um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
(1.1)
Prophylaxis of influenza A and B in patients 1 year and older.
(1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination.
(1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.
(1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis.
(1.3)
1.1
Treatment of Influenza
Oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2
Prophylaxis of Influenza
Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules
[see
Microbiology (12.4)]
.
Oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis
[see
Dosage and Administration (2.4)
and
Use in Specific Populations (8.6)]
.
INDICATIONS AND USAGE
Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
1	INDICATIONS AND USAGE
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)]. An improvement in hemostasis has not been established.
Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. (1)
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.
An improvement in hemostasis has not been established.
Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. (1, 14)
Limitations of Use
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. (1)
Limitations of Use
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
INDICATIONS AND USAGE
ESTRACE (estradiol vaginal cream USP 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
1
INDICATIONS AND USAGE
Lo Loestrin Feis indicated for use by women to prevent pregnancy [
see
Clinical Studies (14)
].
The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated.
Lo Loestrin Feis a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated foruse by women to prevent pregnancy (1)
The efficacy of Lo Loestrin Fe in women with a body mass index of >35kg/m2 has not been evaluated (1, 8.8)
USES:
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
1 INDICATIONSAND USAGE
Diclofenac potassium capsules are indicated for relief of mild to moderate acute pain in adult patients.
Pediatric use information is approved for Assertio Therapeutics Inc's ZIPSOR (diclofenac potassium) Capsules. However, due to Assertio Therapeutics Inc's marketing exclusivity rights, this drug product is not labeled with that information.
Diclofenac potassium capsules are a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult patients (1)
INDICATIONS AND USAGE
Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
INDICATIONS AND USAGE
Halobetasol Propionate Ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
1 INDICATIONS AND USAGE
Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Tramadol hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.
Tramadol hydrochloride extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1)
Tramadol hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic. (1)
1 INDICATIONS AND USAGE
AIRDUO RESPICLICK is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA).
Limitations of Use:
AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.
AIRDUO RESPICLICK is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta2-adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). (1)
Limitations of Use:Not indicated for the relief of acute bronchospasm. (1)
1 INDICATIONS AND USAGE
VIMPAT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older).
VIMPAT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
As the safety of
VIMPAT injection has not been established in pediatric patients, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older) (
1)
1
INDICATIONS AND USAGE
Adrenalin is a non-selective alpha and beta adrenergic agonist indicated for:
Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1)
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2)
1.1 Anaphylaxis
Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
1.2 Hypotension associated with Septic
Shock
Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Indications & Usage
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.3 Hypertriglyceridemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
Calcium acetate capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
INDICATIONS AND USAGE
Thyroid hormone drugs are indicated:
As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema and ordinary hypothyroidism in patients of any age (pediatric patients, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary) or tertiary (hypothalamic) hypothyroidism (see
WARNINGS
).
As pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimotos) and multinodular goiter.
As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Liothyronine sodium tablets can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.
1
INDICATIONS AND USAGE
SAVELLA is indicated for the management of fibromyalgia.
SAVELLA is not approved for use in pediatric patients [see Use in Specific Populations (
8.4
)].
SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (1).
SAVELLA is not approved for use in pediatric patients (1).
INDICATIONS AND USAGE
For the management of nausea and vomiting, and dizziness associated with motion sickness.
INDICATIONS
Valium is 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, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Valium is 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 Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Valium 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.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus,
Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species,
Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.
Uses
health care antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
1INDICATIONS AND USAGE
Pravastatin sodium tablets are indicated:
To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Pravastatin sodiumtablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
1
INDICATIONS AND USAGE
SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)
1. INDICATION AND USAGE
ESKATA is indicated for the treatment of seborrheic keratoses that are raised.
ESKATA is indicated for the treatment of seborrheic keratoses that are raised. (1)
INDICATIONS AND USAGE
Trecator is primarily indicated for the treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs. Its use alone in the treatment of tuberculosis results in the rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility tests. If the susceptibility tests indicate that the patient's organism is resistant to one of the first-line anti-tuberculosis drugs (i.e., isoniazid or rifampin) yet susceptible to ethionamide, ethionamide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to be susceptible.3 If the tuberculosis is resistant to both isoniazid and rifampin, yet susceptible to ethionamide, ethionamide should be accompanied by at least two other drugs to which the M. tuberculosis isolate is known to be susceptible.3
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Trecator and other antibacterial drugs, Trecator should be used only to treat 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.
Patient nonadherence to prescribed treatment can result in treatment failure and in the development of drug-resistant tuberculosis, which can be life-threatening and lead to other serious health risks. It is, therefore, essential that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended for all patients receiving treatment for tuberculosis. Patients in whom drug-resistant M. tuberculosis organisms are isolated should be managed in consultation with an expert in the treatment of drug-resistant tuberculosis.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets, USP are useful for:
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticarial and angioedema
Amelioration of allergic reactions to blood or plasma
Dermographism
Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled
Preoperative, postoperative and obstetric sedation
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness
Antiemetic therapy in postoperative patients
INDICATIONS AND USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis
e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO
2 content is crucial
e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.