um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. (1)
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Avoid any contact with the eyes and lips. (1.2)
1.1 Indication
Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
1 INDICATIONS AND USAGE
Docetaxel Injection, USP is a microtubule inhibitor indicated for:
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1	Breast Cancer
Docetaxel Injection, USP is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection, USP in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2	Non-small Cell Lung Cancer
Docetaxel Injection, USP as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Docetaxel Injection, USP in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3	Prostate Cancer
Docetaxel Injection, USP in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4	Gastric Adenocarcinoma
Docetaxel Injection, USP in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5	Head and Neck Cancer
Docetaxel Injection, USP in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
1 INDICATIONS AND USAGE
Paroxetine is indicated in adults for the treatment of:
Major depressive disorder (MDD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (
1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
INDICATIONS AND USAGE
Enalaprilat injection, USP is indicated for the treatment of hypertension when oral therapy is not practical.
Enalaprilat injection, USP has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension.
In using enalaprilat injection, USP, 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, and that available data are insufficient to show that enalaprilat injection, USP does not have a similar risk. (See WARNINGS.)
In considering use of enalaprilat injection, USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS,
Angioedema
).
1 INDICATIONS AND USAGE
DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.
DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. (1)
1 INDICATIONS AND USAGE
Olopatadine hydrochloride nasal solution (nasal spray) is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
Olopatadine hydrochloride nasal solution (nasal spray) is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
1 INDICATIONS AND USAGE
FIRVANQ is indicated for the treatment of Clostridiumdifficileassociated diarrhea in adults and pediatric patients less than 18years of age.
FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillinresistant strains) in adults and pediatric patients less than 18years of age.
Important Limitations of Use
Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
To reduce the development of drugresistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ 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.
FIRVANQ is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18years of age for the treatment of: (1)
Clostridium difficileassociated diarrhea
Enterocolitis caused by Staphylococcus aureus (including methicillinresistant strains)
Important Limitations of Use: (1) (5.1)
Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
To reduce the development of drugresistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
1 INDICATIONS AND USAGE
Hydroxyprogesterone caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Hydroxyprogesterone caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth (1). The effectiveness of hydroxyprogesterone caproate is based on improvement in the proportion of women who delivered < 37 weeks of gestation (14). There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use:
Hydroxyprogesterone caproate injection
is not intended for use in women with multiple gestations or other risk factors for preterm birth. (1)
1 INDICATIONS AND USAGE
GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1)
GaviLyte-G is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
1 INDICATIONS AND USAGE
Dexmedetomidine hydrochloride injection is a alpha2-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)
1.1 Intensive Care Unit Sedation
Dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine hydrochloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine hydrochloride injection prior to extubation.
1.2 Procedural Sedation
Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
Pediatric use information is approved for Hospira Inc.'s PRECEDEX
TM
(dexmedetomidine hydrochloride) injection and PRECEDEX
TM
(dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
1. INDICATIONS AND USAGE
Lamotrigine tablet for oral suspension USP (chewable dispersible tablet) isindicated for:
Epilepsy - adjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (1.1)
Epilepsy - monotherapy in patients aged 16 years and older:
Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1)
Bipolar disorder:
Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patientstreated for acute mood episodes with standard therapy. (1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets for oral suspension USP (chewable dispersible tablets)in the acute treatment of mood episodes has not been established.
1.1. Epilepsy
Adjunctive Therapy
Lamotrigine tablets for oral suspension USP (chewable dispersible tablets)are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness oflamotrigine tablets for oral suspension USP (chewable dispersible tablets)have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2. Bipolar Disorder
Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.2)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets for oral suspension USP (chewable dispersible tablets) in the acute treatment of mood episodes has not been established.
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to
Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of
Candidaurinary tract infections, peritonitis, and systemic
Candidainfections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
Oxaliplatin Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. (
1)
treatment of advanced colorectal cancer. (
1)
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol Tablets, USP 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
40% (with or without symptomatic heart failure) [see
Clinical Studies (14.2)
].
1.3 Hypertension
Carvedilol Tablets, USP are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)
]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
INDICATIONS AND USAGE
Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets, USP are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for treatment of hypertension. (1.1)
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population.
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
LOWER RESPIRATORY TRACT INFECTIONS
LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens.
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe tablets are an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (1.3)
Limitations of Use (1.4)
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1 Primary Hyperlipidemia
Monotherapy
Ezetimibe tablets, administered alone, are indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with HMG-CoA Reductase Inhibitors (Statins)
Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
Ezetimibe tablets, administered in combination with fenofibrate, are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ezetimibe tablets and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Homozygous Sitosterolemia
Ezetimibe tablets are indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
1.4 Limitations of Use
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
PRED MILD
is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).
1 INDICATIONS AND USAGE
Atovaquone oral suspension is a quinone antimicrobial drug indicated for:Prevention of Pneumocystis jiroveciipneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (
1.1
)Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (
1.2
)
Limitations of Use (
1.3
):Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO2] >45 mm Hg) with atovaquone oral suspension has not been studied.The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
1.1 Prevention of Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1.2 Treatment of Mild-to-Moderate Pneumocystis jiroveciiPneumonia
Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
1.3 Limitations of Use
Clinical experience with atovaquone oral suspension for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO2] 45 mm Hg). Treatment of more severe episodes of PCP with atovaquone oral suspension, USP has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.