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 an anthracycline- 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 tablets are 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 tablets are 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.
1.3	Gastric, Esophageal, or Gastroesophageal Junction Cancer
Capecitabine tablets are 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 tablets are indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
1 INDICATIONS AND USAGE
Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.
Zolmitriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
Zolmitriptan tablets are a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
INDICATIONS AND USAGE
Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepaticand renal disease, including the nephrotic syndrome.
Almost equal diuretic response occurs after oral and parenteral administration of bumetanide.Therefore, if impaired gastrointestinal absorption is suspected or oral administration is notpractical, bumetanide should be given by the intramuscular or intravenous route.
Successful treatment with Bumextabletsfollowing instances of allergic reactions to furosemidesuggests a lack of cross-sensitivity.
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 Patients
Ketorolac 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 intravenous or intramuscular dosingof 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.
Indications and usage
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
1 INDICATIONS AND USAGE
SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age who have had ethmoid sinus surgery.
SINUVA Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients
18years of age who have had ethmoid sinus surgery. (1)
1 INDICATIONS & USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [
see Warnings and Precautions (
5.3)
]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [
see Warnings and Precautions (
5.3)
]
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [
see Clinical Studies (
14.1)
].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [
see Clinical Studies (
14.2)
].
Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [
see Clinical Studies (
14.2)
].
Ziprasidone hydrochloride is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first (
1)
Ziprasidone capsules are indicated for the:
treatment of schizophrenia in adults. (
1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (
1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (
1)
INDICATIONS AND USAGECarefully consider the potential benefits and risks of Piroxicam and other treatment options before deciding to use Piroxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Piroxicam is indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.
1 INDICATIONS AND USAGE
Estradiol vaginal inserts are an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause (1.1)
1.1 Treatment of Atrophic Vaginitis due to Menopause
INDICATIONS AND USAGE
1.1 SchizophreniaQuetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)]
1.2 Bipolar DisorderQuetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2)] .
Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies (14.2)] .
Quetiapine fumarate tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [ see Clinical Studies (14.2)] .
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I DisorderPediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
INDICATIONS AND USAGE
Dicyclomine hydrochloride oral solution is indicated for the treatment of functional bowel/irritable bowel syndrome.
1 INDICATIONS AND USAGE
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. (1)
1
INDICATIONS & USAGE
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
1 INDICATIONS AND USAGE
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses
[see
Warnings and Precautions (5.1)],
reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Tramadol hydrochloride and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and are indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
(1)
Limitations of Use
(1)
Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac sodium delayed-release tablets, are indicated:
For relief of signs and symptoms of osteoarthritis
For relief of signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Limitations of Use
Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].
Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)]
.
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Limitations of Use:
Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months
MAC sedation in the pediatric population is not recommended
Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation
INDICATIONS AND USAGE
Isoproterenol hydrochloride injection is indicated:
For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (See
CONTRAINDICATIONS
).
For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available (See
CONTRAINDICATIONS
).
For bronchospasm occurring during anesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock (See
WARNINGS
).
1 INDICATIONS AND USAGE
Nelarabine Injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.
Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (1)
A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide gel pad 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Adapalene and benzoyl peroxide gel pad 0.1% / 2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (
1)
1 INDICATIONS AND USAGE
Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia
[see
Dosage and Administration (2.2)].
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic. Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (
1,
2.2)
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use. (
1,
2.2,
4,
5.1,
5.4,
5.5,
5.7,
5.9)
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use
[see
Dosage and Administration (2.2),
Contraindications (4),
Warnings and Precautions (5.1,
5.4,
5.5,
5.7,
5.9)]
.
Indications and Usage
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.
INDICATIONS AND USAGE
Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration.
Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes).
In controlled studies in the U.S., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous Verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in heart rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after Verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. The effect of a single injection lasts for 3060 minutes when conversion to sinus rhythm does not occur.
Because a small fraction (<1.0%) of patients treated with Verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation with an accessory bypass tract, marked hypotension, or extreme bradycardia/asystolesee
Contraindications
and
Warnings
), the initial use of intravenous Verapamil hydrochloride should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see
Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patients response is gained, an office setting may be acceptable.
Cardioversion has been used safely and effectively after intravenous Verapamil.
1
INDICATION
S
AND USAGE
Gemmilyis indicated for use by females of reproductive age to prevent pregnancy [
see
Clinical Studies (14)
].
The efficacy of Gemmilyin women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
Gemmily
is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1)
The efficacy of Gemmilyin women with a body mass index (BMI) of >35kg/m2 has not been evaluated (1, 8.8)
1 INDICATIONS AND USAGE
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron orally disintegrating tablets are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50mg/m
2
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
(1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
(1)
postoperative nausea and/or vomiting
(1)