um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.
Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to:
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction and stroke.
Reduce the need for coronary and non-coronary revascularization procedures.
1.2 Hyperlipidemia
Simvastatin tablets are indicated to:
Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Simvastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
LDL cholesterol remains 190 mg/dL; or
LDL cholesterol remains 160 mg/dL and
There is a positive family history of premature cardiovascular disease (CVD) or
Two or more other CVD risk factors are present in the adolescent patient.
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
1.4 Limitations of Use
Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days (see DOSAGE AND ADMINISTRATION, PHARMACEUTICAL INFORMATION FOR KETOROLAC TROMETHAMINE INJECTION).
INDICATIONS AND USAGE
LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the
BOXED WARNING
, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives.
Indicated surgical procedures should be performed in conjunction with antibacterial therapy.
LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated.
LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN 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.
INDICATIONS AND USAGE
DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
INDICATIONS AND USAGE
Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
1 INDICATIONSAND USAGE
Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local
infiltration
Ropivacaine hydrochloride injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
1 INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see
Clinical Studies (14)].
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (
1)
INDICATIONS & USAGE SECTION
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome
INDICATIONS AND USAGE
Epilepsy
Carbamazepine is indicated for use as an anticonvulsant drug.
Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived
from active drug-controlled studies that enrolled patients with the following
seizure types:
Partial seizures with complex symptomatology (psychomotor, temporal lobe).
Patients with these seizures appear to show greater improvement than those with
other types.
Generalized tonic-clonic seizures (grand mal).
Mixed seizure patterns which include the above, or other partial or
generalized seizures. Absence seizures (petit mal) do not appear to be
controlled by carbamazepine (see PRECAUTIONS, General).
Trigeminal Neuralgia
Carbamazepine is indicated in the treatment of the pain
associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal
neuralgia.
This drug is not a simple analgesic and should not be used for the
relief of trivial aches or pains.
1 INDICATIONS AND USAGE
VIRAMUNE is indicated in combination with other antiretroviral agents
for the treatment of human immunodeficiency virus (HIV-1) infection
in adults and pediatric patients 15 days and older [see Clinical
Studies (14.1, 14.2)].
Limitations of Use:Based on
serious and life-threatening hepatotoxicity observed in controlled
and uncontrolled trials, VIRAMUNE is not recommended to be initiated,
unless the benefit outweighs the risk, in:
adult females with CD4+ cell
counts greater than 250 cells/mm3 or
adult males with CD4+ cell counts
greater than 400 cells/mm3
[see
Warnings and Precautions (5.1)].
VIRAMUNE is an NNRTI indicated in combination with other
antiretroviral agents for the treatment of human immunodeficiency
virus (HIV-1) infection in adults and pediatric patients 15 days and
older. (1)
Limitations of Use:Based on serious
and life-threatening hepatotoxicity observed in controlled and uncontrolled
trials, VIRAMUNE is not recommended to be initiated, unless the benefit
outweighs the risk, in:
adult females with CD4+ cell
counts greater than 250 cells/mm3
adult males with CD4+ cell counts
greater than 400 cells/mm3
(1, 5.1)
Indications & Usage Section
Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
1.1 Important Limitation of Use
Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Please review the manufacturer's complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4419ca50-539c-47e8-ab00-dbb45c7c1814
1	INDICATIONS AND USAGE
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)].
An improvement in hemostasis has not been established.
Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. (1)
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.
An improvement in hemostasis has not been established.
Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. (1, 14)
Limitations of Use
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. (1)
Limitations of Use
ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
INDICATIONS & USAGE
Cephalexin capsules, USPis 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 capsules, USPis 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, and
Klebsiella 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 capsules, USPand other antibacterial drugs, cephalexin capsules, USPshould 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
INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years).
The following points should be considered when initiating therapy with INVIRASE/ritonavir:
The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 trial [see Adverse Reactions (6.1)] and pharmacokinetic data [see Clinical Pharmacology (12.3)].
The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.
The number of baseline primary protease inhibitor mutations affects the virologic response to INVIRASE/ritonavir.
INVIRASE is an HIV-1 protease inhibitor indicated for the treatment of HIV-1 infection in combination with ritonavir and other antiretroviral agents in adults (over the age of 16 years). (1)
1 INDICATIONS AND USAGE
Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a -lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.
Piperacillin and Tazobactam for Injection is a combination penicillin-class antibacterial and -lactamase inhibitor indicated for treatment of:
Intra-abdominal infections (
1.1)
Skin and skin structure infections (
1.2)
Female pelvic infections (
1.3)
Community-acquired pneumonia (
1.4)
Nosocomial pneumonia (
1.5)
1.1Intra-abdominal Infections
Appendicitis (complicated by rupture or abscess) and peritonitis caused by -lactamase producing isolates of
Escherichia coli or the following members of the
Bacteroides fragilis group:
B. fragilis,
B. ovatus,
B. thetaiotaomicron, or
B. vulgatus. The individual members of this group were studied in fewer than 10 cases.
1.2Skin and Skin Structure Infections
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by -lactamase producing isolates of
Staphylococcus aureus.
1.3Female Pelvic Infections
Postpartum endometritis or pelvic inflammatory disease caused by -lactamase producing isolates of
Escherichia coli.
1.4Community-acquired Pneumonia
Community-acquired pneumonia (moderate severity only) caused by -lactamase producing isolates of
Haemophilus influenzae.
1.5Nosocomial Pneumonia
Nosocomial pneumonia (moderate to severe) caused by -lactamase producing isolates of
Staphylococcus aureus and by piperacillin/tazobactam-susceptible
Acinetobacter baumannii,
Haemophilus influenzae,
Klebsiella pneumoniae, and
Pseudomonas aeruginosa (Nosocomial pneumonia caused by
P. aeruginosa should be treated in combination with an aminoglycoside) [
see Dosage and Administration (
2)
].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat infections that are proven or strongly suspected to be caused by 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.
Prophylaxis
The preoperative administration of cefotetan may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean contaminated or potentially contaminated (e.g., cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery).
If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated.
1 INDICATIONS AND USAGE
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart, or lung transplants,and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. (1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)], or lung transplant [see Clinical Studies (14.4)] and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)] in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an
aid to smoking cessation treatment.
Bupropion hydrochloride extended-release tablets, USP (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment.
(
1)
INDICATIONS AND USAGE
Nisoldipine is indicated for the treatment of hypertension. It maybe used alone or in combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD). (
1.1)
Risk reduction of NSAID-associated gastric ulcer. (
1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (
1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (
1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-release Capsules is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole Magnesium Delayed-release Capsules is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole Magnesium Delayed-release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-release Capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
[see Dosage and Administration (
2) and Clinical Studies (
14)]
.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted
[see Clinical Pharmacology (
12.4) and the prescribing information for clarithromycin]
.
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole Magnesium Delayed-release Capsules is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
Moxifloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
Moxifloxacin Ophthalmic Solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. (1)