um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE:
Mitoxantrone Injection, USP is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone Injection, USP is not indicated in the treatment of patients with primary progressive multiple sclerosis.
The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.
Mitoxantrone Injection, USP in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.
Mitoxantrone Injection, USP in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.
1.1 Hypertension
Amlodipine Besylate Tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain,burning, urgency, frequency, and other discomforts arising fromirritation of the lower urinary tract mucosa caused by infection,trauma, surgery, endoscopic procedures, or the passage of soundsor catheters. The use of Phenazopyridine HCl for relief ofsymptoms should not delay definitive diagnosis and treatment ofcausative conditions. Because it provides only symptomatic relief,prompt appropriate treatment of the cause of pain must beinstituted and Phenazopyridine HCl should be discontinued whensymptoms are controlled. The analgesic action may reduce oreliminate the need for systemic analgesics or narcotics. It is,however, compatible with antibacterial therapy and can help torelieve pain and discomfort during the interval before antibacterialtherapy controls the infection. Treatment of a urinary tract infectionwith Phenazopyridine HCl should not exceed 2 days because thereis a lack of evidence that the combined administration ofPhenazopyridine HCl and an antibacterial provides greater benefitthan administration of the antibacterial alone after 2 days. (SeeDOSAGE AND ADMINISTRATION section.)
INDICATIONS AND USAGE
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency.
In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy.
Associated symptoms included hypotonia, muscle weakness and failure to thrive.
A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see
Clinical Pharmacology
).
In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms.
Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
1 INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole
is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these
infections due to being severely immunocompromised, such as hematopoietic
stem cell transplant (HSCT) recipients with graft-versus-host disease
(GVHD)or those with hematologic malignancies with prolonged neutropenia
from chemotherapy as follows: (1.2)
Posaconazole
delayed-release tablets:adults and pediatric patients 13 years of age
and older
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.1)] as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older.
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.'s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Piroxicam Capsules are indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
INDICATIONS AND USAGE
Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia.
Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
NIASPAN in combination with
simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
Niacin is also indicated as adjunctive therapy for treatment of adult patients with
severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.
NIASPAN contains extended-release niacin (nicotinic acid), and is indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.(1)
In combination with simvastatin or lovastatin: to treat primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.(1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.(1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (1)
To reduce TG in adult patients with severe hypertriglyceridemia.(1)
Limitations of use:
No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin and lovastatin monotherapy, has been established.
INDICATIONS
Tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function.
PHYSICAL HALF-LIFE & TARGET ORGANS
The physical half-life of technetium, Tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV.
Estimated Absorbed Radiation Dose (Technetium Tc99m Tetrofosmin Injection)
Absorbed radiation dose
Exercise
Rest
Target organ
rad/mCi
Gy/MBq
rad/mCi
Gy/MBq
Gall bladder wall
0.123
33.2
0.180
48.6
Upper large intestine
0.075
20.1
0.113
30.4
Bladder wall
0.058
15.6
0.071
19.3
Lower large intestine
0.057
15.3
0.082
22.2
Small intestine
0.045
12.1
0.063
17.0
Kidney
0.039
10.4
0.046
12.5
Salivary glands
0.030
8.04
0.043
11.6
Ovaries
0.029
7.88
0.035
9.55
Uterus
0.027
7.34
0.031
8.36
Bone surface
0.023
6.23
0.021
5.58
Pancreas
0.019
5.00
0.018
4.98
Stomach
0.017
4.60
0.017
4.63
Thyroid
0.016
4.34
0.022
5.83
Adrenals
0.016
4.32
0.015
4.11
Heart wall
0.015
4.14
0.015
3.93
Red marrow
0.015
4.14
0.015
3.97
Spleen
0.015
4.12
0.014
3.82
Muscle
0.013
3.52
0.012
3.32
Testes
0.013
3.41
0.011
3.05
Liver
0.012
3.22
0.015
4.15
Thymus
0.012
3.11
0.009
2.54
Brain
0.010
2.72
0.008
2.15
Lungs
0.008
2.27
0.008
2.08
Skin
0.008
2.22
0.007
1.91
Breasts
0.008
2.22
0.007
1.83
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976).
Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4),1988) and gave values of 8.61
10-3 mSV/MBq and 1.12
10-2 mSV/MBq after exercise and rest, respectively.
1 INDICATIONS AND USAGE
Simvastatin tablets are indicated:
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
oIn adults with primary hyperlipidemia.
oIn adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: (1)
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
oIn adults with primary hyperlipidemia.
oIn adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate is indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
In using enalapril maleate 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 enalapril maleate does not have a similar risk (see
WARNINGS, Neutropenia/Agranulocytosis
).
In considering use of enalapril maleate 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, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS, Head and Neck Angioedema
).
Uses
temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever
1.1 Partial-Onset Seizures
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in thetreatment of partial-onset seizures in adults with epilepsy.
INDICATION AND USAGE
SPS Suspension is indicated for the treatment of hyperkalemia.
1. INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights; this drug product is not labeled for use in pediatric patients with schizophrenia, bipolar mania or autistic disorder. (1.1, 1.2, 1.3)
1.1 Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
Adolescents
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia .Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
Combination Therapy
Adults
The combination of risperidone with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder. Information regarding the treatment of pediatric patients with irritability associated with autistic disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
Indications & Usage
Indomethacin extended-release capsules are indicated for:
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)
INDICATIONS & USAGE:
A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tineaversicolor. Urea hydrates and is useful for conditions such as dry scalp.
1 INDICATIONS AND USAGE
Cinacalcet is a positive modulator of the calcium-sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.(
1.1)
Limitations of Use:Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (
1.2)
Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.
(
1.3)
1.1
Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adultpatients with chronic kidney disease (CKD) on dialysis
[see Clinical Studies (
14.1
)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not ondialysis because of an increased risk of hypocalcemia
[see Warnings and Precautions (
5.1
)]
.
1.2
Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma
[see Clinical Studies (
14.2
)].
1.3
Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy
[see Clinical Studies (
14.3
)].
INDICATIONS AND USAGE
Hydrocortisone tablets are indicated in the following conditions.
1. 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 hyperplasiaNon suppurative thyroiditisHypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis
4. Dermatologic Diseases
PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia
7. Respiratory Diseases
Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood
10. 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.
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis
12. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
1 INDICATIONS AND USAGE
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat 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.
Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium
tablets are a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
(
1.1)
Acute bacterial otitis media
(
1.2)
Sinusitis
(1.3)
Skin and skin structure infections
(1.4)
Urinary tract infections
(1.5)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of
Haemophilusinfluenzae and
Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of
Staphylococcus aureus, Escherichia coli, and
Klebsiella species
.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of
E. coli, Klebsiellaspecies, and
Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.