DOCSLIB.ORG

Desmopressin Orally Disintegrating Tablet in Japanese Patients with Central Diabetes Insipidus: a Retrospective Study of Switching from Intranasal Desmopressin

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Desmopressin Orally Disintegrating Tablet in Japanese Patients with Central Diabetes Insipidus: a Retrospective Study of Switching from Intranasal Desmopressin Endocrine Journal 2014, 61 (8), 773-779 ORIGINAL Desmopressin orally disintegrating tablet in Japanese patients with central diabetes insipidus: A retrospective study of switching from intranasal desmopressin Takaaki Murakami, Tomonobu Hatoko, Takuo Nambu, Yuki Matsuda, Koji Matsuo, Shin Yonemitsu, Seiji Muro and Shogo Oki Department of Diabetes and Endocrinology, Osaka Red Cross Hospital, Osaka 543-0027, Japan Abstract. Central diabetes insipidus (CDI) is a rare disease characterized by polyuria and polydipsia. Patients with CDI have been successfully treated with desmopressin administered either by intranasal instillation or oral tablets. Recently, a desmopressin orally disintegrating tablet (ODT) was approved as the first oral desmopressin tablet for CDI treatment in Japan. We conducted a retrospective single-center study of 15 Japanese CDI patients treated with desmopressin ODT therapy, which aimed to evaluate the efficacy and safety of switching to desmopressin ODT and to analyze the clinical factors that affect the desmopressin ODT dose in Japanese patients. The daily mean dose of desmopressin ODT was 104 ± 46.30 μg and the mean ratio of oral to nasal desmopressin dose was 17.0 ± 7.6, both of which are considerably smaller than those of previous dose-titration study. Moreover, the nasal spray group needed significantly smaller ratios of nasal to oral desmopressin than the nasal drop group (11.7 ± 6.5 vs 21.0 ± 5.5, p = 0.02). The ratio of oral to nasal desmopressin dose had a significant inverse correlation with the required nasal desmopressin dose. Multiple regression analysis demonstrated the ratios of nasal to oral desmopressin dose depended on intranasal formulations. In conclusion, desmopressin ODT was safe and effective in the treatment of Japanese adult CDI patients. When switching to ODT, we should care about the possibility that patients require smaller ODT doses than what was initially expected based on previously published data and also nasal formulations in terms of their differences of expected switching ratio. Key words: Desmopressin, Orally disintegrating tablet, Diabetes insipidus CENTRAL DIABETES INSIPIDUS (CDI) is a rare pressin therapy has been reported to be as effective as disease characterized by polyuria and polydipsia due to intranasal therapy [2-4] and is preferred for most patients deficient synthesis and/or release of arginine vasopres- because of its convenience [5, 6]. Desmopressin orally sin (AVP). A number of acquired and congenital dis- disintegrating tablet (ODT) has been also widely avail- orders can cause CDI, all these etiologies are associ- able throughout world since it was approved in North ated with destruction of the magnocellular neurons in Europe in 2005. Desmopressin ODT has been reported the hypothalamus. Approximately 80% of the neurons to eliminate ingestion of extra fluids and to have higher may need to be damaged before CDI symptoms arise bioavailability than solid tablets [7]. [1]. The CDI clinical manifestation can vary depending In Japan, desmopressin had been primarily admin- on the extent of neuronal destruction. istered intranasally because oral desmopressin tablets Desmopressin is an AVP synthetic analogue, which were not approved. Desmopressin ODT was approved has been used to successfully treat CDI patients since as the first oral desmopressin tablet for CDI treatment in the 1970s. It’s usually administered through intranasal Japan in 2012. Until now, data regarding desmopressin instillation or in the form of oral tablets. Oral desmo- oral therapy in Japanese CDI patients have been very Submitted Mar. 4, 2014; Accepted May 7, 2014 as EJ14-0097 Authors’ contributions: Takaaki Murakami collected the data and Released online in J-STAGE as advance publication May 20, 2014 wrote the paper, Tomonobu Hatoko collected the data, Takuo Correspondence to: Takaaki Murakami, M.D., Department of Nambu contributed to making the diagnostic and statistic analysis, Diabetes and Endocrinology, Osaka Red Cross Hospital, 5-30 Yuki Matsuda, Koji Matsuo, Shin Yonemitsu, Seiji Muro and Fudegasaki-cho, Tennoji-ku, Osaka 543-0027, Japan. Shogo Oki contributed to making the diagnostic and therapeutic E-mail: [email protected] decisions. ©The Japan Endocrine Society 774 Murakami et al. limited, although Fukuda et al. reported the efficacy of Spray 2.5 Kyowa (Kyowa Hakko Kirin, Tokyo, desmopressin solid tablets [8] and Arima et al. showed Japan), in the form of intranasal desmopressin and the efficacy of desmopressin ODT [9]. MinirinMelt® OD Tablet (Ferring Pharmaceuticals Here, we report a retrospective single-center study Co., Ltd. Tokyo, Japan, and Kyowa Hakko Kirin Co., of 15 Japanese CDI patients treated with desmopressin Ltd. Tokyo, Japan) as ODT. Patients were adminis- ODT therapy. This study aimed to evaluate the effi- tered 60 μg desmopressin ODT just before bedtime. cacy and safety of switching to desmopressin ODT in The patients were required to take an additional des- Japanese patients. This is the first report on desmo- mopressin ODT over thirty minutes before or two pressin ODT therapy in Japanese CDI patients in real hours after meals if they had polydipsia or polyuria. clinical settings after it was approved in Japan. The They were allowed to split a desmopressin ODT in half study’s secondary objective was to analyze the clinical as accurately as possible with knife just before its use. factors that affect the desmopressin ODT dose required In this case, we counted the dose as 30 μg. Data after to maintain adequate antidiuretic effect, including switching to desmopressin ODT were collected when daily dose of intranasal desmopressin and clinical data daily doses of desmopressin were fixed for at least one at diagnosis. week. Treatment compliance was verified at each visit on the basis of interviews. Materials and Methods Laboratory methods Patients Plasma and urine osmolalities and serum sodium We conducted a retrospective single-center study at levels were determined by standard laboratory tech- Osaka Red Cross Hospital between Decamber 2012 niques. Plasma AVP was measured by radioimmuno- and November 2013. This study was approved by the assay (AVP-RIA Mitsubishi, Mitsubishi Kagaku Iatron, institutional review board of Osaka Red Cross Hospital. Tokyo, Japan). Through chart review, we identified 15 patients who were prescribed desmopressin ODT for CDI treatment. Statistics Eligible patients were males or females who were 18 Statistical analyses were performed using Statcel3 years old or older with diagnosed CDI defined as pre- (OMS, Tokyo, Japan) and StatView 5.0 software (SAS viously reported [10]. The exclusion criteria included Institute, Inc., Cary, NC, USA). All data are expressed presence of uncorrected hypothyroidism or hypoadren- as mean ± SEM. Student’s or Welch’s t test, Wilcoxon alism as well as presence of a hypothalamus abnormal- signed-ranks test, and Spearman’s correlation coeffi- ity and dementia leading to thirst disorder. The daily cient by rank test were used. Multiple regression anal- dose of intranasal desmopressin of each eligible patient yses were used to determine whether the association was the same at two successive visits or was stable dur- between the dependent and independent variables of ing admission. In this study, as previously reported, interest remained significant after adjusting for other complete CDI was diagnosed when the urine osmola- potentially confounding independent variables. The lity was less than the plasma osmolality even after a statistical level of significance level wasp < 0.05. water-deprivation test and/or when there was an over 50% increase in the urine osmolality following admin- Results istration of vasopressin. In addition, partial CDI was defined as an over 10% rise in the urine osmolality fol- Baseline characteristics lowing administration of vasopressin, despite the urine The baseline characteristics of the 15 identified CDI osmolality being greater than the plasma osmolality patients are summarized in Table 1. Patients were aged after a water-deprivation test [10-14]. 