um-ids/dailymed-annotations huggingface dataset:
1. INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (14.1)]
Generalized Anxiety Disorder [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]
Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a
few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body
mass index (BMI) of 30 kg/m or higher who have not responded to appropriate weight reducing
regimen (diet and/or exercise) alone. 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.
BODY MASS INDEX (BMI), kg/m Height (feet, inches )
Weight(pounds) 50 53 56 59 60 63
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31
Phendimetrazine tartrate is indicated for use as monotherapy only.
INDICATIONS AND USAGE
Venlafaxinetablets are indicated for the treatment of major depressive disorder.
The efficacy of venlafaxinetablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see
CLINICAL TRIALS
).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxinetablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see
CLINICAL TRIALS
). Nevertheless, the physician who elects to use venlafaxinetablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
1.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
2.For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 (see DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of depression.
The efficacy of citalopram in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
For the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
INDICATIONS AND USAGE
BENICAR HCT
is
indicated for the treatment of hypertension. This fixed dose combination is not
indicated for initial therapy (see
DOSAGE
AND ADMINISTRATION
).
INDICATIONS AND USAGE
Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated
for the treatment of conjunctivitis and other superficial ocular infections due
to susceptible microorganisms, and as an adjunctive in systemic sulfonamide
therapy of trachoma:
Escherichia coli, Staphylococcus aureus, Streptococcus
pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens
and Pseudomonas aeruginosa. A significant
percentage of staphylococcal isolates are completely resistant to sulfa drugs.
1
INDICATIONS AND USAGE
Enter section text here
Amitiza is a chloride channel activator indicated for:
Treatment of chronic idiopathic constipation in adults (1.1)
Treatment of irritable bowel syndrome with constipation in women
18 years
old (1.2)
1.1 Chronic Idiopathic Constipation
Amitiza is indicated for the treatment of chronic
idiopathic constipation in adults.
1.2 Irritable Bowel Syndrome with Constipation
Amitiza is indicated for the treatment of irritable bowel syndrome with
constipation (IBS-C) in women
18 years old.
1 INDICATIONSAND USAGE
Fenofibrate tablet is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablet is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablet is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus[see WARNINGS AND PRECAUTIONS (
5.1
)].
1 INDICATIONS AND USAGE
Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronickidney disease (CKD) on dialysis.
Sevelamer carbonate is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. (1)
1 INDICATIONS AND USAGE
To reduce the development of drugresistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat 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.
Amoxicillin and Clavulanate Potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and Clavulanate Potassium
is a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
(1.1)
Acute bacterial otitis media
(1.2)
Sinusitis
(1.3)
Skin and skin structure infections
(1.4)
Urinary tract infections
(1.5)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of
Haemophilusinfluenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of
H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of
H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of
Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of
E. coli, Klebsiellaspecies, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used.
INDICATIONS AND USAGE
Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS & USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
Ziprasidone hydrochloride is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (1) Ziprasidone capsules are indicated for the:
treatment of schizophrenia in adults. (1) acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1) maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
1 INDICATIONS AND USAGE
Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (
1)
1 INDICATIONS AND USAGE
Lanreotide injection is a somatostatin analog indicated for:
the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. (1.1)
the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. (1.2)
1.1 Acromegaly
Lanreotide Injection is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
1.2 Gastroenteropancreatic Neuroendocrine Tumors
Lanreotide Injection is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
1 INDICATIONSAND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
Famotidine tablet is a histamine-2 (H
2) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg andgreater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
1 INDICATIONS AND USAGE
Digoxinis a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Control of resting ventricular rate in adults with chronic atrial fibrillation. (1.2)
1.1 Heart Failure in Adults
Digoxinis indicated for the treatment of mild to moderate heart failure in adults.Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible,digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2 Atrial Fibrillation in Adults
Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
1 INDICATIONS AND USAGE
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type.
1 INDICATIONS AND USAGE
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.
Terbinafine tablets, are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
INDICATIONS AND USAGE
Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches x 0.0254 = meters.
Body Mass Index (BMI), kg/m2
Weight (pounds)
Height (feet, inches)
50
53
56
59
60
63
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The usefulness of agents of this class (see
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only.
INDICATIONS AND USAGE
SYNALAR Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
INDICATIONS AND USAGE
Labetalol HCl tablets are indicated in the management of hypertension. Labetalol
HCl tablets may be used alone or in combination with other antihypertensive
agents, especially thiazide and loop diuretics.
INDICATIONS AND USAGE
Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below.
1 INDICATIONS AND USAGE
Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated:
for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1)
as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2)
1.1 Severe Hypoglycemia
Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.
1.2 Diagnostic Aid
Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
Tramadol hydrochloride tablets are indicated in adults 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)], reserve tramadol hydrochloride tablets 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.
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin HCl and other antibacterial drugs, Clindamycin HCl 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
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac tablets are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
1.Osteoarthritis
2.Rheumatoid arthritis
For the management of acute pain