um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older).
Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).
PROPHYLAXIS
In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 years of age and older), rimantadine hydrochloride has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since rimantadine hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, rimantadine hydrochloride prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of rimantadine hydrochloride prophylaxis have not been demonstrated for longer than 6 weeks.
TREATMENT
Rimantadine hydrochloride therapy should be considered for adults (17 years and older) who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, rimantadine hydrochloride has been shown to reduce the duration of fever and systemic symptoms.
The following points should be considered before initiating treatment or prophylaxis with rimantadine hydrochloride:
- Rimantadine hydrochloride is not a substitute for early 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 mutations 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 rimantadine hydrochloride.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen sodium tablets and other treatment options before deciding to use naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen sodium tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.
Naproxen sodium tablets are also indicated:
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
1 INDICATIONS AND USAGE
Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetal's or Variant Angina)
Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
1.1 Hypertension
Amlodipine besylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. They may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. They may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
1 INDICATIONS AND USAGE
Clopidogrel is a P2Y
12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin.
Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel is indicated to reduce the rate of MI and stroke.
Azithromycin tablets are 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 ofage) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , 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
Benzonatate acts peripherally by anesthetizing the stretch
receptors located in the respiratory passages, lungs, and pleura by dampening
their activity and thereby reducing the cough reflex at its source. It begins to
act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate
has no inhibitory effect on the respiratory center in recommended dosage.
INDICATIONS AND USAGE
TOBRADEX (tobramycin and dexamethasone ophthalmic suspension) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid 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 superficial ocular 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:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
1 INDICATIONS & USAGE
Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the:
Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium ovale, andPlasmodium vivaxin adult and pediatric patients.(1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients(1.1)
Treatment of rheumatoid arthritis in adults.(1.2)
Treatment of systemic lupus erythematosus in adults.(1.3)
Treatment of chronic discoid lupus erythematosus in adults.(1.4)
Limitations of Use(1.1):
Hydroxychloroquine sulfate tablets arenotrecommended for the:Treatment of complicated malaria.Treatment of chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies.Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
Hydroxychloroquine sulfate tablets areindicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium vivax,andPlasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablets arenotrecommended for: Treatment of complicated malaria. Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies[seeMicrobiology (12.4)].
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary[seeMicrobiology (12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets areindicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablets areindicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablets areindicated for the treatment of chronic discoid lupus erythematosus in adults.
1 INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics:
Monotherapy in the treatment of partial-onset seizures in children 4-16 years
Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years (
1)
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 hemoglobin and its breakdown products. 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 CO2 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.
1 INDICATIONS AND USAGE
XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
XALATAN is a prostaglandin F2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older.
Limitations of Use:
Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets
[see Microbiology
(12.4)].
Lopinavir and ritonavir tablets are an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older).
(1)
INDICATIONS AND USAGE
Olopatadine hydrochloride ophthalmic
solution USP, 0.1% is indicated for the treatment of the signs and symptoms
of allergic conjunctivitis.
INDICATIONS AND USAGE
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits (see "DOSAGE AND ADMINISTRATION")
1	INDICATIONS AND USAGE
Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
1 INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride extended-release capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)
1.1 Major Depressive Disorder
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see
Clinical Studies (14.1)
].
1.2 Seasonal Affective Disorder
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see
Clinical Studies (14.2)
].
INDICATIONS AND USAGE
Finasteride tablets USP, 5 mg is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1	INDICATIONS AND 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.
Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8):
Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
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 (TypeIIIHyperlipoproteinemia).
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 LDLC, TotalC, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin calcium tablets have not been studied in Fredrickson TypeI and V dyslipidemias.