um-ids/dailymed-annotations huggingface dataset:
1. INDICATIONS AND USAGE
1.1 Induction of AnesthesiaSUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.
1.2 Maintenance of AnesthesiaSUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.
After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [See WARNINGS AND PRECAUTIONS (5.3) and CLINICAL STUDIES (14.5)].
Supraneis an inhalation agent indicated:
for induction and/or maintenance of anesthesia in adults (1.1)
for maintenance of anesthesia in pediatric patients following induction with agents other than Suprane and intubation.
1.1 Induction of Anesthesia in Adults
SUPRANE (desflurane, USP) is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe uppoer airway adverse events.
1.2 Maintenance of Anesthesia
SUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.
After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions
[see Warnings and Precautions (5.3) and Clinical Studies (14.5)].
1 INDICATIONS AND USAGE
Gadavist is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (1.1)
To assess the presence and extent of malignant breast disease in adult patients (1.2)
To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (1.3)
To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). (1.4).
1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)
Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
1.2 MRI of the Breast
Gadavist is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease.
1.3 Magnetic Resonance Angiography (MRA)
Gadavist is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease.
1.4 Cardiac MRI
Gadavist is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
INDICATIONS AND USAGE
The intra-articular or soft tissue administration
of
Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP)
is indicated as adjunctive therapy for short-term administration (to tide
the patient over an acute episode or exacerbation) in acute gouty arthritis,
acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis,
rheumatoid arthritis, synovitis, or osteoarthritis.
The intralesional administration of Kenalog-10 Injection is indicated for alopecia
areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated,
inflammatory lesions of granuloma annulare, lichen planus, lichen simplex
chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica
diabeticorum. Kenalog-10 Injection may also be useful in cystic tumors of
an aponeurosis or tendon (ganglia).
INDICATIONS AND USAGE
Anxiety Disorders:Alprazolam tablets are indicated for the management of anxiety
disorder (a condition corresponding most closely to the APA Diagnostic and
Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the
short-term relief of symptoms of anxiety. Anxiety or tension associated with the
stress of everyday life usually does not require treatment with an
anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive
anxiety and worry (apprehensive expectation) about two or more life
circumstances, for a period of six months or longer, during which the person has
been bothered more days than not by these concerns. At least 6 of the following
18 symptoms are often present in these patients: Motor
Tension (trembling, twitching, or feeling shaky; muscle tension, aches,
or soreness; restlessness; easy fatigability); Autonomic
Hyperactivity (shortness of breath or smothering sensations; palpitations
or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness
or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or
chills; frequent urination; trouble swallowing or lump in throat); Vigilance and Scanning (feeling keyed up or on edge;
exaggerated startle response; difficulty concentrating or mind going blank
because of anxiety; trouble falling or staying asleep; irritability). These
symptoms must not be secondary to another psychiatric disorder or caused by some
organic factor.
Anxiety associated with depression is responsive to alprazolam.
Panic Disorder:Alprazolam is also indicated for the treatment of panic disorder,
with our without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses
corresponded closely to the DSM-III-R/IV criteria for panic disorder (see
CLINICAL STUDIES).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic
attacks, ie, a discrete period of intense fear or discomfort in which four (or
more) of the following symptoms develop abruptly and reach a peak within 10
minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2)
sweating; (3) trembling or shaking; (4) sensations of shortness of breath or
smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or
abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9)
derealization (feelings or unreality) or depersonalization (being detached from
oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias
(numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam by systematic clinical
study are limited to four months duration for anxiety disorder and 4 to 10 weeks
duration for panic disorder; however, patients with panic disorder have been
treated on an open basis for up to 8 months without apparent loss of benefit.
The physician should periodically reassess the usefulness of the drug for the
individual patient.
1 INDICATIONS AND USAGE
HYCAMTIN capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.
HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC). (1)
1 INDICATIONS AND USAGE
LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi
[see Clinical Studies (14)].
LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi. (1)
1 INDICATIONS AND USAGE
Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Limitations of Use
Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older (1).
Limitations of Use
Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
INDICATIONS AND USAGE
Prednisone tablets, USPare 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
De
rmatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
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, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Respiratory Diseases
Symptomatic sarcoidosis; Loefflers syndrome not manageable by other means; berylliosis; 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.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
1 INDICATIONS AND USAGE
SPRYCEL (dasatinib) is indicated for the treatment of adult patients with
newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with
Ph+ CML in chronic phase.
newly diagnosed Ph+ ALL in combination with chemotherapy.
SPRYCEL is a kinase inhibitor indicated for the treatment of
newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1, 14)
adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1, 14)
adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1, 14)
pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1, 14)
pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1, 14)
Hypertension
Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.
1 INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassiumis indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by betalactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections - caused by betalactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Amoxicillin and Clavulanate Potassiumis a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a betalactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassiumshould not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassiumand other antibacterial drugs, Amoxicillin and Clavulanate Potassiumshould be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassiumshould not be used.
Usage
To reduce the development of drugresistant bacteria and maintain the effectiveness ofAmoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassiumshould 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
Ranolazine extended-release tablets are 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 AND USAGE
Pentazocine Hydrochloride and Acetaminophen Tablets are indicated for the relief of mild to moderate pain.
INDICATIONS AND USAGE
Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
INDICATIONS AND USAGE
Supplementation of the diet with vitamins A, C and D.Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride forcaries prophylaxis.
The American Academy of Pediatrics recommends that children upto age 16, in areas where drinking water contains less than optimallevels of fluoride, receive daily fluoride supplementation.The American Academy of Pediatrics recommend that infants andyoung children 6 months to 3 years of age, in areas where thedrinking water contains less than 0.3 ppm of fluoride, and children3-6 years of age, in areas where the drinking water contains 0.3through 0.6 ppm of fluoride, receive 0.25 mg of supplementalfluoride daily which is provided in a dose of 1 mL of Tri-Vite Dropswith Fluoride 0.25 mg
(See
Dosage and Administration
).
Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts ofvitamins A, C and D to supplement the diet, and to help assure thatnutritional deficiencies of these vitamins will not develop.Thus, in a single easy-to-use preparation, children obtain essentialvitamins and fluoride.
1 INDICATIONS AND USAGE
Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with:
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysisor peritoneal dialysis(1.2).
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Montelukast sodium chewable tablets area 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 patients6 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.
INDICATIONS AND USAGE
Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties.
Methocarbamol does not directly relax tense skeletal muscles in man.
Sucralfate tablets, USP are indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
INDICATIONS AND USAGE
Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.