um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Epinastine HCl Ophthalmic Solution 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis.
Epinastine HCl Ophthalmic Solution 0.05% is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. (1)
1 INDICATIONS AND USAGE
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
PROTONIX is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered.
Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
PROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Indications and Usage
Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
Perennial Allergic Rhinitis
Cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
1 INDICATIONS AND USAGE
Quetiapine tablet USP is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1)
Bipolar I disorder manic episodes (
1.2)
Bipolar disorder, depressive episodes (
1.2)
1.1 Schizophrenia
Quetiapine tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets USP in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see
CLINICAL STUDIES (
14.1
)].
1.2 Bipolar Disorder
Quetiapine tablets USP are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see
CLINICAL
STUDIES (
14.2
)].
Quetiapine tablets USP are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see
CLINICAL
STUDIES (
14.2
)].
Quetiapine tablets USP are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets USP as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see
CLINICAL
STUDIES (
14.2
)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
Piroxicam capsule is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA) (1)
Relief of the signs and symptoms of rheumatoid arthritis
(RA) (1)
Piroxicam capsules are indicated:
For relief of the signs and symptoms of
osteoarthritis.
For relief of the signs and symptoms of
rheumatoid arthritis.
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy
[see Clinical Studies (
14)]
.
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use:
Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity
[see Clinical Studies (
14)]
.
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (
1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (
1,
14)
INDICATIONS AND USAGE
Fluconazole Tablets USP are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conduct
Prophylaxis
Fluconazole Tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS AND USAGE
LDO Plus is a medicated Hydrogel wound dressing in a Metered Dose (MDOSE) bottle containing lidocaine 4%, an amide type local anesthetic, indicated for: Painful wounds such as post-surgical incisions, cuts and abrasions.
DOSAGE
Apply to the affected area as directed. Maximum 12 pumps per day.
INDICATIONS AND USAGE
Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke.
Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
1 INDICATIONS AND USAGE
Liothyronine sodium is an L-triiodothyronine (T3) indicated for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (1.1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer (1.2)
Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy (1.3)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)
1.1 Hypothyroidism
Liothyronine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
1.2 Pituitary Thyrotropin
(Thyroid-Stimulating Hormone, TSH) Suppression
Liothyronine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
1.3 Thyroid Suppression Test
Liothyronine sodium tablets are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Limitations of Use
Liothyronine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)].
Liothyronine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see CLINICAL STUDIES (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
1
INDICATIONS AND USAGE
TAZORAC Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1)
TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2)
Limitations of Use
The safety of TAZORAC Gel use on more than 20% body surface area has not been established.(1.3)
1.1 Plaque Psoriasis
TAZORAC (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.
1.2 Acne Vulgaris
TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patientswith facialacne vulgaris of mild to moderate severity.
The efficacy of TAZORAC Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.
1.3
Limitat
ions of Use
The safety of TAZORAC Gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (
5.1
) and Use in Specific Populations (
8.1
)].
INDICATIONS: PRENATE
Enhance is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE
Enhance can also be beneficial in improving the nutritional status of women prior to conception.
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:
Major Depressive Disorder (MDD)
[see Clinical Studies (
14.1)]
Generalized Anxiety Disorder (GAD)
[see Clinical Studies (
14.2)]
Social Anxiety Disorder (SAD)
[see Clinical Studies (
14.3)]
Panic Disorder (PD)
[see Clinical Studies (
14.4)]
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:
Major Depressive Disorder (MDD) (
1)
Generalized Anxiety Disorder (GAD) (
1)
Social Anxiety Disorder (SAD) (
1)
Panic Disorder (PD) (
1)
1 INDICATIONS AND USAGE
OPVEE nasal spray is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
OPVEE nasal spray is not a substitute for emergency medical care.
OPVEE nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
OPVEE nasal spray is not a substitute for emergency medical care.
INDICATIONS AND USAGE: BP 10-1 Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS AND USAGE
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
INDICATIONS AND USAGE
Lidocaine HCl Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1. Indications and Usage
Gabapentin Capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
INDICATIONS AND USAGE
DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
1. Primary hypogonadism (congenital or acquired )-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
2. Hypogonadotropic hypogonadism (congenital or acquired )- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
INDICATIONS AND USAGE
Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
INDICATIONS AND USAGE
Metformin hydrochloride extended release tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS & USAGE
Pimozide Tablets, USP is indicated for the suppression of motor and phonic tics in patients with Tourettes Disorder who have failed to respond satisfactorily to standard treatment. Pimozide Tablets, USP is not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide Tablets, USP should be reserved for use in Tourettes Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics.
Evidence supporting approval of Pimozide Tablets, USP for use in Tourettes Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older.
INDICATIONS AND USAGE
Buprenorphine HCl Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS: Addiction, Abuse, and Misuse] reserve Buprenorphine HCl Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
1 INDICATIONS AND USAGE
WELCHOL is a bile acid sequestrant indicated as an adjunct to diet and exercise to:
reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1).
reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1).
improve glycemic control in adults with type 2 diabetes mellitus (1.2).
Limitations of Use (1.3):
Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V dyslipidemias
1.1
Primary Hyperlipidemia
WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
WELCHOL is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.
1.2
Type 2 Diabetes Mellitus
WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.3
Limitations of Use
WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
WELCHOL has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1 INDICATIONS & USAGE
Duloxetine delayed-release capsulesare 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 capsule is 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)
1 INDICATIONS AND USAGE
Simvastatin tablets are 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):
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.
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):
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:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.