DOCSLIB.ORG

DE H 5442 001 PAR.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
DE H 5442 001 PAR.Pdf Decentralised Procedure Public Assessment Report Desiject 5 mg/ml Injektionslösung in einer Fertigspritze Midazolam DE/H/5442/001/DC Applicant: Desitin Arzneimittel GmbH, Germany Date: 14.03.2019 This module reflects the scientific discussion for the approval of Desiject 5 mg/ml Injektionslösung in einer Fertigspritze. The procedure was finalised on 13.12.2018. TABLE OF CONTENTS I INTRODUCTION ......................................................................................................................... 4 II EXECUTIVE SUMMARY .......................................................................................................... 4 II.1 PROBLEM STATEMENT............................................................................................................... 4 II.2 ABOUT THE PRODUCT ................................................................................................................ 4 II.3 GENERAL COMMENTS ON THE SUBMITTED DOSSIER ............................................................... 4 II.4 GENERAL COMMENTS ON COMPLIANCE WITH GMP, GLP, GCP AND AGREED ETHICAL PRINCIPLES ........................................................................................................................................... 4 III SCIENTIFIC OVERVIEW AND DISCUSSION .................................................................... 5 III.1 QUALITY ASPECTS .................................................................................................................... 5 III.2 NON CLINICAL ASPECTS ........................................................................................................... 5 III.3 CLINICAL ASPECTS ................................................................................................................... 5 IV BENEFIT RISK ASSESSMENT ............................................................................................... 9 Desiject 5 mg/ml Injektionslösung in einer Fertigspritze, DE/H/5442/001/DC Public AR 2/9 ADMINISTRATIVE INFORMATION Name of the medicinal product in the Desiject 5 mg/ml Injektionslösung in einer Fertigspritze RMS Name of the drug substance (INN Midazolam name): Pharmaco-therapeutic group N03AE (ATC Code): Pharmaceutical form(s) and Solution for injection in pre-filled syringe; 5 mg/ml strength(s): Reference Number(s) for the DE/H/5442/001/DC Decentralised Procedure Reference Member State: DE Concerned Member States: Withdrawn: LU Legal basis of application: Art. 10(3) of Dir. 2001/83/EC Applicant (name and address) Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Names and addresses of all proposed hameln rds a.s. manufacturer(s) responsible for Horná 36 batch release in the EEA 900 01 Modra Slovakia Siegfried Hameln GmbH Langes Feld 13 31789 Hameln Germany Desiject 5 mg/ml Injektionslösung in einer Fertigspritze, DE/H/5442/001/DC Public AR 3/9 I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Desiject 5 mg/ml Injektionslösung in einer Fertigspritze for the treatment of acute prolonged convulsive seizures lasting > 5 min (corresponding to early status epilepticus) in adults is approved. II EXECUTIVE SUMMARY Problem statement N/A About the product Midazolam is a short-acting benzodiazepine incorporating an imidazole ring fused in position 1, 2 which confers higher basicity and, hence, the capacity to form salts with hydrochloric, maleic or lactic acid that are readily water soluble with acceptable stability at pH 4 and below. It also contains fluorine at position 2 of the phenyl group. Midazolam is a potent sedative agent that requires titration and slow administration. Titration is strongly recommended to safely obtain the desired level of sedation according to the clinical need, physical status, age and concomitant medication. Midazolam is currently indicated in adults for conscious sedation (before and during diagnostic or therapeutic procedures with or without local anaesthesia) anaesthesia (premedication before induction of anaesthesia, induction of anaesthesia and as a sedative component in combined anaesthesia) sedation in intensive care units The same indications have been also approved for children, except that midazolam is not indicated for “induction of anaesthesia” and “as a sedative component in combined anaesthesia” in children. Different from these indications approved for the reference product, the indication proposed for “Desiject 5 mg/ml Injektionslösung in einer Fertigspritze” is "treatment of acute prolonged convulsive seizures lasting >5 min (corresponding to early status epilepticus) in adults”. In addition, the pharmaceutical form “pre-filled syringe” of the concerned generic product differs from that of the