um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
1.1 Prevention of Cardiovascular Disease in Adults
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina
In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:
Reduce the risk of non-fatal myocardial infarction
Reduce the risk of fatal and non-fatal stroke
Reduce the risk for revascularization procedures
Reduce the risk of hospitalization for CHF
Reduce the risk of angina
1.2 Hyperlipidemia
Atorvastatin calcium tablets are indicated:
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (
Fredrickson Types IIa and IIb);
As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (
Fredrickson Type IV);
For the treatment of adult patients with primary dysbetalipoproteinemia (
Fredrickson Type III) who do not respond adequately to diet;
To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present:
LDL-C remains
190 mg/dL or
LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the pediatric patient
1.3 Limitations of Use
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (
Fredrickson Types I and V).
1 INDICATIONS AND USAGE
Enter section text here
Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic
rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic
urticaria (1.3)
1.1 Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the
relief of symptoms associated with seasonal allergic rhinitis in adults and
children 6 years of age and older.
Pediatric use information in pediatric patients (age 2 to
5 years) with seasonal allergic rhinitis is approved for UCB Inc.'s
levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s
marketing exclusivity rights; this drug product is not labeled for such use in
those pediatric patients.
1.2 Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the
relief of symptoms associated with perennial allergic rhinitis in adults and
children 6 years of age and older.
Pediatric use information in pediatric patients (age 6
months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.'s
levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s
marketing exclusivity rights; this drug product is not labeled for such use in
those pediatric patients.
1.3 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the
treatment of the uncomplicated skin manifestations of chronic idiopathic
urticaria in adults and children 6 years of age and older.
Pediatric use information in pediatric patients (age 6
months to 5 years) with chronic idiopathic urticaria is approved for UCB Inc.'s
levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s
marketing exclusivity rights; this drug product is not labeled for such use in
those pediatric patients.
1INDICATIONS AND USAGE
NEVANAC 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery.
NEVANAC is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (
14.1)
].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1).
Indications & Usage
Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.
1 INDICATIONS AND USAGE
ADIPEX-P
is 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 greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 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.
The limited usefulness of agents of this class, including ADIPEX-P
, [
see Clinical Pharmacology (
12.1,
12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
ADIPEX-P
is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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 greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (
1)
The limited usefulness of agents of this class, including ADIPEX-P
, should be measured against possible risk factors inherent in their use. (
1)
Figure 1
1 INDICATIONS AND USAGE
Vigabatrin for oral solution is indicated for the treatment of:
Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent(1.1)
Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss (1.2)
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.
1.2
Infantile Spasms (IS)
Vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1)
1 INDICATIONS & USAGE
Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients (
1.1)
Herpes labialis (cold sores)
oTreatment of recurrent episodes
Genital herpes
oTreatment of recurrent episodes
oSuppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV)-Infected Adult Patients (
1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrentepisodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1 INDICATIONS AND USAGE
Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.
Sumatriptan succinate tablets are a serotonin (5-HT ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( )
1B/1D
1
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. ( )
1
Not indicated for the prophylactic therapy of migraine attacks. ( )
1
Not indicated for the treatment of cluster headache. ( )
1
INDICATIONS AND USAGE
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).
1 INDICATIONS AND USAGE
Budesonide inhalation suspension is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (Error! Hyperlink reference not valid.)
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
1.1 Maintenance Treatment of Asthma
Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use:
Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Seizure Disorders:
Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.
In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may re-establish efficacy.
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H1receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3)
1.1
Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
1.2
Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older.
1.3
Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
1 INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Mild to severe chronic heart failure (1.1)
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.1 Heart Failure
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) and Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of
40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. They can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
1 INDICATIONS AND USAGE
ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
ALECENSA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. (1)
1 INDICATIONS AND USAGE
Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (
1.1)
Social Anxiety Disorder (SAD) (
1.2)
1.1 Major Depressive Disorder
Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [
see Clinical Studies (
14.1
)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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.
1.2 Social Anxiety Disorder
Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [
see Clinical Studies (
14.2
)].
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of oxaprozin
tablet, USP and other treatment options before deciding to use oxaprozin tablet,
USP. Use the lowest effective dose for the shortest duration consistent with
individual patient treatment goals (see WARNINGS).
Oxaprozin Tablet, USP is indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of juvenile rheumatoid arthritis