um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Methylprednisolone tablets are indicated in the following conditions:
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
Psoriatic arthritis
EpicondylitisAcute gouty arthritis
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme
(Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Serum sickness
Contact dermatitis
Bronchial asthma
Atopic dermatitis
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Keratitis
Optic neuritis
Allergic conjunctivitis
Chorioretinitis
Iritis and iridocyclitis
Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
Nervous System
Acute exacerbations of multiple sclerosis
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
INDICATIONS AND USAGE
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin Injection, USP 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 antibiotic-associated pseudomembranous colitis, as described in the
BOXED WARNING
, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes,
Streptococcus pneumoniae, other streptococci (except
E. faecalis), and
Staphylococcus aureus.
Skin and skin structure infections caused by
Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by
Staphylococcus aureus, streptococci (except
Enterococcus faecalis), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by
Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection, USP and other antibacterial drugs, Clindamycin Injection, USP 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.
Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
CLOSE
1 INDICATIONS AND USAGE
Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine oral suspension is indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics:
oMonotherapy in the treatment of partial-onset seizures in children 4 to 16 years
oAdjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years (1)
Diltiazem hydrochloride extended-release capsules, USP
are indicated for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive medications.
Diltiazem
hydrochloride extended-release capsules, USP are indicated for the
management of chronic stable angina and angina due to coronary artery
spasm.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli,
Klebsiella species,
Enterobacter species,
Morganella morganii,
Proteus mirabilis and
Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprimtablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprimtablets are not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of
Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis
jiroveci
Pneumonia: For the treatment of documented
Pneumocystis
jiroveci pneumonia and for prophylaxis against
P.
jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
P.
jiroveci pneumonia.
Travelers Diarrhea in Adults: For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic
E. coli.
INDICATIONS AND USAGE
For the treatment of hypoglycemia:
Glucagon is indicated as a treatment for severe
hypoglycemia.
Because patients with type1
diabetes may have less of an increase in blood glucose levels compared with
a stable type2 patient, supplementary carbohydrate should be given as soon
as possible, especially to a pediatric patient.
For use as a diagnostic aid:
Glucagon is indicated as a diagnostic aid in the
radiologic examination of the stomach, duodenum, small bowel, and colon when
diminished intestinal motility would be advantageous.
Glucagon
is as effective for this examination as are the anticholinergic drugs. However,
the addition of the anticholinergic agent may result in increased side effects.
INDICATIONS AND USAGE
Bacterial Vaginosis (BV). Metronidazole extended-release 750 mg tablets are indicated in the treatment of BV in non-pregnant women.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole extended-release tablets and other antibacterial drugs, metronidazole extended-release tablets 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
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 nonsteroidal 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
Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (5.2).
1.1 Asthma
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast sodium chewable tablets are not indicated for the treatment of an acute asthma attack.
1 INDICATIONS AND USAGE
Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3)
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3)
Limitations of Use (1.4):
Do not use simultaneously with cyclosporine.
Intravenous use reserved for patients who can not tolerate capsules orally.
Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus inkidney transplant has not been established.
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that Tacrolimus be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [see Clinical Studies (14.1)]. Therapeutic drug monitoring is recommended for all patients receiving Tacrolimus Capsules USP [see Dosage and Administration (2.6)].
1.2 Prophylaxis of Organ Rejection in Liver Transplant
Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Tacrolimus be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)]. Therapeutic drug monitoring is recommended for all patients receiving Tacrolimus Capsules USP [see Dosage and Administration (2.6)].
1.3 Prophylaxis of Organ Rejection in Heart Transplant
Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Tacrolimus Capsules USP be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [see
Clinical Studies (14.3)]. Therapeutic drug monitoring is recommended for all patients receiving Tacrolimus Capsules USP [see
Dosage and Administration (2.6)].
1.4 Limitations of Use
Tacrolimus Capsules USP should not be used simultaneously with cyclosporine [see Dosage and Administration (2.5)].
Tacrolimus Injection should be reserved for patients unable to take Tacrolimus Capsules USP orally [see Dosage and Administration (2.1) and see Warnings and Precautions (5.11)].
Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of Tacrolimuswith sirolimus has not been established in kidney transplant [see Warnings and Precautions (5.12)].
INDICATIONS AND USAGE
Sulfasalazine tablets, USPare indicated:
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
for the prolongation of the remission period between acute attacks of ulcerative colitis.
1	INDICATIONS AND USAGE
DULERA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for:
Treatment of asthma in patients 5 years of age and older. (1.1)
Important Limitation of Use:
Not indicated for the relief of acute bronchospasm. (1.1)
1.1	Treatment of Asthma
DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older.
DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).
Important Limitation of Use:
DULERA is NOT indicated for the relief of acute bronchospasm.
INDICATIONS AND USAGE
For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F.
1 INDICATIONS AND USAGE
DEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for:
Healing of all grades of erosive esophagitis (EE). (1.1)
Maintenance of healed EE and relief of heartburn. (1.2)
Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3)
1.1	Healing of Erosive Esophagitis
DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.
1.2	Maintenance of Healed Erosive Esophagitis and Relief of Heartburn
DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.
1.3	Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease
DEXILANT is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
INDICATIONS AND USAGE
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide injection, USP (metoclopramide hydrochloride, USP) 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, USPis indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
The Prevention of Postoperative Nausea and Vomiting
Metoclopramide injection, USPis indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
Small Bowel Intubation
Metoclopramide injection, USPmay 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, USPmay 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.
1 INDICATIONS AND USAGE
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
Mupirocin Ointment USP, 2% is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated in adults 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated or are not expected to be tolerated.
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Tramadol hydrochloride is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (1).
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opiod combination products]:
Have not been tolerated or are not expected to be tolerated (1)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1)
Tramadol hydrochloride tablets should not be used for an extended period of times unless the pain remains severe enough to require an opiod analgesic and for which alternative treatment options continue to be inadequate.