reference product, which is a solution for injection, infusion or rectal administration. All other parameters like active substance, strength and intramuscular route of administration are comparable to the reference product. General comments on the submitted dossier This decentralised application in accordance with Art. 10(3) of Dir. 2001/83/EC as amended concerns a generic version of midazolam hydrochloride. The originator product is “Dormicum 5 mg/ml solution for injection” by Roche Pharma AG, authorised in Germany since 22nd December 1998 (German MA no. 41119.00.00). Hence, data protection has expired and generic successors can be licensed. With Germany as the Reference Member State in this Decentralized Procedure, Desitin Arzneimittel GmbH, Hamburg, Germany, is applying for the Marketing Authorisation of Desiject 5 mg/ml Injektionslösung in einer Fertigspritze in DE. LU was withdrawn. General comments on compliance with GMP, GLP, GCP and agreed ethical principles The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports, ‘close-out letters’ or ‘exchange of information’ issued by the inspection services of the competent authorities (or those countries with which the EEA has a Mutual Recognition Agreement for their own territories) as certification that acceptable standards of GMP are in place at those non-Community sites. GMP active substance Regarding the statement on GMP for the active substance a statement/declaration is provided from the Desiject 5 mg/ml Injektionslösung in einer Fertigspritze, DE/H/5442/001/DC Public AR 4/9 manufacturer responsible for manufacture of the finished product and batch release situated in the EU. III SCIENTIFIC OVERVIEW AND DISCUSSION Quality aspects Drug Substance The active substance Midazolam is described in the European Pharmacopoeia. The quality of the drug substance Midazolam is controlled in compliance with the corresponding Ph. Eur. monograph. The suitability of the monograph to test the drug substance has been verified by EDQM and is documented by the issue of a certificate of suitability. The declared re-test period of the API is 5 years when stored in a double polyethylene bag in an aluminium bag placed in a fiberboard drum. Drug Product The drug product is presented as a solution for intramuscular injection in a pre-filled syringe with 2 ml solution of Midazolam with a concentration of 5 mg/ml. Excipients are water for injections and sodium chloride as well as HCl for pH adjustment, all of which are of Ph. Eur. quality. Process validation has been performed on three pilot scale batches. Since a standard process is used, process validation data on production scale batches should be supplied post approval. Release and shelf-life specifications include the required tests relevant to this dosage form. The analytical test methods used for analysing drug product have been adequately described and validated. Stability data of pilot scale batches are presented up to 2 years at long term storage conditions, up to 1 year at intermediate storage conditions and up to 6 months at accelerated storage conditions. The storage conditions chosen for the stability studies are those of the general case. An alternative approach to determining water loss at reference relative humidity through calculation from higher relative humidity according to stability guideline ICH Q1A (R2) is applied. The stability results provided justify the proposed shelf life of 2 years. The need of the labelled storage condition “Keep the pre- filled syringe in the outer carton to protect from light” has been justified by results of photostability studies. Non clinical aspects Pharmacological and toxicological properties of midazolam are generally considered well known. The non-clinical overview has been revised which is acceptable. The instructions on use of midazolam during pregnancy and lactation as well as the preclinical safety and fertility data have been revised in accordance with the more applicable instructions of “Buccolam” (EMEA/H/C/2267-IAIN/36) as indicated in the separately enclosed documents. Environmental Risk Assessment (ERA) The applicant provided a Phase I ERA in accordance with the guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Corr 2.). The PECsurface water
Load more

Recommended publications
  • Legal Rights of Children with Epilepsy in School and Child Care – an Advocate’S Manual
