um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the
WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II to III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (
1.1)
1.1 Pulmonary Arterial Hypertension
Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II to III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
INDICATIONS AND USAGE
Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
INDICATIONS AND USAGE
Duodenal Ulcer
ZEGERID with Magnesium Hydroxide is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Gastric Ulcer
ZEGERID with Magnesium Hydroxide is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer.)
Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
ZEGERID with Magnesium Hydroxide is indicated for the treatment of heartburn and other symptoms associated with GERD.
Erosive Esophagitis
ZEGERID with Magnesium Hydroxide is indicated for the short-term treatment (4-8weeks) of erosive esophagitis which has been diagnosed by endoscopy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)The efficacy of ZEGERID with Magnesium Hydroxide used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.
Maintenance of Healing of Erosive Esophagitis
ZEGERID with Magnesium Hydroxide is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.
INDICATIONS AND USAGE
Hypertension
Lisinopril tablet is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
Heart Failure
Lisinopril tablet is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.
Acute Myocardial Infarction
Lisinopril tablet is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers.
In using Lisinopril tablet, 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, and that available data are insufficient to show that Lisinopril tablet does not have a similar risk (See WARNINGS).
In considering the use of Lisinopril tablet, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).
INDICATIONS AND USAGE
Felbatol is not indicated as a first line antiepileptic
treatment (see
Warnings
). Felbatol is recommended for use only in those
patients who respond inadequately to alternative treatments and whose
epilepsy is so severe that a substantial risk of aplastic anemia and/or
liver failure is deemed acceptable in light of the benefits conferred by
its use.
If these criteria are met and the patient has been fully advised
of the risk, and has provided written acknowledgement,
Felbatol can be considered for either monotherapy or
adjunctive therapy in the treatment of partial seizures, with and
without generalization, in adults with epilepsy and as adjunctive
therapy in the treatment of partial and generalized seizures associated
with Lennox-Gastaut syndrome in children.
1 INDICATIONS AND USAGE
BYFAVO is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. (1)
INDICATIONS AND USAGE
Betamethasone dipropionate cream, 0.05% (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [
see Clinical Studies
(14)
].Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Tamsulosin hydrochlorideis an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia
(1)
Tamsulosin hydrochloridecapsules are not indicated for the treatment of hypertension
(1)
1 INDICATIONS AND USAGE
Vancomycin hydrochloride capsule is indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsule is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.
Vancomycin hydrochloride capsules is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: (1)
Clostridioides difficile-associated diarrhea
Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
Limitations of Use: (1) (5.1)
Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin hydrochloride injection must be given orally for these infections.
Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsule and other antibacterial drugs, vancomycin hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
Limitations of Use
Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsule must be given orally for these infections.
Orally administered vancomycin hydrochloride capsule is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsule and other antibacterial drugs, vancomycin hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
1.
Vaginal candidiasis (vaginal yeast infections due to Candida)
2.
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively
small numbers of patients, fluconazole tablets were also effective for the treatment of
Candida urinary tract infections, peritonitis, and systemic Candida infections including
candidemia, disseminated candidiasis, and pneumonia.
3.
Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal
meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
KEPPRA XR
is indicated for the treatment of partial-onset seizures in patients 12 years of age and older.
KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (
1)
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (
1)
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (
1)
Celecoxib is indicated
1.1 Osteoarthritis(OA)
For the management of the signs and symptoms of OA [ see CLINICAL STUDIES (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [ see CLINICAL STUDIES (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [ see CLINICAL STUDIES (14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [ see CLINICAL STUDIES (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [ see CLINICAL STUDIES (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [ see CLINICAL STUDIES (14.5)]
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.
1 INDICATIONS AND USAGE
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (1).
1 INDICATIONS AND USAGE
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (
1)
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
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (
1.1)
Levetiracetam tablets are indicated for adjunctive therapy for the treatment of:
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
tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
PYLERA is a combination antibacterial indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1)
1.1	Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease
PYLERA in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Indomethacin has been found effective in active stages of the following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
Moderate to severe ankylosing spondylitis.
Moderate to severe osteoarthritis.
Acute painful shoulder (bursitis and/or tendinitis).
Acute gouty arthritis.
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.
OphthalmicDiseases
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
Clopidogrel tablets are 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 tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke.
(1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke
(1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.
(1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are 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 tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are 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 tablets 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 tablets are indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Desoximetasone cream USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).