EGCG) in Diseases with Uncontrolled Immune Activation: Could Such a Scenario Be Helpful to Counteract COVID-19?
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Truvada (Emtricitabine / Tenofovir Disoproxil)
Pre-exposure Prophylaxis (2.3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Recommended dose in HIV-1 uninfected adults: One tablet TRUVADA safely and effectively. See full prescribing information (containing 200 mg/300 mg of emtricitabine and tenofovir for TRUVADA. disoproxil fumarate) once daily taken orally with or without food. (2.3) TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Recommended dose in renally impaired HIV-uninfected Initial U.S. Approval: 2004 individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH uninfected individuals while using TRUVADA for PrEP, evaluate STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF potential causes and re-assess potential risks and benefits of HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF continued use. (2.4) TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION -----------------------DOSAGE FORMS AND STRENGTHS------------------- See full prescribing information for complete boxed warning. Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 Lactic acidosis and severe hepatomegaly with steatosis, mg/150 mg of emtricitabine and tenofovir disoproxil fumarate . (3) including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. (5.1) --------------------------------CONTRAINDICATIONS----------------------------- TRUVADA is not approved for the treatment of chronic Do not use TRUVADA for pre-exposure prophylaxis in individuals with hepatitis B virus (HBV) infection. Severe acute unknown or positive HIV-1 status. TRUVADA should be used in exacerbations of hepatitis B have been reported in patients HIV-infected patients only in combination with other antiretroviral coinfected with HIV-1 and HBV who have discontinued agents. -
Page: Treatment-Drugs
© National HIV Curriculum PDF created September 29, 2021, 5:12 am Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine (Symtuza) Table of Contents Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza Summary Drug Summary Key Clinical Trials Key Drug Interactions Drug Summary The fixed-dose combination tablet darunavir-cobicistat-tenofovir alafenamide-emtricitabine is a single-tablet regimen that can be considered for treatment-naïve or certain treatment-experienced adults living with HIV. This single-tablet regimen offers a one pill daily regimen with high barrier to resistance (due to the darunavir- cobicistat), with potentially less renal and bone toxicity as compared to regimens that include tenofovir DF; however, it has potential gastrointestinal adverse effects and drug-drug interactions, primarily due to the cobicistat component. In clinical trials, darunavir-cobicistat-tenofovir alafenamide-emtricitabine was compared to darunavir-cobicistat plus tenofovir DF-emtricitabine as initial therapy for treatment-naïve individuals and found to be equally effective in terms of viral suppression. A switch to the fixed-dose combination tablet was also compared to continuing a boosted protease inhibitor plus tenofovir DF- emtricitabine and again determined to have equivalent efficacy. The FDA has approved darunavir-cobicistat- tenofovir alafenamide-emtricitabine as a complete regimen for treatment-naïve individuals or treatment- experienced individuals who have a suppressed HIV RNA level on a stable regimen for at least 6 months and no resistance to darunavir or tenofovir. Key Clinical Trials A phase 3 trial in treatment-naïve individuals compared the fixed-dose single-tablet regimen darunavir- cobicistat-tenofovir alafenamide-emtricitabine with the regimen darunavir-cobicistat plus tenofovir DF- emtricitabine emtricitabine [AMBER]. -
Pureweigh®-FM
