um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
REYATAZ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg.
Limitations of Use:
REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)].
Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].
REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. (1)
1 INDICATIONS AND USAGE
Derma-Smoothe/FS is a corticosteroid indicated for the
topical treatment of atopic dermatitis in adult patients (1.1)
topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (1.2)
Limitations of Use:
Apply the least amount to cover affected areas.Discontinue when disease is controlled. (1.3)
Do not use in the diaper area. (1.3)
Do not use on the face, axillae, or groin. (1.3, 6.2, 8.4)
1.1 Adult Patients with Atopic Dermatitis
Derma-Smoothe/FS is indicated for the topical treatment of atopic dermatitis in adult patients.
1.2 Pediatric Patients with Atopic Dermatitis
Derma-Smoothe/FS is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.
1.3 Limitations of Use
Apply the least amount of Derma-Smoothe/FS needed to cover the affected areas. As with other corticosteroids, Derma-Smoothe/FS should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.
Derma-Smoothe/FS should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.
Derma-Smoothe/FS should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see Adverse Reactions (6) and Use in Specific Populations (8.4)].
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinsons disease.
Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinsons disease (PD) (
1)
1 INDICATIONS& USAGE
Tamsulosin Hydrochloride Capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)
]. Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension.
Tamsulosin Hydrochloride Capsules is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1)
Tamsulosin Hydrochloride Capsules
are not indicated for the treatment of hypertension (1)
INDICATIONS AND USAGE
Fluphenazine Hydrochloride Injection, USP is indicated in the management of manifestations of psychotic disorders.
Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
INDICATIONS AND USAGE
AVELOX Tablets and I.V. are indicated for the treatment of adults
( 18 years of age) with infections caused by susceptible strains of the
designated microorganisms in the conditions listed below. (See
DOSAGE AND ADMINISTRATION for specific
recommendations. In addition, for I.V. use, see
PRECAUTIONS, Geriatric Use.)
Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute Bacterial Exacerbation of Chronic Bronchitis
caused by Streptococcus pneumoniae, Haemophilus influenzae,
Haemophilus parainfluenzae,
Klebsiella
pneumoniae, methicillin-susceptible Staphylococcus
aureus, or Moraxella catarrhalis.
Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant
strains*), Haemophilus influenzae, Moraxella
catarrhalis, methicillin-susceptible Staphylococcus
aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.
* MDRSP, Multi-drug resistant Streptococcus
pneumoniae includes isolates previously known as PRSP
(Penicillin-resistant S. pneumoniae), and are strains
resistant to two or more of the following antibiotics: penicillin (MIC
2
g/mL), 2nd generation cephalosporins (e.g., cefuroxime),
macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Uncomplicated Skin and Skin Structure Infections
caused by methicillin-susceptible Staphylococcus
aureus or Streptococcus pyogenes.
Complicated Intra-Abdominal Infections including
polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus,
Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis,
Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.
Complicated Skin and Skin Structure Infections caused
by methicillin-susceptible Staphylococcus aureus,
Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae (See
Clinical Studies).
Appropriate culture and susceptibility tests should be performed before
treatment in order to isolate and identify organisms causing infection and to
determine their susceptibility to moxifloxacin. Therapy with AVELOX may be
initiated before results of these tests are known; once results become
available, appropriate therapy should be continued.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used
only to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)
INDICATIONS AND USAGE
GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS & USAGE SECTION
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patients clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
In Anesthesia
Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects(e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
INDICATIONS AND USAGE
Hydrocortisone tablets are 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
Non suppurative 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
Systemic dermatomyositis (polymyositis)
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
Serum sickness
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
7. Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy
Aspiration pneumonitis
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 when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
INDICATIONS AND USAGE
Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).
1 INDICATIONS AND USAGE
Tramadol hydrochloride oral solutionis indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Tramadol hydrochloride oral solutionis 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 (
5.2), reserve tramadol hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated or are not expected to be tolerated (
1).
Have not provided adequate analgesia, or are not expected to provide adequate analgesia (
1).
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses
[see Warnings and Precautions (
5.2)]
, reserve tramadol hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated or are not expected to be tolerated.
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
1INDICATIONS AND USAGE
Chronic Lymphocytic Leukemia (CLL)
ARZERRA (ofatumumab) is indicated:
in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)]
in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)]
for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)]
for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)]
ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia (CLL) (1):
in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL.
for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
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 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.
Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.
INDICATIONS AND USAGE
Albuterol tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
1 INDICATIONS AND USAGE
Oxycodone hydrochloride tablets are indicated 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 (
5.1)]
, reserveoxycodone hydrochloride tablets 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 tablets are an opioid agonist indicated 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, reserveoxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
1 INDICATIONS AND USAGE
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat moderate acne for women at least 14 years old only
if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral Contraceptive
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy.
1.3 Acne
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1 INDICATIONS AND USAGE
Simvastatin tablets are indicated:
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: (1)
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
1 INDICATIONS AND USAGE
Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1,intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1,intermediate-2, and high-risk International Prognostic Scoring System groups.
1 INDICATIONS AND USAGE
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older(
1)
1 INDICATIONS AND USAGE
Fluoxetine Capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see Clinical Studies
(14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see Clinical Studies
(14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see Clinical Studies
(14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia
[see Clinical Studies
(14.4)].
Fluoxetine Capsules and Olanzapine in Combination are indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine Capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using Fluoxetine Capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine Capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD)
(1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
(1)
Acute and maintenance treatment of Bulimia Nervosa
(1)
Acute treatment of Panic Disorder, with or without agoraphobia
(1)
Fluoxetine Capsules and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder
(1)