Appendix a - Product Name Index
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PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects
International Journal of Molecular Sciences Review PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects Rosalin Mishra , Hima Patel, Samar Alanazi , Mary Kate Kilroy and Joan T. Garrett * Department of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267-0514, USA; [email protected] (R.M.); [email protected] (H.P.); [email protected] (S.A.); [email protected] (M.K.K.) * Correspondence: [email protected]; Tel.: +1-513-558-0741; Fax: +1-513-558-4372 Abstract: The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies. This review focuses on the current landscape of various PI3K inhibitors either as monotherapy or in combination therapies and the treatment outcomes involved in various phases of clinical trials in different cancer types. There is a discussion of the drug-related toxicities, challenges associated with these PI3K inhibitors and the adverse events leading to treatment failure. In addition, novel PI3K drugs that have potential to be translated in the clinic are highlighted. Keywords: cancer; PIK3CA; resistance; PI3K inhibitors Citation: Mishra, R.; Patel, H.; Alanazi, S.; Kilroy, M.K.; Garrett, J.T. -
Ceftazidime for Injection) PHARMACY BULK PACKAGE – NOT for DIRECT INFUSION
PRESCRIBING INFORMATION FORTAZ® (ceftazidime for injection) PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4 thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1 azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C22H32N6O12S2, representing a molecular weight of 636.6. FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. The Pharmacy Bulk Package vial contains 709 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3mEq) per gram of ceftazidime. FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 6g of anhydrous ceftazidime. The Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE. -
This Fact Sheet Provides Information to Patients with Eczema and Their Carers. About Topical Corticosteroids How to Apply Topic
This fact sheet provides information to patients with eczema and their carers. About topical corticosteroids You or your child’s doctor has prescribed a topical corticosteroid for the treatment of eczema. For treating eczema, corticosteroids are usually prepared in a cream or ointment and are applied topically (directly onto the skin). Topical corticosteroids work by reducing inflammation and helping to control an over-reactive response of the immune system at the site of eczema. They also tighten blood vessels, making less blood flow to the surface of the skin. Together, these effects help to manage the symptoms of eczema. There is a range of steroids that can be used to treat eczema, each with different strengths (potencies). On the next page, the potencies of some common steroids are shown, as well as the concentration that they are usually used in cream or ointment preparations. Using a moisturiser along with a steroid cream does not reduce the effect of the steroid. There are many misconceptions about the side effects of topical corticosteroids. However these treatments are very safe and patients are encouraged to follow the treatment regimen as advised by their doctor. How to apply topical corticosteroids How often should I apply? How much should I apply? Apply 1–2 times each day to the affected area Enough cream should be used so that the of skin according to your doctor’s instructions. entire affected area is covered. The cream can then be rubbed or massaged into the Once the steroid cream has been applied, inflamed skin. moisturisers can be used straight away if needed. -
Betamethasone Valerate Foam: a Look at the Clinical Data
Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs. -
Acetadote (Acetylcysteine) Injection Is Available As a 20% Solution in 30 Ml (200Mg/Ml) Single Dose Glass Vials
