um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of (1):acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (1)
Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
1 INDICATIONS AND USAGE
SEASONIQUE is indicated for use by females of reproductive potential to prevent pregnancy.
SEASONIQUE is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1)
INDICATIONS AND USAGE:
METROCREAM (metronidazole topical cream) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
INDICATIONS AND USAGE
TREZIX(acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve TREZIX 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
To reduce the development of drug-resistant 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 tablets, oral suspension and chewable tablets are 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 beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
Caused by beta-lactamaseproducing isolates of H.influenzae and M.catarrhalis.
1.3 Sinusitis
Caused by beta-lactamaseproducing isolates of H.influenzae and M.catarrhalis.
1.4 Skin and Skin Structure Infections
Caused by beta-lactamase producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
Caused by beta-lactamase producing isolates of E.coli, Klebsiella species, and Enterobacter species.
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
Pemetrexed Injection is a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (1.1)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous 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 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 Injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non- squamous 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 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 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
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Severe hypercalcemia in adult patients with primary HPT who are unable to parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)]
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [see Clinical Studies (14.3)].
INDICATIONS AND USAGE
Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.
1 INDICATIONS AND USAGE
Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.
Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age. (1)
1
INDICATIONS AND USAGE
TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.
TIVORBEX is a nonsteroidal anti-inflammatory drug indicated for treatment of mild to moderate acute pain in adults(1)
1 INDICATIONSAND USAGE
Silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.
Silodosin capsules, an alpha-1 adrenergic receptor antagonist, are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). (1) Silodosin capsules are not indicated for the treatment of hypertension.
1 INDICATIONS AND USAGE
JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JENTADUETO XR is a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Limitations of Use
Not recommended in patients with type 1 diabetes mellitus (1)
Has not been studied in patients with a history of pancreatitis (1)
Limitations of Use
JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus.
JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2)].
INDICATIONS AND USAGE
Plasma-Lyte 148
and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection,
Type 1, USP) is indicated as a source of water, electrolytes, and
calories, or as an alkalinizing agent.
1 INDICATIONS AND USAGE
Valproic Acid is an anti-epileptic drug indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy ofsimple and complex absence seizures; adjunctive therapy in patients with multiple seizure typesthat include absence seizures (1)
1.1 Epilepsy
Valproic Acid 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. Valproic Acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which 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 Precaution
(
5.1
) for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopment 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 Contraindications (4)].
INDICATIONS AND USAGE
Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.
Nizatidine is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
Nizatidine is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
INDICATIONS AND USAGE:
Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The lOP lowering efficacy of brimonidine tartrate ophthalmic solution 0.2% diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
1 INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (
1.1)
Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (
1.2)
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
1.1 Malignant Diseases
Cyclophosphamide is indicated for the treatment of:
malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
multiple myeloma
leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
mycosis fungoides (advanced disease)
neuroblastoma (disseminated disease)
adenocarcinoma of the ovary
retinoblastoma
carcinoma of the breast
Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.
Limitations of Use:
The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
INDICATIONS AND USAGE:
Adapalene gel, 0.1% is indicated for the topical treatment of acne vulgaris.
INDICATIONS AND USAGE
Butalbital, acetaminophen, and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see
Dosage and Administration (
2)
].
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (
1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (
1)
1 INDICATIONS AND USAGE
Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Busulfan Injection is an alkylating drug indicated for:
Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML). (1)
1 INDICATIONS AND USAGE
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric six months and older with the following infections:
Uncomplicated Urinary Tract Infections (
1.1)
Pharyngitis and Tonsillitis (
1.3)
Acute Exacerbations of Chronic Bronchitis (
1.4)
Uncomplicated Gonorrhea (cervical/urethral) (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
1.1 Uncomplicated Urinary Tract Infections
Cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of
Escherichia coli and
Proteus mirabilis.
1.3 Pharyngitis and Tonsillitis
Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of
Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of
Streptococcus pyogenes infections.
Cefixime capsules are generally effective in the eradication of
Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
Cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of
Streptococcus pneumoniae and
Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
Cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of
Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
1.6 Usage
To reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS & USAGE
Ziprasidone hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 (5.3) Ziprasidone capsule is indicated as an oral formulation for the: Treatment of schizophrenia. (1) Acute treatment 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. (1)