26–86 years (mean 48.9 years) and five of 15 (33.3%) were male. The duration of diagnosed CDI was 1– 30 Study protocol years. Fourteen of 15 patients used intranasal desmo- This was a single-center retrospective study. Each pressin before switching to desmopressin ODT. Only eligible patient was treated with desmopressin ace- one patient was initiated on desmopressin ODT as the tate hydrate, Desmopressin Intranasal 0.01% Kyowa first-time desmopressin therapy. The CDI etiologies (Kyowa Hakko Kirin, Tokyo, Japan) or Desmopressin were lymphocytic hypophysitis (n = 3), Langerhans Oral desmopressin in diabetes insipidus 775 Table 1 Patient characteristics Age Osm. Increasing Nasal Nasal Oral Dose Nasal Oral No. (yrs) Sex Etiology AP ratio Type AVP ratio device dose dose ratio Weeks sodium sodium 1 26 F Idiopathic (-) 0.36 C N/A 250 D 7.5 60 8 12 140 N/A 2 48 F Lymphocytic hypophysitis L,FS,T,A 0.16 C 1.1 232 S 12.5 120 9.6 9 141 141 3 38 F Idiopathic (-) 0.93 C 1 N/A D 2.5 60 24 11 139 139 4 36 F Lymphocytic hypophysitis (-) N/A* C N/A* N/A* S 12.5 180 14.4 1 139 N/A 5 41 M Idiopathic FS.T 0.82 C N/A 118 S 5 120 24 27 142 N/A 6 36 M Langerhans cell histiocytosis (-) 0.23 C 0.9 807 D 7.5 180 24 26 140 N/A 7 66 F Idiopathic A 0.97 C 0.5 111 D 3.7 60 16.2 14 N/A N/A 8 77 F Idiopathic L,FS,T,A 0.83 C N/A 21. D 2.5 60 24 7 141 140 9 86 F Idiopathic (-) 0.69 C 0.7 N/A D 5 120 24 13 146 141 10 41 M Idiopathic (-) 1.43 P 1.5 17 S 20 120 6 9 141 140 11 53 M Lymphocytic hypophysitis (-) 1.12 P 0.8 61 S 15 60 4 14 143 N/A 12 42 F Idiopathic (-) 1.47 P 0.7 57 D 2.5 60 24 13 138 N/A 13 56 F Rathke’s cleft cyst (-) N/A N/A N/A N/A S 5 60 12 4 140 137 14 46 F Craniopharyngioma (-) N/A N/A N/A N/A No N/A 120 N/A 4 139 142 15 42 M Idiopathic L,FS,A N/A N/A N/A N/A D 7.5 180 24 16 138 133 yrs, years old; F, female; M, male; AP, Anterior pituitary dysfunction; L, LH; FS, FSH; A, ACTH; T, TSH; Osm.
Load more

Recommended publications
  • Intranasal and Rectal Diazepam for Rescue Therapy: Assessment of Pharmacokinetics and Tolerability a Dissertation Submitted to T
    INTRANASAL AND RECTAL DIAZEPAM FOR RESCUE THERAPY: ASSESSMENT OF PHARMACOKINETICS AND TOLERABILITY A DISSERTATION SUBMITTED TO THE FACULTY OF THE GRADUATE SCHOOL OF THE UNIVERSITY OF MINNESOTA BY VIJAY DEEP IVATURI IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY ADVISER: JAMES. C. CLOYD DECEMBER 2010 © VIJAY DEEP IVATURI 2010 ACKNOWLEDGEMENTS This thesis was carried out at the Center for Orphan Drug Research, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, United States. I would like to thank the following persons who have all contributed to this thesis and have been important to me throughout my time as a research student; My supervisor/adviser Professor James Cloyd for giving me the opportunity to join the Orphan Drug Research group. Thank you for sharing your vast knowledge and enthusiasm about research. Thanks for all the care and consideration that you and Mrs. Cloyd have always shown and for letting me experience a family away from home. I also appreciate you letting me pursue my personal interest in the application of Pharmacometrics into our research projects and for letting me take a break from my studies to go to GlaxoSmithKline and try a world outside the university. My second committee member Dr. Robert Kriel for showing interest in my work and always questioning the usability and necessity of things and for also being the first to give comments back on reports and manuscripts. Thanks for sharing your expert clinical knowledge and giving me an opportunity to do a clinical clerkship at Hennipen County Medical Center and Gillette Children’s Hospital.
