National Preferred Formulary January 2021
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Current Status of Local Penile Therapy
International Journal of Impotence Research (2002) 14, Suppl 1, S70–S81 ß 2002 Nature Publishing Group All rights reserved 0955-9930/02 $25.00 www.nature.com/ijir Current status of local penile therapy F Montorsi1*, A Salonia1, M Zanoni1, P Pompa1, A Cestari1, G Guazzoni1, L Barbieri1 and P Rigatti1 1Department of Urology, University Vita e Salute – San Raffaele, Milan, Italy Guidelines for management of patients with erectile dysfunction indicate that intraurethral and intracavernosal injection therapies represent the second-line treatment available. Efficacy of intracavernosal injections seems superior to that of the intraurethral delivery of drugs, and this may explain the current larger diffusion of the former modality. Safety of these two therapeutic options is well established; however, the attrition rate with these approaches is significant and most patients eventually drop out of treatment. Newer agents with better efficacy-safety profiles and using user-friendly devices for drug administration may potentially increase the long-term satisfaction rate achieved with these therapies. Topical therapy has the potential to become a first- line treatment for erectile dysfunction because it acts locally and is easy to use. At this time, however, the crossing of the barrier caused by the penile skin and tunica albuginea has limited the efficacy of the drugs used. International Journal of Impotence Research (2002) 14, Suppl 1, S70–S81. DOI: 10.1038= sj=ijir=3900808 Keywords: erectile dysfunction; local penile therapy; topical therapy; alprostadil Introduction second patient category might be represented by those requesting a fast response, which cannot be obtained by sildenafil; however, sublingual apomor- Management of patients with erectile dysfunction phine is characterized by a fast onset of action and has been recently grouped into three different may represent an effective solution for these 1 levels. -
Eyelash Growth Induced by Topical Prostaglandin Analogues, Bimatoprost, Tafluprost, Travoprost, and Latanoprost in Rabbits
JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS ORIGINAL ARTICLE Volume 00, Number 0, 2013 ª Mary Ann Liebert, Inc. DOI: 10.1089/jop.2013.0075 Eyelash Growth Induced by Topical Prostaglandin Analogues, Bimatoprost, Tafluprost, Travoprost, and Latanoprost in Rabbits Ama´lia Turner Giannico,1 Leandro Lima,1 Heloisa Helena Abil Russ,2 and Fabiano Montiani-Ferreira1 Abstract Purpose: Prostaglandin analogues (PGA) are ocular hypotensive agents used for the treatment of glaucoma. Hypertrichosis of the eyelashes has been reported in humans as a side effect. Eyelash growth was investigated with clinical trials in people using bimatoprost. Scattered reports of eyelash growth during the treatment of glaucoma with other PGA are also found in the literature. We investigated the effect of 4 different topical PGA on eyelash length. Methods: Forty New Zealand white rabbits were divided into 4 groups and received daily topical application of bimatoprost, tafluprost, travoprost, and latanoprost in the left eye for 4 weeks. The right eye received no treatment. Eyelash length was measured in both eyes before and after treatment using a stainless steel digital caliper. Results: Bimatoprost and tafluprost groups had significant increases in eyelash length. We did not observe significant eyelash growth in rabbits receiving travoprost and latanoprost after 1 month of treatment. Conclusions: Today, only bimatoprost is approved for growing eyelashes, and our research shows that ta- fluprost could be further explored by the cosmetic and pharmaceutical industry. Additional research using travoprost and latanoprost as agents for eyelash growth should be performed in the future using prolonged treatment periods to determinate whether or not these PGA induce eyelash growth, and investigate other possible side effects. -
Totalcare Medicaid 2017 Q2 GB
Preferred Drug List Molina Healthcare of New York, Inc. 2017 *Molina mandates the use of generic drugs, if available. Brand names listed are for reference only. THIS LIST IS SUBJECT TO CHANGE. You can get more information and updates to this document on our website at www.molinahealthcare.com MCD_CO_ESIPREFDRUGQ3_0817_08/27/2017 6025633NY0417 Table of Contents Anti - Infectives....................................................................................................................................................3 Antineoplastic / Immunosuppressant Drugs ......................................................................................................12 Autonomic / Cns Drugs, Neurology / Psych ......................................................................................................17 