    Legal Rights of Children with Epilepsy in School & Child Care AN ADVOCATE’S MANUAL AN ADVOCATE’S AN ADVOCATE’S MANUAL AN ADVOCATE’S First Edition Legal Rights of Children with Epilepsy in School and Child Care – An Advocate’s Manual First Edition Prepared by Leslie Seid Margolis Managing Attorney Maryland Disability Law Center Edited by Gary Gross Director Jeanne A. Carpenter Epilepsy Legal Defense Fund Epilepsy Foundation of America® User is hereby granted permission to copy or disseminate this publication, either in print or electronic format, provided such copies are not made, distributed or used for commercial purposes, and that the user affixes the Epilepsy Foundation’s copyright notice, and states that copying is by permission of the Epilepsy Foundation. To disseminate otherwise, or to republish, requires written permission from the Epilepsy Foundation. Permission can be obtained by contacting the Foundation’s Legal Department at 301-459-3700. The Epilepsy Foundation does not evaluate, promote or endorse commercial products, and nothing contained in this document is intended to be an endorsement of any particular treatment for seizures or epilepsy. © 2008 Epilepsy Foundation of America, Inc. Epilepsy Foundation® and Epilepsy Foundation of America® are registered trademarks of the Epilepsy Foundation of America, Inc. TABLE OF CONTENTS ACKNOWLEDGEMENTS …………………………………………….xiii ABOUT THE AUTHOR ...........................................................................xiv INTRODUCTION …………………………………………………………1 CHAPTER ONE What Do Attorneys
    [Show full text]
  • Rectal Administration of Aid-In-Dying Medications
    Rectal Administration of Aid-in-Dying Medications (NOTE: This is a medical procedure and requires a trained clinician who can evaluate the patient for this procedure, do a rectal exam to be sure that the procedure can be safely accomplished, and be responsible for potential complications. We do not recommend that this be done by families alone without significant direct clinician participation.) by Thalia DeWolf, RN, CHPN For questions and/or information, email [email protected] An Essential Warning: Aid-in-dying medications are a thick suspension of powders. They can clog a Macy Catheter. So while Macy Catheters are indeed wonderful and useful devices for end-of- life care, they should not be used for medical aid in dying. See below for proper materials. Pre-care: An intact, empty, warm, moist, well-perfused rectum assures thorough absorption of rectally administered aid-in-dying medications. Be sure your patient has good bowel care in the 72 hours before aid in dying. A daily soft BM is recommended. The best practice is to do an enema the day before or the morning of aid in dying. Within 24 hours of the procedure (or at the time of the procedure) a digital rectal exam must be performed by an experienced clinician (RN or physician) The clinician must ascertain that the lumen is patent and will accept the catheter; that the rectal vault is not filled with stool (small amounts of stool will not interfere with absorption of medications, large amounts, especially of thick, pasty stool, are likely to bind the medications and prevent absorption; that tumor has not invaded the rectum; that the rectum is warm and well-perfused).
    [Show full text]
  • Mucosal Delivery Systems of Antihypertensive Drugs: a Practical Approach in General Practice Lukasz P
    Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Jun; 162(2):71-78. Mucosal delivery systems of antihypertensive drugs: A practical approach in general practice Lukasz P. Bialya,b, Cezary Wojcikc, Izabela Mlynarczuk-Bialya,b Patients who are unable to receive oral medication (p.o.) are a major problem in outpatient settings, especially in home health care systems. Mucosal administration of drugs offers an alternative to the oral route, especially when the parenteral mode cannot be used. There are three main pathways of mucosal administration: sublingual/buccal, intranasal and rectal. We discuss the possibility of mucosal delivery of antihypertensive drugs. Perindopril arginine and Amlodipine besylate are registered in the EU as orodispersible tablets for oromucosal delivery, however, they are not available in all countries. For this reason, we describe other drugs suitable for mucosal delivery: Captopril and Nitrendipine in the sublingual system and Metoprolol tartrate, Propranolol and Furosemide by the transrectal route. Based on the published data and common clinical practice we discuss the use of mucosal delivery systems of all these antihypertensive drugs with special attention to their pharmacokinetics. We illustrate this mini-review with a case report of the prolonged-term use of mucosal delivery of sublingual Captopril and Nitrendipine combined with rectal Metoprolol tartrate and Furosemide in a patient with severe hypertension unable to receive medication p.o. This is also a report on the first human use of Furosemide-containing suppositories as well as prolonged-term transmucosal administration of these four drugs, describing a practical approach leading to successful control of severe hyperten- sion with four antihypertensive drugs delivered via the mucosal route.
