um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Isosulfan Blue Injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. 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; lymph node response to therapeutic modalities (1.1).
1.1 Lymphatic Vessel Delineation
Isosulfan Blue Injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. 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.
INDICATIONS AND USAGE
1.1Indication
BLEMISH ERASER is a combination of hydrocortisone (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and a tretinoin (a retinoid) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen.
1.2 Limitations of Use
The safety and efficacy of BLEMISH ERASER in pregnant women and nursing mothers have not been established.
BLEMISH ERASER is a hydroquinone (a melanin synthesis inhibitor) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. (1)
1 INDICATIONS AND USAGE
WYNZORA Cream is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
WYNZORA Cream is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. (1)
1 INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
1 INDICATIONS AND USAGE
Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for:
Twice-daily treatment of asthma in patients aged 4 years and older. (1.1)
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2)
Important Limitation of Use: Not indicated for relief of acute bronchospasm. (1.1, 1.2)
1.1 Treatment of Asthma
Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalation powder should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).
Important Limitation of Use
Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.
1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg over fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg has not been demonstrated.
Important Limitation of Use
Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.
INDICATIONS AND USAGE
Carboprost tromethamine, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
Failure of expulsion of the
fetus during the course of treatment by another method;
Premature rupture of membranes
in intrauterine methods with loss of drug and insufficient or absent
uterine activity;
Requirement of a repeat
intrauterine instillation of drug for expulsion of the fetus;
Inadvertent or spontaneous
rupture of membranes in the presence of a previable fetus and absence of
adequate activity for expulsion.
Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injectionhas resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injectionused in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
INDICATIONS & USAGE
Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).
INDICATIONS AND USAGE
Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by
Candida
albicans and other susceptibleCandidaspecies.
Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
1 INDICATIONS AND USAGE
SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room
[see Contraindications (
4)].
As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS, SUBSYS may be dispensed by outpatient pharmacies only to outpatients enrolled in the program. [
see Warnings and Precautions (
5.7
)]. For inpatient administration of SUBSYS, patient and prescriber enrollment are not required.
SUBSYS is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. (
1)
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS.
Limitations of Use (
1):
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room.
As a part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS, SUBSYS may be dispensed by outpatient pharmacies only to outpatients enrolled in the program (
5.7). For inpatient administration of SUBSYS, patient and prescriber enrollment are not required.
INDICATIONS AND USAGE
Sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized.
Sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.
Sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure.
INDICATIONS AND USAGE
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.
Some loss of effect may occur during the course of clonazepam treatment (see
PRECAUTIONS: Loss of Effect
).
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).
1 INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (
1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (
1.2)
Esophageal candidiasis (
1.3)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (
1.4)
1.1 Invasive Aspergillosis
Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were
Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of
Aspergillus other than
A. fumigatus[see
Clinical Studies (14.1, 14.5) and
Microbiology (12.4)].
1.2 Candidemia in Non-Neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following
Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
[see
Clinical Studies (14.2, 14.5) and
Microbiology (12.4)]
1.3 Esophageal Candidiasis
Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older
[see
Clinical Studies (14.3, 14.5) and
Microbiology (12.4)]
1.4 Scedosporiosis and Fusariosis
Voriconazole for injection is indicated for the treatment of serious fungal infections caused by
Scedosporium apiospermum (asexual form of
Pseudallescheria boydii) and
Fusarium spp. including
Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy
[see
Clinical Studies (14.4) and
Microbiology
(12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor indicated for:
Colorectal Cancer
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1)
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.(
1.1)
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1)
Breast Cancer
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. (
1.2)
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (
1.2)
Gastric, Esophageal, or Gastroesophageal Junction Cancer
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (
1.3)
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (
1.3)
Pancreatic Cancer
adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (
1.4)
1.1
Colorectal Cancer
Capecitabine tablets, USP are indicated for the:
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination
chemotherapy regimen.
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.
1.2 Breast Cancer
Capecitabine tablets USP are indicated for the:
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
1.3 Gastric, Esophageal, or Gastroesophageal Junction Cancer
Capecitabine tablets USP are indicated for the:
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction
cancer as a component of a combination chemotherapy regimen.
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
who have not received prior treatment for metastatic disease as a component of a combination regimen.
1.4 Pancreatic Cancer
Capecitabine tablets USP are indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as
a component of a combination chemotherapy regimen.
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
1 INDICATIONS AND USAGE
Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
Moderately emetogenic cancer chemotherapy
prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (1.1)
Highly emetogenic cancer chemotherapy
prevention of acute nausea and vomiting associated with initial and repeat courses (1.1)
1.1 Chemotherapy-Induced Nausea and Vomiting in Adults
Palonosetron Hydrochloride (HCl) Injection is indicated for:
Moderately emetogenic cancer chemotherapy
prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
Highly emetogenic cancer chemotherapy
prevention of acute nausea and vomiting associated with initial and repeat courses
INDICATIONS AND USAGE
Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS).
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinol is indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
1.2 Left Ventricular Dysfunction following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see CLINICAL STUDIES (14.2)].
1 INDICATIONS AND USAGE
Hypothyroidism
SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid
-Stimulating Hormone, TSH) Suppression
SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use
SYNTHROID is 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 SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (
5.1
)].
SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
SYNTHROID is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis
1.2 Infantile Spasms (IS)
Vigabatrinfor oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [
see Warnings and Precautions (
5.1
)].
INDICATIONS AND USAGE
Terconazole Vaginal Suppositories, 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
1 INDICATIONS AND USAGE
Bendamustine hydrochloride for injection is an alkylating drug indicated for treatment of patients with:
Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1)
Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2)
1.1 Chronic Lymphocytic Leukemia (CLL)
Bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
1.2Non-Hodgkin Lymphoma (NHL)
Bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.