um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONSAND 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 has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1 Primary Hyperlipidemia
Monotherapy
Ezetimibe tablets, administered alone, is indicated as adjunctive therapyto 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 therapyto 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, is 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 has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Desipramine hydrochloride tablets, USP is indicated for the treatment of depression.
INDICATIONS AND USAGE
NORPRAMIN is indicated for the treatment of depression.
INDICATIONS AND USAGE
Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days).
For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Indications
Triderma is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
INDICATIONS:
PureVit DualFe Plus is indicated for the treatment of iron deficiency
anemia and folate deficiency as in extended convalescence, menorrhagia,
pregnancy, puberty, excessive blood loss and advanced age. Also for
treatment of condition in which iron deficiency and vitamin C
deficiency occur together, along with a deficient intake or increased
need for B-Complex vitamins in chronic and acute illness, as well as
cases of metabolic stress, and in convalescence.
1 INDICATIONS AND USAGE
Famotidine for oral suspension is indicated in adults for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:
peptic ulcer disease.
GERD with or without esophagitis and ulcerations.
Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
Famotidine for oral suspension is a histamine-2 (H2) receptor antagonist indicated (1):
In adults for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
In pediatric patients 1 year of age and older for the treatment of:
peptic ulcer
GERD with or without esophagitis and ulcerations
In pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
1 INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophytonfloccosum, Trichophytonmentagrophytes, and Trichophytonrubrum in patients 17 years and older.
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophytonfloccosum, Trichophytonmentagrophytes, and Trichophytonrubrum in patients 17 years and older. (
1
)
1 INDICATIONS AND USAGE
Lacosamide oral solution is indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (
1.1)
1.1 Partial-Onset Seizures
Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.s VIMPAT
(lacosamide) oral solution. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
INDICATIONS AND USAGE
Butalbital, Acetaminophen, and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
INDICATIONS & USAGE
Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
INDICATIONS
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Donepezil hydrochloride
tablets are indicated for the treatment of dementia of the Alzheimers type.
Efficacy has been demonstrated in patients with mild, moderate, and severe
Alzheimers disease.
Donepezil hydrochloride
tablets are indicated for the treatment of dementia of the Alzheimers type.
Efficacy has been demonstrated in patients with mild, moderate, and severe
Alzheimers Disease (1).
INDICATIONS AND USAGE
Clonidine hydrochloridetablets, USP areindicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.
1 INDICATIONS AND USAGE
Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].
Contraindicated in pediatric patients under 12 years of age [see
Contraindications (4),
Use in Specific Populations (8.4)
].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see
Contraindications (4), Use in Specific Populations (8.4)
].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see
Warnings and Precautions (5.1)
], reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is a combination of codeine, an opioid agonist, promethazine, a phenothiazine, and phenylephrine, an alpha-1 adrenergic receptor agonist, indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. (1)
Important Limitations of Use (1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor.
Tenofovir disoproxil fumarate is
indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults and pediatric patients 2 years of
age and older. (1)
Tenofovir disoproxil fumarate is
indicated for the treatment of chronic hepatitis B in adults and pediatric
patients 12 years of age and older. (1)
1.1 HIV-1 Infection
Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of HIV-1 infection:
Tenofovir disoproxil fumarate should
not be used in combination with ATRIPLA, COMPLERA,
DESCOVY, GENVOYA, ODEFSEY,
STRIBILD, TRUVADor VEMLIDY[See Warnings and Precautions (5.4)].
1.2 Chronic Hepatitis B
Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of HBV infection:
The indication in adults is based on
safety and efficacy data from treatment of subjects who were
nucleoside-treatment-nave and subjects who were treatment-experienced
with documented resistance to lamivudine. Subjects were adults with
HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated
liver disease [See Clinical Studies (14.2)].
Tenofovir disoproxil fumarate was
evaluated in a limited number of subjects with chronic hepatitis B and
decompensated liver disease. [See Adverse Reactions (6.1), Clinical
Studies (14.2)].
The number of subjects in clinical
trials who had adefovir resistance-associated substitutions at baseline
were too small to reach conclusions of efficacy [See Microbiology (12.4), Clinical Studies
(14.2)].
INDICATIONSAND USAGE
Protriptyline hydrochloride tablets are indicated for the
treatment of symptoms of mental depression in patients who are under close
medical supervision. Its activating properties make it particularly suitable for
withdrawn and anergic patients.
INDICATIONSAND USAGE
Desipramine hydrochloride tablets, USP is indicated for the treatment of depression.
1 INDICATIONS AND USAGE
KEPPRA is an antiepileptic drug indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients one month of age and older with epilepsy (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial Onset Seizures
KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy
KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Trazodone hydrochloride is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (
1).
1 INDICATIONS AND USAGE
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
INDICATIONS AND USAGE
Microgestin 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
2
INDICATIONS AND USAGE
Conversion of Atrial Fibrillation/ Flutter
In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (seeDOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued.
Reduction of Frequency of Relapse into Atrial Fibrillation/Flutter
Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate.In patients with histories of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy, and a single recurrence should not be interpreted as therapeutic failure.
Suppression of Ventricular Arrhythmias
Quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recommended, and treatment of patients with asymptomatic ventricular premature contractions should be avoided. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise.Antiarrhythmic drugs (including quinidine gluconate) have not been shown to enhance survival in patients with ventricular arrhythmias.
1	INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Zolpidem tartrate tablets are, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. (1)
1
INDICATIONS AND USAGE
LILETTA is indicated for prevention of pregnancy for up to 8years.
LILETTAis a progestin-containing intrauterine system indicated for prevention of pregnancy for up to 8years. (1)
1 INDICATIONS AND USAGE
Abiraterone acetate is indicated in combination with prednisone for the treatment of patients with
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Abiraterone acetate is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
1. Indications and Usage
Celecoxib is indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see CLINICAL STUDIES (14.1)].
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see CLINICAL STUDIES (14.2)].
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see CLINICAL STUDIES (14.3)].
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see CLINICAL STUDIES (14.4)].
1.5 Acute Pain
For the management of acute pain in adults [see CLINICAL STUDIES (14.5)].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see CLINICAL STUDIES (14.5)].
1 INDICATIONS AND USAGE
Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Sevelamer carbonate is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. (
1)
1 INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride, is a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
1 INDICATIONS AND USAGE
Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)Important limitations of use:
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)
Formoterol fumarate inhalation solution is not indicated to treat asthma. (1.2)
1.1
Maintenance Treatment of COPD
Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1.2
Important Limitations of Use
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions
(5.2)].
Formoterol fumarate inhalation solution is not indicated to treat asthma. The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established.
1 INDICATIONS AND USAGE
Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy
[see
Dosage and Administration (2)]
.
Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.
Amiodarone hydrochloride injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (
1)
INDICATIONS AND USAGE
Predialysis Patients
Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.
Dialysis Patients
Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.
Hypoparathyroidism Patients
Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.