um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Ondansetron 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/m
2.
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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets
are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m
2. (
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)
1 INDICATIONS AND USAGE
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Etodolac tablets, USP are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
INDICATIONSAND USAGE
Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
INDICATIONSAND USAGE
Treatment of Toxoplasmosis: Pyrimethamine tablets are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
INDICATIONS AND USAGE
Isosulfan Blue 1% Injection delineates the lymphatic vessels following subcutaneous administration. It is an adjunct to lymphography (in primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities) for visualization to the lymphatic system draining the region of injection
INDICATIONS AND USAGE
Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
1 INDICATIONS AND USAGE
Pediatric use information
for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR
(rosuvastatin calcium) tablets. However, due to AstraZenecas marketing
exclusivity rights, this drug product is not labeled with that pediatric
information.
Rosuvastatin is an
HMG Co-A reductase inhibitor indicated for:
adult patients with
hypertriglyceridemia as an adjunct to diet (
1.3)
adult patients with
primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to
diet (
1.4)
adult patients with
homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and
ApoB (
1.5)
Limitations of use (
1.8): Rosuvastatin has not been studied in
Fredrickson Type I and V dyslipidemias.
1.3Hypertriglyceridemia
Rosuvastatin is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4Primary Dysbetalipoproteinemia (Type III
Hyperlipoproteinemia)
Rosuvastatin is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial
Hypercholesterolemia
Rosuvastatin is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin has not been studied in Fredrickson Type I and V dyslipidemias.
1. Indications and Usage Section
1. INDICATIONS AND USAGE
Celecoxib is indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see CLINICAL STUDIES (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see CLINICAL STUDIES (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see CLINICAL STUDIES (14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see CLINICAL STUDIES (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see CLINICAL STUDIES (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see CLINICAL STUDIES (14.5)]
1 INDICATIONS & USAGE
Donepezil hydrochloride tablet, USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride tablet, USP is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (
1).
1 INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets, USP is an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (
1.1)
Norgestimate and Ethinyl Estradiol Tablets, USP is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Norgestimate and Ethinyl Estradiol Tablets, USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (
1.2)
1.1 Oral Contraceptive
Norgestimate and Ethinyl Estradiol Tablets, USP is indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)]
.
1.2 Acne
Norgestimate and Ethinyl Estradiol Tablets, USP is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see
CLINICAL STUDIES (
14)].
INDICATIONS AND USAGE
Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the:
Treatment of moderate to severe vasomotor symptoms associated with menopause.
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg is also indicated in women who have a uterus for the:
3. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
1 INDICATIONS AND USAGE
Divalproex sodium delayed-release tablets, USP are antiepileptic drugs indicated for:
Treatment of manic episodes associated with bipolar disorder (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
1.1 Mania
Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablets, USP was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see
Clinical Studies
(14.1)
].
The safety and effectiveness of divalproex sodium delayed-release tablets, USP for long-term use in mania, i.e., more than 3 weeks, has not beendemonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets, USP for extended periods should continually re-evaluate the long-term usefulness of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed-release tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets, USP are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3 Migraine
Divalproex sodium delayed-release tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets, USP are useful in the acute treatment of migraine headaches.
1.4 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3,5.4), Use in Specific Populations (8.1), andPatient Counseling Information (17.3)].
Divalproex sodium is contraindicated for prophylaxis of migraine headaches in women who are pregnant.
1 INDICATIONSAND USAGE
Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenza
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group
, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections. (
1)
INDICATIONS AND USAGE
MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.
1 INDICATIONS AND USAGE
Risedronate sodium tablets are a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Pagets disease (1.4)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.5)
1.1 Postmenopausal Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].
1.2 Osteoporosis in Men
Risedronate sodium tablets are is indicated for treatment to increase bone mass in men with osteoporosis.
1.3 Glucocorticoid-Induced Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
1.4 Pagets Disease
Risedronate sodium tablets are indicated for treatment of Pagets disease of bone in men and women.
1.5 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. Allpatients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD). (1.1)Efficacy was established in four short-term and one maintenance trial in adults. (14.1)
Generalized Anxiety Disorder (GAD). (1.2)Efficacy was established in three short-term and one maintenance trial in adults. (14.2)
Diabetic Peripheral Neuropathic Pain (DPNP). (1.3)
Fibromyalgia (FM). (1.4)
Chronic Musculoskeletal Pain. (1.5)
1.1 Major Depressive Disorder
Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta 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
Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta 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
Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)].
1.4 Fibromyalgia
Cymbalta is indicated for the management of fibromyalgia (FM) [see Clinical Studies (14.4)].
1.5 Chronic Musculoskeletal Pain
Cymbalta is indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis [see Clinical Studies (14.5)].
1.2	Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1 INDICATIONS AND USAGE
Sumatriptan Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks.
Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.
Sumatriptan injection is a serotonin (5-HT
1B/1D) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (
1)
Acute treatment of cluster headache in adults (
1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. (
1)
Not indicated for the prophylactic therapy of migraine or cluster headache attacks. (
1)
INDICATIONS AND USAGE
Adult Patients
Flumazenil Injection, USPis indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection, USPis indicated for the reversal of conscious sedation induced with benzodiazepines (see
PRECAUTIONS: Pediatric Use
).
INDICATIONS & USAGE
Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
1 INDICATIONS AND USAGE
Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients
(1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients
(1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis:
Valganciclovir tablets
are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see
Clinical Studies
(14.1)
].
Prevention of CMV Disease:
Valganciclovir tablets
are indicated for the prevention of CMV disease in kidney,heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see
Clinical Studies
(14.1)
].
1.2 Pediatric Patients
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age)andheart transplant patients
(1 month to 16 years of age) at high risk [see
Clinical Studies (
14.2)
].
1 INDICATIONS AND USAGE
Latanoprost Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Latanoprost is a prostaglandin F2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are once daily
controlled-release tablets indicated for the treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency, and frequency.
Pediatric use information for the treatment of patients aged 6 years and
older with symptoms of detrusor overactivity associated with a neurological
condition (e.g., spina bifida) is approved for Alza Corporations oxybutynin
extended-release tablets. However, due to Alza Corporations marketing
exclusivity rights, this drug product is not labeled for pediatric use.
INDICATIONS AND USAGE
Midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride. After initiation of treatment, midodrine hydrochloride should be continued only for patients who report significant symptomatic improvement.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:
treatment
of major depressive disorder (MDD) (1.1)
prevention
of seasonal affective disorder (SAD) (1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4 week controlled inpatient trials and one 6 week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8 week study of acute treatment [see Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].