    [Show full text]
  • Intranasal Drug Delivery System- a Glimpse to Become Maestro
    Journal of Applied Pharmaceutical Science 01 (03); 2011: 34-44 Received: 17-05-2011 Revised on: 18-05-2011 Intranasal drug delivery system- A glimpse to become Accepted: 21-05-2011 maestro Shivam Upadhyay, Ankit Parikh, Pratik Joshi, U M Upadhyay and N P Chotai, ABSTRACT Intranasal drug delivery – which has been practiced for thousands of years, has been given a new lease of life. It is a useful delivery method for drugs that are active in low doses and Shivam Upadhyay, Ankit Parikh, Pratik show no minimal oral bioavailability such as proteins and peptides. One of the reasons for the low Joshi, N P Chotai, Dept of Pharmaceutics, A R Collage of degree of absorption of peptides and proteins via the nasal route is rapid movement away from the Pharmacy, V.V.Nagar, Gujarat,India. absorption site in the nasal cavity due to the Mucociliary Clearance mechanism. The nasal route circumvents hepatic first pass elimination associated with the oral delivery: it is easily accessible and suitable for self-medication. The large surface area of the nasal mucosa affords a rapid onset of therapeutic effect, potential for direct-to-central nervous system delivery, no first-pass metabolism, and non-invasiveness; all of which may maximize patient convenience, comfort, and compliance. IN delivery is non -invasive, essentially painless, does not require sterile preparation, U M Upadhyay and is easily and readily administered by the patient or a physician, e.g., in an emergency setting. Sigma Institute of Pharmacy, Baroda, Furthermore, the nasal route may offer improved delivery for “non-Lipinski” drugs.
    [Show full text]
  • Ophthalmic Adverse Effects of Nasal Decongestants on an Experimental
    A RQUIVOS B RASILEIROS DE ORIGINAL ARTICLE Ophthalmic adverse effects of nasal decongestants on an experimental rat model Efeitos oftálmicos adversos de descongestionantes nasais em modelo experimental com ratos Ayse Ipek Akyuz Unsal1, Yesim Basal2, Serap Birincioglu3, Tolga Kocaturk1, Harun Cakmak1, Alparslan Unsal4, Gizem Cakiroz5, Nüket Eliyatkın6, Ozden Yukselen7, Buket Demirci5 1. Department of Ophthalmology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 2. Department of Otorhinolaringology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 3. Department of Pathology, Veterinary Faculty, Adnan Menderes University, Aydin, Turkey. 4. Department of Radiology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 5. Department of Medical Pharmacology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 6. Department of Medical Pathology, Medical Faculty, Adnan Menderes University, Aydin, Turkey. 7. Department of Pathology, Aydin State Hospital, Aydin, Turkey. ABSTRACT | Purpose: To investigate the potential effects of cause ophthalmic problems such as dry eyes, corneal edema, chronic exposure to a nasal decongestant and its excipients cataracts, retinal nerve fiber layer, and vascular damage in on ocular tissues using an experimental rat model. Methods: rats. Although these results were obtained from experimental Sixty adult male Wistar rats were randomized into six groups. animals, ophthalmologists should keep in mind the potential The first two groups were control (serum physiologic) and ophthalmic adverse effects of this medicine and/or its excipients Otrivine® groups. The remaining four groups received the and exercise caution with drugs containing xylometazoline, Otrivine excipients xylometazoline, benzalkonium chloride, ethylene diamine tetra acetic acid, benzalkonium chloride and sorbitol, and ethylene diamine tetra acetic acid. Medications sorbitol for patients with underlying ocular problems.
    [Show full text]
  • Fee-For-Service Preferred Drug List
    Prescription Drug Program Apple Health Medicaid: Fee-for-Service Preferred Drug List What is new in this version of the preferred drug list? Effective for dates of service on and after October 1, 2018, the Health Care Authority will make the following changes: Change Due to the implementation of the Apple Health Preferred Drug List (PDL), a PDL that applies to fee-for-service (FFS) clients as well as Apple Health managed care enrollees, the following changes have occurred: On the Fee-For-Service only Preferred Drug List • Drug classes that are currently on the Apple Health PDL have been removed. These classes and the drug statuses can be found on the Apple Health Preferred Drug List. On the Apple Health Preferred Drug List • New drug classes have been added. This means drugs not previously on the PDL have been added with preferred and nonpreferred statuses. Some drugs may also have additional prior authorization (PA) requirements. • For existing drug classes, preferred statuses may have changed. Some drugs may have additional PA requirements that did not previously require PA. October 25, 2018 Correction • Two drug classes were erroneously removed and have been added back to the list: Asthma – Leukotriene Modifiers Skeletal Muscle Relaxants (Rev. 10/24/2018) (Eff. 10/1/2018) – 1 – Apple Health Medicaid PDL Prescription Drug Program What is the preferred drug list? The Health Care Authority (the agency) has developed a list of preferred drugs within a chosen therapeutic class that are selected based on clinical evidence of safety, efficacy, and effectiveness. The drugs within a chosen therapeutic class are evaluated by the Drug Use Review Board, which makes recommendations to the agency regarding the selection of the preferred drugs.