NDA 21-539/S-004 Page 3 Acetadote® (acetylcysteine) Injection Package Insert NDA 21-539/S-004 Page 4 RX ONLY PRESCRIBING INFORMATION ACETADOTE® (acetylcysteine) Injection For Intravenous Use DESCRIPTION Acetylcysteine injection is an intravenous (I.V.) medication for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine, NAC). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: H CH3 N SH O COOH Acetadote is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetadote contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP. CLINICAL PHARMACOLOGY Acetaminophen Overdose: Acetaminophen is absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. It is extensively metabolized in the liver to form principally the sulfate and glucoronide conjugates which are excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by isozyme CYP2E1 of the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite. The toxic metabolite preferentially conjugates with hepatic glutathione to form nontoxic cysteine and mercapturic acid derivatives, which are then excreted by the kidney. -
Information for the User ZYTIGA 500 Mg Film-Coated Tablets Abiraterone
Package leaflet: Information for the user ZYTIGA 500 mg film-coated tablets abiraterone acetate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What ZYTIGA is and what it is used for 2. What you need to know before you take ZYTIGA 3. How to take ZYTIGA 4. Possible side effects 5. How to store ZYTIGA 6. Contents of the pack and other information 1. What ZYTIGA is and what it is used for ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy ). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood. -
The Promise of N-Acetylcysteine in Neuropsychiatry
Review The promise of N-acetylcysteine in neuropsychiatry 1,2,3,4 5,6 1 1,2,4 Michael Berk , Gin S. Malhi , Laura J. Gray , and Olivia M. Dean 1 School of Medicine, Deakin University, Geelong, Victoria, Australia 2 Department of Psychiatry, University of Melbourne, Parkville, Victoria, Australia 3 Orygen Research Centre, Parkville, Victoria, Australia 4 The Florey Institute of Neuroscience and Mental Health, Victoria, Australia 5 Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, Australia 6 CADE Clinic, Department of Psychiatry, Level 5 Building 36, Royal North Shore Hospital, St Leonards, 2065, Australia N-Acetylcysteine (NAC) targets a diverse array of factors with the pathophysiology of a diverse range of neuropsy- germane to the pathophysiology of multiple neuropsy- chiatric disorders, including autism, addiction, depression, chiatric disorders including glutamatergic transmission, schizophrenia, bipolar disorder, and Alzheimer’s and Par- the antioxidant glutathione, neurotrophins, apoptosis, kinson’s diseases [3]. Determining precisely how NAC mitochondrial function, and inflammatory pathways. works is crucial both to understanding the core biology This review summarises the areas where the mecha- of these illnesses, and to opening the door to other adjunc- nisms of action of NAC overlap with known pathophysi- tive therapies operating on these pathways. The current ological elements, and offers a pre´ cis of current literature article will initially review the possible mechanisms of regarding the use of NAC in disorders including cocaine, action of NAC, and then critically appraise the evidence cannabis, and smoking addictions, Alzheimer’s and Par- that suggests it has efficacy in the treatment of neuropsy- kinson’s diseases, autism, compulsive and grooming chiatric disorders. -
Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies
