um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Risperidone tablets are an atypical antipsychotic indicated for:
Treatment of schizophrenia (
1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (
1.2)
Treatment of irritability associated with autistic disorder (
1.3)
1.1 Schizophrenia
Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults
[see
Clinical Studies (14.1)]
.
1.2 Bipolar Mania
Monotherapy
Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)
[see
Clinical Studies (14.2)]
.
Adjunctive Therapy
Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults
[see
Clinical Studies (14.3)]
.
1.3 Irritability Associated with Autistic Disorder
Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)
[see
Clinical Studies (14.4)]
.
1. Indications and Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, 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 tablets USP 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*:
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 should not be used.
INDICATIONS AND USAGE
MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.
MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.
The routes of administration and indicated MARCAINE concentrations are:
local infiltration0.25%
peripheral nerve block 0.25% and 0.5%
retrobulbar block0.75%
sympathetic block0.25%
lumbar epidural0.25%, 0.5%, and 0.75%
(0.75% not for obstetrical anesthesia)
caudal0.25% and 0.5%
epidural test dose 0.5% with epinephrine 1:200,000
dental blocks0.5% with epinephrine 1:200,000
(See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
1 INDICATIONS ANDUSAGE
Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV- 1 infection in adults and pediatric patients 14 days and older.
Limitations of Use:
Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir
[
see Microbiology (12.4)]
.
Lopinavir and ritonavir is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 daysand older). (
1)
1 INDICATIONS & USAGE
Eszopiclone tabletsare 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 areindicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance (
1)
1	INDICATIONS AND USAGE
Cisatracurium Besylate Injection is indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age
to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU
to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older
Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age. (1)
to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance. (1)
for mechanical ventilation in the ICU in adults. (1)
Limitations of Use:
Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. (1)
Limitations of Use
Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
1 INDICATIONS AND USAGE
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron orally disintegrating tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50mg/m2
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen (1)
postoperative nausea and/or vomiting (1)
INDICATIONS AND USAGE Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
INDICATIONS AND USAGE
For the treatment of the following conditions:
OphthalmicSteroid responsive inflammatory conditions of the palpebral and
bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic
conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster
keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent
hazard of steroid use is accepted to obtain an advisable diminution in edema and
inflammation; corneal injury from chemical or thermal burns, or penetration of
foreign bodies.
OticSteroid responsive inflammatory conditions of the external
auditory meatus, such as allergic otitis externa, selected purulent and
nonpurulent infective otitis externa when the hazard of steroid use is accepted
to obtain an advisable diminution in edema and inflammation.
INDICATIONS AND USAGE
MALES
Androgens are indicated for replacement therapy in conditions
associated with a deficiency or absence of endogenous testosterone.
a.Primary hypogonadism (congenital or acquired)
- testicular failure due to cryptorchidism, bilateral torsion,
orchitis, vanishing testes syndrome; or orchiectomy.
b.Hypogonadotropic hypogonadism (congenital or
acquired) -gonadotropic LHRH deficiency, or pituitary
- hypothalamic injury from tumors, trauma or radiation.
If the above conditions occur prior to puberty, androgen
replacement therapy will be needed during the adolescent years for
development of secondary sex characteristics. Prolonged androgen
treatment will be required to maintain sexual characteristics in these
and other males who develop testosterone deficiency after puberty.
Safety and efficacy of Testopel (testosterone pellets) in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
c.Androgens may be used to stimulate puberty in
carefully selected males with clearly delayed puberty. These
patients usually have a familial pattern of delayed puberty that is
not secondary to a pathological disorder; puberty is expected to
occur spontaneously at a relatively late date. Brief treatment with
conservative doses may occasionally be justified in these patients
if they do not respond to psychological support. The potential
adverse effect on bone maturation should be discussed with the
patient and parents prior to androgen administration. An x-ray of
the hand and wrist to determine bone age should be taken every 6
months to assess the effect of treatment on epiphyseal centers (see
WARNINGS).
1. INDICATIONS AND USAGE
Simvastatin tablet is indicated:
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
oIn adults with primary hyperlipidemia.
oIn adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
o Primary dysbetalipoproteinemia.
o Hypertriglyceridemia.
Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: (
1)
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
o	In adults with primary hyperlipidemia.
o	In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
o	Primary dysbetalipoproteinemia.
o	Hypertriglyceridemia.
1
INDICATIONS AND USAGE
AFREZZA is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
Limitations of Use:
AFREZZA is not recommended for the treatment of diabetic ketoacidosis [see Warning and Precautions (5.6)].
The safety and effectiveness of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking.
AFREZZA is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. (1)
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis (1)
Not recommended in patients who smoke or who have recently stopped smoking (1)
1. INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD)
(1.1)
Generalized Anxiety Disorder
(GAD) (1.2)
Diabetic Peripheral Neuropathic
Pain (DPNP) (1.3)
1.1 Major Depressive Disorder
Duloxetine delayed-release capsules, USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short term and one maintenance trial in adults [see CLINICAL STUDIES (14.1)].
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 5 of the following 9 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, or a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Duloxetine delayed-release capsules, USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine was established in three short-term trials and one maintenance trial in adults [see CLINICAL STUDIES ( 14.2)].
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
1.3 Diabetic Peripheral Neuropathic Pain
Duloxetine delayed-release capsules, USP are indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy [see CLINICAL STUDIES ( 14.3 )].
INDICATIONS AND USAGE
Terbutaline sulfate injection is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
1 INDICATIONS AND USAGE
Monotherapy
Fulvestrant injection is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Combination Therapy
Fulvestrant injection is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
(1)
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
(1)
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.
(1)
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
(1)
INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic suspension) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
INDICATIONS AND USAGE
Hypertension
Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. It 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 tablets, USP cause 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 improve 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.
Indications & Usage Section
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/m2 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/m2 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.
Please review the manufacturer's complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07bf3488-09e7-436f-af3f-94c35a7be025