um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)
Pantoprazole sodium delayed-release tablets, USP are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets, USP are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets, USP are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole sodium delayed-release tablets, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights; this drug product is not labeled for use in pediatric patients with schizophrenia, bipolar mania or autistic disorder. (1.1, 1.2, 1.3)
1.1 Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
Adolescents
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia .Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
Combination Therapy
Adults
The combination of risperidone with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
Due to Janssen Pharmaceuticals Corporations marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder. Information regarding the treatment of pediatric patients with irritability associated with autistic disorder, 5 to 16 years of age, is approved for Janssen Pharmaceuticals Corporations risperidone drug products.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see
WARNINGS
].
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.
INDICATIONS AND USAGE
Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent 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.
1
INDICATIONS AND USAGE
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XYZAL is a histamine H1receptor
antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic
rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic
urticaria (1.3)
1.1 Seasonal Allergic Rhinitis
XYZAL is indicated for the relief of symptoms associated with
seasonal allergic rhinitis in adults and children 2 years of age and
older.
1.2 Perennial Allergic Rhinitis
XYZAL
is indicated for the relief of symptoms associated with perennial allergic
rhinitis in adults and children 6 months of age and older.
1.3 Chronic Idiopathic Urticaria
XYZAL
is indicated for the treatment of the uncomplicated skin manifestations of
chronic idiopathic urticaria in adults and children 6 months of age and
older.
INDICATIONS AND USAGE
Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in:cystathionine beta-synthase (CBS),5,10-methylenetetrahydrofolate reductase (MTHFR),cobalamin cofactor metabolism (cbl).Patient response to Cystadane can be monitored by homocysteine plasma levels (see DOSAGE AND ADMINISTRATION). Response usually occurs within a week and steady state within a month.Cystadane has been administered concomitantly with vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate.
Warfarin sodium tablets are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
INDICATIONS AND USAGE
Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Lamivudine and zidovudine tablet, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Lamivudine and zidovudine tablet, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
1 INDICATIONS AND USAGE
COLCRYS (colchicine, USP) is an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
1.1	Gout Flares
COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares:
COLCRYS is indicated for prophylaxis of gout flares.
Treatment of Gout Flares:
COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2	Familial Mediterranean Fever (FMF)
COLCRYS (colchicine, USP) tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
INDICATIONS AND USAGE:
Tetracaine hydrochloride is indicated for the production of spinal anesthesia for procedures requiring two to three hours.
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of:
Parkinson's
disease (PD) (1.1)
Moderate-to-severe primary Restless Legs
Syndrome (RLS) (1.2)
1.1 Parkinsons Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
1 INDICATIONS AND USAGE
Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)].
Dalfampridine is a potassium channel blocker indicated to improve walking inadult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed (1,
14).
1 INDICATIONS AND USAGE
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
To improve exercise ability and delay clinical worsening.
In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability
[see
Clinical Studies (14.2)].
Studies establishing effectiveness included predominantly patients with WHO Functional Class IIIII symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
To improve exercise ability and delay clinical worsening.
In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class IIIII symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) (
1).
1 INDICATIONS & USAGE
Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients (
1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients (
1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
[see Clinical Studies (
14.1)].
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
[see Clinical Studies (
14.1)].
1.2 Pediatric Patients
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk
[see Clinical Studies (
14.2)].
INDICATIONS & USAGE SECTION
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
INDICATIONS AND USAGE
DMSA is to be used as an aid in the scintigraphic evaluation of renal parenchymal disorders.
INDICATIONS & USAGE
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
INDICATIONS AND USAGE:
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment may be used in children over one year of age as well as in adults.
INDICATIONS AND USAGE
Utira
-C
tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
Indications and Usage
Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.
It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.
1 INDICATIONS AND USAGE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):
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 AND USAGE
Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. (1)
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)
1 INDICATIONS AND USAGE
Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (1.1)
Otitis media (1.2)
Skin and skin structure infections (1.3)
Bone infections (1.4)
Genitourinary tract infections (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1 Respiratory Tract Infections
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
1 INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
[see
Clinical Studies (14.1)]
, heart
[see
Clinical Studies (14.2)]
or liver transplants
[see
Clinical Studies (14.3)],
in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants (
1)
1.2Epilepsy
Divalproex sodium extended-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium extended-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1 INDICATIONS AND USAGE
Micafungin for Injection is indicated for:
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1)and Use in Specific Populations (8.4)].
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].
Limitations of Use
Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Mycamine (micafungin for injection). However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Micafungin for injection is an echinocandin indicated in adult and pediatric patients for (1):
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).