um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule,
is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (
1).
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules, are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
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)].
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,
5.5,
5.7,
5.9)]
.
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic 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,
5.5,
5.7,
5.9)
1 INDICATIONS & USAGE
Rabeprazole sodium delayed-release tabletsis a proton pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (
1.1)
Maintenance of Healing of Erosive or Ulcerative GERD (
1.2)
Treatment of Symptomatic GERD (
1.3)
Healing of Duodenal Ulcers (
1.4)
Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence (
1.5)
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (
1.6)
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (
1.7)
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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 (12.2)
and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
1. INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsy
adjunctive therapy in patients aged 2 years and older:
Partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (
1.1)
Epilepsymonotherapy in patients aged 16 years and older:
Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (
1.1)
Bipolar disorder:
Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (
1.2)
Limitations of Use:
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy
[see Clinical Studies (
14.2)]
.
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y
12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke (MI) in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Amiloride hydrochloride and hydrochlorothiazide tablets are
indicated in those patients with hypertension or with congestive heart failure
who develop hypokalemia when thiazides or other kaliuretic diuretics are used
alone, or in whom maintenance of normal serum potassium levels is considered to
be clinically important, e.g., digitalized patients, or patients with
significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients
receiving diuretics for uncomplicated essential hypertension when such patients
have a normal diet.
Amiloride hydrochloride and hydrochlorothiazide tablets may be used alone or
as an adjunct to other antihypertensive drugs, such as methyldopa or beta
blockers. Since amiloride hydrochloride and hydrochlorothiazide enhances the
action of these agents, dosage adjustments may be necessary to avoid an
excessive fall in blood pressure and other unwanted side effects.
This fixed combination drug is not indicated for the initial
therapy of edema or hypertension except in individuals in whom the development
of hypokalemia cannot be risked.
1 INDICATIONS AND USAGE
Ranolazine extended-release tablet is indicated for the treatment of chronic angina.
Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine extended-release tablet is an antianginal indicated for the treatment of chronic angina. (
1)
1 INDICATIONS AND USAGE
Prasugrel is a P2Y
12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis)
in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) (
1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (
1.1).
1.1 Acute Coronary Syndrome
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events(including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
Prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death
[see Clinical Studies (
14)]
.
1.5 Uncomplicated Skin and Skin Structure Infections
Levofloxacin in 5% Dextrose Injection is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible
Staphylococcus aureus, or
Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
L
imitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
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 should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Tramadol hydrochloride is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (1).
L
i
m
itations of Use
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated or are not expected to be tolerated, (1)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1)
Tramadol hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
1
INDICATIONS AND USAGE
ALTABAX is indicated for use in adults and pediatric patients
aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in
pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates
only) or Streptococcus pyogenes
[see Clinical Studies (14)].
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should
1 INDICATIONS AND USAGE
Monotherapy
Fulvestrant injection is indicated for the treatment of:
Hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced breast cancer in postmenopausal women not previously treated with
endocrine therapy, or
HR-positive advanced
breast cancer in postmenopausal women with disease progression following
endocrine therapy.
Combination Therapy
Fulvestrant injection is indicated for the treatment of:
HR-positive,
HER2-negative advanced or metastatic breast cancer in postmenopausal women
in combination with ribociclib as initial endocrine based therapy or
following disease progression on endocrine therapy.
HR-positive,
HER2-negative advanced or metastatic breast cancer in combination with
palbociclib or abemaciclib in women with disease progression after
endocrine therapy.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of:
Hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced breast cancer in postmenopausal women not previously treated with
endocrine therapy. (1)
HR-positive advanced
breast cancer in postmenopausal women with disease progression following
endocrine therapy. (1)
HR-positive,
HER2-negative advanced or metastatic breast cancer in postmenopausal women
in combination with ribociclib, as initial endocrine based therapy or
following disease progression on endocrine therapy. (1)
HR-positive,
HER2-negative advanced or metastatic breast cancer in combination with
palbociclib or abemaciclib in women with disease progression after
endocrine therapy. (1)
INDICATIONS AND USAGE
Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See
WARNINGS
.)
1 INDICATIONSAND USAGE
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
1 INDICATIONS AND USAGE
Pemetrexed for Injectionis a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (1.1)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1)
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1)
Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1)
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2)
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for Injectionis indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies (14.1)].
1.2 Mesothelioma
Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
1 INDICATIONS AND 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 ziprasidone's 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 is 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 is 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 is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults
[see
Clinical Studies (
14.2)]
.
Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of Ziprasidone 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)
1 INDICATIONS AND USAGE
Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.
Gabapentin tablets are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
INDICATIONS AND USAGE
For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Indications and Usage
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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.
Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1 Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of Haemophilus influenzaeand Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of H. influenzaeand M. catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of H. influenzaeand M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, andKlebsiellaspecies.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of E. coli, Klebsiella species, andEnterobacterspecies.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
1 INDICATIONS AND USAGE
Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
Melodetta 24 Fe 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)