    [Show full text]
  • Diazepam Rectal Gel (Diastat) Administration
    LOS ANGELES UNIFIED SCHOOL DISTRICT Student Health and Human Services Division District Nursing Services DIAZEPAM RECTAL GEL (DIASTAT) ADMINISTRATION I. GENERAL GUIDELINES A. PURPOSE 1. To control acute, repetitive or prolonged seizures. 2. To prevent status epilepticus, a life-threatening condition in which seizures are continuous. 3. To administer Diastat safely and in a timely manner. B. GENERAL INFORMATION 1. Diazepam rectal gel (Diastat) is an “emergency anti-seizure medication” approved by Food and Drug Administration (FDA). Education Code 49414.7 allows unlicensed school staff to administer emergency anti-seizure medication to students with acute, prolonged or repetitive seizure 2. Licensed healthcare provider and parent authorizations for medication must be completed and signed. Healthcare Provider Authorization must specify student specific seizure symptoms, including frequency, type, duration, medication dosage, potential side effects and instructions when to call the paramedics. 3. Diastat training must be student specific- demonstration. Verbalization of the following by the trainee will occur upon completion of the training: a. Identification of characteristics of student’s seizures b. Understanding of Diastat order from the licensed healthcare provider c. Location, storage and disposal of Diastat d. Appropriate steps of administration of Diastat e. Care of the student before, during and after the administration of Diastat f. Documentation of Diastat administration 4. Parent/guardian must notify the school if Diastat was administered within the past 4 hours on a school day. C. PERSONNEL 1. School nurse or school physician 2. Designated school personnel who possess current First Aid and CPR Certification and are trained by the school nurse or the school physician.
    [Show full text]
  • Intramuscular and Rectal Therapies of Acute Seizures
    Epilepsy & Behavior 49 (2015) 307–312 Contents lists available at ScienceDirect Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh Review Intramuscular and rectal therapies of acute seizures Ilo E. Leppik a,b,c,⁎,SimaI.Patelb,c a Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA b MINCEP Epilepsy Care, University of Minnesota Physicians, Minneapolis, MN, USA c Department of Neurology, University of Minnesota Medical School, Minneapolis, MN, USA article info abstract Article history: The intramuscular (IM) and rectal routes are alternative routes of delivery for antiepileptic drugs (AEDs) Accepted 1 May 2015 when the intravenous route is not practical or possible. For treatment of acute seizures, the AED used should Available online 11 June 2015 have a short time to maximum concentration (Tmax). Some AEDs have preparations that may be given intramus- cularly. These include the benzodiazepines (diazepam, lorazepam, and midazolam) and others (fosphenytoin, le- Keywords: vetiracetam). Although phenytoin and valproate have parenteral preparations, these should not be given Intramuscular intramuscularly. A recent study of prehospital treatment of status epilepticus evaluated a midazolam (MDZ) Rectal Acute seizures autoinjector delivering IM drug compared to IV lorazepam (LZP). Seizures were absent on arrival to the emergen- Antiepileptic drugs cy department in 73.4% of the IM MDZ compared to a 63.4% response in LZP-treated subjects (p b 0.001 for supe- riority). Almost all AEDs have been evaluated for rectal administration as solutions, gels, and suppositories. In a placebo-controlled study, diazepam (DZP) was administered at home by caregivers in doses that ranged from 0.2 to 0.5 mg/kg.