Cardiovascular, Hypertension / Lipids...............................................................................................................34 Dermatologicals/Topical Therapy......................................................................................................................41 Diagnostics / Miscellaneous Agents ..................................................................................................................56 Ear, Nose / Throat Medications..........................................................................................................................64 Endocrine/Diabetes ............................................................................................................................................66 -
New Directions for Erectile Dysfunction Therapies
International Journal of Impotence Research (2002) 14, Suppl 1, S82–S92 ß 2002 Nature Publishing Group All rights reserved 0955-9930/02 $25.00 www.nature.com/ijir New directions for erectile dysfunction therapies K-E Andersson1* and P Hedlund1 1Department of Clinical Pharmacology, Lund University Hospital, S-22185, Lund, Sweden Research in the field of erectile function and dysfunction has continued to expand rapidly. Based on the information available, some directions for future erectile dysfunction therapies can be identified. The first direction is improvement of current therapeutic principles. A second generation of orally active phosphodiesterase (PDE) inhibitors is being introduced, and further developments within this field can be expected. The recent introduction of apomorphine has opened the way for new dopamine receptor agonists. The second direction is combinations of existing therapeutic principles. Combinations of apomorphine and sildenafil and apomorphine and a1-adrenoceptor (AR) antagonists, for example, seem attractive and may have a therapeutic potential in patients not responding satisfactorily to single-drug treatment. Nitrosylated a1-AR antagonists, combining nitric oxide donation and a1-ora2-AR antagonism, are currently being evaluated. The third direction is new targets within the central nervous system. Melanocortin receptor agonists have shown promise not only in animal models, but also in preliminary studies in humans. Other possible targets, such as growth hormone-releasing peptide receptors, are being explored. The fourth direction is new peripheral targets. Rho-kinase antagonism and non-nitric oxide-mediated stimulation of soluble guanylyl cyclase have been suggested as possible new principles for drug development. The fourth direction is gene therapy. Progress has been made in intracavernosal somatic gene therapy and will probably continue. -
Effect of Bimatoprost on Intraocular Pressure in Prostaglandin FP Receptor Knockout Mice
Effect of Bimatoprost on Intraocular Pressure in Prostaglandin FP Receptor Knockout Mice Jonathan G. Crowston,1 James D. Lindsey,1 Christy A. Morris,1 Larry Wheeler,2 Felipe A. Medeiros,1 and Robert N. Weinreb1 PURPOSE. To determine the effect of bimatoprost on intraocular ing are not known, it has been suggested that bimatoprost pressure in the prostaglandin FP receptor knockout mouse. fundamentally differs from latanoprost, by lowering IOP ETHODS through mechanisms that are independent of FP receptor sig- M . The IOP response to a single 1.2- g(4 L) dose of 5 bimatoprost was measured in the treated and untreated fellow naling. However, there is considerable controversy regarding eyes of homozygote (FPϩ/ϩ, n ϭ 9) and heterozygote (FPϮ, n the role of FP receptor signaling, because bimatoprost has ϭ been shown to bind and activate the FP receptor in cultured 10) FP-knockout mice, as well as in wild-type C57BL/6 mice 6 (FPϩ/ϩ, n ϭ 20). Serial IOP measurements were also per- human trabecular meshwork and human ciliary muscle cells. Measurement of aqueous humor dynamics in the mouse eye formed after topical bimatoprost in a separate generation of 7 homozygous FP-knockout mice and wild-type littermate con- has been detailed recently. The FP knockout mouse, gener- trol animals (n ϭ 4 per group). Aqueous humor protein ated by homologous translocation with a target vector that  concentrations were measured to establish the state of the replaces the second exon of the FP gene with the -galactosi- blood–aqueous barrier. Tissue, aqueous humor and vitreous dase and neomycin-resistance gene, was produced to demon- strate the critical role of the interaction of PGF2␣ with FP concentrations of bimatoprost, latanoprost, and their C-1 free 8 acids were determined by liquid chromatography and tandem receptors in the initiation of parturition in pregnant mice. -
Pharmacology of Ophthalmic Agents
