um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor indicated for:
Colorectal Cancer
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1)perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1)treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1)
Breast Cancer
treatment of patients with advanced or metastatic breast cancer as a single agent if ananthracycline-or taxane-containing chemotherapy is not indicated. (1.2)treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (1.2)
Gastric, Esophageal, or Gastroesophageal Junction Cancer
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (1.3)treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (1.3)
Pancreatic Cancer
adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (1.4)
1.1 Colorectal Cancer
Capecitabine is indicated for the:
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.
1.2 Breast Cancer
Capecitabine is indicated for the:treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
1.3Gastric, Esophageal, or Gastroesophageal Junction Cancer
Capecitabine is indicated for the:treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen.treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.
1.4
Pancreatic Cancer
Capecitabine is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
INDICATIONS AND USAGE
Technetium Tc-99m Mebrofenin by intravenous administration is indicated as a hepatic imaging agent, used in the diagnosis of liver disease
INDICATIONS AND USAGE
Lactated Ringer's Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
1 INDICATIONS AND USAGE
Fenofibrate is 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 tablet 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)].
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP is 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 has 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
Pediatric use information for patients7 to 17years of ageis 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 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 ):
Rosuvastatintablets has not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatintablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatintablets are indicated as an adjunct to diet for the treatment of adultpatients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatintablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
DUTASTERIDE is a 5 alpha-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, and
reduce the risk of the need for BPH-related surgery.
DUTASTERIDE in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: DUTASTERIDE is not approved for the prevention of prostate cancer. (1.3)
1.1 Monotherapy
DUTASTERIDE (dutasteride) soft gelatin capsules 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 (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination with Alpha-adrenergic Antagonist
DUTASTERIDE in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
DUTASTERIDE is not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
Cephalexin for Oral Suspension, USP is indicated for the
treatment of the following infections when caused by susceptible strains of the
designated microorganisms:
Respiratory tract infections caused by Streptococcus
pneumoniae and Streptococcus pyogenes
(Penicillin is the usual drug of choice in the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin for Oral Suspension, USP is generally effective in the eradication of
streptococci from the nasopharynx; however, substantial data establishing the
efficacy of cephalexin in the subsequent prevention of rheumatic fever are not
available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus
influenzae, Staphylococcus aureus, Streptococcus
pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureus
and/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, andKlebsiella pneumoniae
Note - Culture and susceptibility tests should be
initiated prior to and during therapy. Renal function studies should be
performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin for Oral Suspension, USP and other antibacterial
drugs, Cephalexin for Oral Suspension, USP 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 & USAGE
Montelukast sodium tablets area leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients15 years of age and older, andperennial allergic rhinitis (PAR) in patients15 years of age and older (
1.3).
1.1 Asthma
Montelukast sodium tablets areindicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablets areindicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.
1 INDICATIONS AND USAGE
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. (1)
1 INDICATIONS AND USAGE
RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.
RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than two days. (1)
Limitations of Use:
Efficacy based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled. (1)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1)
Efficacy could not be established in patients with serious influenza requiring hospitalization. (1)
Limitations of Use:
Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4)].
The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium Chloride Extended-Release Capsules, USP contain potassium chloride, a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic does reduction is insufficient. (1)
Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
INDICATIONS AND USAGE
Hypertension
Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Nephropathy in Type 2 Diabetic Patients
Irbesartan is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see
CLINICAL PHARMACOLOGY: Clinical Studies
).
INDICATIONS AND USAGE
Angina PectorisNadolol tablets are indicated for the long-term management of
patients with angina pectoris.
HypertensionNadolol tablets are indicated in the management of hypertension;
it may be used alone or in combination with other antihypertensive agents,
especially thiazide-type diuretics.
1 INDICATIONS AND USAGE
STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Limitations of Use
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
1 INDICATIONS & USAGE
Morphine Sulfate Extended-Release Tablets are indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
Morphine sulfate extended-release tablets are not for use:
As an as-needed (prn) analgesic.
For pain that is mild or not expected to persist for an extended period of time
For acute pain
In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
Morphine sulfate extended-release 100 mg and 200 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
Morphine sulfate extended-release tablets are an opioid agonist product indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)
Limitations of Use
Morphine sulfate extended-release tablets are not for use:
As an as-needed (prn) analgesic (1)
For pain that is mild or not expected to persist for an extended period of time (1)
For acute pain (1)
In the immediate postoperative period (1)
For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time (1)
Morphine sulfate extended-release 100 mg and 200 mg tablets are only for patients in whom tolerance to an opioid of comparable potency is established. (1)
INDICATIONS AND USAGE
Sulfasalazine tablets are indicated:
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
for the prolongation of the remission period between acute attacks of ulcerative colitis.
1 INDICATIONS & USAGE
Meloxicam is indicated for management of osteoarthritis pain.
Meloxicam is a non-steroidal anti-inflammatory drug indicated for management of osteoarthritis (OA) pain. (1)
1 INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]
The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1)
The efficacy in women with a body mass index of more than 35 kg/m2 has not been evaluated (1, 8.8)
1 INDICATIONS AND USAGE
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1)
INDICATIONS AND USAGE
Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
INDICATIONS AND USAGE
Folic acid, USPis effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP(as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
INDICATIONS AND USAGENizatidine is indicated for up to 8 weeks for the treatment of
active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine is indicated for maintenance therapy for duodenal ulcer patients,
at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer.
The consequences of continuous therapy with nizatidine for longer than 1 year
are not known.
Nizatidine is indicated for up to 12 weeks for the treatment of
endoscopically diagnosed esophagitis, including erosive and ulcerative
esophagitis, and associated heartburn due to GERD.
Nizatidine is indicated for up to 8 weeks for the treatment of active benign
gastric ulcer. Before initiating therapy, care should be taken to exclude the
possibility of malignant gastric ulceration.