um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE SECTION
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 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 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 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 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 patients with elevated serum TG levels (Fredrickson Type IV);
For the treatment of 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 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 boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
a. LDL-C remains
190 mg/dL or
b. 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).
INDICATIONS & USAGE SECTION
Bupropion hydrochloride extended-release tablets, USP (SR)are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (
14)].
The efficacy of bupropion hydrochloride extended-release tablets, USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (
14)].
INDICATIONS & USAGE SECTION
Pantoprazole Sodium Delayed-Release Tabletsare indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tabletsare indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (
1.1)
Otitis media (
1.2)
Skin and skin structure infections (
1.3)
Bone infections (
1.4)
Genitourinary tract infections (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of
Streptococcus pneumoniae,
Haemophilus influenzae,
Staphylococcus aureus,
Streptococcus pyogenes, and
Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus and
Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of
Staphylococcus aureus and
Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of
Escherichia coli,
Proteus mirabilis, and
Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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
Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1)
Complicated intra-abdominal infections (adult and pediatric patients). (1.2)
Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection (I.V.) and other antibacterial drugs, meropenem for injection (I.V.) should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)
Meropenem for injection (I.V.) is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients)
Meropenem for injection (I.V.) is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)
Meropenem for injection (I.V.) is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae,Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.
Meropenem for injection (I.V.) has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection (I.V.) and other antibacterial drugs, meropenem for injection(I.V.) should only be used 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
Piroxicam capsules, USP are indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA)
Relief of the signs and symptoms of rheumatoid arthritis (RA)
INDICATIONS & USAGE
Granisetron HCl is indicated for the prevention of :
Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. [see Warnings and Precautions (5.1)]
Celecoxib capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [see Contraindications (4) and Warnings and Precautions (5.1)]
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. [see Warnings and Precautions (5.2)]
1 INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.
Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. (1)
1 INDICATIONS & USAGE
PRAMIPEXOLE DIHYDROCHLORIDE tablets is a non-ergot dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD) (1.1)
1.1 Parkinson's Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
1 INDICATIONS AND USAGE
Phentermine hydrochloride tablets, USP are 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
30 kg/m2, or
27 kg/m2 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 phentermine hydrochloride tablets, USP [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride 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
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, USP, should be measured against possible risk factors inherent in their use. (1)
Image of the Body Mass Index Chart
INDICATIONS AND USAGE
Exelon (rivastigmine tartrate) is
indicated for the treatment of mild to moderate dementia of the Alzheimer's
type.
Exelon (rivastigmine tartrate) is indicated for
the treatment of mild to moderate dementia associated with Parkinsons
disease.
The dementia of Parkinsons disease is purportedly characterized by
impairments in executive function, memory retrieval, and attention in patients
with an established diagnosis of Parkinsons disease. The diagnosis of the
dementia of Parkinsons disease, however, can reliably be made in patients in
whom a progressive dementia syndrome occurs (without the necessity to document
the specific deficits described above) at least 2 years after a diagnosis of
Parkinsons disease has been made, and in whom other causes of dementia have
been ruled out (see CLINICAL PHARMACOLOGY, Clinical Trial Data).
1 INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence.Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Buprenorphine and naloxone sublingual tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence.(1)
Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
INDICATIONS AND USAGE
Aurovela Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
Adapted from RA Hatcher et al, Reference 7.* The authors best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
** This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
*** N/A - Data not available.
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
Lowest
Expected*
Typical**
(No contraception) Oral contraceptives Combined progestin only Diaphragm with spermicidal
cream or jelly
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) Vaginal Sponge nulliparous parousImplant Injection: depot medroxyprogesterone acetate IUD progesterone T copper T 380A LNg 20 Condom without spermicides female male Cervical Cap with spermicidal cream or jelly nulliparous
parous Periodic abstinence (all methods) Withdrawal Female sterilization Male sterilization
(85)0.10.5669200.050.31.50.60.1539261 to 940.50.1
(85)3N/A***N/A***202620400.050.320.80.12114204025190.50.15
1 INDICATIONS AND USAGE
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older
[see
Dosage and Administration (2.4)]
.
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older (
2.4).
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
INDICATIONS AND USAGE
Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.
Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
1 INDICATIONS AND USAGE
Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC).
Ursodiol tablets, 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. (1)
1
INDICATIONS & USAGE
Adenosine Injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE ANDADMINISTRATION
.
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
INDICATIONS & USAGE SECTION
1.1 Monotherapy EpilepsyTopiramatetablets, USPare indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2 Adjunctive Therapy EpilepsyTopiramate tablets, USPare indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].