    [Show full text]
  • Hypotonic Delivery of Drugs and Drug-Loaded Nanoparticles to the Gastrointestinal Tract
    HYPOTONIC DELIVERY OF DRUGS AND DRUG-LOADED NANOPARTICLES TO THE GASTROINTESTINAL TRACT By Katharina Maisel A dissertation submitted to Johns Hopkins University in conformity with the requirements for the degree of Doctor of Philosophy Baltimore, Maryland December, 2014 © 2014 Katharina Maisel All Rights Reserved ABSTRACT Innovative gastrointestinal (GI) drug delivery vehicles such as mucus penetrating nanoparticles (MPP) and fluid-absorption inducing (hypotonic) delivery vehicles have potential to improve therapeutic outcomes over conventional methods such as mucoadhesive particles (MAP) for GI diseases, including ulcerative colitis (UC) and HIV pre-exposure prophylaxis (PrEP). More than 80% of all drugs are absorbed via the GI tract for either systemic or local treatment. MAP delivered to the GI tract are thought to improve oral absorption or local targeting of difficult-to-deliver drug classes. Mucus is a continuously secreted barrier that effectively traps foreign particulates to protect the underlying epithelium. Rapid clearance of the most superficial luminal mucus layers in the GI tract may limit the effectiveness of MAP. Here, I test the current dogma of mucoadhesion by comparing MAP and MPP GI drug delivery via the oral and rectal routes. In addition I investigate the development of several vehicles including rectal enemas and gels for more effective delivery of nanocarriers or free drugs. First, I illustrate that MPP uniformly coat all surfaces of the GI epithelium, while MAP aggregated in mucus in the center of the lumen, far away from the absorptive epithelium, both in healthy mice and mice with UC. In the mouse colorectum, MPP penetrated into mucus in the deeply in-folded surfaces to evenly coat the entire epithelial surface.
    [Show full text]
  • Achievements in Thermosensitive Gelling Systems for Rectal Administration
    International Journal of Molecular Sciences Review Achievements in Thermosensitive Gelling Systems for Rectal Administration Maria Bialik, Marzena Kuras, Marcin Sobczak and Ewa Oledzka * Department of Biomaterials Chemistry, Chair of Analytical Chemistry and Biomaterials, Faculty of Pharmacy, Medical University of Warsaw, 1 Banacha St., 02-097 Warsaw, Poland; [email protected] (M.B.); [email protected] (M.K.); [email protected] (M.S.) * Correspondence: [email protected]; Tel.: +48-22-572-07-55 Abstract: Rectal drug delivery is an effective alternative to oral and parenteral treatments. This route allows for both local and systemic drug therapy. Traditional rectal dosage formulations have histori- cally been used for localised treatments, including laxatives, hemorrhoid therapy and antipyretics. However, this form of drug dosage often feels alien and uncomfortable to a patient, encouraging refusal. The limitations of conventional solid suppositories can be overcome by creating a thermosen- sitive liquid suppository. Unfortunately, there are currently only a few studies describing their use in therapy. However, recent trends indicate an increase in the development of this modern therapeutic system. This review introduces a novel rectal drug delivery system with the goal of summarising recent developments in thermosensitive liquid suppositories for analgesic, anticancer, antiemetic, antihypertensive, psychiatric, antiallergic, anaesthetic, antimalarial drugs and insulin. The report also presents the impact of various types of components and their concentration on the properties of this rectal dosage form. Further research into such formulations is certainly needed in order to meet Citation: Bialik, M.; Kuras, M.; the high demand for modern, efficient rectal gelling systems. Continued research and development Sobczak, M.; Oledzka, E.