Manufacturers of Hypo-al ler gen ic Nutritional Sup ple ments PureWeigh®-FM INTRODUCED 2000 What Is It? than DHEA in stimulating the thermogenic enzymes of the liver, helping to support a leaner BMI (Body Mass PureWeigh®-FM is an encapsulated supplement companion Index) and healthy weight control. In a double blind to PureWeigh® PREMEAL Beverage containing banaba study involving 30 overweight adults, 7-KETO supported (Lagerstroemia speciosa L.) extract, green tea extract, healthy body composition and BMI when combined with taurine, 7-KETO™ DHEA, biotin, magnesium citrate and exercise.* chromium polynicotinate. PureWeigh®-FM may also be used independently of PureWeigh® PREMEAL Beverage to support • Biotin, facilitating protein, fat and carbohydrate healthy glucose metabolism and promote weight loss.* metabolism by acting as a coenzyme for numerous metabolic reactions. A clinical study reported that high Features Include dose administration of biotin helped promote healthy glucose metabolism. A number of animal studies support • Banaba extract, containing a triterpenoid compound this claim. Biotin may also act to promote transcription called corosolic acid, reported in studies to support and translation of glucokinase, an enzyme found in the healthy glucose function and absorption. A recent liver and pancreas that participates in the metabolism phase II, double-blind, placebo-controlled multi-center of glucose to form glycogen. In addition, a double-blind trial in Japan suggested that banaba extract maintained study reported that biotin supplementation may promote healthy glucose function and was well tolerated by healthy lipid metabolism, citing an inverse relationship volunteers. Furthermore, an independent U.S. between plasma biotin and total lipids.* preliminary clinical study reported statistically significant weight loss in human volunteers • Magnesium citrate, providing a highly bioavailable supplementing with a 1% corosolic acid banaba extract. -
Applications of in Silico Methods to Analyze the Toxicity and Estrogen T Receptor-Mediated Properties of Plant-Derived Phytochemicals ∗ K
Food and Chemical Toxicology 125 (2019) 361–369 Contents lists available at ScienceDirect Food and Chemical Toxicology journal homepage: www.elsevier.com/locate/foodchemtox Applications of in silico methods to analyze the toxicity and estrogen T receptor-mediated properties of plant-derived phytochemicals ∗ K. Kranthi Kumara, P. Yugandharb, B. Uma Devia, T. Siva Kumara, N. Savithrammab, P. Neerajaa, a Department of Zoology, Sri Venkateswara University, Tirupati, 517502, India b Department of Botany, Sri Venkateswara University, Tirupati, 517502, India ARTICLE INFO ABSTRACT Keywords: A myriad of phytochemicals may have potential to lead toxicity and endocrine disruption effects by interfering Phytochemicals with nuclear hormone receptors. In this examination, the toxicity and estrogen receptor−binding abilities of a QSAR modeling set of 2826 phytochemicals were evaluated. The endpoints mutagenicity, carcinogenicity (both CAESAR and ISS Toxicity models), developmental toxicity, skin sensitization and estrogen receptor relative binding affinity (ER_RBA) Nuclear hormone receptor binding were studied using the VEGA QSAR modeling package. Alongside the predictions, models were providing pos- Self−Organizing maps sible information for applicability domains and most similar compounds as similarity sets from their training Clustering and classification schemes sets. This information was subjected to perform the clustering and classification of chemicals using Self−Organizing Maps. The identified clusters and their respective indicators were considered as potential hotspot structures for the specified data set analysis. Molecular screening interpretations of models wereex- hibited accurate predictions. Moreover, the indication sets were defined significant clusters and cluster in- dicators with probable prediction labels (precision). Accordingly, developed QSAR models showed good pre- dictive abilities and robustness, which observed from applicability domains, representation spaces, clustering and classification schemes. -
Epzicom and Ziagen Safety Review