    [Show full text]
  • Study Protocol
    RESEARCH PROTOCOL Project Title A multicenter, single blind, randomized controlled trial of virucidal effect of Polyvinylpyrrolidone-Iodine on SARS-CoV-2 as well as safety of its application on nasopharynx & oropharynx of COVID-19 positive patients BMRC Reg. No: 38624012021 Page-1/17 Project Title A multicenter, single blind, randomized controlled trial of virucidal effect of Polyvinylpyrrolidone- Iodine on SARS-CoV-2 as well as safety of its application on nasopharynx & oropharynx of COVID- 19 positive patients. Summary Povidone Iodine (Iodine with water soluble polymer Polyvinylpyrolidone) or PVP-I is a proven and time trusted antiseptic agent having best possible (99.99%) virucidal effect in it‟s only 0.23% concentration, against all viruses including SARS-Co, MERS-CoV; even in SARS-COV-2 due to it‟s nonspecific mode of action for virus killing and having no resistance [1,2]. Corona virus is transmitted by/via respiratory droplets or aerosol, produced from sneezing or coughing of infected persons to healthy individual through mouth and nose mainly [5, 6]. The routes of entry of coronavirus in human body are mouth, nose and eye. PVP-I products for gargling the throat and spraying or washing the nose may have a preventive effect on COVID-19 and if it is proved in this study following human trial, this will be a landmark research in COVID-19 pandemic. In line of this, PVP-I containing oro-nasal spray, proposed Bangasafe, which should be regarded as PONS (Povidone Iodine oro-nasal spray) in this protocol, has been developed and proposed to use against corona virus disease.
    [Show full text]
  • DDAVP Nasal Spray Is Provided As an Aqueous Solution for Intranasal Use
    DDAVP® Nasal Spray (desmopressin acetate) Rx only DESCRIPTION DDAVP® Nasal Spray (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Mol. wt. 1183.34 Empirical formula: C46H64N14O12S2•C2H4O2•3H2O 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Nasal Spray is provided as an aqueous solution for intranasal use. Each mL contains: Desmopressin acetate 0.1 mg Sodium Chloride 7.5 mg Citric acid monohydrate 1.7 mg Disodium phosphate dihydrate 3.0 mg Benzalkonium chloride solution (50%) 0.2 mg The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (desmopressin acetate) per spray. CLINICAL PHARMACOLOGY DDAVP contains as active substance desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal DDAVP has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU. 1. The biphasic half-lives for intranasal DDAVP were 7.8 and 75.5 minutes for the fast and slow phases, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone used in this condition. As a result, intranasal DDAVP provides a prompt onset of antidiuretic action with a long duration after each administration. 1 2. The change in structure of arginine vasopressin to DDAVP has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.
    [Show full text]
  • Topical Management of Chronic Rhinosinusitis
    Open Access Advanced Treatments in ENT Disorders Review Article Topical Management of chronic rhinosinusitis - A literature review ISSN 1 2 2640-2777 Aremu Shuaib Kayode * and Tesleem Olayinka Orewole 1ENT Department, Federal Teaching Hospital, Ido-Ekiti/Afe Babalola University, Ado Ekiti, Nigeria 2Department of Anaesthesia, Federal Teaching Hospital, Ido Ekiti/Afe Babalola University, Ado Ekiti, Nigeria *Address for Correspondence: Dr. Aremu Shuaib Introduction Kayode, ENT Department, Federal Teaching Chronic rhinosinusitis (CRS) is an inlammatory condition involving nasal passages Hospital, Ido-Ekiti/Afe Babalola University, Ado Ekiti, Nigeria, Tel: +2348033583842; and the paranasal sinuses for 12 weeks or longer [1]. It can be subdivided into three Email: [email protected] types: CRS with nasal polyposis (CRS with NP), CRS without nasal polyposis (CRS Submitted: 08 April 2019 without NP), and Allergic fungal rhinosinusitis (AFRS). To diagnose CRS we require Approved: 25 April 2019 at least two of four of its cardinal signs/symptoms (nasal obstruction, mucopurulent Published: 26 April 2019 discharge, facial pain/pressure, and decreased sense of smell). In addition, direct Copyright: © 2019 Aremu SK, et al. This is visualization or imaging for objective documentation of mucosal inlammation is an open access article distributed under the required. CRS therapy is aimed to reduce its symptoms and improve quality of life as it Creative Commons Attribution License, which cannot be cured in most patients. Thus, the goals of its therapy include the following: permits unrestricted use, distribution, and reproduction in any medium, provided the 1: Control mucosal edema and inlammation of nasal and paranasal sinuses original work is properly cited 2: Maintain adequate sinus ventilation and drainage 3: Treat any infecting or colonizing micro-organisms, if present 4: Reduce the number of acute exacerbations Mucosal remodeling is the most likely underlying mechanism causing irreversible chronic sinus disease, similar to that occur in severe asthma.
