um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Hypothyroidism
Levothyroxine sodium tablets are 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
Levothyroxine sodium tablets are 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:
Levothyroxine sodium tablets are 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 levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)].
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablets are 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.
INDICATIONS AND USAGE
Fluconazole Tablet, USP is 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 was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. Fluconazole is 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.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism
As therapy for anaphylactic reactions to epinephrine and other standard measures after the acute manifestations have been controlled.
adjunctive
INDICATIONS AND USAGE
Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.
1.1 Treatment
of CMV Retinitis
Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
1 INDICATIONS AND USAGE
NOCDURNA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.
In the NOCDURNA clinical trials nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production.
Before starting NOCDURNA:
Evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and address other treatable causes of nocturia.
Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously.
NOCDURNA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. (1)
INDICATIONS AND USAGE:
Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block. They are not to be used for lumbar or caudal epidural anesthesia.
Nesacaine-MPF 2% and 3% Injections, in single dose vials without preservative and without EDTA, are indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks.
Nesacaine and Nesacaine-MPF Injections are not to be used for subarachnoid administration.
INDICATIONS AND USAGE
In patients without structural heart disease, propafenone HCl is indicated to prolong the time to recurrence of- paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.- paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.The use of propafenone in patients with chronic atrial fibrillation has not been evaluated. Propafenone should not be used to control ventricular rate during atrial fibrillation.Propafenone is also indicated for the treatment of-documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits out-weigh the risks.Initiation of propafenone treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.Propafenone, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias.
1 INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see Clinical Studies ( 14)] .
Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults
(1) .
INDICATIONS AND USAGE
1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.
1.1 Mania
Depakote ER is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).
The efficacy of Depakote ER is based in part on studies of Depakote (divalproex sodium delayed release tablets) in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies (14.1)].
The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use Depakote ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
INDICATIONS AND USAGE
Halcinonide cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1.1 Major Depressive Disorder
Fluoxetine capsules, USP is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)].
1 INDICATIONS AND USAGE
AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:
CDC coryneform group G*
Haemophilus influenzae
Staphylococcus aureus
Streptococcus mitis group
Streptococcus pneumoniae
* Efficacy for this organism was studied in fewer than 10 infections.
AzaSite is a macrolide antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. (1)
1 INDICATIONS AND USAGE
SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence [see Clinical Pharmacology (12.1) and Clinical Studies (14)].
If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. (12.1, 14)
If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
1.7 Inhalational Anthrax (Post-Exposure)
Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized
Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.
1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see
CLINICAL STUDIES (
14.2)].
1 INDICATIONS AND USAGE
Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see
Dosage and Administration (2)
]
Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Acute bacterial exacerbations of chronic bronchitis in adults (Error! Hyperlink reference not valid.)
Acute bacterial sinusitis in adults (Error! Hyperlink reference not valid.)
Uncomplicated skin and skin structure infections in adults (Error! Hyperlink reference not valid.)
Urethritis and cervicitis in adults (Error! Hyperlink reference not valid.)
Genital ulcer disease in men (Error! Hyperlink reference not valid.)
Acute otitis media in pediatric patients (Error! Hyperlink reference not valid.)
Community-acquired pneumonia in adults and pediatric patients (Error! Hyperlink reference not valid., Error! Hyperlink reference not valid.)
Pharyngitis/tonsillitis in adults and pediatric patients (Error! Hyperlink reference not valid., Error! Hyperlink reference not valid.)
Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (Error! Hyperlink reference not valid.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (Error! Hyperlink reference not valid.)
1 INDICATIONS AND USAGE
Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age (1)
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age (1)
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients (1)
Sedation for Adult Patients in Combination with Regional Anesthesia (1)
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients (1)
Limitations of Use
Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months (1)
MAC sedation in the pediatric population is not recommended (1)
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation (1)
Limitations of Use
Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].
Safety, effectiveness and dosing guidelines for Propofol Injectable Emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].
Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1
INDICATIONS AND USAGE
Ropinirole tablet is a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate- to-severe primary Restless Legs Syndrome (RLS). (
1.1, 1.2)
1.1
Parkinson's Disease
Ropinirole tablets are indicated for the treatment of Parkinsons disease.
1.2
Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) ( )
1.1
Generalized Anxiety Disorder (GAD) ( )
1.2
Diabetic Peripheral Neuropathic Pain (DPNP) ( )
1.3
Chronic Musculoskeletal Pain ( )
1.5
1.1 Major Depressive Disorder
Duloxetine delayed-release capsules USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USP was established in four short-term and one maintenance trial in adults [ ].
see Clinical Studies ( )
14.1
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Duloxetine delayed-release capsules USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USP was established in three short-term trials and one maintenance trial in adults [ ].
see Clinical Studies ( )
14.2
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
1.3 Diabetic Peripheral Neuropathic Pain
Duloxetine delayed-release capsules USP are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [ ].
see Clinical Studies ( )
14.3
1.5 Chronic Musculoskeletal Pain
Duloxetine delayed-release capsules USP are indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis .
[see Clinical Studies ( )]
14.5
INDICATIONSAND USAGE
Methocarbamol tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with:
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (1.1)
Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2)
1.1 Acute Myeloid Leukemia
RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA approved test [see Dosage and Administration (2.1), Clinical Studies (14.1)].
Limitations of Use
RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
1.2 Systemic Mastocytosis
RYDAPT is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
Duloxetine delayed-release capsules, USP are indicated for the treatment of:
Major Depressive Disorder[see Clinical Studies 14.1]
Generalized Anxiety Disorder[see Clinical Studies 14.2]
Diabetic Peripheral Neuropathy[see Clinical Studies 14.3]
Chronic Musculoskeletal Pain[see Clinical Studies 14.5]
1 INDICATIONS AND USAGE
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (
14
)].
Bupropion hydrochloride is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
INDICATIONS AND USAGE
Clotrimazole Troches (clotrimazole lozenges) are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.Clotrimazole Troches (clotrimazole lozenges) are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)