um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Metformin Hydrochloride Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Metformin Hydrochloride Tabletis a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1)
1.2 Non-small Cell Lung Cancer
Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1 INDICATIONS AND USAGE
Lovenox is a low molecular weight heparin (LMWH) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and nonQ-wave myocardial infarction (MI) (1.3)
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4)
1.1	Prophylaxis of Deep Vein Thrombosis
Lovenox is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1)]
in patients undergoing hip replacement surgery, during and following hospitalization
in patients undergoing knee replacement surgery
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
1.2	Treatment of Acute Deep Vein Thrombosis
Lovenox is indicated for:
the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium
1.3	Prophylaxis of Ischemic Complications of Unstable Angina and NonQ-Wave Myocardial Infarction
Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and nonQ-wave myocardial infarction, when concurrently administered with aspirin.
1.4	Treatment of Acute ST-Segment Elevation Myocardial Infarction
Lovenox, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
1 INDICATIONS AND USAGE
Sildenafil tablets are 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 tablets were 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-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil tablets are 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-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).
(1)
INDICATIONS AND USAGE
Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.
1 INDICATIONS AND USAGE
Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2)
Limitations of Use
The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3)
1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
1.3 Limitations of Use
The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.
INDICATIONS AND USAGE
Flucytosine capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine capsules. (see
MICROBIOLOGY
).
1
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspensionshould 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.
Amoxicillin for Oral Suspension is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin for Oral Suspension is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1
1.5)
In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the ear, nose, and throat
-due to Streptococcus species.(- and -hemolytic isolates only),
Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the genitourinary tract
- due to
Escherichia coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3Infections of the skin and skin structure
-due to
Streptococcus spp.
(- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4Infections of the lower respiratory tract
- due to
Streptococcus spp.
(- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5Gonorrhea, acute uncomplicated (ano-genital and urethral infections in males and females)
- due to
Neisseria gonorrhoeae.
Because of high rates of Amoxicillin resistance, Amoxicillin for Oral Suspension is not recommended for empiric treatment of gonorrhea. Amoxicillin for Oral Suspension use should be limited to situations where
N. gonorrhoeae isolates are known to be susceptible to Amoxicillin.
1.6
Triple therapy for
Helicobacter pylori
with clarithromycin and
lansoprazole:
Amoxicillin for Oral Suspension in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual therapy for
H. pylori with lansoprazole
Amoxicillin for Oral Suspension, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Cefadroxil monohydrate is indicated for the treatment of patients
with infection caused by susceptible strains of the designated organisms in the
following diseases:
Urinary tract infections caused by E. coli, P. mirabilis,
and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or
streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus
pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of
administration has been shown to be effective in the prophylaxis of rheumatic
fever. Cefadroxil monohydrate is generally effective in the eradication of
streptococci from the oropharynx. However, data establishing the efficacy of
cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not
available.
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 cefadroxil for oral suspension and other antibacterial drugs,
cefadroxil for oral suspension 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 & USAGE SECTION
1.1 Major Depressive Disorder
Duloxetinedelayed-release capsules USPare indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USPwas established in four short-term and one maintenance trial in adults [see Clinical Studies (
14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Duloxetinedelayed-release capsules USPare indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USPwas established in three short-term trials and one maintenance trial in adults [see Clinical Studies (
14.2)].
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
1.3 Diabetic Peripheral Neuropathic Pain
Duloxetinedelayed-release capsules USPare indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (
14.3)].
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 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 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.
1 INDICATIONS & USAGE
Famciclovir, USPa prodrug of penciclovir, is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients(1.1)
Herpes labialis (cold sores)
o Treatment of recurrent episodes
Genital herpes
o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir have not been established for:
Patients with first episode of genital herpes Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patient
Herpes labialis(cold sores): Famciclovir is indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes:
Recurrent episodes: Famciclovir is indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir is indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir is indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir, USPis indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir, USPwhen initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of Use
The efficacy and safety of famciclovir have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1 INDICATIONS & USAGE
Fluoxetine is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see Clinical Studies (
14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see Clinical Studies (
14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see Clinical Studies (
14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia
[see Clinical Studies (
14.4)].
Fluoxetine and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (
1)
Acute and maintenance treatment of Bulimia Nervosa (
1)
Acute treatment of Panic Disorder, with or without agoraphobia (
1)
Fluoxetine capsules and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (
1)
I. Indications for Use
The Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D)
and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be
used only with automated apheresis devices for collecting human blood and blood
components. The anticoagulant solution is metered by the apheresis machine into
the collected whole blood. It is not to be infused directly into the donor. After the
anticoagulant is used, the bag in which it was contained is discarded. When
collecting plasma in the RBCP protocol, the plasma is collected into an empty plasma
collection bag. One hundred milliliters (100ml) of AS-3 is transferred into one RBC
collection bag when using the RBCP protocol or 2 separate bags when using the
2RBC protocol. AS-3 solution provides nutrients to keep the red blood cells viable for
42 days when refrigerated.
CP2D is also indicated for the collection of FFP and PF24 plasma, collected and
stored plasma collected using the 822, 822-2P and 822F-2P disposable sets may be
frozen within 8 hours (FFP) or within 24 hours which includes 8 hours room
temperature storage and 16 hours refrigeration storage (PF24).
The 300mL AS-3 is used in conjunction with automated red blood cell washing
devices. AS-3 serves as the nutrient solution for storage of the red blood cell product
after deglycerolization. The red blood cells are washed using the Model 215 System.
AS-3 is used for priming the disposable and for the last wash of the red blood cells.
The washed cells are then re-suspended in 100mL of the AS-3 before transfer into a
product collection bag or storage bag. Additive Solution Formula 3 (AS-3) provides
nutrients to keep the washed red blood cells viable for up to 14 days after washing
when refrigerated.
Neither the CP2D nor the AS-3 container is used for the storage of blood or blood
components.
1 INDICATIONS AND USAGE
Pantoprazole is a proton pump inhibitor indicated (PPI) 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 are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets 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 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 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 are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
INDICATIONS AND USAGE
Postherpetic Neuralgia
Neurontin (gabapentin) is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Neurontin (gabapentin) is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Neurontin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3
12 years.
1 INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (
1.1)
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (
1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (
1.3)
1.1 Adjunctive Therapy
Lamotrigine extended-release tablets USP are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
Lamotrigine extended-release tablets USP are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine extended-release tablets USP have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of NALFON tablets, USP and other treatment options before deciding to use NALFON tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
NALFON tablets are indicated:
For relief of mild to moderate pain in adults.
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.