Ophthalmic Pharmacology Richard Alan Lewis M.D., M.S., PHARMACOLOGY FOPS PHARMACOKINETICS OF Professor, Departments of Ophthalmology, • The study of the absorption, OPHTHALMIC Medicine, Pediatrics, and Molecular distribution, metabolism, AGENTS and Human Genetics and excretion of a drug or and the National School of Tropical agent Introduction and Review Medicine Houston, Texas PHARMACOKINETICS Factors Affecting Drug Penetration Factors Affecting Drug Penetration into Ocular Tissues • A drug can be delivered to ocular tissue: into Ocular Tissues – Locally: • Drug concentration and solubility: The higher the concentration the better the penetration, • Surfactants: The preservatives in ocular • Eye drop but limited by reflex tearing. preparations alter cell membrane in the cornea • Ointment and increase drug permeability, e.g., • Viscosity: Addition of methylcellulose and benzalkonium and thiomersal • Periocular injection polyvinyl alcohol increases drug penetration by • pH: The normal tear pH is 7.4; if the drug pH is • Intraocular injection increasing the contact time with the cornea and altering corneal epithelium. much different, it will cause reflex tearing. – Systemically: • Lipid solubility: Because of the lipid rich • Drug tonicity: When an alkaloid drug is put in • Orally environment of the epithelial cell membranes, relatively alkaloid medium, the proportion of the uncharged form will increase, thus more • IM the higher lipid solubility, the more the penetration. • IV penetration. FLUORESCEIN FLUORESCEIN Chemistry Dosage ● C20H1205, brown crystal ● Adults: 500-750 mg IV ● M.W. 322.3 e.g., 3 cc 25% solution ● Peak absorption 485-500 nm. 5 cc 10% solution ● Peak emission 520-530 nm. ● Children: 1.5-2.5 mg/kg IV Richard Alan Lewis, M.D., M.S. -
Pharmaceuticals Appendix
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ADAPALENE 106685-40-9 ABANOQUIL 90402-40-7 ADAPROLOL 101479-70-3 ABECARNIL 111841-85-1 ADEMETIONINE 17176-17-9 ABLUKAST 96566-25-5 ADENOSINE PHOSPHATE 61-19-8 ABUNIDAZOLE 91017-58-2 ADIBENDAN 100510-33-6 ACADESINE 2627-69-2 ADICILLIN 525-94-0 ACAMPROSATE 77337-76-9 ADIMOLOL 78459-19-5 ACAPRAZINE 55485-20-6 ADINAZOLAM 37115-32-5 ACARBOSE 56180-94-0 ADIPHENINE 64-95-9 ACEBROCHOL 514-50-1 ADIPIODONE 606-17-7 ACEBURIC ACID 26976-72-7 ADITEREN 56066-19-4 ACEBUTOLOL 37517-30-9 ADITOPRIME 56066-63-8 ACECAINIDE 32795-44-1 ADOSOPINE 88124-26-9 ACECARBROMAL 77-66-7 ADOZELESIN 110314-48-2 ACECLIDINE 827-61-2 ADRAFINIL 63547-13-7 ACECLOFENAC 89796-99-6 ADRENALONE 99-45-6 ACEDAPSONE 77-46-3 AFALANINE 2901-75-9 ACEDIASULFONE SODIUM 127-60-6 AFLOQUALONE 56287-74-2 ACEDOBEN 556-08-1 AFUROLOL 65776-67-2 ACEFLURANOL 80595-73-9 AGANODINE 86696-87-9 ACEFURTIAMINE 10072-48-7 AKLOMIDE 3011-89-0 ACEFYLLINE CLOFIBROL 70788-27-1 -
New Zealand Data Sheet 1. Product Name 2. Qualitative
NEW ZEALAND DATA SHEET BIMATOPROST MULTICHEM 1. PRODUCT NAME Bimatoprost multichem 0.3 mg/mL eye drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 0.3 mg bimatoprost. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Bimatoprost multichem eye drops are a clear, isotonic, colourless, sterile ophthalmic solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Bimatoprost multichem is indicated as monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents. 4.2 Dose and method of administration Monotherapy The recommended dose is one drop of Bimatoprost multichem in the affected eye(s) once daily, administered in the evening. Adjunctive therapy The recommended dose is one drop of Bimatoprost multichem in the affected eye(s) once daily, administered in the evening. More frequent administration has not been shown to provide increased efficacy. If more than one topical ophthalmic medication is to be used, the other medication should not be used within 5 minutes of using Bimatoprost multichem eye drops. In order to minimise systemic absorption of Bimatoprost multichem eye drops, patients should be instructed to apply pressure to the tear duct immediately following administration of the drug. Paediatric use Safety and effectiveness in patients below 18 years of age has not been established. Use in elderly No dosage adjustment in elderly patients is necessary. 4.3 Contraindications Bimatoprost multichem eye drops are contraindicated in patients with hypersensitivity to bimatoprost or to any component of the medication. -
(12) Patent Application Publication (10) Pub. No.: US 2002/0187986 A1 Horn (43) Pub