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance Date: July 11, 2018 Safety Evaluator: Margee P. Webster, Pharm.D., BCPS Division of Pharmacovigilance – I (DPV-I) Medical Officer: Ivone Kim, MD, FAAP DPV-I Team Leader: Kelly Cao, Pharm.D. DPV-II Deputy Division Director: Ida-Lina, Pharm.D., MS DPV-II Product Name: Abacavir (Ziagen®) and Abacavir/Lamivudine (Epzicom®) Pediatric Labeling Approval Date: Ziagen: March 23, 2015/Epzicom: September 17, 2015 Application Type/Number: NDA 020977 (Ziagen)/ NDA 021652 (Epzicom) Applicant/Sponsor: ViiV HealthCare/GlaxoSmithKline OSE RCM #: 2018-589 1 Reference ID: 4289856 TABLE OF CONTENTS Executive Summary........................................................................................................................ 1 1 Introduction............................................................................................................................. 1 1.1 Pediatric Regulatory History............................................................................................ 1 1.2 Relevant Labeled Safety Information .............................................................................. 1 1.2.1 Ziagen product labeling ........................................................................................... 1 1.2.2 Epzicom product labeling ....................................................................................... -
Download Product Insert (PDF)
PRODUCT INFORMATION (−)-Epigallocatechin Gallate Item No. 70935 CAS Registry No.: 989-51-5 Formal Name: 3,4-dihydro-5,7-dihydroxy-2R-(3,4,5- OH trihydroxyphenyl)-2H-1-benzopyran-3R- OH yl-3,4,5-trihydroxy-benzoate H HO O Synonym: EGCG OH MF: C22H18O11 O FW: 458.4 H OH OH Purity: ≥96% O UV/Vis.: λmax: 276 nm Supplied as: A crystalline solid OH Storage: -20°C OH Stability: ≥2 years Item Origin: Plant/Folium camelliae Information represents the product specifications. Batch specific analytical results are provided on each certificate of analysis. Laboratory Procedures (−)-Epigallocatechin gallate (EGCG) is supplied as a crystalline solid. A stock solution may be made by dissolving the EGCG in an organic solvent purged with an inert gas. EGCG is soluble in organic solvents such as ethanol, DMSO, and dimethyl formamide. The solubility of EGCG in these solvents is approximately 20, 25, and 30 mg/ml, respectively. Further dilutions of the stock solution into aqueous buffers or isotonic saline should be made prior to performing biological experiments. Ensure that the residual amount of organic solvent is insignificant, since organic solvents may have physiological effects at low concentrations. Organic solvent-free aqueous solutions of EGCG can be prepared by directly dissolving the crystalline compound in aqueous buffers. The solubility of EGCG in PBS (pH 7.2) is approximately 25 mg/ml. We do not recommend storing the aqueous solution for more than one day. Description EGCG is a phenol that has been found in green and black tea plants and has diverse biological activities.1-7 1 It is lytic against T. -
Effect of Epigallocatechin-3-Gallate, Major Ingredient of Green Tea, on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Journal name: Drug Design, Development and Therapy Article Designation: Original Research Year: 2017 Volume: 11 Drug Design, Development and Therapy Dovepress Running head verso: Kim et al Running head recto: Effect of green tea on the pharmacokinetics of rosuvastatin open access to scientific and medical research DOI: http://dx.doi.org/10.2147/DDDT.S130050 Open Access Full Text Article ORIGINAL RESEARCH Effect of epigallocatechin-3-gallate, major ingredient of green tea, on the pharmacokinetics of rosuvastatin in healthy volunteers Tae-Eun Kim1 Abstract: Previous in vitro studies have demonstrated the inhibitory effect of green tea on Na Ha2 drug transporters. Because rosuvastatin, a lipid-lowering drug widely used for the prevention of Yunjeong Kim2 cardiovascular events, is a substrate for many drug transporters, there is a possibility that there Hyunsook Kim1 is interaction between green tea and rosuvastatin. The aim of this study was to investigate the Jae Wook Lee3 effect of green tea on the pharmacokinetics of rosuvastatin in healthy volunteers. An open-label, Ji-Young Jeon2 three-treatment, fixed-sequence study was conducted. On Day 1, 20 mg of rosuvastatin was given to all subjects. After a 3-day washout period, the subjects received 20 mg of rosuvastatin Min-Gul Kim2,4 plus 300 mg of epigallocatechin-3-gallate (EGCG), a major ingredient of green tea (Day 4). 1 Department of Clinical After a 10-day pretreatment of EGCG up to Day 14, they received rosuvastatin (20 mg) plus Pharmacology, Konkuk University Medical Center, Seoul, 2Center for EGCG (300 mg) once again (Day 15). Blood samples for the pharmacokinetic assessments Clinical Pharmacology, Biomedical were collected up to 8 hours after each dose of rosuvastatin. -
