um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg(
1.1)
1.1
Partial-Onset Seizures
MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
INDICATIONS AND USAGE
CatapresTTS transdermal therapeutic system is indicated in the treatment of hypertension.
It may be employed alone or concomitantly with other antihypertensive agents.
1 INDICATIONS & USAGE
HIV-1 Treatment (1.1) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (1.2): Emtricitabine and Tenofovir Disoproxil Fumarate is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tabletsare indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].
1.2 HIV-1 Pre-Exposure Prophylaxis(PrEP)
Emtricitabine and tenofovir disoproxil fumarate tabletsare indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
1. INDICATIONS AND USAGE
Ranolazine extended-release tablets is indicated for the treatment of chronic angina.
Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine extended-release tablets are antianginal indicated for the treatment of chronic angina. (
1)
INDICATIONS:
Vitrexyl + Iron is indicated for the treatment of iron deficiency anemia
and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive
blood loss and advanced age.Also for treatment of condition in which iron deficiency and
vitamin C deficiency occur together, alongwith a deficient intake or increased need for
B-Complex vitamins in chronic and acute illness, as well ascases of metabolic stress, and in
convalescence.
1 INDICATIONSAND USAGE
Adults
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Treatment of PAH in Pediatric Patients (Ages 1-17) information is approved for Viatris Specialty LLCs Revatio (Sildenafil) for oral suspension. However, due to Viatris Specialty LLCs marketing exclusivity rights, this drug product is not labeled with this information.
Adults
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
(1)
1 INDICATIONS AND USAGE
Microgestin 24 Fe is a progestin/estrogen COC indicated for use by women to prevent pregnancy. (1)
The efficacy of Microgestin 24 Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated. (1, 8.8)
Microgestin 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Microgestin 24 Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
1 INDICATIONS AND USAGE
Calcitonin Salmon Nasal Solution is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated. (1.1)
Limitations of Use:
Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis. (1.2, 5.4)
Calcitonin Salmon Nasal Solution has not been shown to increase bone mineral density in early postmenopausal women. (1.2)
1.1 Treatment of Postmenopausal Osteoporosis
Calcitonin Salmon Nasal Solution is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Calcitonin Salmon Nasal Solution should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
1.2 Important Limitations of Use
Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see WARNINGS and PRECAUTIONS (5.4)].
Calcitonin Salmon Nasal Solution has not been shown to increase spinal bone mineral density in early postmenopausal women.
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for:
Schizophrenia (
14.1)
Irritability Associated with Autistic Disorder (
14.4)
Treatment of Tourettes disorder (
14.5)
1 INDICATIONS AND USAGE
Topotecan Hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of:
Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent (
1.1)
Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent (
1.2)
Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin (
1.3)
1.1 Ovarian Cancer
Topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy.
1.2 Small Cell Lung Cancer
Topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
1.3 Cervical Cancer
Topotecan hydrochloride for injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
INDICATIONS AND USAGE
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.
Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
1	INDICATIONS AND USAGE
Tolvaptan is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Tolvaptan tablets are a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) (1)
Limitations of use:
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets (1)
It has not been established that tolvaptan tablets provide a symptomatic benefit to patients (1)
Limitations of Use
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan.
It has not been established that raising serum sodium with tolvaptan provides a symptomatic benefit to patients.
INDICATIONS & USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis
e.g., insulin in uncomplicated diabetes, blood volume
restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial
e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
1 INDICATIONS AND USAGE
Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients (
1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients (
1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
[see
Clinical Studies (14.1)]
.
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney, heart, andkidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
[see
Clinical Studies (14.1)]
.
1.2 Pediatric Patients
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk
[see
Clinical Studies (14.2)]
.
1.INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)
]
CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1Osteoarthritis (OA)
CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)
]
1.2Rheumatoid Arthritis (RA)
CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)
]
1.3 Juvenile Rheumatoid Arthritis (JRA)
CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)
]
1.4Ankylosing Spondylitis (AS)
CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)
]
1.5Acute Pain (AP)
CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)
]
1.6Primary Dysmenorrhea (PD)
CELEBREX is indicated for the treatment of PD [see Clinical Studies (14.5)
]
INDICATIONS AND USAGE
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.
This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli,
Haemophilus
influenzae
,
Klebsiella
/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia
marcescens
and Streptococci, including Streptococcus pneumoniae.
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 AND USAGE
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
Metoclopramide Injection, USP is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
The Prevention of Postoperative Nausea and Vomiting
Metoclopramide Injection, USP is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
Small Bowel Intubation
Metoclopramide Injection, USP may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
Radiological Examination
Metoclopramide Injection, USP may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine
INDICATIONS AND USAGE
IMODIUM (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. IMODIUM is also indicated for reducing the volume of discharge from ileostomies.
1 INDICATIONS AND USAGE
Levetiracetam tablets USP are indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients one month of age and
older with epilepsy (
1.1)
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 tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Indications and Usage
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.
1 INDICATIONS AND USAGE
Naproxen delayed-release tablets are indicated for:
The relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen delayed-release tablets are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
1.	INDICATIONS AND USAGE
CARDIOLITE is a myocardial perfusion agent indicated for:
detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects)
evaluating myocardial function and developing information for use in patient management decisions
Myocardial Imaging:
CARDIOLITE, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. CARDIOLITE evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).
It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.
Breast Imaging:
MIRALUMA, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.
MIRALUMA is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
INDICATIONS AND USAGE
Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
INDICATIONSAND USAGE
Milrinone Lactate in 5% Dextrose Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.