um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Mesalamine is an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Benzonatate Capsule is indicated for the symptomatic relief of cough.
INDICATIONS AND USAGE
Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which 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.
SEE FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.
WARNINGS
INDICATIONS AND USAGE
Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
1. Primary hypogonadism (congenital or acquired )-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of Testosterone Cypionate Injection in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Indication:
Estrogen Receptor Positive Metastatic Breast Cancer
INDICATIONS AND USAGE
Myocardial Infarction
Metoprolol Tartrate Injection, USP is indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRA-INDICATIONS, and WARNINGS).
INDICATIONSAND USAGE
Doxepin Hydrochloride Capsules, USP are recommended for the treatment of:
1.Psychoneurotic patients with depression and/or anxiety.
2.Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
3.Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
4.Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride capsules is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.
1 INDICATIONS & USAGE
Dexrazoxane for Injection is indicated for reducing the incid ence and severity of cardiomyopathy associated with doxorubicin ad m inistration in wo men with
metastatic breast cancer who have received a cu mulative doxorubicin dose of 300 mg / m2and who will c ontinue to receive doxor ubicin therapy to maintain tu mor control. Do not use with the initiat ion of doxorubicin therapy
[see Warnings and Precautions (5.2 ) ].
Dexrazoxane for Injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use Dexrazoxane for Injection with doxorubicin initiation. (1)
1 INDICATIONS AND USAGE
Paricalcitol is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with:
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2).
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Oxaprozin tablets are indicated:
* For relief of the signs and symptoms of osteoarthritis
* For relief of the signs and symptoms of rheumatoid arthritis
* For relief of the signs and symptoms of juvenile rheumatoid arthritis
1 INDICATIONS & USAGE
Cephalexin is 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 and other antibacterial drugs, Cephalexin 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 is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is 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 is 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 is indicated for the treatment of bone infections caused by susceptible isolates of
Staphylococcus aureus and
Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is 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 and other antibacterial drugs, Cephalexin 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
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II to III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
INDICATIONS AND USAGE
Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
INDICATIONS AND USAGE
Doxepin hydrochloride capsules are recommended for the treatment of:
Psychoneurotic
patients with depression and/or anxiety.
Depression
and/or anxiety associated with alcoholism (not to be taken concomitantly with
alcohol).
Depression
and/or anxiety associated with organic disease (the possibility of drug
interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic
depressive disorders with associated anxiety including involutional depression
and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.
INDICATIONS AND USAGE
CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.
Cefdinir capsules, USPare indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Useand
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
INDICATIONS AND USAGE
Diclofenac sodium delayed-release tablets are indicated for the acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
1 INDICATIONS AND USAGE
Finasteride, is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (
1.1):
Improve symptoms
Reduce the risk of acute urinary retention
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score) (
1.2).
Limitations of Use: Finasteride is not approved for the prevention of prostate cancer (
1.3).
1.1 Monotherapy
Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
-Improve symptoms
-Reduce the risk of acute urinary retention
-Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets 5 mg administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride is not approved for the prevention of prostate cancer.
INDICATIONS
Entacapone tablets, USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose wearing-off in patients with Parkinsons disease (see
CLINICAL PHARMACOLOGY, Clinical Studies
).
Entacapone tablets, USP effectiveness has not been systematically evaluated in patients with Parkinsons disease who do not experience end-of-dose wearing-off.
1 INDICATIONS AND USAGE
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (
1)
1.1 Myelodysplastic Syndromes (MDS)
Azacitidine for injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
1 INDICATIONS AND USAGE
Valganciclovir is 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 for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
[see
Clinical Studies (14.1)]
.
Prevention of CMV Disease:Valganciclovir for oral solution is 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 for oral solution is 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)]
.
1 INDICATIONSAND USAGE
Tramadol
-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Tramadol
hydrochloride 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.
Limit
ations of Use
Because of the risks of addiction, abuse,
and misuse with opioids, even at recommended doses, 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.
and misuse with opioids, even at recommended doses, 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
Tramadol hydrochloride extended-release
tablets are not indicated as an as-needed (prn) analgesic.
tablets are not indicated as an as
Tramadol hydrochloride is an opioid agonist 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.
(1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, 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 are not indicated as an as-needed (prn) analgesic.
(1)
1 INDICATIONS AND USAGE
NAPRELAN Tablets are indicated for the treatment of:
rheumatoid arthritis (RA)
osteoarthritis (OA)
ankylosing spondylitis (AS)
tendinitis, bursitis
acute gout
primary dysmenorrhea (PD)
the relief of mild to moderate pain
[see Warnings and Precautions (5)].
NAPRELAN is a nonsteroidal anti-inflammatory drug indicated for the treatment of:
rheumatoid arthritis (RA)(1)
osteoarthritis (OA)(1)
ankylosing spondylitis (AS)(1)
tendinitis, bursitis (1)
acute gout (1)
primary dysmenorrhea (PD) (1)
the relief of mild to moderate pain (1)
1 INDICATIONS AND USAGE
LOVAZA (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting LOVAZA therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as betablockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined.
LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined. (1)
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Naproxen 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 arthritits
Naproxen 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 dymenorrhea
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of:
Parkinsons disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2)
1.1 Parkinson's Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinsons disease.
1.2 Restless Legs Syndrome
Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).