um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Everolimus tablets are a kinase inhibitor indicated for the treatment of:
Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3)
Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)
Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5)
1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer
Everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.
1.2 Neuroendocrine Tumors (NET)
Everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.
Everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.
Limitations of Use:Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors[seeClinical Studies (14.2)].
1.3 Renal Cell Carcinoma (RCC)
Everolimus tablets are indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib.
1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma
Everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.
1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
Everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.
INDICATIONS & USAGE SECTION
1.1 Major Depressive Disorder
Escitalopram tablet USP is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies (
14.1) ].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablet USP is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies (
14.2) ].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
INDICATIONS:
INATAL ADVANCE
is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced can also be beneficial in improving the nutritional status of women prior to conception.
INDICATIONS AND USAGE
Cefprozil tablets are indicated for the
treatment of patients with mild to moderate infections caused by susceptible
strains of the designated microorganisms in the conditions listed below:
Upper Respiratory Tract:
Pharyngitis/Tonsillitis:
Caused by Streptococcus
pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic fever, is
penicillin given by the intramuscular route. Cefprozil is generally effective in
the eradication of Streptococcus pyogenes from the
nasopharynx; however, substantial data establishing the efficacy of cefprozil in
the subsequent prevention of rheumatic fever are not available at present.
Otitis Media:
Caused by Streptococcus
pneumoniae, Haemophilus influenzae (including -lactamase-producing
strains), and Moraxella (Branhamella) catarrhalis
(including -lactamase-producing strains). (See
CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to -lactamase producing
organisms, cefprozil had bacteriologic eradication rates somewhat lower than
those observed with a product containing a specific -lactamase inhibitor. In
considering the use of cefprozil, lower overall eradication rates should be
balanced against the susceptibility patterns of the common microbes in a given
geographic area and the increased potential for toxicity with products
containing -lactamase inhibitors.
Acute Sinusitis:
Caused by Streptococcus
pneumoniae, Haemophilus influenzae (including
-lactamase producing strains), and Moraxella (Branhamella)
catarrhalis (including -lactamase-producing strains).
Lower Respiratory Tract:
Secondary Bacterial Infection of Acute Bronchitis and Acute
Bacterial Exacerbation of Chronic Bronchitis:
Caused by Streptococcus
pneumoniae, Haemophilus influenzae (including -lactamase-producing
strains), and Moraxella (Branhamella) catarrhalis
(including -lactamase-producing strains).
Skin and Skin Structure:
Uncomplicated Skin and Skin-Structure Infections:
Caused by Staphylococcus
aureus (including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical
drainage.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefprozil tablets and other antibacterial drugs, cefprozil
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
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone
[see Clinical Studies (
14)].
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (
1).
Efficacy was established in trials of trazodone immediate release formulation in patients with major depressive disorder (
14).
INDICATIONS AND USAGE
Phenoxybenzamine hydrochloride capsules, USP is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.
1 INDICATIONSAND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH (ED/BPH) (
1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1	Erectile Dysfunction
Tadalafil tablets, USP areindicated for the treatment of erectile dysfunction (ED).
1.2	Benign Prostatic Hyperplasia
Tadalafil tablets, USP areindicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3	Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets, USP areindicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4	Limitation of Use
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown
[see Clinical Studies (
14.3)]
.
Influenza A Prophylaxis
Amantadine Hydrochloride Tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride Tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, Amantadine Hydrochloride Tablets prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response
INDICATIONSAND USAGE:
BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.
INDICATIONS AND USAGE
Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Indications and Usage Section
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION).
Diclofenac is indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Gallium Ga 68 Gozeotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Gallium Ga 68 GozetotideInjection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. (
1)
1 INDICATIONS AND USAGE
LANTUS is indicated to improve glycemic control in adults and
children with type 1 diabetes mellitus and in adults with type 2 diabetes
mellitus.
Important Limitations of Use:
LANTUS is not recommended for the treatment of diabetic ketoacidosis.
Intravenous short-acting insulin is the preferred treatment for this
condition.
LANTUS is a long- acting human insulin analog indicated to
improve glycemic control in adults and children with type 1 diabetes mellitus
and in adults with type 2 diabetes mellitus. (1)
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous,
short-acting insulin instead.
INDICATIONS AND USAGE
BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.
INDICATIONS AND USAGE
Hailey Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE 1
LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
Lowest
Expected*
Typical**
(No contraception)
(85)
(85)
Oral contraceptives
3
Combined
0.1
N/A***
progestin only
0.5
N/A***
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge
nulliparous
9
20
parous
20
40
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD
progesterone T
1.5
2
copper T 380A
0.6
0.8
LNg 20
0.1
0.1
Condom without spermicides
female
5
21
male
3
14
Cervical Cap with spermicidal cream or jelly
nulliparous
9
20
parous
26
40
Periodic abstinence (all methods)
1 to 9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.1
0.15
Adapted from RA Hatcher et al, Reference 7.
*The authors best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
**This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
***N/A-Data not available.
1 INDICATIONS AND USAGE
JALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. (1.1)
Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. (1.2)
1.1 Benign Prostatic Hyperplasia (BPH) Treatment
JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.2 Limitations of Use
Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.
For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Note
Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
1 INDICATIONS AND USAGE
Fenofibrate tablets for oral use are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets for oral use are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets for oral use are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of Fenofibrate tablets for oral use was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see War
nings and Precautions
(
5.1
)
].
INDICATIONS AND USE
MetforminHCl extended release tablets, USPare indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Cocaine Hydrochloride nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Cocaine hydrochloride nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. (1)
INDICATIONS AND USAGE
Promethazine hydrochloride and dextromethorphan hydrobromide oral solutionis indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
INDICATIONS AND USAGE
Sensipar is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis.
Sensipar is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.
1 INDICATIONS AND USAGE
Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
Ropivacaine hydrochloride injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
Triamterene and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).
Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia in pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
INDICATIONS
Lithium carbonate is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness and possibly hostility. When given to a patient experiencing a manic episode, lithium carbonate may produce a normalization of symptomatology within 1 to 3 weeks.
1 INDICATIONS AND USAGE
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) (1).
INDICATIONS AND USAGE
Methocarbamol Tablets, USP are 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.
1 INDICATIONS AND USAGE
ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above:
To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)
For the treatment of processing-deficient Progeroid Laminopathies with either:
Heterozygous LMNA mutation with progerin-like protein accumulation
Homozygous or compound heterozygous ZMPSTE24 mutations
Limitations of Use
ZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.
ZOKINVY is a farnesyltransferase inhibitor indicated in patients 12 months of age and older with a body surface area of 0.39 m2 and above (1):
To reduce risk of mortality in Hutchinson-Gilford Progeria Syndrome
For treatment of processing-deficient Progeroid Laminopathies with either:
Heterozygous LMNA mutation with progerin-like protein accumulation
Homozygous or compound heterozygous ZMPSTE24 mutations
Limitations of Use
Not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations (1)