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies
(14.1)
].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1 INDICATIONS AND USAGE
Topiramate is an antiepileptic (AED) agent indicated for:
Monotherapy epilepsy: Initial monotherapy in patients
2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1)
Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2)
1.1	Monotherapy Epilepsy
Topiramatetablets, USPare indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2	Adjunctive Therapy Epilepsy
Topiramate tablets, USPare indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Trimethobenzamide hydrochloride capsules are indicated for the treatment of
postoperative nausea and vomiting and for nausea associated with
gastroenteritis.
1 INDICATIONS AND USAGE
Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. (1)
Limitations of Use
Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. (1)
Limitations of Use
Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
1 INDICATIONS AND USAGE
Droxidopa capsules indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.
Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (
1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (
1.2)
Preventive treatment of migraine in patients 12 years of age and older (
1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
INDICATIONS AND USAGE
Benazepril hydrochloride tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
In using benazepril hydrochloride tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see
WARNINGS
).
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.
INDICATIONS AND USAGE
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
1 INDICATIONS AND USAGE
Ondansetron is indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron
is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2. (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1)
postoperative nausea and/or vomiting. (1)
INDICATIONS AND USAGE
Dihydroergotamine Mesylate Injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
1 INDICATIONS AND USAGE
Ritonavir tabletsare indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Ritonavir tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection (1)
INDICATIONS AND USAGE
For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest and profound hypotension.
1 INDICATIONS AND USAGE
DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
DICLEGIS has not been studied in women with hyperemesis gravidarum.
DICLEGIS is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (1)
1 INDICATIONS AND USAGE
Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see
Microbiology (12.4) and Clinical Studies (14)]
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 2 years of age and older. (1)
INDICATIONS AND USAGE:
Diclofenac Sodium Ophthalmic is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate capsules are indicated in adults for the:
short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks oftherapy.
short-term treatment (4 to 8 weeks) of active benign gastriculcer.
treatment of heartburn and other symptoms associated with GERD for up to 4weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy inadults.
The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established.If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may beconsidered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12months.
Omeprazole and sodium bicarbonate capsules are proton pump inhibitor (PPI).
Omeprazole and sodium bicarbonate capsules are indicated in adults for:
Treatment of active duodenal ulcer(1)
Treatment of active benign gastric ulcer(1)
Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD)(1)
Maintenance of healing of EE(1)
1 INDICATIONS AND USAGE
Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) postoperative nausea and/or vomiting. (1.2)
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron Injection is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes.
Ondansetron Injection is approved for patients aged 1 month and older.
INDICATIONS AND USAGE
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surfaceocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, causedby susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus pneumoniae, Streptococcus
virida
ns
,
Haemophilus
influenzae and
Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Methadone Hydrochloride Oral Solution is indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.2)], reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use:
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see
Dosage and Administration (2.1)
].
Methadone Hydrochloride Oral Solution is an opioid agonist indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long acting opioids, reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use:
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12. (2.1)
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See
CONTRAINDICATIONS, WARNINGS
and
ADVERSE REACTIONS.
)
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Acute Pain in Adult Patients
Ketorolac tromethamine is 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 intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine 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 therapy is not to exceed 5 days.
1
INDICATIONS AND USAGE
AmlodipineBesylate and Benazepril Hydrochloride Capsules area combination capsuleof amlodipine, a dihydropyridine calcium channel blocker (DHPCCB) and benazepril, anangiotensin converting enzyme (ACE) inhibitor. AmlodipineBesylate and Benazepril Hydrochloride Capsules areindicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1)
1.1
Hypertension
AmlodipineBesylate and Benazepril Hydrochloride Capsulesare indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
1 INDICATIONS AND USAGE
Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.
Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease. (1)
INDICATIONS AND USAGE
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, and serum sickness.
Dermatologic Diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and 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, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous
Diagnostic testing of adrenocortical hyperfunction, 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, craniotomy, or head injury.
Ophthalmic Diseases
Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal Diseases
To induce a 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.
1. INDICATIONS AND USAGE
Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochlorideis an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1)