    [Show full text]
  • KAYEXALATE (Sodium Polystyrene Sulfonate) Is a Cream Or Light Brown Fine Powder of Sodium Polystyrene Sulfonate
    PRESCRIBING INFORMATION ® PrKAYEXALATE (Sodium Polystyrene Sulfonate) Cation - Exchange Resin sanofi-aventis Canada Inc. Date of Revision: 2905 Place Louis R.-Renaud September 19, 2018 Laval, Quebec H7V 0A3 Submission Control No.: 217331 s-a Version 5.0 dated September 19, 2018 KAYEXALATE Prescribing Information Page 1 of 12 DESCRIPTION KAYEXALATE (sodium polystyrene sulfonate) is a cream or light brown fine powder of sodium polystyrene sulfonate. KAYEXALATE is a cation-exchange resin prepared in the sodium phase, with an in vivo exchange capacity of approximately 1 mmol (in vitro approximately 3.1 mmol) of potassium per gram. The sodium content is approximately 4.1 mmol (100 mg) per gram of the drug. KAYEXALATE can be administered either orally or as an enema. ACTION Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. As the resin passes through the gastrointestinal tract, the resin removes the potassium ions by exchanging it for sodium ions. Most of this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. Potassium exchange also occurs in the colon following retention of the resin, when administered as an enema. The efficiency of this process is limited and unpredictable. It commonly approximates the order of 33 per cent but the range is so large that definite indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable. INDICATION KAYEXALATE is indicated for the treatment of hyperkalemia. CONTRAINDICATIONS KAYEXALATE should not be administered to patients with the following conditions: • serum potassium <5 mmol/L • history of hypersensitivity to polystyrene sulfonate resins • obstructive bowel disease KAYEXALATE should not be administered orally to neonates or in neonates with reduced gut motility (postoperatively or drug induced).
    [Show full text]
  • EPI 1: Antiepileptic Medications for Management of Acute Convulsive
    [Updated 2015] EPI 1: Antiepileptic medications for management of acute convulsive seizures when no intravenous access is available [Updated 2015] SCOPING QUESTION: In adults with acute convulsive seizures in first-level care or in the community (when no IV access is available), which antiepileptic medications produce benefits and/or harm when compared to comparator? BACKGROUND The treatment for acute convulsive seizures is aimed at earliest cessation of seizures in order to prevent progression to status epilepticus, cardiorespiratory compromise and cerebral damage. Absence of timely intervention may lead to a protracted seizure episode that is more difficult to control with significant subsequent neurological morbidity and mortality (Chen et al., 2014). Rapid and sustained control of seizure status may obviate the need for multiple anti-epileptics and prolonged hospitalization and drastically reduces the chances of adverse outcomes (Chen et al., 2014). It is generally accepted that brief tonic-clonic seizures do not require medication treatment, as they are usually self-limiting. However, seizures of more than five minutes duration, recurrent seizures, delayed recovery of consciousness and a compromised cardio-respiratory system warrant emergency medication treatment. The ideal anti-epileptic medication is one that can be given safely and easily, is rapidly acting, has minimum cardiorespiratory adverse effects, has a long-lasting effect and is inexpensive (Shorvon, 2012). Dispensing antiepileptic medications intravenously is the fastest route of administration; however, achieving peripheral venous access may be difficult in a convulsing patient. This situation is compounded by resource constraints, lack of trained personnel and pre-hospital settings, resulting in the frequent use of non-intravenous routes as the first line for administration of anti-epileptic medications in resource-limited settings (Anderson and Saneto, 2012).