US 2002O187986A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0187986 A1 Horn (43) Pub. Date: Dec. 12, 2002 (54) OPHTHALMIC FORMULATION WHICH Related U.S. Application Data MODULATES DILATION (62) Division of application No. 09/710,758, filed on Nov. (76) Inventor: Gerald Horn, Deerfield, IL (US) 8, 2000, now Pat. No. 6,420,407. Publication Classification Correspondence Address: Bell, Boyd & Lloyd LLC (51) Int. Cl." .................. A61K 31/517; A61K 31/4745; P.O. BOX 1135 A61K 31/4168; A61K 31/4164 Chicago, IL 60690 (US) (52) U.S. Cl. ..................... 514/252.17; 514/283; 514/401 (57) ABSTRACT (21) Appl. No.: 10/165,459 An ophthalmic formulation is disclosed which reduces dila (22) Filed: Jun. 7, 2002 tion in dim light and reduces redness. US 2002/0187986 A1 Dec. 12, 2002 OPHTHALMC FORMULATION WHICH 0007 A formulation for optimizing pupil size in extreme MODULATES DILATION lighting conditions is disclosed. The formulation is prefer ably a Solution of the type used in an artificial tear formu FIELD OF THE INVENTION lation having dissolved therein a therapeutically effective 0001. The present invention relates to a composition amount of a compound characterized by its ability to reduce formulated and administered to a human eye to reduce dilation of the eye, particularly in dim light. The compound dilation and redness. generally interferes with a natural biochemical reaction which results in the stimulation of the dilator muscles of the BACKGROUND OF THE INVENTION eye. The formulation is preferably further comprised of a compound which reduces eye redness, e.g. -
Treatment of Eyebrow Hypotrichosis Using Bimatoprost: a Randomized, Double-Blind, Vehicle-Controlled Pilot Study
ORIGINAL ARTICLE Treatment of Eyebrow Hypotrichosis Using Bimatoprost: A Randomized, Double-Blind, Vehicle-Controlled Pilot Study † KENNETH R. BEER, MD,* HILLARY JULIUS, PA,* MONICA DUNN, RN,* AND FRED WILSON,MS BACKGROUND The Food and Drug Administration has approved bimatoprost ophthalmic solution (0.03%) for the treatment of eyelash hypotrichosis. Previous reports of its efficacy in eyebrow hypotrichosis are anecdotal. OBJECTIVE To assess the efficacy and safety of bimatoprost 0.03% ophthalmic solution applied to the eyebrows in a randomized, double-blind, vehicle-controlled study. METHODS Subjects (n = 20) with mild to moderate eyebrow hypotrichosis enrolled in the study. One group (Bim) applied bimatoprost to each eyebrow daily for 9 months, and another applied vehicle nightly to each eyebrow for 5 months. Subjects in the latter group were re-randomized to apply bimatoprost (Veh-Bim Group) or vehicle (Veh Group) daily to each eyebrow for 4 months. The primary end point was investigator-assessed eyebrow appearance; secondary end points were subject-reported outcomes. RESULTS Investigator assessments showed significant improvements from baseline to 6 (p = .002) and 7 (p = .005) months for the eyebrows treated with bimatoprost. p-Values for the Veh-Bim and Veh groups were not significant at any time point. End-of-study subject satisfaction with eyebrow fullness or thickness and darkness or color was greater in the Bim group than in the Veh group. Adverse effects were not observed. CONCLUSION Bimatoprost 0.03% ophthalmic solution applied daily for 9 months improves the appearance of eyebrows noticeably more than vehicle, without side effects. This study was funded with a research grant by Allergan, Inc. -
API Manufacturing
API Manufacturing The Importance of Process Understanding When it comes to process understanding and commercial manufacturing, no other manufacturer can match Cayman’s knowledge of prostaglandin chemistry. We are the industry leaders in prostaglandin synthesis with over 30 years of experience. Our expert chemists use this knowledge daily to synthesize commercially available eicosanoids as active pharmaceutical ingredients (APIs). Our talented team of scientists in Ann Arbor, Michigan, USA and Neratovice, Czech Republic has filed numerous patents for the complex synthesis and commercial manufacture of over seven APIs with additional compounds currently under development. OPH Cayman’s Center of Excellence in Ann Arbor focuses primarily on the synthesis, scale-up, and registration of new API manufacturing processes. Once registration batches have been completed, the GMP portion of the process and all supporting documentation are transferred to our commercial manufacturing Center of Excellence in Neratovice. The facility at Cayman Pharma has over 30 years of commercial prostaglandin and eicosanoid registration and manufacturing experience, is ISO certified, and has an excellent track record with customers and regulatory authorities VA S worldwide, including being US FDA and EMA compliant. Commercial API production We currently manufacture the following APIs according to the latest ICH and CGMP requirements for commercial distribution. Contact our sales department for more information about pricing and availability. VET · CGMP Bimatoprost · CGMP Latanoprost · CGMP Tafluprost · CGMP Travoprost · CGMP Epoprostenol (sodium salt) CS · CGMP (+)-Cloprostenol (sodium salt) · CGMP (±)-Cloprostenol (sodium salt) Development API production · Alfaprostol · Latanoprostene Bunod · Treprostinil (sodium salt) Cayman Pharma s.r.o. Phone: (+420) 315 664 381 [email protected] 2019 CAYMAN PHARMA S.R.O. -
The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.