um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].
Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
1INDICATIONS AND USAGE
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).
PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, andis characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
NUEDEXTA is a combination product containing dextromethorphan hydrobromide (anuncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of pseudobulbar affect (PBA). (1)
INDICATIONS AND USAGE
Hypertension
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 tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS and
WARNINGS).
INDICATIONS AND USAGE GENERALIntravascular
OMNIPAQUE 350 is indicated in adults for angiocardiography (ventriculography, selective coronary arteriography), aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches, intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels, peripheral arteriography, and excretory urography.
OMNIPAQUE 350 is indicated in pediatric patients for angiocardiography
(ventriculography, pulmonary arteriography, and venography; studies of the collateral arteries and aortography, including the aortic root, aortic arch, ascending and descending aorta). OMNIPAQUE 300 is indicated in adults for aortography including studies of the aortic arch, abdominal aorta and its branches, cerebral arteriography, peripheral venography (phlebography), and excretory urography.
OMNIPAQUE 300 is indicated in pediatric patients for angiocardiography (ventriculography), excretory urography.
INDICATIONS AND USAGE
Oxycodone hydrochloride tablets, USP, are an immediate-release oral formulation
of oxycodone hydrochloride indicated for the management of moderate to severe
pain where the use of an opioid analgesic is appropriate.
INDICATIONS
Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Anxiety associated with depression is also responsive to oxazepam therapy.
This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients.
Alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy.
The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
INDICATIONS AND USAGE
Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis.
The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability.
Mitoxantrone in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer.
Mitoxantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.
1 INDICATIONS AND USAGE
Levetiracetam tablets, USP are antiepileptic drug indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients 4 years 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 as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.s levetiracetam tablets and oral solution. However, due to UCB Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets, USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 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 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 AND USAGE
Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2)
1.1 Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
1.2 Important Limitation of Use
Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
INDICATIONS
Orphenadrine citrate is indicated as an adjunct to rest, physical
therapy, and other measures for the relief of discomfort associated with acute
painful musculo-skeletal conditions. The mode of action of the drug has not been
clearly identified, but may be related to its analgesic properties. Orphenadrine
citrate does not directly relax tense skeletal muscles in man.
INDICATIONS AND USAGE
Zonisamide is indicated as adjunctive therapy in the treatment of
partial seizures in adults with epilepsy.
INDICATIONS AND USAGE
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
INDICATIONS & USAGE SECTION
Metformin Hydrochloride Tablets USP, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus
1	INDICATIONS AND USAGE
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m
2, or
27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows:
pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [
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/m
2, or
27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (
1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (
1)
Figure
1 INDICATIONS AND USAGE
Activated DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
DEFINITY RT is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. (1)
INDICATION:
Pyridostigmine Bromide Oral Solution, USP is useful in the treatment of myasthenia gravis.
1 INDICATIONS AND USAGE
SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)
1 INDICATIONS AND USAGE
Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories.
Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. (1)
INDICATIONS AND USAGE
Diethylpropion hydrochloride tablets USP, 25 mg 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 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 patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches
0.0254 = meters.
Body Mass Index (BMI), kg/m2
Weight (pounds)
Height (feet, inches)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
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 tablets USP, 25 mg are indicated for use as monotherapy only.
INDICATIONS AND USAGE
Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see
DOSAGE AND ADMINISTRATION).
It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.
INDICATIONS AND USAGE
Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts.
The 10,000 BAU/mL dose form is indicated for percutaneous testing.
If negative, 100,000 BAU/mL dose form can be used for percutaneous testing.
For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration)
The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient.
Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed.
For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages.
If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.
INDICATIONS AND USAGE
Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors:
1. Adenocarcinoma of the breast.
2. Adenocarcinoma of the ovary.
3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
4. For the treatment of superficial papillary carcinoma of the urinary bladder.
While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable)
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 Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors 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)
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of
Haemophilus influenzae and
Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of
Staphylococcus aureus,
Escherichia coli, and
Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of
E. coli,
Klebsiella species, and
Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, USP, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should not be used.
1 INDICATIONS AND USAGE
Clopidogrel bisulfate is a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel bisulfate has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel bisulfate has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel bisulfate has been shown to reduce the combined endpoint of new ischemic stroke, new MI, and other vascular death. (1.2)
1.1 Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel bisulfate has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel bisulfate has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of clopidogrel bisulfate therapy in ACS is unknown.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel bisulfate has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
1 INDICATIONS AND USAGE
Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (
1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (
1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did
not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Treatment of Severe Hypertriglyceridemia
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied.
1.2 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
1.3	Limitations of Use
Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus
[see
Warnings and Precautions (5.1)]
.
1.4	General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.