um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Depakote ER is indicated for:
Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
1.1 Mania
Depakote ER is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).
The efficacy of Depakote ER is based in part on studies of Depakote (divalproex sodium delayed release tablets) in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1)].
The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use Depakote ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
1.2 Epilepsy
Depakote ER is indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote ER is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3 Migraine
Depakote ER is indicated for prophylaxis of migraine headaches. There is no evidence that Depakote ER is useful in the acute treatment of migraine headaches. Because it may be a hazard to the fetus, Depakote ER should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment [see Warnings and Precautions(5.2), Patient Counseling Information(17.3)].
1
INDICATIONS AND USAGE
MS CONTIN is indicated for
the management of pain severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative treatment options
are inadequate.
Limitations of Use
Because of the risks of addiction, abuse,
and misuse with opioids, even at recommended doses, and because of
the greater risks of overdose and death with extended-release opioid
formulations [see Warnings and Precautions (5.1)], reserve MS CONTIN for use
in patients for whom alternative treatment options (e.g., non-opioid
analgesics or immediate-release opioids) are ineffective, not tolerated,
or would be otherwise inadequate to provide sufficient management
of pain.
MS CONTIN is not indicated as an as-needed
(prn) analgesic.
MS CONTIN is an opioid
agonist indicated for the management of pain severe enough to require
daily, around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate. (1)
Limitations
of Use
Because of the risks of addiction, abuse,
and misuse with opioids, even at recommended doses, and because of
the greater risks of overdose and death with extended-release opioid
formulations, reserve MS CONTIN for use in patients for whom alternative
treatment options (e.g., non-opioid analgesics or immediate-release
opioids) are ineffective, not tolerated, or would be otherwise inadequate
to provide sufficient management of pain. (1)
MS CONTIN is not indicated as an as-needed
(prn) analgesic. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS;
Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac potassium tablets are indicated:
for treatment of primary dysmenorrhea
for relief of mild to moderate pain
for relief of the signs and symptoms of osteoarthritis
for relief of the signs and symptoms of rheumatoid arthritis
1	INDICATIONS AND USAGE
ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ALIQOPA is a kinase inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies (1).
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
INDICATIONS
Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see
CLINICAL PHARMACOLOGY, Clinical Studies).
Entacapone tablets effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose "wearing-off".
INDICATIONS & USAGE SECTION
Prednisolone Oral Solution is indicated in the following conditions:
1. 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
2. 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
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
4. Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme
(Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Allergic conjunctivitis
Keratitis
Chorioretinitis
Optic neuritis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Loefflers syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. 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.
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
In addition to the above indications Prednisolone Oral Solution is indicated for systemic dermatomyositis (polymyositis).
INDICATIONS AND USAGE
Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis,Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonasaeruginosa.**
**Efficacy for this organism in this organ system was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Vasostrict is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Vasostrict is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. (1)
INDICATIONS AND USAGE
Fluocinonide Ointment, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1INDICATIONS AND USAGE
Levetiracetam tablet is indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients 4 years of age and older with epilepsy (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial Onset Seizures
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of primarygeneralized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)
Important limitations of use:
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)
Formoterol fumarate inhalation solution is not indicated to treat asthma. (1.2)
1.1 Maintenance Treatment of COPD
Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1.2 Important Limitations of Use
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)].
Formoterol fumarate inhalation solution is not indicated to treat asthma. The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established.
1 INDICATIONS AND USAGE
Bupropion hydrochloride
is an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD) (
1.1)
prevention of seasonal affective disorder (SAD) (
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see
Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see
Clinical Studies (14.2)].
INDICATIONS AND USAGE
Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
INDICATIONS & USAGE
Prazosin Hydrochloride Capsules, USP 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 thisdrug.
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 seenregularly.
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 issimilar 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 pressuregoal.
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 oftherapy.
Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Trazodone hydrochloride tablets are is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (
1).
INDICATIONS AND USAGE
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.
3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss.
These hypertonic sodium chloride solutions are also indicated for the following clinical conditions.
Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids.
Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections.
Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.
INDICATIONS AND USAGE
Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
INDICATIONS & USAGE SECTION
Mania
Divalproex sodium delayed-release tablets (divalproex sodium) are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablets was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania (see
Clinical Trials under
CLINICAL PHARMACOLOGY).
The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
Epilepsy
Divalproex sodium delayed-release tablets (divalproex sodium) are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets (divalproex sodium) are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
Migraine
Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see
WARNINGS,
Usage In Pregnancy,
PRECAUTIONS,
Information for Patients).
SEE
WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.
1 INDICATIONS AND USAGE
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
KEVEYIS is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants (
1)
INDICATIONS AND USAGE:
For the treatment of superficialocular 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 ofophthalmia caused by penicillinase-producing N.gonorrhoeae is not established.
For infants born to mothers with clinically apparentgonorrhea, intravenous or intramuscular injections ofaqueous crystalline penicillin G should be given; a singledose of 50,000 units for term infants or 20,000 units forinfants of low birth weight. Topical prophylaxis alone isinadequate for these infants.
1	INDICATIONS AND USAGE
AUBAGIO is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (1)