um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Oxycodone hydrochloride tablets USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets 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.
Oxycodone hydrochloride tablet is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (
1
)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-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.
1.6
Limitations of Use
Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specificGram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4)].
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14)].
INDICATIONS
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception
1. INDICATIONS AND USAGE
Irbesartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. Irbesartan and Hydrochlorothiazide Tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and Hydrochlorothiazide Tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Irbesartan and Hydrochlorothiazide Tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with mono therapy.
Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with Irbesartan and Hydrochlorothiazide Tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with Irbesartan and Hydrochlorothiazide Tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.
*For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to- treat analysis).
The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure 140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).The likelihood of achieving these goals on Irbesartan and Hydrochlorothiazide Tablets rises to about 40% (systolic) or 70% (diastolic).
Irbesartan and Hydrochlorothiazide Tablets USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
In patients not adequately controlled with monotherapy. (1)
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1)
Figure 1 2
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for:
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
1.3 Migraine
Depakote ER is indicated for prophylaxis of migraine headaches. There is no evidence that Depakote ER is useful in the acute treatment of migraine headaches.
INDICATIONS AND USAGE
CIPRODEX Otic is indicated for the treatment of infections
caused by susceptible isolates of the designated microorganisms in the specific
conditions listed below:
Acute Otitis Media in pediatric patients (age 6
months and older) with tympanostomy tubes due to Staphylococcus
aureus, Streptococcus pneumoniae, Haemophilus
influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
Acute Otitis Externa in pediatric (age 6 months and
older), adult and elderly patients due to Staphylococcus
aureus and Pseudomonas aeruginosa.
INDICATIONS
ETHAMBUTOL HCl is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following:
ETHAMBUTOL HCl plus isoniazidETHAMBUTOL HCl plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ETHAMBUTOL HCl should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with ETHAMBUTOL HCl have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
INDICATIONS AND USAGE:
Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin 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.Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections.
Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria.
Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.
If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected.
In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1. Indications and Usage
Naproxen Tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
INDICATIONS AND USAGE
Herpes Zoster Infections :
Acyclovir tablets is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes :
Acyclovir tablets is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox:
Acyclovir tablets is indicated for the treatment of chickenpox (varicella).
INDICATIONS AND USAGE
Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Upper Respiratory Tract:
Pharyngitis/Tonsillitis:
Caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
Otitis Media:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains). (See
CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to -lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific -lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing -lactamase inhibitors.
Acute Sinusitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
Lower Respiratory Tract:
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
Skin And Skin Structure:
Uncomplicated Skin and Skin-Structure Infections:
Caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil for oral suspension and other antibacterial drugs, cefprozil 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.
1 INDICATIONS AND USAGE
1.1 Monotherapy - Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ...
1.1 Monotherapy
Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets 5 mg 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.
INDICATIONS AND USAGE
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.
Edema: Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is particularly useful when an agent with greater diuretic potential is desired.
Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Furosemide Injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.
If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Furosemide Injection is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.
1 INDICATIONS AND USAGE
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:
for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. (1.1)
in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (1.1)
in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). (1.2)
in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). (1.3)
in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). (1.4)
1.1 Non-Small Cell Lung Cancer
IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
1.2 Small Cell Lung Cancer
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
1.3 Biliary Tract Cancers
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
1.4 Hepatocellular Carcinoma
IMFINZI in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
INDICATIONS AND USAGE
Because of its life-threatening side effects and the substantial management difficulties associated with amiodarone use (see
"WARNINGS"
below), Pacerone (Amiodarone HCl) Tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
Recurrent ventricular fibrillation.
Recurrent hemodynamically unstable ventricular tachycardia.
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone HCl tablets favorably affects survival.
Pacerone (Amiodarone HCl) Tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy and potential exacerbation of the arrhythmia, initiation of therapy with Pacerone (Amiodarone HCl) Tablets should be carried out in the hospital.
1 INDICATIONS AND USAGE
Valproate Sodium Injection isindicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions:
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1)
1.1 Epilepsy
Valproate Sodium Injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions:
Valproate Sodium Injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproate Sodium Injection is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See WARNINGS AND PRECAUTIONS (5.1) for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see WARNINGS AND PRECAUTIONS
(5.2, 5.3, 5.4), USE IN SPECIFIC POPULATIONS (8.1), and PATIENT COUNSELING INFORMATION (17)].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see
CONTRAINIDICATIONS
(4)].
1 INDICATIONS AND USAGE
Doxorubicin Hydrochloride Injection/for Injection is an anthracycline topoisomerase inhibitor indicated:
as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer (1.1).
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).
1.1	Adjuvant Breast Cancer
Doxorubicin Hydrochloride Injection/for Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.
1.2	Other Cancers
Doxorubicin Hydrochloride Injection/for Injection is indicated for the treatment of
acute lymphoblastic leukemia
acute myeloblastic leukemia
Hodgkin lymphoma
non-Hodgkin lymphoma (NHL)
metastatic breast cancer
metastatic Wilms' tumor
metastatic neuroblastoma
metastatic soft tissue sarcoma
metastatic bone sarcoma
metastatic ovarian carcinoma
metastatic transitional cell bladder carcinoma
metastatic thyroid carcinoma
metastatic gastric carcinoma
metastatic bronchogenic carcinoma
1 INDICATIONS AND USAGE
Locoid Lipocreamis indicated for:
Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults.
The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age.
Locoid Lipocream is a corticosteroid indicated for:
Relief of the inflammatory and pruritic manifestations ofcorticosteroid-responsive dermatoses in adults. (1)
The treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age. (1)
INDICATIONS AND USAGE
Cefadroxil Tablets,USPare indicatedfor the treatment of patients withinfection caused by susceptiblestrains of the designated organismsin the following diseases:
Urinary tract infections caused byE. coli, P. mirabilis, and Klebsiella
species.
Skin and skin structure infectionscaused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitiscaused by Streptococcus pyogenes (Group A beta-hemolyticstreptococci).
Note: Only penicillin by theintramuscular route of administrationhas been shown to be effective inthe prophylaxis of rheumatic fever.Cefadroxil is generally effectivein the eradication of streptococcifrom the oropharynx. However, dataestablishing the efficacy of cefadroxilfor the prophylaxis of subsequentrheumatic fever are not available.
Note: Culture and susceptibilitytests should be initiated prior toand during therapy. Renal functionstudies should be performed whenindicated.
To reduce the development ofdrug-resistant bacteria andmaintain the effectiveness ofCefadroxil Tablets, USP and otherantibacterial drugs, CefadroxilTablets, USP should be used only totreat or prevent infections that areproven or strongly suspected tobe caused by susceptible bacteria.When culture and susceptibilityinformation are available, theyshould be considered in selectingor modifying antibacterial therapy.In the absence of such data, localepidemiology and susceptibilitypatterns may contribute to theempiric selection of therapy.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1
INDICATIONS AND USAGE
Dorzolamide HCl Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dorzolamide Hydrochloride (HCl) Ophthalmic Solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1)