um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Montelukast sodium tablets is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age or older (1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp's montelukast tablet products. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age and older.
1 INDICATIONS AND USAGE
ALYQ is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1)
1.1 Pulmonary Arterial Hypertension
ALYQ is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II
III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
INDICATIONS & USAGE
Nitroglycerin ointment is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
INDICATIONS AND USAGE
1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids
where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisPost-traumatic osteoarthritisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisEpicondylitisAcute gouty arthritis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)
4. Dermatologic Diseases
PemphigusExfoliative dermatitisBullous dermatitis herpetiformisMycosis fungoidesSevere erythema multiforme
(Stevens-Johnson syndrome)Severe psoriasisSevere seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic
conditions intractable to adequate trials of
conventional treatment.Seasonal or perennial allergic rhinitisContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactionsBronchial asthma
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisAnterior segment inflammationKeratitisAllergic corneal marginal ulcersDiffuse posterior uveitis and choroiditisHerpes zoster ophthalmicusIritis and iridocyclitisOptic neuritisChorioretinitisSympathetic ophthalmia
7. Respiratory Diseases
Symptomatic sarcoidosisLoeffler's syndrome not manageable by other
meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyBerylliosisAspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adultsAcquired (autoimmune) hemolytic anemiaSecondary thrombocytopenia in adultsErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis
12. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.)
1 INDICATIONS & USAGE
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use:
Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Repaglinide tablets are glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitation of Use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1)
1 INDICATIONS & USAGE
Levocetirizine dihydrochloride tabletsare a histamine H
1-receptor antagonist indicated for:
The relief of symptoms associated withperennial allergic rhinitis (
1.1)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria
(1.2)
1.2 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.
1 INDICATIONS AND USAGE
Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women.
Finasteride tablets is a 5-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1).
Finasteride tablets is not indicated for use in women (1, 4, 5.1).
1 INDICATIONS AND USAGE
Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).
1 INDICATIONS AND USAGE
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (1)
INDICATIONS AND USAGE
Propofol Injectable Emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below.
Table 3. Indications for Propofol Injectable Emulsion
Indication
Approved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation
Adults only
Combined sedation and regional anesthesia
Adults only (see
PRECAUTIONS
)
Induction of General Anesthesia
Patients greater than or equal to 3 years of age
Maintenance of General Anesthesia
Patients greater than or equal to 2 months of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients
Adults only
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
PRECAUTIONS
,
Pediatric 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.
In the Intensive Care Unit (ICU), Propofol Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see
PRECAUTIONS
,
Pediatric Use
).
Propofol Injectable Emulsion is not recommended for obstetrics, including Cesarean section deliveries. Propofol Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of Propofol Injectable Emulsion may be associated with neonatal depression (see
PRECAUTIONS
).
Propofol Injectable Emulsion is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see
PRECAUTIONS
).
1 INDICATIONSAND USAGE
Azelastine HCl Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
Azelastine HCl Nasal Spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
1 INDICATIONS AND USAGE
Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults.
L
i
m
itati
o
n
s of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks.
Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks.
Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.
Eletriptan hydrobromide tablets are a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults(1)
Limitations of Use:
Use only after a 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)
1 INDICATIONS AND USAGE
ALBUMIN (HUMAN) 25% is indicated for the restoration and maintenance of circulating blood volume for:
Hypovolemia. (1.1)
Hypoalbuminemia. (1.2)
Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.3)
Ovarian hyperstimulation syndrome (OHSS). (1.4)
Adult respiratory distress syndrome (ARDS). (1.5)
Acute nephrosis. (1.6)
Hemolytic disease of the newborn (HDN). (1.7)
1.1 Hypovolemia
ALBUMIN (HUMAN) 25% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]
When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [
1
]
1.2 Hypoalbuminemia
For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN)25% infusions may be indicated. [
3
] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN)25% will be temporary unless the underlying disorder is reversed.
1.3 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)
ALBUMIN (HUMAN) 25% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [
2
]
1.4 Ovarian Hyperstimulation Syndrome (OHSS)
ALBUMIN (HUMAN) 25% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]
1.5 Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)
ALBUMIN (HUMAN) 25% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [
5
]
1.6 Acute Nephrosis (Treatment Adjunct)
ALBUMIN (HUMAN) 25% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [
1
]
1.7 Hemolytic Disease of the Newborn (HDN)
ALBUMIN (HUMAN) 25% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and to enhance its removal. [
6
]
1 INDICATIONS AND USAGE
Hailey 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
Hailey 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. (1) The efficacy of Hailey 24 Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated. (1, 8.8)
1
INDICATIONS AND USAGE
Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for
the management of breakthrough cancer pain in patients 16 and older with
malignancies who are already receiving and who are
tolerant to around-the-clock opioid therapy for their underlying persistent
cancer pain. Patients considered opioid tolerant are those who are taking
around-the-clock medicine consisting of at least 60 mg of oral morphine daily,
at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone
daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of
another opioid daily for a week or longer. Patients must remain on
around-the-clock opioids when taking OTFC.
This product must not be used in opioid
non-tolerant patients because life-threatening respiratory depression and death
could occur at any dose in patients not on a chronic regimen of opioids. For
this reason, OTFC is contraindicated in the management of acute or postoperative
pain.
OTFC is intended to be used only in the care of cancer patients and only by
oncologists and pain specialists who are knowledgeable of and skilled in the use
of Schedule II opioids to treat cancer pain.
OTFC is an opioid analgesic indicated only for the management of
breakthrough cancer pain in patients 16 and older with malignancies who are
already receiving and who are tolerant to around-the-clock
opioid therapy for their underlying persistent cancer pain. Patients must
remain on around-the-clock opioids when taking OTFC. (1)
1 INDICATIONS AND USAGE
Yuvafem is an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause (1.1)
1.1 Treatment of Atrophic Vaginitis due to Menopause
INDICATION AND USAGE
psorcon (diflorasone diacetate cream), 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Calcitonin salmon synthetic injection is a calcitonin, indicated for the following conditions:
Treatment of symptomatic Pagets disease of bone when alternative treatments are not suitable (
1.1)
Treatment of hypercalcemia (
1.2)
Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (
1.3)
Limitations of Use:
Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (
1.4,
5.3)
1.1	Treatment of Pagets Disease of Bone
Calcitonin salmon injection is indicated for the treatment of symptomatic Pagets disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Calcitonin salmon injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
1.2	Treatment of Hypercalcemia
Calcitonin salmon injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
1.3	Treatment of Postmenopausal Osteoporosis
Calcitonin salmon injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Calcitonin salmon injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
1.4	Important Limitations of Use
Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis
[see
Warnings and Precautions (5.3)]
.
INDICATIONS
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules is 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
Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated 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.
Hypothyroidism
Levothyroxine Sodium Tablets are indicated 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 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 (5.4)].
Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
INDICATIONS AND USAGE
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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.
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)
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.
INDICATIONS AND USAGE
Chateal EQ is indicated for use by females of reproductive potential to prevent pregnancy.