um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Lamotrigine tablet is indicated for:
Epilepsyadjunctive 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 AED. (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 tablets in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine tablet is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine tablet 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 tablet 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 tablet 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 (14.1)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamorigine tablets in the acute treatment of mood episodes has not been established.
INDICATIONS AND USAGE
Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is 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
), reserve tramadol 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
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcuspneumoniae and Streptococcuspyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcuspneumoniae, Haemophilusinfluenzae, Staphylococcus aureus, treptococcus pyogenes, and Moraxellacatarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus yogenes
Bone infections caused by Staphylococcus aureus and/or Proteusmirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichiacoli, Proteusmirabilis, and Klebsiellapneumoniae
Note
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP 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
KALBITOR (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. (1)
1
INDICATIONS AND USAGE
LENVIMA is a kinase inhibitorthat is indicated:
Differentiated Thyroid Cancer
(DTC)
For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).(1.1)
Renal Cell Carcinoma (RCC)
In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2)
In combination with everolimus, for the treatment of adult patients withadvancedrenal cell carcinoma (RCC) following one prior anti-angiogenictherapy. (1.2)
Hepatocellular Carcinoma (HCC)
For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). (1.3)
Endometrial Carcinoma (EC)
In combination with pembrolizumab, for the treatment of patients withadvanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H),
who have diseaseprogression following prior systemic therapy in any setting and are not candidates forcurative surgery or radiation. (1.4,2.1)
1.1
Differentiated Thyroid Cancer
LENVIMA is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
1.2
Renal Cell Carcinoma
LENVIMA, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
LENVIMA, in combination with everolimus, is indicated for the treatment of adult patients with advancedRCC following one prior anti-angiogenictherapy.
1.
3
Hepatocellular
Carcinoma
LENVIMA is indicated for thefirst-linetreatment of patients with unresectablehepatocellular carcinoma (HCC).
1.
4
Endometrial
Carcinoma
LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, ornot microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation[see Dosage and Administration (
2.1
)].
INDICATIONS AND USAGE
Indicated for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.
Platelet concentrates are not intended to be made with this product.
INDICATIONS AND USAGE
LidocaineHCl Topical Solution, 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract.
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 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 cardiovascular (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)]
.
INDICATIONS AND USAGE
Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see
DOSAGE AND ADMINISTRATION
).
1	INDICATIONS AND USAGE
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:
Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. (1)
Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. (1)
Adult Patients:
SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2), and Clinical Studies (14)]
genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin
genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
Pediatric Patients:
SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see Dosage and Administration (2.3) and Clinical Studies (14.5)].
1.3 Sinusitis
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1 INDICATIONS AND USAGE
Instructions for Use
Clean and dry the affected area.
Gently apply a thin film--1-2 grams, 1-2 times daily or as directed by your physician.
Do not apply over a large area of skin.
Thoroughly wash and dry hands before the next step.
Roll out Soft Silicone to the desired length, tear at the perforated line and then remove adhesive backing.
Place Soft Silicone onto the affected area, and gently apply pressure around the edges for complete coverage.
Use the Soft Silicone tape in conjuction with Fluocinonide Cream 0.1%, only as directed by your physician.
Fluovix Plus contains Fluocinonide Cream USP, 0.1%,
a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use:
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Avoid use on the face, groin, or axillae.
Avoid use in perioral dermatitis or rosacea.
1.1 Indication
Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [
see Use in Specific Populations (8.4)].
1.2 Limitation of Use
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
1 INDICATIONS AND USAGE
Dextrose Injection is indicated as source of water and calories.
Dextrose Injection is indicated as a source of water and calories. (1)
1 INDICATIONS AND USAGE
Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (1).
INDICATIONS AND USAGE
HypertensionAtenolol tablets are indicated in the management of hypertension. They may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.Angina Pectoris Due to Coronary AtherosclerosisAtenolol tablets are indicated for the long-term management of patients with angina pectoris.Acute Myocardial InfarctionAtenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patients clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
1 INDICATIONS AND USAGE
Hydroxyurea capsules, USP is indicated for the treatment of:
Resistant chronic myeloid leukemia.
Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.
Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. (1)
Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)
1 INDICATIONS AND USAGE
FELDENE is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
FELDENE is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA) (1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) (1)
1	INDICATIONS AND USAGE
VIREAD is a nucleotide analog HIV-1 reverse transcriptase and HBV polymerase inhibitor.
Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. (1)
Viread is indicated for the treatment of chronic hepatitis B in adults. (1)
1.1	HIV-1 Infection
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection:
VIREAD should not be used in combination with TRUVADA or ATRIPLA [See Warnings and Precautions (5.4)
].
1.2	Chronic Hepatitis B
VIREAD is indicated for the treatment of chronic hepatitis B in adults.
The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:
This indication is based on data from one year of treatment in primarily nucleoside-treatment-nave adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Efficacy in Patients with Chronic Hepatitis B (14.2)].
The numbers of patients in clinical trials who were nucleoside-experienced or who had lamivudine-associated mutations at baseline were too small to reach conclusions of efficacy [See Clinical Efficacy in Patients with Chronic Hepatitis B (14.2)].
VIREAD has not been evaluated in patients with decompensated liver disease.
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets 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
], reserve hydrocodone bitartrate 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
1 INDICATIONS AND USAGE
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)
INDICATIONS AND USAGE
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.
Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood-stream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
H influenzae, specifically meningeal infections.
Escherichia coli, specifically urinary tract infections.
Aerobacter aerogenes, specifically bacteremia.
Klebsiella pneumoniae, specifically bacteremia.
NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B
SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B 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
Palonosetron hydrochloride injection is indicated in adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer
chemotherapy, including highly emetogenic cancer chemotherapy.
Palonosetron hydrochloride is a serotonin-3 (5-HT3) receptor antagonist indicated in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1)
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1)
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1)
Pediatric patients aged 1 month to less than 17 years for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC). (1)
INDICATIONS AND USAGE
Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.