um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. (1)
INDICATIONS AND USAGE
Promethazine hydrochloride tablets are useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.Preoperative, postoperative and obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Flurbiprofen tablet, USP and other treatment options before deciding to use Flurbiprofen tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Flurbiprofen tablet, USP is indicated:For relief of the signs and symptoms of rheumatoid arthritis.For relief of the signs and symptoms of osteoarthritis.
1 INDICATIONS AND USAGE
Bortezomib for Injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy (1.2)
1.1 Multiple Myeloma
Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma.
1.2 Mantle Cell Lymphoma
Bortezomib for Injection is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescents aged 13-17 years(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 and alone in children and adolescents aged 10-17 years (1.2)
Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years (1.3)
1.1 Schizophrenia
Adults
Risperidone oral solution is indicated for the acute and maintenance treatment of schizophrenia [see
Clinical Studies
(14.1)
].
Adolescents
Risperidone oral solution is indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years [see Clinical Studies (14.1)
].
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone oral solution is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years[see
Clinical Studies
(14.2)
].
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
Risperidone oral solution is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)
].
INDICATIONS AND USAGE
FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.
INDICATIONS AND USAGE
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.
The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.
For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given: a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
1 INDICATIONS AND USAGE
OFEV is a kinase inhibitor indicated in adults for:
Treatment of idiopathic pulmonary fibrosis (IPF). (1.1)
Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (1.2)
Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (1.3)
1.1
Idiopathic Pulmonary Fibrosis
OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).
1.2
Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
OFEV is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies (14.2)].
1.3
Systemic Sclerosis-Associated Interstitial Lung Disease
OFEV is indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
1 INDICATIONS AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitation of Use
Consider TWIRLAs reduced effectiveness in women with a BMI
25 to < 30 kg/m2 before prescribing TWIRLA [see Use in Specific Populations (8.9) and Clinical Studies (14)]. TWIRLA is contraindicated in women with a BMI
30 kg/m2
[see Contraindications (4)].
TWIRLA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.(1)
Limitation of Use
Consider TWIRLAs reduced effectiveness in women with a BMI
25 to < 30 kg/m2 before prescribing. (4,8.9, 14)
INDICATIONS & USAGE
Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
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 x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
[BMI]
The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Maintenance Treatment of Bipolar I Disorder
ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES (14.2)].
INDICATIONS AND USAGE
Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures.
Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.
1 INDICATIONS AND USAGE
Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets
.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
Indications
& Usage
Uses
For the treatment and / or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin.
INDICATIONS AND USAGE
Triazolam is indicated for the short-term treatment of insomnia (generally 710 days). Use for more than 23 weeks requires complete reevaluation of the patient (see WARNINGS).
Prescriptions for triazolam should be written for short-term use (710 days) and it should not be prescribed in quantities exceeding a 1-month supply.
INDICATIONS AND USAGE:
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.
1.4 Limitations of Use
Clarithromycin Extended-release Tablets, USP are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of Clarithromycin Extended-release Tablets, USP in treating other infections for which other formulations of clarothromycin are approved have not been established.
There is resistance to macrolides in certain bacterial infections caused by
Streptococcus pneumoniae and
Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are an acetylcholinase inhibitorindicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease (1.0).
Donepezil hydrochloride tablets are an acetylcholinase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1.0).
1.1 Refractory Complex Partial Seizures (CPS)
Vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (
5.1
)]. Vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures.
INDICATIONS AND USAGE
Propoxyphene napsylate and acetaminophen tablets, 100 mg/650 mg are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.
1 INDICATIONS AND USAGE
Arsenic Trioxide Injection is an arsenical indicated:
For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2)
1.2 Relapsed or Refractory APL
Arsenic Trioxide Injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
1 INDICATIONS AND USAGE
SIKLOS is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises
SIKLOS is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin capsules have been found effective in active stages of the following:
1.
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
2.
Moderate to severe ankylosing spondylitis.
3.
Moderate to severe osteoarthritis.
4.
Acute painful shoulder (bursitis and/or tendinitis).
5.
Acute gouty arthritis.
1 INDICATIONS AND USAGE
Sunitinib malate is a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1)
treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2)
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3)
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4)
1.1 Gastrointestinal StromalTumor
Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
1.2 Advanced Renal Cell Carcinoma
Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).
1.3 Adjuvant Treatment of Renal CellCarcinoma
Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
1.4 Advanced Pancreatic NeuroendocrineTumors
Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
Indications and Usage
25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia.25% Dextrose Injection also provides a minimal source of carbohydrate calories.
1 INDICATIONS AND USAGE
1.1 Intensive Care Unit Sedation
Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.
Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.
1.2 Procedural Sedation
Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Precedex is a relatively selective alpha2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Precedex by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2)
1 INDICATIONS AND USAGE
Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for:
Clobetasol propionate cream, 0.05% (emollient) is a corticosteroid indicated for:
The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1)
The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2)
Limitations of Use
Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. (1.3)
The total dosage should not exceed 50 grams per week. (1.3)
Avoid use if skin atrophy is present at the treatment site. (1.3)
1.1 Corticosteriod-Responsive Dermatoses
Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
1.2 Moderate to Severe Plaque-Type Psoriasis
Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.
1.3 Limitations of Use
Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
The total dosage should not exceed 50 grams per week.
Avoid use if skin atrophy is present at the treatment site.
1 INDICATIONS AND USAGE
Jaimiess is indicated for use by females of reproductive potential to prevent pregnancy.
Jaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (
1)
1 INDICATIONS AND USAGE
KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Important Limitations of Use:KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. (1)
Important Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. (1)
INDICATIONS AND USAGE
Doxepin is recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety.
Depression and/or anxiety associated with alcoholism (not to be taken
concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility
of drug interaction should be considered if the patient is receiving other drugs
concomitantly).
Psychotic depressive disorders with associated anxiety including
involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to
doxepin include anxiety, tension, depression, somatic symptoms and concerns,
sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin is safe and well tolerated even in
the elderly patient. Owing to lack of clinical experience in the pediatric
population, doxepin is not recommended for use in children under 12 years of
age.