molecules Article Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies Pradeep Kumar Bolla 1 , Carlos A. Meraz 1, Victor A. Rodriguez 1, Isaac Deaguero 1, Mahima Singh 2 , Venkata Kashyap Yellepeddi 3,4 and Jwala Renukuntla 5,* 1 Department of Biomedical Engineering, College of Engineering, The University of Texas at El Paso, 500 W University Ave, El Paso, TX 79968, USA 2 Department of Pharmaceutical Sciences, University of the Sciences in Philadelphia, Philadelphia, PA 19104, USA 3 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT 84112, USA 4 Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA 5 Department of Basic Pharmaceutical Sciences, Fred Wilson School of Pharmacy, High Point University, High Point, NC 27240, USA * Correspondence: [email protected] Received: 9 August 2019; Accepted: 28 August 2019; Published: 29 August 2019 Abstract: Global incidence of superficial fungal infections caused by dermatophytes is high and affects around 40 million people. It is the fourth most common cause of infection. Clotrimazole, a broad spectrum imidazole antifungal agent is widely used to treat fungal infections. Conventional topical formulations of clotrimazole are intended to treat infections by effective penetration of drugs into the stratum corneum. However, drawbacks such as poor dermal bioavailability, poor penetration, and variable drug levels limit the efficiency. The present study aims to load clotrimazole into ufosomes and evaluate its topical bioavailability. Clotrimazole loaded ufosomes were prepared using cholesterol and sodium oleate by thin film hydration technique and evaluated for size, polydispersity index, and entrapment efficiency to obtain optimized formulation. -
TRP Mediation
molecules Review Remedia Sternutatoria over the Centuries: TRP Mediation Lujain Aloum 1 , Eman Alefishat 1,2,3 , Janah Shaya 4 and Georg A. Petroianu 1,* 1 Department of Pharmacology, College of Medicine and Health Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates; [email protected] (L.A.); Eman.alefi[email protected] (E.A.) 2 Center for Biotechnology, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates 3 Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, The University of Jordan, Amman 11941, Jordan 4 Pre-Medicine Bridge Program, College of Medicine and Health Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates; [email protected] * Correspondence: [email protected]; Tel.: +971-50-413-4525 Abstract: Sneezing (sternutatio) is a poorly understood polysynaptic physiologic reflex phenomenon. Sneezing has exerted a strange fascination on humans throughout history, and induced sneezing was widely used by physicians for therapeutic purposes, on the assumption that sneezing eliminates noxious factors from the body, mainly from the head. The present contribution examines the various mixtures used for inducing sneezes (remedia sternutatoria) over the centuries. The majority of the constituents of the sneeze-inducing remedies are modulators of transient receptor potential (TRP) channels. The TRP channel superfamily consists of large heterogeneous groups of channels that play numerous physiological roles such as thermosensation, chemosensation, osmosensation and mechanosensation. Sneezing is associated with the activation of the wasabi receptor, (TRPA1), typical ligand is allyl isothiocyanate and the hot chili pepper receptor, (TRPV1), typical agonist is capsaicin, in the vagal sensory nerve terminals, activated by noxious stimulants. -
Abiraterone Acetate for Chemotherapy-Naive
Fan et al. BMC Urology (2018) 18:110 https://doi.org/10.1186/s12894-018-0416-6 RESEARCHARTICLE Open Access Abiraterone acetate for chemotherapy- naive metastatic castration-resistant prostate cancer: a single-centre prospective study of efficacy, safety, and prognostic factors Liancheng Fan†, Baijun Dong†, Chenfei Chi†, Yanqing Wang†, Yiming Gong†, Jianjun Sha, Jiahua Pan, Xun Shangguan, Yiran Huang, Lixin Zhou* and Wei Xue* Abstract Background: To evaluate the efficacy and safety of abiraterone acetate (AA) plus prednisone compared with prednisone alone in Asian patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), and to identify predictive factors. Methods: We reviewed the medical records of 60 patients with chemotherapy-naive mCRPC at Renji Hospital who were treated with AA plus prednisone (n = 43) or prednisone alone (n = 17). All patients were assessed for prostate- specific antigen (PSA) response, PSA progression-free survival (PSA PFS), radiographic progression-free survival (rPFS), and overall survival (OS). The ability of several parameters to predict PSA PFS, rPFS, and OS was studied. Results: The median follow-up time was 14.0 months (range 7.0–18.5 months), at which time 19 death events had been reported: 11 in the AA + prednisone group and 8 in the prednisone group. The AA + prednisone group had significantly longer median PSA PFS (10.3 vs 3.0 months, P < 0.001), rPFS (13.9 vs 3.9 months, P < 0.001), and OS (23. 