    [Show full text]
  • MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults
    MTN-037 A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults Microbicide Trials Network Funding Agencies: Division of AIDS, US National Institute of Allergy and Infectious Diseases US Eunice Kennedy Shriver National Institute of Child Health and Human Development US National Institute of Mental Health US National Institutes of Health Grant Numbers: UM1AI068633, UM1AI068615, UM1AI106707 DAIDS Protocol ID: 35122 IND Sponsor: DAIDS IND #TBD Protocol Chair: Craig Hendrix, MD Version 1.0 November 9, 2017 MTN-037 A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults TABLE OF CONTENTS LIST OF ABBREVIATIONS AND ACRONYMS ..................................................................... 6 PROTOCOL TEAM ROSTER ............................................................................................. 11 PROTOCOL SUMMARY ..................................................................................................... 20 1 KEY ROLES .................................................................................................................. 23 1.1 Protocol Identification ............................................................................................ 23 1.2 Funding Agencies, Sponsor and Monitor Identification ......................................... 23 1.3 Medical Officer .....................................................................................................
    [Show full text]
  • Diastat Administration Instructions
    CHILD ADMINISTRATION INSTRUCTIONS 1 2 3 Put person on their side where they can’t fall. Get medicine. Get syringe. Note: seal pin is attached to the cap. 4 5 6 Push up with thumb and pull to remove cap Lubricate rectal tip with lubricating jelly. Turn person on side facing you. from syringe. Be sure seal pin is removed with the cap. 7 8 9 Bend upper leg forward to expose rectum. Separate buttocks to expose rectum. Gently insert syringe tip into rectum. Note: rim should be snug against rectal opening. SLOWLY… COUNT OUT LOUD TO THREE…1…2…3 10 11 12 Slowly count to 3 while gently pushing plunger Slowly count to 3 before removing syringe from Slowly count to 3 while holding buttocks in until it stops. rectum. together to prevent leakage. ONCE DIASTAT® IS GIVEN CALL FOR HELP IF ANY OF THE FOLLOWING OCCUR • Seizure(s) continues 15 minutes after giving DIASTAT® or per the doctor’s instructions: 13 • Seizure behavior is different from other episodes Keep person • You are alarmed by the frequency or severity of the seizure(s) on the side facing you, note • You are alarmed by the color or breathing of the person time given, and • The person is having unusual or serious problems continue to Local emergency number: Doctor’s number: observe. (Please be sure to note if your area has 911) Information for emergency squad: Time DIASTAT® given: Dose: DIASTAT® Indication DIASTAT® AcuDial™ (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity, for patients 2 years and older.
    [Show full text]
  • Drug Delivery on Rectal Absorption: Suppositories
    Int. J. Pharm. Sci. Rev. Res., 21(1), Jul – Aug 2013; n° 13, 70-76 ISSN 0976 – 044X Review Article Drug Delivery on Rectal Absorption: Suppositories *Pushkar Baviskara, Anjali Bedsea, Sayyed Sadiqueb, Vikas Kundea, Shivkumar Jaiswala a S.M.B.T College of Pharmacy, Nandi hills Dhamangaon, Igatpuri, Nasik, (M.S.), India. b Amrutvahini College of pharmacy, Sangamner, Ahamednagar, 422608 (M.S.), India. *Corresponding author’s E-mail: [email protected] Accepted on: 07-04-2013; Finalized on: 30-06-2013. ABSTRACT Studies the rectal membrane are interesting for biochemical research as well as providing a basis for the development of new formulations of poorly absorbed drugs such as some moderately large water soluble drugs and peptides. The rectal routes avoid hepatic first-pass effect. The rectum offers a relatively constant environment for drug delivery provided the drug is presented in a well absorbable form. The rate controlled dosage forms resulting in constant steady-state concentration of drugs in plasma selected therapeutic indications. The release rate of a drug dose from suppositories is affected by characteristics of the excipients (melting temperature and rate viscosity at rectal temperature hydro-lipophilic characteristics) hence with a difference in drug availability. The most interesting publications which have appeared within the last decade on the bioavailability of drugs from suppositories are taken into consideration. The rate and extent of rectal drug absorption are often lower than with oral absorption possibly an inherent factor owing to the relatively small surface area available for drug uptake. Keywords: Rectal Drug Delivery, Rectal Absorption, Suppositories. INTRODUCTION the cultural or emotional points of view.
    [Show full text]