Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Medicell Pharmaceutical(malaysia) Sdn.bhd
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
28tablet Tablets
Lotus Pharmaceutical Co Ltd
_Consumer Medication Information Leaflet (RiMUP) _ ___________________________________________________________________________ 1 DESUD PLUS 8 MG/2 MG SUBLINGUAL TABLETS Buprenorphine 8mg / Naloxone 2mg WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Desud Plus. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Desud Plus against the benefits expected for you. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. IF ANY OF THE SIDE EFFECTS GETS SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT DESUD PLUS IS USED FOR Desud Plus is part of a medical, social and psychological treatment program for patients addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence. Treatment with Desud Plus is intended for use in adults and adolescents over 15 years of age. Desud Plus should be used only with caution in adolescents aged 15 ≤ 18. HOW DESUD PLUS WORKS Desud Plus works by targeting receptors and deterring intravenous misuse of this product, thus suppressing withdrawal symptoms and reducing cravings. If taken properly, Desud Plus will not make you high, instead it will reduce withdrawal symptoms and eventually lead to the remission of opiate addiction. BEFORE YOU USE DESUD PLUS _When you must not take it_ Do not take Desud Plus if you have: • Hypersensitivity towards Buprenorphine, Naloxone, or any component of this product • Severe respiratory insufficiency • Severe hepatic insufficiency • Acute alcoholism or delirium tremens • Are pregnant and/or Lees het volledige document
/ 12 1 Controlled Medicine DESUD PLUS 8 MG/ 2 MG SUBLINGUAL TABLETS COMPOSITION EACH DESUD PLUS 8 MG/2 MG SUBLINGUAL TABLET CONTAINS: Buprenorphine . HCl…… 8.624mg and Naloxone . HCl . 2H 2 O…….2.443mg (Eq. to Buprenorphine……8.0mg and Naloxone……………………..2.0mg) PRODUCT DESCRIPTION Desud Plus 8 mg/2 mg sublingual tablets contain buprenorphine HCI and naloxone HCI dihydrate with a 4:1 buprenorphine to naloxone ratio (free bases). The tablets are orange, hexagon, biconvex tablets, debossed with “LP” on one side and “24” on the other side for identification purpose. STRUCTURAL FORMULA OF BUPRENORPHINE HCL Naloxone hydrochloride is a white to slightly off-white powder and is soluble in water, in dilute acids and in strong alkali. Chemically, naloxone is 17-Allyl-4,5 α -epoxy-3, 14- dihydroxymorphinan-6-one hydrochloride. Naloxone hydrochloride has the molecular formula C 19 H 21 NO 4 HCl .2H 2 O and the molecular weight is 399.87 STRUCTURAL FORMULA OF NALOXONE HCI / 12 2 Desud Plus 8 mg/2 mg sublingual tablets are uncoated hexagonal orange tablets intended for sublingual administration at a dose of 8mg buprenorphine free base plus 2mg naloxone free base. CLINICAL PHARMACOLOGY _MAIN EFFECTS: _ Comparisons of buprenorphine with full agonists such as methadone and hydromorphone suggested that sublingual buprenorphine produced typical opioid agonist effects which are limited by a ceiling effect. In non-dependent subjects, acute sublingual doses of buprenorphine + naloxone tablets produced opioid agonist effects, which reached a maximum between doses of 8 mg and 16mg of Buprenorphine sublingual tablets. The effects of 16mg buprenorphine + naloxone sublingual tablets were similar to those produced by 16mg buprenorphine sublingual tablets Opioid agonist ceiling effects were also observed in a double-blind, parallel group, dose ranging comparison of single doses of buprenorphine sublingual solution (1, 2, 4, 8, 16, or 32 mg), placebo, and a full agonist control at various doses. Th Lees het volledige document