Dolutegravir-Abacavir-Lamivudine (Triumeq)
© National HIV Curriculum PDF created September 24, 2021, 7:23 pm Dolutegravir-Abacavir-Lamivudine (Triumeq) Table of Contents Dolutegravir-Abacavir-Lamivudine Triumeq Summary Drug Summary Key Clinical Trials Resistance Key Drug Interactions Drug Summary Dolutegravir-abacavir-lamivudine is a single-tablet regimen that is used primarily for treatment-naïve individuals. It has high potency, a relatively robust barrier to resistance (due to the dolutegravir component), and few drug interactions. It may be especially advantageous for individuals with renal insufficiency or risk factors for renal disease or osteoporosis, as it avoids the use of tenofovir DF. In certain treatment- experienced individuals, dolutegravir-abacavir-lamivudine may provide an option for switch or simplification of therapy. Abacavir can cause a life-threatening hypersensitivity reaction in individuals who are HLA-B*5701 positive; all patients need to undergo testing for HLA-B*5701 prior to receiving dolutegravir-abacavir- lamivudine and those who test positive for HLA-B*5701 should not receive this single tablet regimen. Dolutegravir blocks tubular secretion of creatinine and therefore causes a small increase in serum creatinine in the first 4 to 8 weeks of use; this increase is benign and does not indicate a change in true creatinine clearance. Key Clinical Trials In antiretroviral-naïve individuals, dolutegravir plus abacavir-lamivudine demonstrated superior virologic responses when compared with efavirenz-tenofovir disoproxil fumarate (DF)-emtricitabine [SINGLE], with superiority largely driven by the greater tolerability of the dolutegravir plus abacavir-lamivudine regimen. In a comparison of 2 NRTIs plus either dolutegravir or raltegravir in treatment-naïve patients, virologic responses in the subset of patients who received dolutegravir plus abacavir-lamivudine were equivalent to those receiving raltegravir plus either tenofovir DF-emtricitabine or abacavir-lamivudine [SPRING-2]. -
Reducing Toxic Reactive Carbonyl Species in E-Cigarette Emissions
RSC Advances View Article Online PAPER View Journal | View Issue Reducing toxic reactive carbonyl species in e- cigarette emissions: testing a harm-reduction Cite this: RSC Adv., 2020, 10,21535 strategy based on dicarbonyl trapping Bruna de Falco, †af Antonios Petridis,†ac Poornima Paramasivan,b Antonio Dario Troise, de Andrea Scaloni,e Yusuf Deeni,b W. Edryd Stephens*c and Alberto Fiore *a Reducing the concentration of reactive carbonyl species (RCS) in e-cigarette emissions represents a major goal to control their potentially harmful effects. Here, we adopted a novel strategy of trapping carbonyls present in e-cigarette emissions by adding polyphenols in e-liquid formulations. Our work showed that the addition of gallic acid, hydroxytyrosol and epigallocatechin gallate reduced the levels of carbonyls formed in the aerosols of vaped e-cigarettes, including formaldehyde, methylglyoxal and glyoxal. Liquid chromatography mass spectrometry analysis highlighted the formation of covalent adducts between Creative Commons Attribution 3.0 Unported Licence. aromatic rings and dicarbonyls in both e-liquids and vaped samples, suggesting that dicarbonyls were formed in the e-liquids as degradation products of propylene glycol and glycerol before vaping. Short- Received 6th March 2020 term cytotoxic analysis on two lung cellular models showed that dicarbonyl-polyphenol adducts are not Accepted 29th May 2020 cytotoxic, even though carbonyl trapping did not improve cell viability. Our work sheds lights on the DOI: 10.1039/d0ra02138e ability of polyphenols to trap RCS in high carbonyl e-cigarette emissions, suggesting their potential value rsc.li/rsc-advances in commercial e-liquid formulations. Introduction smoking-related symptoms and conditions to become manifest, This article is licensed under a it is too early to evaluate the long-term clinical effects of vaping The use of e-cigarettes is a major issue in public health. -
Galiellalactone Induces Cell Cycle Arrest and Apoptosis Through the ATM/ATR Pathway in Prostate Cancer Cells
