Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
PAHANG PHARMACY SDN. BHD.
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
28tablet Tablets; 7tablet Tablets
Noripharma Sdn. Bhd.
BUPREN SUBLINGUAL TABLET Buprenorphine (as hydrochloride) 8mg / Naloxone (as hydrochloride) 2mg Buprenorphine (as hydrochloride) 2mg / Naloxone (as hydrochloride) 0.5mg _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What BUPREN is used for? 2. How BUPREN works 3. Before you use BUPREN 4. How to use BUPREN 5. While you are using BUPREN 6. Side effects 7. Storage and disposal of BUPREN 8. Product description 9. Manufacturer and product registration Holder 10. Date of revision WHAT BUPREN IS USED FOR? Medicinal product used in opioid dependence. BUPREN 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 BUPREN sublingual tablets is intended for use in adults and adolescents over 15 years of age. HOW BUPREN WORKS BUPREN contain the active ingredients buprenorphine and naloxone. Buprenorphine acts as a substitute for opiate drugs like heroin or morphine and it helps withdrawal from opiate drugs over a period of time. When taken sublingually (under the tongue) as prescribed, naloxone has no effect, as it is very poorly absorbed. However, if BUPREN sublingual tablet is injected, naloxone will act to block the effects of other opiates like heroin or morphine, leading to bad withdrawal symptoms. Therefore, naloxone is included in BUPREN to discourage misuse by injection, (intravenous abuse) as it can cause very bad withdrawal symptoms. BUPREN sublingual tablet should be used exactly as prescribed. BEFORE YOU USE BUPREN When you must not take it If you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of BUPREN, If you have serious breathing problems, If you have serious problems with your liver, If you are intoxicated due to alcohol or have delirium tremens. USING BUPREN , WITH FOOD AND DRINK Do not take BUPREN together with alcoholic beverages as alco Lees het volledige document
1 BUPREN SUBLINGUAL TABLET DESCRIPTION: BUPREN 8MG/2MG: A white to off white hexagonal shaped tablet with a dimension of 11mmx10mm BUPREN 2MG/0.5MG: A white to off white hexagonal shaped tablet with a dimension of 6.5mmx5.9mm PHARMACODYNAMICS: Buprenorphine is an opioid partial agonist/antagonist which binds to the µ (mu) and K (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the µ receptors, which over a prolonged period, might minimize the need of addicted patients for drugs. Naloxone is an antagonist at µ (mu)-opioid receptors. Because of its almost complete first pass metabolism, naloxone administered orally or sublingually has no detectable pharmacological activity. However, when administered intravenously to opioid dependent persons, the presence of naloxone in BUPREN produces marked opioid antagonist effect and opioid withdrawal, thereby deterring intravenous abuse. PHARMACOKINETIC: BUPRENORPHINE Absorption Buprenorphine when taken orally undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver. The use of this medicinal product by the oral route is therefore inappropriate. Peak plasma concentrations are achieved 90 minutes after sublingual administration. Plasma levels of buprenorphine increases with the sublingual dose. Distribution: The absorption of buprenorphine is followed by a rapid distribution phase. Metabolism and elimination: Buprenorphine is metabolized by 14 N-dealkylation and glucuroconjugation of the parent molecule and the dealklated metabolite. Elimination of buprenorphine is bi-or tri-exponential, with t1/2 from plasma of 32 hours. Buprenorphine is eliminated in the feces by biliary excretion of the glucuroconjugated metabolites (70%), the rest being eliminated in the urine. NALOXONE: Absorption and distribution: Plasma naloxone concentration are low and decline rapidly following a sublingual administration. Metabolism and elimination: The drug is me Lees het volledige document