um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)].
The following points should be considered when initiating therapy with EPIVIR-HBV:
Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
EPIVIR-HBV has not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
EPIVIR-HBV has not been evaluated in pediatric patients younger than 2 years of age with chronic HBV infection.
EPIVIR-HBV is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. (1)
1
INDICATIONS AND USAGE
Nitroglycerin Lingual Aerosolis indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin Lingual Aerosol is a nitrate vasodilatorindicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease (1).
1 INDICATIONS AND USAGE
Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
Clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men.
Alosetron Hydrochloride Tablets are a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy. (1)
Severe IBS includes diarrhea and 1 or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS. (1)
1 INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients who weigh
60 kg (
1.3)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see
Clinical Studies
(
14.1)
].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see
Clinical Studies
(
14.1)
].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg [
see Dosage and Administration (
2.4) and Clinical Studies (
14.2)
].
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. (1)
INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of depression.
The efficacy of citalopram in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).
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. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Atropine sulfate ophthalmic solution, 1% is indicated for:
Atropine is an anti-muscarinic agent indicated for:
Cycloplegia (1.1)
Mydriasis (1.2)
Penalization of the healthy eye in the treatment of amblyopia. (1.3)
1.1 Cycloplegia
1.2 Mydriasis
1.3 Penalization of the Healthy
Eye in the Treatment of Amblyopia
1 INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets is an antimalarial indicated for:
prophylaxis of
Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported (
1.1)
treatment of acute, uncomplicated
P. falciparum malaria (
1.2)
1.1 Prevention of Malaria
Atovaquone and proguanil hydrochloride tablets
are indicated for the prophylaxis of
Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
1.2 Treatment of Malaria
Atovaquone and proguanil hydrochloride tablets
are indicated for the treatment of acute, uncomplicated
P. falciparum malaria.
Atovaquone and proguanil hydrochloride tablets
have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
1 INDICATIONS AND USAGE
ACTOS is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2)
1.1
Monotherapy and Combination Therapy
ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
1.2
Important Limitation of Use
ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin.
ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
INDICATIONS AND USAGE
Verapamil hydrochloride tablets USP are indicated for the treatment of the following:
Angina
1.Angina at rest including:
-Vasospastic (Prinzmetal's variant) angina
-Unstable (crescendo, pre-infarction) angina
2.Chronic stable angina (classic effort-associated angina)
Arrhythmias
1.In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see
WARNINGS: Accessory bypass tract
)
2.Prophylaxis of repetitive paroxysmal supraventricular tachycardia
Essential hypertension
Verapamil hydrochloride is indicated for the treatment of hypertension, 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 this drug.
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.
INDICATIONS AND USAGE
Benztropine mesylate tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism.
Useful also in the control of extrapyramidal disorders (except tardive dyskinesia - see
PRECAUTIONS
) due to neuroleptic drugs (e.g., phenothiazines).
Indications And Usage
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Bupivacaine HCI safely and effectively. See full prescribing information for Bupivacaine HCI.
Bupivacaine HCI Injectables, USP
Initial U.S. Approval:2013
Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated bupivacaine hydrochloride injection, USP concentrations are:
local infiltration 0.25%
peripheral nerve block 0.25% and 0.5%
retrobulbar block 0.75%
sympathetic block 0.25%
lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)
caudal 0.25% and 0.5%
epidural test dose (see PRECAUTIONS)
(See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride injection, USP.
Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated bupivacaine hydrochloride injection, USP concentrations are:
local infiltration 0.25%
peripheral nerve block 0.25% and 0.5%
retrobulbar block 0.75%
sympathetic block 0.25%
lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)
caudal 0.25% and 0.5%
epidural test dose (see PRECAUTIONS)
(See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride injection, USP.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Bupivacaine HCI safely and effectively. See full prescribing information for Bupivacaine HCI.
Bupivacaine HCI Injectables, USP
Initial U.S. Approval:2013
1 INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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 Oxycodone Hydrochloride Oral Solution 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
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid-analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution 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
INDICATIONS AND USAGE: NP Thyroid tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimotos), multinodular goiter, and in the management of thyroid cancer.
1 INDICATIONS AND USAGE
125 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents throughLiebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the followingLiebel-Flarsheim power injectors: Angiomat, Illumena, Illumena No, CT9000, CT9000 ADV, Optistat, Optivantage and Optistar Elite.
For use in flushing compatible contrast agents throughLiebel-Flarsheimintravenous administration sets into indwelling intravascular access devices (1)
1 INDICATIONS AND USAGE
ORLISTAT is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. ORLISTAT is also indicated to reduce the risk for weight regain after prior weight loss. ORLISTAT is indicated for obese patients with an initial body mass index (BMI) 30 kg/m 2 or 27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
Table 1
illustrates body mass index (BMI) according to a variety of weights and heights. The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5
'
5
"
would have a BMI of 30.
Table 1 Body Mass Index (BMI), kg/m 2
Conversion Factors: Weight in lbs
2.2 = weight in kilograms (kg) Height in inches
0.0254 = height in meters (m) 1 foot = 12 inches
ORLISTAT is a reversible inhibitor of gastrointestinal lipases indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. ( 1)
ORLISTAT is also indicated to reduce the risk for weight regain after prior weight loss. ( 1)
Table 1
INDICATIONS AND USAGE
1.Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50 mg/m2.
2.Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3.Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
4.Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
1 INDICATIONS AND USAGE
ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults.
ZEMBRACE SymTouch is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. (1)
Not indicated for the prophylactic therapy of migraine. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.
ZEMBRACE SymTouch injection is not indicated for the prevention of migraine attacks.
INDICATIONS AND USAGE
Intramuscular
Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection and Kenalog-80 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use as follows:
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenitaladrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.
Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Intra-Articular
The intra-articular or soft tis sue administration of Kenalog-40 Injection and Kenalog-80 Injection are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecifictenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
1 INDICATIONS AND USAGE
ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older.
In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older.
The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4)].
ELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age (1).
1 INDICATIONS AND USAGE
Essential hypertension, alone or as an adjunct.