um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
METADATE ER is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of 1 or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
Hypertension
Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Essential Tremor
Propranolol hydrochloride tablets, USP are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride tablets, USP improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolol hydrochloride tablets, USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
1 INDICATIONS AND USAGE
Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of:
Partial onset seizures in patients one month 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 tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets USP are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:
Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1)
Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1)
Treatment of esophageal candidiasis. (1)
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1)
1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients
Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1, 14.5)].
1.2 Treatment of Candidemia and Other Candida Infections
Caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
1.3 Treatment of Esophageal Candidiasis
Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC [see Clinical Studies (14.3)].
1.4 Treatment of Invasive Aspergillosis in Patients Who Are Refractory to or Intolerant of Other Therapies
Caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [see Clinical Studies (14.4, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been studied as initial therapy for invasive aspergillosis.
INDICATIONS AND USAGE:
Pilocarpine hydrochloride tablets, USPare indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.
INDICATIONS AND USAGE
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
1 INDICATIONS AND USAGE
Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Ga 68 DOTATOC Injection is
a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. (1)
INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION
).
In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See
WARNINGS
.)
In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See
WARNINGS
,
Lisinopril
.)
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance (
1)
1 INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
INDICATIONS AND USAGE
Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) (1).
Primary Humoral Immunodeficiency Diseases (PI)
Octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.
INDICATIONS AND USAGE
Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by
Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and
Streptococcus pyogenes
Note:
-lactamase-negative, ampicillin-resistant (BLNAR) strains of
Haemophilus influenzae should be considered resistant to cefaclor despite apparent
in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia, caused by
Streptococcus pneumoniae, Haemophilus influenzae, and
Streptococcus pyogenes
Note:
-lactamase-negative, ampicillin-resistant (BLNAR) strains of
Haemophilus influenzae should be considered resistant to cefaclor despite apparent
in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by
Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by
Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by
Staphylococcus aureus and
Streptococcus pyogenes
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor for Oral Suspension 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.
INDICATIONS AND USAGE
For the treatment of constipation. In patients with a history of chronic
constipation, lactulose solution therapy increases the number of bowel movements
per day and the number of days on which bowel movements occur.
1 INDICATIONS AND USAGE
Rasuvo is a folate analog metabolic inhibitor indicated for the:
Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1)
Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2)
Limitation of Use
Rasuvo is not indicated for the treatment of neoplastic diseases (1.3).
1.1	Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis
Rasuvo is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
1.2	Psoriasis
Rasuvo is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses.
1.3	Limitation of Use
Rasuvo is not indicated for the treatment of neoplastic diseases.
INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for: - Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
- Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2 )
- Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
- Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)
1 INDICATIONS & USAGE
Venlafaxine Hydrochloride Extended-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major Depressive Disorder (MDD) Generalized Anxiety Disorder (GAD)Social Anxiety Disorder (SAD) Panic Disorder (PD)
1.1 Major Depressive Disorder
Venlafaxine Hydrochloride Extended-release Capsulesis indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.2 Generalized Anxiety Disorder
Venlafaxine Hydrochloride Extended-release Capsules is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.
1.3 Social Anxiety Disorder
Venlafaxine Hydrochloride Extended-release Capsules is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
1.4 Panic Disorder
Venlafaxine Hydrochloride Extended-release Capsules is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1 INDICATIONS AND USAGE
Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)
].
Limitations of Use:
Quinine sulfate oral capsules are not approved for:
Treatment of severe or complicated P. falciparum malaria.
Prevention of malaria.
Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)
].
Quinine sulfate is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. (1)
Limitations of Use:
Quinine sulfate is not approved for:
Treatment of severe or complicated P. falciparum malaria.
Prevention of malaria.
Treatment or prevention of nocturnal leg cramps
1	INDICATIONS AND USAGE
FOSAMAX is a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2)
Treatment to increase bone mass in men with osteoporosis (1.3)
Treatment of glucocorticoid-induced osteoporosis (1.4)
Treatment of Paget's disease of bone (1.5)
Limitations of use:Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6)
1.1	Treatment of Osteoporosis in Postmenopausal Women
FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]
1.2	Prevention of Osteoporosis in Postmenopausal Women
FOSAMAX is indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)].
1.3	Treatment to Increase Bone Mass in Men with Osteoporosis
FOSAMAX is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
1.4	Treatment of Glucocorticoid-Induced Osteoporosis
FOSAMAX is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)].
1.5	Treatment of Paget's Disease of Bone
FOSAMAX is indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease. [See Clinical Studies (14.5).]
1.6	Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS AND USAGE
Methylprednisolone tablets, USP 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 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: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis
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
Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis
5.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis
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 Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis
7.
Respiratory Diseases
Symptomatic sarcoidosis Berylliosis Loefflers syndrome not manageable by other means 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.
Nervous System
Acute exacerbations of multiple sclerosis
13.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.