www.impactjournals.com/oncotarget/ Oncotarget, Vol. 7, No. 4 Galiellalactone induces cell cycle arrest and apoptosis through the ATM/ATR pathway in prostate cancer cells Víctor García1, Maribel Lara-Chica1, Irene Cantarero1, Olov Sterner2, Marco A. Calzado1, Eduardo Muñoz1 1 Maimónides Biomedical Research Institute of Córdoba, Reina Sofía University Hospital, Department of Cell Biology, Physiology and Immunology, University of Córdoba, Córdoba, Spain 2Department of Science, Centre for Analysis and Synthesis, Lund University, Lund, Sweden Correspondence to: Marco A. Calzado, e-mail: [email protected] Eduardo Muñoz, e-mail: [email protected] Keywords: galiellalactone, cancer, cell cycle, ATM/ATR, CHK1 Received: September 11, 2015 Accepted: November 26, 2015 Published: December 14, 2015 ABSTRACT Galiellalactone (GL) is a fungal metabolite that presents antitumor activities on prostate cancer in vitro and in vivo. In this study we show that GL induced cell cycle arrest in G2/M phase, caspase-dependent apoptosis and also affected the microtubule organization and migration ability in DU145 cells. GL did not induce double strand DNA break but activated the ATR and ATM-mediated DNA damage response (DDR) inducing CHK1, H2AX phosphorylation (γH2AX) and CDC25C downregulation. Inhibition of the ATM/ATR activation with caffeine reverted GL-induced G2/M cell cycle arrest, apoptosis and DNA damage measured by γH2AX. In contrast, UCN-01, a CHK1 inhibitor, prevented GL-induced cell cycle arrest but enhanced apoptosis in DU145 cells. Furthermore, we found that GL did not increase the levels of intracellular ROS, but the antioxidant N-acetylcysteine (NAC) completely prevented the effects of GL on γH2AX, G2/M cell cycle arrest and apoptosis. -
Tranilast VS
L-CITRULLINE Pharmacy Compounding Advisory Committee November 20-21, 2017 A.J. Day, PharmD Director of Clinical Services, PCCA L-Citrulline Source • FDA-registered & inspected cGMP facility • Fermentation pathway • Common Dose Range • 500-650 mg • Weight-based, so dose will vary • Handful of pharmacies across the USA specialize in these disorders • Relevance for MOU THANK YOU Questions from the Committee? PREGNENOLONE Pharmacy Compounding Advisory Committee November 20-21, 2017 A.J. Day, PharmD Director of Clinical Services, PCCA FDA Briefing Material July 2017 FDA Request for Nominator Clarification FAERS and CAERS data Ritsner et al. (2010) FDA – Concerns of Downstream Effects • Marx et al. (2009) • Dr. Marx has not seen any adverse events in any of her studies, ongoing and published Marx 2009 – Safety Data Marx 2009 – Safety Data FDA Briefing – Safety Data • Marx et al. (2011), historical studies FDA Briefing – Safety Information • Osuji et al. (2010) – 8 weeks • Brown et al. (2014) – 12 weeks • Marx et al. (2014) – 8 weeks • Kashani et al. (2017) – 8 weeks FDA Approval of NDA for Ziprasidone https://www.fda.gov/ohrms/dockets/ac/00/backgrd/3619b1a.pdf • 3 out of 4 short-term (4 to 6 weeks), fixed-dose, placebo- controlled trials showed superior efficacy of ziprasidone over placebo • 1 study was 52 weeks (no active control, just placebo) FDA Approval of NDA for Quetiapine https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf “There are multiple FDA-approved products indicated to treat the conditions proposed…” -
Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide
PATIENT & CAREGIVER EDUCATION Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Brand Names: US Symtuza Brand Names: Canada Symtuza Warning Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop giving this drug to your child without calling your child’s doctor. This drug is not approved to treat hepatitis B. Hepatitis B testing needs to be done before your child takes this drug. What is this drug used for? It is used to treat HIV infection. Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide 1/8 What do I need to tell the doctor BEFORE my child takes this drug? If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had. If your child has any of these health problems: Kidney disease or liver disease. If your child takes any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this drug. If your child is taking any other drugs to treat HIV.