um-ids/dailymed-annotations huggingface dataset:
Indications and Usage
Methylprednisolone 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 hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. 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
Epicondylitis
Acute gouty arthritis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
5. 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
6. 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
7. 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
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute 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 colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. 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
Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1)
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Do not use if atrophy is present at the treatment site. (1.2)
Do not use for rosacea or perioral dermatitis. (1.2)
1.1 Indication
Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. [see Use in Specific Populations (8.4)]
1.2 Limitations of Use
Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
INDICATIONS AND
USAGE
The use of metoclopramidetablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.
Symptomatic Gastroesophageal Reflux:
Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.
The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms.
If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day.
Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d.
As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.
Diabetic Gastroparesis (Diabetic Gastric Stasis):
Metoclopramide tablets, USPare indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals.
Significant relief of nausea occurs early and continues to improve over a three-week period.
Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.
1 INDICATIONS AND USAGE
Glimepiride Tablet, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (
14.1)
].
Glimepiride Tablet USP is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1.1).
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1.1).
1.1 Important Limitations of Use
Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
1 INDICATIONS AND USAGE
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of InappropriateAntidiureticHormone(SIADH).
Limitations of Use
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.
It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.
Tolvaptan tablets is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) (1)
Limitations of Use:
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets (1)
It has not been established that tolvaptan tablets provides a symptomatic benefit to patients (1)
1 INDICATIONS AND USAGE
ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with:
First-line acute lymphoblastic leukemia (1.1)
Acute lymphoblastic leukemia and hypersensitivity to asparaginase (1.2)
1.1	First Line Acute Lymphoblastic Leukemia (ALL)
ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL.
1.2	Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase
ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
1 INDICATIONS AND USAGE
Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.
Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitation of Use: The dosage of this product is for HIV-1 and not for HBV. (1)
1 INDICATIONS AND USAGE
Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
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/long-acting opioid formulations[see Warnings and Precautions (5.1)], reserve fentanyl transdermal system 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.
Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.
Fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. (2.1)
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, reserve fentanyl transdermal system 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. (1)
Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.
1 INDICATIONS AND USAGE
ULTIVA is indicated for intravenous (IV) administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
As an analgesic component of monitored anesthesia care in adult patients.
ULTIVA is an opioid agonist indicated for intravenous administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. (1)
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. (1)
As an analgesic component of monitored anesthesia care in adult patients. (1)
INDICATIONS & USAGE
Postherpetic Neuralgia
Gabapentin is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3
12 years.
1 INDICATIONS AND USAGE
Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].
Dalfampridine extended-release tablets are a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed (1, 14).
1 INDICATIONS AND USAGE
Gabapentinis indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
1 INDICATIONS AND USAGE
IXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting [see Clinical Studies (
14)].
IXEMPRA is indicated as a single agent for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine [see Clinical Studies (
14)].
IXEMPRA is a microtubule inhibitor indicated for treatment:
In combination with capecitabine for patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. (
1).
As a single agent for patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine. (
1).
1 INDICATIONS AND USAGE
Ximino is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)
Limitations of Use
Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14)
1.1 Indication
Ximino is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Ximino should be used only as indicated [see Warnings and Precautions (5.11)].
1.2 Limitations of Use
Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Clofarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. (
1
)
1 INDICATIONS AND USAGE
Estradiol transdermal system continuous delivery (once-weekly) is indicated for:
Estradiol transdermal system continuous delivery (once-weekly) is an estrogen indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2)
Limitations of Use:When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure (1.3)
Prevention of Postmenopausal Osteoporosis (1.4)
Limitations of Use:When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1.3Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure
1.4Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1 INDICATIONS AND USAGE
Clofarabine is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine.
Clofarabine is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine. (
1)
INDICATIONS AND USAGE
Promethazine hydrochloride injection is indicated for the following conditions:
Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmicsurgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesicas an adjunct to anesthesia and analgesia.
1. INDICATIONS AND USAGE
Pravastatin sodium tablet is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (1.1)
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (1.2)
Reduce elevated serum TG levels in patients with hypertriglyceridemia. (1.2)
Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (1.2)
Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2)
Limitations of use:
Pravastatin sodium tablets have not been studied in Fredrickson Types I and V dyslipidemias. (1.3)
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 hypercholesterolemia. Drug 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.
1.1 Prevention of Cardiovascular Disease
In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to:
reduce the risk of myocardial infarction (MI).
reduce the risk of undergoing myocardial revascularization procedures.
reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
1.2 Hyperlipidemia
Pravastatin sodium tablets are indicated:
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1
as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
a. LDL-C remains
190 mg/dL or
b. LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the patient.
1.3 Limitations of Use
Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
1 INDICATIONS AND USAGE
Tranexamic Acid Tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14)].
Tranexamic Acid Tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. (1)