    [Show full text]
  • 7.Inhalation Testing
    Analytical Challenges in Implementing Effective QC/Stability testing of Inhalation Drug Products Wayland Rushing, Ph.D. Director, Scientific Affairs Eurofins BioPharma Product Testing www.Eurofins.com Inhalation Overview Delivery of one or more drug products to the lungs or nasal mucosa Benefits: § Directly targets the lungs § Rapid onset of drug action • Quick absorption into bloodstream § Low doses required § Fewer side effects 2 Drug/Device Combination Devices Orally Inhaled and Nasal Drug Products (OINDP) § Metered Dose Inhaler (pMDI or simply MDI) • HFA propellant Driven § Dry Powder Inhaler (DPI) • Patient driven § Nebulizer • Aerosolizes solutions for constant delivery § Nasal Spray • Liquid or powder delivery to nasal cavity 3 Regulatory Guidance FDA Guidances § Guidance for Container Closure Systems for Packaging Human Drugs and Biologics (1999) § Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993) § Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) (revised 2018) § Nasal Spray and Inhalers Solution, Suspension, and Spray Drug Products (2002) § Drug Products Packaged in Semipermeable Container Closure Systems (2002) USP Chapters § USP <5>: Inhalation and Nasal Drug Products—General Information and Product Quality Tests § USP <601>: Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders— Performance Quality Tests § USP <1602>: Spacers and Valved Holding Chambers Used with Inhalation Aerosols— Characterization Tests § USP <1664.1>: Orally Inhaled and Nasal Drug Products 4 Revise
    [Show full text]
  • Nasal and Sinus Surgery After Care
    ENT SURGICAL CONSULTANTS 2201 Glenwood Ave., Joliet, IL 60435 (815) 725-1191, (815) 725-1248 fax Michael G. Gartlan, MD, FAAP, FACS 1890 Silver Cross Blvd, Pavilion A, Suite 435, New Lenox, IL 60451 Rajeev H. Mehta, MD, FACS 815-717-8768 Scott W. DiVenere, MD Sung J. Chung, MD 900 W. Rte 6, Suite 960., Morris, IL 60450 (815) 941-1972 Ankit M. Patel, MD Walter G. Rooney, MD www.entsurgicalillinois.com NASAL & SINUS SURGERY (7/13) Nasal Drainage and Bleeding Immediately after surgery, you will have drainage from your nose. At first, there may be a small amount of bright red bleeding, but do not be alarmed. A small amount is normal and may continue through the first week. A gauze dressing will be place on your upper lip to absorb this drainage. It may be necessary to change this dressing several times on the day of your surgery. Any bright red bleeding that lasts more than ten minutes, orEar, is heavy, Nose &spray Throat two Diseases puffs of over-the-counter Afrin decongestant nasal spray (or generic equivalent) in each nostril every ten minutesOtolaryngology until the bleeding-Head & subsides. Neck Surgery This should only be used for active bleeding. This medication is available. Facial Plastic & Reconstructive Surgery Relax with your head elevated,Thyroid tilt your and headParathyroid forward Surgery and gently pinch your nostrils with an ice pack over the bridge of your nose. Persistent bleeding should be reportedPediatric to Otolaryngologyyour doctor immediately. Old blood, which accumulated during surgery, is dark reddish-brown and will drain for a week or more.
