um-ids/dailymed-annotations huggingface dataset:
1
INDICATIONS AND USAGE
Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS(defined as wild-type in bothKRAS andNRAS as determined by an FDA-approved test for this use)metastatic colorectal cancer (mCRC):
In combination with FOLFOX for first-line treatment. (1.1, 14.2)
As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.(1.1, 14.1)
Limitation of Use: Vectibix is not indicated for the treatment of patients with
RAS-mutant mCRC or for whom RASmutation status is unknown.(1.1,2.1,5.2, 12.1)
1.1
Metastatic Colorectal Cancer
Vectibix is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRASas determined by an FDA-approved test for this use)metastatic colorectal cancer (mCRC)[see Dos
age
and Administration (
2.1
)]:
As first-line therapy in combination with FOLFOX[
see
Clinical Studies (
14.2
)]
.
As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see
Clinical Studies (
14.1
)]
.
Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RASmutation status is unknown[see
Dosage and Administration (
2.1
)
,
Warnings and Precautions (
5.2
)
,
and
Clinical Pharmacology (
12.1
)
].
INDICATIONS AND USAGE
Diltiazem hydrochloride extended-release capsules are indicated
for the treatment of hypertension. They may be used alone or in combination with
other antihypertensive medications.
Diltiazem hydrochloride extended-release capsules are indicated for the
management of chronic stable angina and angina due to coronary artery spasm.
1 INDICATIONS AND USAGE
Norepinephrine Bitartrate Injection, USP is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Norepinephrine Bitartrate Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)
1 INDICATIONS AND USAGE
Tinidazole Tablet is a nitroimidazole antimicrobial indicated for:
Trichomoniasis (
1.1)
Giardiasis: in patients age 3 and older (
1.2)
Amebiasis: in patients age 3 and older (
1.3)
Bacterial Vaginosis: in adult women (
1.4,
8.1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria
(1.5).
1.1 Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by
Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection
[see Clinical Studies (
14.1)].
1.2 Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by
Giardia duodenalis (also termed
G. lamblia) in both adults and pediatric patients older than three years of age
[see Clinical Studies (
14.2)].
1.3 Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by
Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage
[see Clinical Studies (
14.3,
14.4)].
1.4 Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as
Haemophilus vaginitis,
Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in adult women
[see Use in Specific Populations (
8.1
)
and Clinical Studies (
14.5
)
].
Other pathogens commonly associated with vulvovaginitis such as
Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and
Herpes simplex virus should be ruled out.
1.5 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE:
Adenosine injection is indicated for the following.
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration.
It is important to be sure the adenosine solution actually reaches the systemic circulation (see
DOSAGE AND ADMINISTRATION
).
Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration.
1 INDICATIONS AND USAGE
DARZALEX is indicated for the treatment of adult patients with multiple myeloma:
in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.
in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.
in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma:
in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma
who have received one to three prior lines of therapy
in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. (
1)
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
1.Vaginal candidiasis (vaginal yeast infections due to Candida).
2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relativelysmall numbers of patients, fluconazole tabletswere also effective for the treatment of Candidaurinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3.
Cryptococcal meningitis. Before prescribing fluconazole tabletsfor AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole tabletsto amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tabletsare 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.
1 INDICATIONS AND USAGE
Dutasteride capsules is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: Dutasteride capsules is not approved for the prevention of prostate cancer. (1.3)
1.1 Monotherapy
Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination with Alpha-adrenergic Antagonist
Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
Dutasteride capsules are not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.
1 INDICATIONS AND USAGE
VYJUVEK is indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
(1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.
Naproxen as naproxen sodium tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
1 INDICATIONS AND USAGE
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance (1)
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3)
1.1
Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
Pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
1.2
Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older.
Pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
1.3	Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Pediatric use information in pediatric patients (age 6 months to 5 years) with chronic idiopathic urticaria is approved for UCB Inc.'s levocetirizine dihydrochloride drug product. However, due to UCB Inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients with severe hypertriglyceridemia (
1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see Warnings and Precautions (
5.1)].
1 INDICATIONS AND USAGE
Atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg.
Limitations of Use:
Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
Use of atazanavir/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].
Atazanavir sulfate capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. (1)
1 INDICATIONS AND USAGE
ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. (
1.1)
1.1
Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD)
ZONTIVITY
is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
INDICATIONS:
For professional use in gonioscopic examinations.
1 INDICATIONS AND USAGE
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
INDICATIONS
For the temporary relief of pain of muscles and joints associated with:
Arthritis
Simple Backache
Strains
Sprains
Bruises
DIRECTIONS
Adults and children over 12 years
Apply generously to affected area
Massage into painful area until thoroughly absorbed into skin, repeat as necessary, not more than 3-4 times daily
Store at 20-25C (68-77 F). Avoid direct sunlight.
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia, bipolar mania or autistic disorder. (1.1, 1.2, 1.3)
1.1 Schizophrenia
Adults
Risperidone is indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
Adolescents
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
1.2 Bipolar Mania
Monotherapy
Adults and Pediatrics
Risperidone is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
Combination Therapy
Adults
The combination of risperidone with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder. Information regarding the treatment of pediatric patients with irritability associated with autistic disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
1 INDICATIONS AND USAGE
MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency (1).
Limitations of Use:
The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m2 (1).
Limitations of Use
The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m2.