um-ids/dailymed-annotations huggingface dataset:
1. Indications and Usage
Azithromycin 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)]
1.1 Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2 Pediatric Patients
[see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.2)]
Acute otitis media (> 6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
Community-acquired pneumonia (> 6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis (> 2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3 Limitations 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 such as any of the following:
patients with cystic fibrosis,
patients with nosocomial infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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.
INDICATIONS AND USAGE
Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan succinate tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache, which is present in an older, predominantly male population.
INDICATIONS AND 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.
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see
WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION).
Mefenamic acid is indicated:
For relief of mild to moderate pain in patients
14 years of age, when therapy will not exceed one week (7 days).
For treatment of primary dysmenorrhea.
1 INDICATIONS AND USAGE
NEUPRO is a dopamine agonist indicated for the treatment of:
Parkinson's disease (1.1)
Moderate-to-severe primary Restless Legs Syndrome (1.2)
1.1	Parkinson's Disease (PD)
NEUPRO is indicated for the treatment of Parkinson's disease.
1.2	Restless Legs Syndrome (RLS)
NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.
INDICATIONS AND USAGE
Methazolamide Tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.
INDICATIONS AND USAGE
Benazepril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
1. Indications and Usage
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
(1)
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli; Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and
Serratia marcescens.
INDICATIONS AND USAGE
Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi
(7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.
Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.
Uses
For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.
INDICATIONS AND USAGECyclobenzaprine hydrochloride tablets are indicated as an adjunct
to rest and physical therapy for relief of muscle spasm associated with acute,
painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs
and symptoms, namely, pain, tenderness, limitation of motion, and restriction in
activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only
for short periods (up to two or three weeks) because adequate evidence of
effectiveness for more prolonged use is not available and because muscle spasm
associated with acute, painful musculoskeletal conditions is generally of short
duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the
treatment of spasticity associated with cerebral or spinal cord disease, or in
children with cerebral palsy.
1 INDICATIONSAND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
1.Schizophrenia [see CLINICAL STUDIES (14.1)]
2.Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulation is indicated for:
1. Schizophrenia (14.1)
2.Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2)
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or 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.
The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1.
Motor tension:
shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2.
Autonomic hyperactivity:sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3.
Apprehensive expectation:anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4.
Vigilance and scanning:
hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE:
Sterile Water for Injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced.
For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.
INDICATIONS AND USAGE
Loperamide hydrochloride capsules are indicated for the control and symptomaticrelief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatorybowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge fromileostomies.
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. (
1.1)
For treatment of adult patients with severe hypertriglyceridemia. (
1.2)
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.
(
5.1)
1.1 Primary
Hypercholesterolemia
or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see
Warnings and Precautions (5.1)]
.
1 INDICATIONS AND USAGE
ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Limitations of Use:
If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patients acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)].
ABSORICA and ABSORICA LD are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1)
Limitations of Use:
If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patients acne may continue to improve following a 15 to 20-week course of therapy. (1)
1 INDICATIONS AND USAGE
Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Tranexamic Acid Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
INDICATIONS AND USAGE
AROMASIN is indicated for adjuvant treatment of postmenopausal
women with estrogen-receptor positive early breast cancer who have received two
to three years of tamoxifen and are switched to AROMASIN for completion of a
total of five consecutive years of adjuvant hormonal therapy.
AROMASIN is indicated for the treatment of advanced breast cancer in
postmenopausal women whose disease has progressed following tamoxifen therapy.
Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
1 INDICATIONS & USAGE
Alprazolam is indicated for the:
acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults.
Alprazolam is a benzodiazepine indicated for the:
Acute treatment of generalized anxiety disorder in adults. (1)
Treatment of panic disorder with or without agoraphobia in adults. (1)
1 INDICATIONS AND USAGE
Hydrocodone bitartrate and homatropine methylbromide is indicated for thesymptomatic relief of cough 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 less than 6 years of age [
see
Contraindications (4)].
Because of the risks of addiction, abuse, and misuse with opioids, even atrecommended doses [
see Warnings and Precautions (5.1)], reserve hydrocodonebitartrate and homatropine methylbromide for use in adult patients for whom thebenefits of cough suppression are expected to outweigh the risks, and in whom anadequate assessment of the etiology of the cough has been made.
Hydrocodone bitartrate and homatropine methylbromide is acombination of hydrocodone, an opioid agonist; and homatropine, amuscarinic antagonist, indicated for the symptomatic relief of coughin 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 hydrocodone bitartrate and homatropine methylbromide 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.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ADRENALIN safely and effectively. See full prescribing information for ADRENALIN.
ADRENALIN (epinephrine injection) 1 mg/mL, for intramuscular, subcutaneous, and intravenous use
Initial U.S. Approval: 1939
1 INDICATIONS AND USAGE
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.
Adrenalinis 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)
INDICATIONS And USAGE
Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.(1)
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
INDICATIONS & USAGE
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilsons disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules are limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patients dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.
1 INDICATIONSAND USAGE
Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see
Warnings and Precautions (5.2)
], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated for the management of pain severe enough to require an opioid-analgesic and for which alternative treatments are inadequate. (
1)
Limitations of Use (
1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia (
1)
INDICATIONS & USAGE SECTION
Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate 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.Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.