um-ids/dailymed-annotations huggingface dataset:
Indications
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG).
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
Omega-3-acid ethyl esters capsules, USP are combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG). (1)
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. (1)
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined. (1)
1 INDICATIONS AND USAGE
Desloratadine is a histamine-1 (H1) receptor antagonist indicated for:
Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1)
Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. (1.2)
1.1 Seasonal Allergic Rhinitis
Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.
1.2 Perennial Allergic Rhinitis
Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.
INDICATIONS AND USAGE
URIMAR-T CAPS is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
INDICATIONS AND USAGE
Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table II 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 these methods can result in lower failure rates.
TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.
Adapted from Hatcher et al., 1998, Ref#1.
%
of
Women
Experiencing
an
Unintended
Pregnancy
within
the
First
Year
of
Use
%
of
Women
Continuing
Use
at
One
YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
Method
(
1
)
Typical
UseAmong typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(
2
)
Perfect
UseAmong couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(
3
)
(
4
)
ChanceThe percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
85
85
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.
26
6
40
Periodicabstinence
25
63
Calendar
9
OvulationMethod
3
Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
2
Post-Ovulation
1
Withdrawal
19
4
CapWith spermicidal cream or jelly.
ParousWomen
40
26
42
NulliparousWomen
20
9
56
Sponge
ParousWomen
40
20
42
NulliparousWomen
20
9
56
Diaphragm
20
6
56
CondomWithout spermicides.
Female(Reality)
21
5
56
Male
14
3
61
Pill
5
71
ProgestinOnly
0.5
Combined
0.1
IUD
ProgesteroneT
2.0
1.5
81
CopperT380A
0.8
0.6
78
LNg20
0.1
0.1
81
Depo-Provera
0.3
0.3
70
NorplantandNorplant-2
0.05
0.05
88
FemaleSterilization
0.5
0.5
100
MaleSterilization
0.15
0.10
100
INDICATIONS AND USAGE
Metvixia Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physicians office when other therapies are unacceptable or considered medically less appropriate.
INDICATIONS AND USAGE
Hypertension
Propranolol hydrochloride tablets are indicated in the
management of hypertension. They may be used alone or used in combination with
other antihypertensive agents, particularly a thiazide diuretic. Propranolol
hydrochloride tablets are not indicated in the management of hypertensive
emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride tablets are indicated to decrease
angina frequency and increase exercise tolerance in patients with angina
pectoris.
Atrial Fibrillation
Propranolol hydrochloride tablets are indicated to control
ventricular rate in patients with atrial fibrillation and a rapid ventricular
response.
Myocardial Infarction
Propranolol hydrochloride tablets are indicated to reduce
cardiovascular mortality in patients who have survived the acute phase of
myocardial infarction and are clinically stable.
Migraine
Propranolol hydrochloride tablets are indicated for the
prophylaxis of common migraine headache. The efficacy of propranolol in the
treatment of a migraine attack that has started has not been established, and
propranolol is not indicated for such use.
Essential Tremor
Propranolol hydrochloride tablets are indicated in the
management of familial or hereditary essential tremor. Familial or essential
tremor consists of involuntary, rhythmic, oscillatory movements, usually limited
to the upper limbs. It is absent at rest, but occurs when the limb is held in a
fixed posture or position against gravity and during active movement.
Propranolol hydrochloride tablets, USP causes a reduction in the tremor
amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are
not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride tablets improve NYHA functional
class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolol hydrochloride tablets are indicated as an
adjunct to alpha-adrenergic blockade to control blood pressure and reduce
symptoms of catecholamine-secreting tumors.
INDICATIONS AND USAGE
Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
1 INDICATIONS AND USAGE
Paroxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD)
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)
INDICATIONS AND USAGE
Hyperprolactinemia-Associated Dysfunctions
Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. AcromegalyBromocriptine mesylate tablets are indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately one-half of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested.
Parkinson's Disease
Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing "end of dose failure" on levodopa therapy. Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function ("on-off" phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than two years has not been established.Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate treated patients than in levodopa/carbidopa treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.
INDICATIONS AND USAGE
For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.
INDICATIONS:
Venexa FE is indicated for the treatment of iron deficiency anemia
and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive
blood loss and advanced age. Also for treatment of condition in which iron deficiency and
vitamin C deficiency occur together, along with a deficient intake or increased need for
B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in
convalescence.
INDICATIONS:
Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
1 INDICATIONS AND USAGE
EXKIVITY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], whose disease has progressed on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1, 2.1)
1 INDICATIONS AND USAGE
Diclofenac sodium is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1)
Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or
shoulder. (14.1)
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.
INDICATIONS AND USAGE:
Fluphenazine Hydrochloride Injection, USP is indicated in the management of manifestations of psychotic disorders.
Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
1 INDICATIONSAND USAGE
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.(1)
1 INDICATIONS AND USAGE
TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Limitations of Use
Should not be used in patients with type 1 diabetes (1)
Has not been studied in patients with a history of pancreatitis (1)
Limitations of Use
TRADJENTA should not be used in patients with type 1 diabetes as it would not be effective.
TRADJENTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Prasugrel tablets are a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed withpercutaneous coronary intervention (PCI) as follows:
Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).
1.1 Acute Coronary Syndrome
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
Prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see
Clinical Studies (14)
].
INDICATIONS
Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis,hypercalcemia associated with cancer.
Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: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, acute rheumatic carditis.
Dermatologic 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, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions.
Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia.
Respiratory diseases: symptomatic sarcoidosis,Loeffler's 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.
In addition to the above indications, Prednisone Tablets, USP are indicated for systemic dermatomyositis (polymyositis).
1 INDICATIONS AND USAGE
Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Limitation of Use: Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.
Mesna Injection is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. (1)
Limitation of Use:
Mesna Injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. (1)