um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Hypothyroidism
Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)].
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablets are levothyroxine sodium (T4) indicated for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
INDICATIONS AND USAGE
Dorzolamide HCl Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
INDICATIONS & USAGE
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia.
In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
1.
INDICATIONS AND USAGE
Enter section text here
TARCEVA is a tyrosine
kinase inhibitor indicated for the treatment of:
Locally advanced or metastatic non-small cell
lung cancer (NSCLC) after failure of at least one prior chemotherapy
regimen. (1.1)
First-line
treatment of patients with locally advanced, unresectable or
metastatic pancreatic cancer, in combination with gemcitabine. (1.2)
1.1 Non-Small Cell Lung Cancer (NSCLC)
TARCEVA monotherapy is indicated for the treatment of patients
with locally advanced or metastatic non-small cell lung cancer after
failure of at least one prior chemotherapy regimen [see Clinical
Studies (14.1)].
Results from two, multicenter, placebo-controlled, randomized,
Phase 3 trials conducted in first-line patients with locally advanced
or metastatic NSCLC showed no clinical benefit with the concurrent
administration of TARCEVA with platinum-based chemotherapy
[carboplatin and paclitaxel or gemcitabine and cisplatin] and its use
is not recommended in that setting [see Clinical Studies (14.3)].
1.2
Pancreatic Cancer
TARCEVA in combination with gemcitabine is indicated for the
first-line treatment of patients with locally advanced, unresectable
or metastatic pancreatic cancer [see Clinical Studies (14.3)].
1.5 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clarithromycin Extended-release Tablets, USP
and other antibacterial drugs, Clarithromycin Extended-release Tablets, USP 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
ABLYSINOL
is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.
ABLYSINOL is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. (
1)
INDICATIONS AND USAGE
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.
MD-Gastroview may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.
1 INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
Epidermophyton floccosum, Trichophyton mentagrophytes, and
Trichophyton rubrum in patients 17 years and older.
Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
Epidermophyton floccosum, Trichophyton mentagrophytes, and
Trichophyton rubrum in patients 17 years and older. (
1)
INDICATIONSDiazepam tablets 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
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.
Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. (1)
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. (1)
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1)
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see
Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
ZILRETTA is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. (1)
Limitation of Use
The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. (2.1)
Limitation of Use
The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. [see Dosage and Administration (2.1)].
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; posttraumatic 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 anti-tuberculous chemotherapy, trichinosis with neurologic or myocardial involvement.
In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).
INDICATIONS AND USAGE
Levobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.
INDICATIONS AND USAGE
BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis.
Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3days. However, symptomatic relief may not occur in some patients for as long as 2weeks. BECONASE AQ Nasal Spray should not be continued beyond 3weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa.
BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.
Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.
1 INDICATIONS AND USAGE
Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. (
1)
INDICATIONS AND USAGE
Phendimetrazine tartrate extended-release capsules are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters
The usefulness of agents of this class (see
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below. Phendimetrazine tartrate is indicated for use as monotherapy only.
Body Mass Index Table
INDICATIONS AND USAGE
Hydrochlorothiazide Capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing
combination diuretic products, Hydrochlorothiazide Capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
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 of 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. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the 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 AND USAGE
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are 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 I 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 I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
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.
%OfWomenExperiencinganUnintendedPregnancy
intheFirstYearofContinuousUse
Method
LowestExpected*
Typical**
(Nocontraception)
(85)
(85)
Oralcontraceptives
3
Combined
0.1
N/A***
progestinonly
0.5
N/A***
Diaphragmwithspermicidalcreamorjelly
6
20
Spermicidesalone(foam,creams,gels,vaginalsuppositories
andvaginalfilm)
6
26
VaginalSponge
nulliparous
9
20
parous
20
40
Implant
0.05
0.05
Injection:depotmedroxyprogesteroneacetate
0.3
0.3
IUD
progesteroneT
1.5
2.0
copperT380A
0.6
0.8
LNg20
0.1
0.1
Condomwithoutspermicides
female
5
21
male
3
14
CervicalCapwithspermicidalcreamorjelly
nulliparous
9
20
parous
26
40
Periodicabstinence(allmethods)
1-9
25
Withdrawal
4
19
Femalesterilization
0.5
0.5
Malesterilization
0.10
0.15
1. Indications and Usage
1.1 Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following:
1. Mild to moderate pain
2. Osteoarthritis
3. Rheumatoid arthritis
INDICATIONS AND USAGE
Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.