    [Show full text]
  • Nasal Delivery of Aqueous Corticosteroid Solutions Nasale Abgabe Von Wässrigen Corticosteroidlösungen Administration Nasale De Solutions Aqueuses De Corticostéroïdes
    (19) TZZ _¥__T (11) EP 2 173 169 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A01N 43/04 (2006.01) A61K 31/715 (2006.01) 21.05.2014 Bulletin 2014/21 (86) International application number: (21) Application number: 08781216.0 PCT/US2008/068872 (22) Date of filing: 30.06.2008 (87) International publication number: WO 2009/003199 (31.12.2008 Gazette 2009/01) (54) NASAL DELIVERY OF AQUEOUS CORTICOSTEROID SOLUTIONS NASALE ABGABE VON WÄSSRIGEN CORTICOSTEROIDLÖSUNGEN ADMINISTRATION NASALE DE SOLUTIONS AQUEUSES DE CORTICOSTÉROÏDES (84) Designated Contracting States: • ZIMMERER, Rupert, O. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Lawrence, KS 66047 (US) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT • SIEBERT, John, M. RO SE SI SK TR Olathe, KS 66061-7470 (US) (30) Priority: 28.06.2007 PCT/US2007/072387 (74) Representative: Dörries, Hans Ulrich et al 29.06.2007 PCT/US2007/072442 df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB (43) Date of publication of application: Theatinerstrasse 16 14.04.2010 Bulletin 2010/15 80333 München (DE) (73) Proprietor: CyDex Pharmaceuticals, Inc. (56) References cited: Lenexa, KS 66214 (US) WO-A1-2005/065649 US-A1- 2006 194 840 US-A1- 2007 020 299 US-A1- 2007 020 330 (72) Inventors: • PIPKIN, James, D. Lawrence, KS 66049 (US) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations.
    [Show full text]
  • Scope and Limitations on Aerosol Drug Delivery for the Treatment of Infectious Respiratory Diseases Hana Douafer, Jean Michel Brunel, Véronique Andrieu
    Scope and limitations on aerosol drug delivery for the treatment of infectious respiratory diseases Hana Douafer, Jean Michel Brunel, Véronique Andrieu To cite this version: Hana Douafer, Jean Michel Brunel, Véronique Andrieu. Scope and limitations on aerosol drug delivery for the treatment of infectious respiratory diseases. Journal of Controlled Release, Elsevier, 2020, 325, pp.276-292. 10.1016/j.jconrel.2020.07.002. hal-03084998 HAL Id: hal-03084998 https://hal.archives-ouvertes.fr/hal-03084998 Submitted on 8 Jan 2021 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Scope and limitations on aerosol drug delivery for the treatment of infectious respiratory diseases Hana Douafer, PhD1, Véronique Andrieu, PhD2 and Jean Michel Brunel, PhD1* Corresponding Author: Jean-Michel Brunel, PhD 1 Aix Marseille Univ, INSERM, SSA, MCT, 13385 Marseille, France. E-mail : [email protected]. Phone : (+33) 689271645 2Aix Marseille Univ, IRD, APHM, MEPHI, IHU Méditerranée Infection, Faculté de Médecine et de Pharmacie, 13385 Marseille, France. Abstract: The rise of antimicrobial resistance has created an urgent need for the development of new methods for antibiotics delivery to patients with pulmonary infections in order to mainly increase the effectiveness of the drugs administration, to minimize the risk of emergence of resistant strains, and to prevent patients reinfection.
    [Show full text]
  • Intranasal Medication Administration – Adult/Pediatric – Inpatient/Ambulatory/Primary Care Clinical Practice Guideline
    Intranasal Medication Administration – Adult/Pediatric – Inpatient/Ambulatory/Primary Care Clinical Practice Guideline Note: Active Table of Contents – Click to follow link Executive Summary ................................................................................................................................ 3 Scope ..................................................................................................................................................... 7 Methodology ......................................................................................................................................... 7 Definitions ............................................................................................................................................. 8 Introduction ........................................................................................................................................... 8 Recommendations ................................................................................................................................. 9 General Recommendations for Intranasal Administration ....................................................................... 9 Drug-Specific Practice Recommendations ............................................................................................. 10 UW Health Implementation ................................................................................................................. 14 Appendix A. Evidence Grading Scheme ................................................................................................
    [Show full text]