3 vs 17.5 months, P = 0.016) than the prednisone-alone group. The most frequently reported grade 3 or 4 adverse event in both the AA + prednisone and prednisone-alone groups was elevated alanine aminotransferase level in 5 of 43 patients (11.6%) and 2 of 17 patients (11.8%), respectively. -
The Two Faces of Capsaicin
Published OnlineFirst April 12, 2011; DOI: 10.1158/0008-5472.CAN-10-3756 Cancer Review Research The Two Faces of Capsaicin Ann M. Bode and Zigang Dong Abstract Capsaicin (trans-8-methyl-N-vanillyl-6-nonenamide) is the principal pungent component in hot peppers, including red chili peppers, jalapeños, and habaneros. Consumed worldwide, capsaicin has a long and convoluted history of controversy about whether its consumption or topical application is entirely safe. Conflicting epidemiologic data and basic research study results suggest that capsaicin can act as a carcinogen or as a cancer preventive agent. Capsaicin is unique among naturally occurring irritant compounds because the initial neuronal excitation evoked is followed by a long-lasting refractory period, during which the previously excited neurons are no longer responsive to a broad range of stimuli. This process is referred to as desensitization and has been exploited for its therapeutic potential. Capsaicin-containing creams have been in clinical use for many years to relieve a variety of painful conditions. However, their effectiveness in pain relief is also highly debated and some adverse side effects have been reported. We have found that chronic, long-term topical application of capsaicin increased skin carcinogenesis in mice treated with a tumor promoter. These results might imply that caution should be exercised when using capsaicin-containing topical applications in the presence of a tumor promoter, such as, for example, sunlight. Cancer Res; 71(8); 2809–14. Ó2011 AACR. Introduction tion of gastric juice. The structure of capsaicin was partially solved by Nelson in 1919 (5), and the compound was originally Capsaicin (trans-8-methyl-N-vanillyl-6-nonenamide; Fig. -
Excluded Drug List
Excluded Drug List The following drugs are excluded from coverage as they are not approved by the FDA ACTIVE-PREP KIT I (FLURBIPROFEN-CYCLOBENZAPRINE CREAM COMPOUND KIT) ACTIVE-PREP KIT II (KETOPROFEN-BACLOFEN-GABAPENTIN CREAM COMPOUND KIT) ACTIVE-PREP KIT III (KETOPROFEN-LIDOCAINE-GABAPENTIN CREAM COMPOUND KIT) ACTIVE-PREP KIT IV (TRAMADOL-GABAPENTIN-MENTHOL-CAMPHOR CREAM COMPOUND KIT) ACTIVE-PREP KIT V (ITRACONAZOLE-PHENYTOIN SODIUM CREAM CMPD KIT) ADAZIN CREAM (BENZO-CAPSAICIN-LIDO-METHYL SALICYLATE CRE) AFLEXERYL-LC PAD (LIDOCAINE-MENTHOL PATCH) AFLEXERYL-MC PAD (CAPSAICIN-MENTHOL TOPICAL PATCH) AIF #2 DRUG PREPERATION KIT (FLURBIPROFEN-GABAPENT-CYCLOBEN-LIDO-DEXAMETH CREAM COMPOUND KIT) AGONEAZE (LIDOCAINE-PRILOCAINE KIT) ALCORTIN A (IODOQUINOL-HYDROCORTISONE-ALOE POLYSACCHARIDE GEL) ALEGENIX MIS (CAPSAICIN-MENTHOL DISK) ALIVIO PAD (CAPSAICIN-MENTHOL PATCH) ALODOX CONVENIENCE KIT (DOXYCYCLINE HYCLATE TAB 20 MG W/ EYELID CLEANSERS KIT) ANACAINE OINT (BENZOCAINE OINT) ANODYNZ MIS (CAPSAICIN-MENTHOL DISK) APPFORMIN/D (METFORMIN & DIETARY MANAGEMENT CAP PACK) AQUORAL (ARTIFICIAL SALIVA - AERO SOLN) ATENDIA PAD (LIDOCAINE-MENTHOL PATCH) ATOPICLAIR CRE (DERMATOLOGICAL PRODUCTS MISC – CREAM) Page 1 of 9 Updated JANUARY 2017 Excluded Drug List AURSTAT GEL/CRE (DERMATOLOGICAL PRODUCTS MISC) AVALIN-RX PAD (LIDOCAINE-MENTHOL PATCH) AVENOVA SPRAY (EYELID CLEANSER-LIQUID) BENSAL HP (SALICYLIC ACID & BENZOIC ACID OINT) CAMPHOMEX SPRAY (CAMPHOR-HISTAMINE-MENTHOL LIQD SPRAY) CAPSIDERM PAD (CAPSAICIN-MENTHOL