um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic.Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children.
INDICATIONS
Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD). (1.1)
Risk reduction of NSAID-associated gastric ulcer. (1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-release Capsules is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole Magnesium Delayed-release Capsules is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole Magnesium Delayed-release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-release Capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole Magnesium Delayed-release Capsules is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
INDICATIONSAND USAGE
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
INDICATIONS AND USAGE
Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.
Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage.This product is highly palatable, pleasant tasting,and tolerable, even when a administered for long periods.
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings:
FLUDEOXYGLUCOSE F 18 INJECTION USP is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology:
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1	Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2	Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3	Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS AND USAGE
Hyoscyamine Sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of colic (elixir and drops). Hyoscyamine Sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a "drying agent" in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
INDICATIONS AND USAGE
Hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.
1 INDICATIONS AND USAGE
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. (1)
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants (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).
1 INDICATIONS AND USAGE
Zorcaineis indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
Zorcaineis a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. in adults and pediatric patients 4 years of age or older.
1
INDICATIONS AND USAGE
DOJOLVIis indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
DOJOLVIis amedium-chain triglyceride indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
INDICATIONS AND USAGE
Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3
INDICATIONS AND USAGE
Mephyton is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.
Mephyton tablets are indicated in:
anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
hypoprothrombinemia secondary
to antibacterial therapy;
hypoprothrombinemia secondary to administration of salicylates;
hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.
Indications and Usage Section
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Etodolac tablets are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium extended release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals
(see
WARNINGS;
Gastrointestinal Bleeding, Ulceration, and Perforation
)
.
Diclofenac sodium extended-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Heparin sodium injection is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;
Atrial fibrillation with embolization;
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism.
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
Heparin sodium injection is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
Atrial fibrillation with embolization
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures
1	INDICATIONS AND USAGE
JELMYTO is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). (1)
1
INDICATIONS AND USAGE
SUSTIVA (efavirenz) in combination
with other antiretroviral agents is indicated for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection. This indication is based on two clinical trials
of at least one year duration that demonstrated prolonged suppression of HIV
RNA
[see Clinical Studies
(14)
].
SUSTIVA
is a non-nucleoside reverse transcriptase inhibitor indicated in combination
with other antiretroviral agents for the treatment of human immunodeficiency
virus type 1 infection. (1)
1	INDICATIONS AND USAGE
BYETTA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
Not a substitute for insulin. BYETTA should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis (1.2).
Concurrent use with prandial insulin has not been studied and cannot be recommended (1.2).
Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis (1.2).
1.1	Type 2 Diabetes Mellitus
BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.2	Important Limitations of Use
BYETTA is not a substitute for insulin. BYETTA should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
The concurrent use of BYETTA with prandial insulin has not been studied and cannot be recommended.
Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.
INDICATIONS & USAGE
Torsemide tablet is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. Torsemide tablets are indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women.(1.1)
Limitations of UseOptimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2)
1.1 Treatment of Postmenopausal Osteoporosis
Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14)].
1.2 Important Limitations of Use
The safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year 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. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS & USAGE
Clopidogrel is a P2Y
12 platelet inhibitor indicated for:
Acute coronary syndrome
-For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin.
Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel is indicated to reduce the rate of MI and stroke.
1 INDICATIONSAND USAGE
Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for:
First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1)
Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1)
1 INDICATIONS AND USAGE
NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. (1)
1 INDICATIONS AND USAGE
Temozolomide capsules are an alkylating drug indicated for the treatment of adult patients with:
Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1)
Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2)
1.1 Newly Diagnosed Glioblastoma
Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
1.2 Refractory Anaplastic Astrocytoma
Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
INDICATION & USAGE
Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (
see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).