um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Albendazole Tablets is an anthelmintic drug indicated for:
Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium. (
1.1)
Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus. (
1.2)
1.1 Neurocysticercosis
Albendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm,
Taenia solium.
1.2 Hydatid Disease
Albendazole Tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus.
Indications and Usage:
A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
1INDICATIONS AND USAGE
PATANASE is indicated for the relief of the symptoms of seasonal allergic rhinitis (SAR) in adults and pediatric patients 6 years of age and older.
PATANASE is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis (SAR) in adults and pediatric patients 6 years of age and older (1).
1INDICATIONS AND USAGE
JADENU is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
JADENU is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2)
Limitations of Use:
The safety and efficacy of JADENU when administered with other iron chelation therapy have not been established. (1.3)
1.1Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
JADENU is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
1.3Limitations of Use
The safety and efficacy of JADENU when administered with other iron chelation therapy have not been established.
INDICATIONS AND USAGE:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 conjunctivitises 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 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 drugs in this product is active against the following common bacterial eye pathogens:
Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacterspecies, Niesseriaspecies, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratiamarcescensand Streptococci, including Streptococcus pneumoniae.
INDICATIONS & USAGE
Postherpetic Neuralgia
Gabapentin is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3to 12 years.
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]
1.1 Osteoarthritis (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain (AP)
Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea (PD)
Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)]
INDICATIONS AND USAGE
Estradiol tablets are indicated in the:
1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See CLINICAL PHARMACOLOGY, Clinical Studies).
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 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
1 INDICATIONS AND USAGE
Gabapentin oral solution is 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
Gabapentin oral solution is indicated for:
Postherpetic neuralgia in adults(1)
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(1)
1 INDICATIONS AND USAGE
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (
1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain.
Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.
1 INDICATIONS AND USAGE
Quetiapine tablet 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 tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets 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 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 tablet is 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 tablet is 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 tablet is 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 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
Naproxen tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis
Naproxen tablets are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
Naproxen tablets are non-steroidal anti- inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen tablets are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
1 INDICATIONS AND USAGE
Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
Sufentanil Citrate Injection is indicated for epidural administration:
as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
Sufentanil Citrate Injection is an opioid agonist indicated (1):
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
INDICATIONS
Entacapone tablets, USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose wearing-off in patients with Parkinsons disease (see
CLINICAL PHARMACOLOGY, Clinical Studies).
Entacapone tablets, USP effectiveness has not been systematically evaluated in patients with Parkinsons disease who do not experience end-of-dose wearing-off.
1 INDICATIONS AND USAGE
GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1)
1 INDICATIONS AND USAGE
1.1 Alzheimers Disease
ExelonPatch (rivastigminetransdermalsystem) is indicated for the treatment of mild to moderate dementia of the Alzheimers type.
1.2 Parkinsons Disease Dementia
ExelonPatch (rivastigminetransdermalsystem) is indicated for the treatment of mild to moderate dementia associated with Parkinsons disease.
The dementia of Parkinsons disease is purportedly characterized by impairments in executive function, memory retrieval, and attention in patients with an established diagnosis of Parkinsons disease. The diagnosis of dementia of Parkinsons disease can be made reliably in patients in whom a progressive dementia syndrome occurs (without the necessity to document the specific deficits described above) at least 2 years after a diagnosis of Parkinsons disease has been made, and in whom other causes of dementia have been ruled out.
1 INDICATIONS & USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of UseFosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of (1):acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (1)
Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
INDICATIONS & USAGE
Parkinsons Disease
RopiniroleTabletsare indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease.
The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinsons disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).
Restless Legs Syndrome
Ropinirole Tablets areindicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
1 INDICATIONS AND USAGE
GAVRETO is a kinase inhibitor indicated for treatment of:
Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).1 (1.1)
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.1 (1.2)
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).1 (1.3)
1 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
1.1
Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
1.2
RET-Mutant Medullary Thyroid Cancer
GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
1.3
RET Fusion-Positive Thyroid Cancer
GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
INDICATIONS AND USAGE
Caffeine citrate is indicated for the treatment of apnea of prematurity.
Seizure Disorders:
Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.
In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may re-establish efficacy.
Panic Disorder:
Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: CLINICAL TRIALS).
Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes:
(1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).