um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Toviaz is indicated for the treatment of:
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2)
1.1 Adult Overactive Bladder
Toviaz is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
1.2 Pediatric Neurogenic Detrusor Overactivity
Toviaz is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.
1.3 Community-Acquired Bacterial Pneumonia
Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of
Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae, and Legionella pneumophila.
1 INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)
Drospirenone and ethinyl estradiol tablet USP is indicated for use by women to prevent pregnancy.
1 INDICATIONS AND USAGE
Epinephrine Injection, USP is a non-selective alpha and beta adrenergic agonist indicated for:
Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1)
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2)
1.1 Anaphylaxis
Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
1.2 Hypotension associated with Septic Shock
Epinephrine Injection, USP is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
INDICATIONSAND USAGE
Hypertension
Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Ventricular Arrhythmias
Acebutolol hydrochloride capsules, USP are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
Oxycodone hydrochloride tablets 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.
1 INDICATIONS AND USAGE
Lenalidomide capsules are thalidomide analogue indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone (1.1).
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3).
Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4).
Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).
Limitations of Use:
Lenalidomide capsule is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.4).
1.1
Multiple Myeloma
Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM).
Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).
1.2
Myelodysplastic Syndromes
Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
1.3 Mantle Cell Lymphoma
Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
1.4
Follicular Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
1.5 Marginal Zone Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
1.6
Limitations of Use
Lenalidomide capsulesare not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].
1 INDICATIONS AND USAGE
Latanoprost Ophthalmic Solution is a prostaglandin F2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Latanoprost Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablets are phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (
1)
1 INDICATIONS AND USAGE
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 indicated 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.
LYPQOZET, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2)
Limitations of Use
No incremental benefit of LYPQOZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. LYPQOZET has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. (1.3)
1.1 Primary Hyperlipidemia
LYPQOZET is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
LYPQOZET is indicated for the reduction of elevated 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.
1.3 Limitations of Use
No incrementalbenefit of LYPQOZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. LYPQOZET has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
1 INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD).(
1.1)
Risk reduction of NSAID-associated gastric ulcer.(
1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
(1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (
1.4)
1.1 Treatment of Gastroesophageal Reflux Disease
(GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-Release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-Release Capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric
Ulcer
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3
H. pylori
Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole Magnesium Delayed-Release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules, in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
[see
Dosage and Administration (2)
and
Clinical Studies (14)]
.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted
[see
Clinical Pharmacology (12.4
)
and
the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions
Including Zollinger-Ellison Syndrome
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
INDICATIONS AND USAGE
Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
Lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.
Other uses may be considered if deemed clinically relevant.
1 INDICATIONSAND USAGE
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor.
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1)
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. (1)
1.1 HIV-1 Infection
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection:
Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA, COMPLERA, DESCOVY, GENVOYA, ODEFSEY, STRIBILD, TRUVADA, or VEMLIDY
[See Warnings and Precautions (5.4)].
1.2 Chronic Hepatitis B
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HBV infection:
The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-nave and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease
[See Clinical Studies (14.2)].
Tenofovir disoproxil fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease [
See Adverse Reactions (6.1)
,
Clinical Studies (14.2)]
.
The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [
See Microbiology (12.4),
Clinical Studies (14.2)
].
INDICATIONS AND USAGE
Buspirone Hydrochloride Tablets, USP are indicated for the management of anxiety disorders or 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.
The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m2.
2. Prevention of nausea and vomiting associated with initial and repeat course of moderately emetogenic cancer chemotherapy.
3. Prevention of 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.
4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE
DIFFERIN Cream is indicated for the
topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Bortezomib for injection is a proteasome inhibitor indicated for:
Treatment of adult patients with multiple myeloma. (1.1)
Treatment of adult patients with mantle cell lymphoma. (1.2)
1.1	Multiple Myeloma
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma.
1.2	Mantle Cell Lymphoma
Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma.
1 INDICATIONS AND USAGE
Phentermine Hydrochloride, USP 15 mg and 30 mg 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 greater than or equal to 30 kg/m
2, or greater than or equal to 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 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, [
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 greater than or equal to 30 kg/m
2, or greater than or equal to 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)
BMI
INDICATIONS AND USAGE
ALREX ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
1 INDICATIONS AND USAGE
Testosterone gel 1.62% isindicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of testosterone gel 1.62% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [seeIndications and Usage (1)and
Clinical Pharmacology (12.3)].
Testosterone gel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired)(1)
Hypogonadotropic hypogonadism (congenital or acquired)(1)
Limitations of use:
Safety and efficacy of testosterone gel 1.62% in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established.(1,8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.(1,12.3)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen as naproxen or naproxen sodium tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritisFor the relief of the signs and symptoms of osteoarthritisFor the relief of the signs and symptoms of ankylosing spondylitisFor the relief of the signs and symptoms of juvenile arthritis
Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.
Naproxen as naproxen and naproxen sodium tablets are also indicated:
For relief of the signs and symptoms of tendonitisFor relief of the signs and symptoms of bursitisFor relief of the signs and symptoms of acute goutFor the management of painFor the management of primary dysmenorrhea
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day
[see
Clinical Studies (14.1)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is a carbonic anhydrase inhibitor with a beta adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (
1)