Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEMANTINE HYDROCHLORIDE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
MEMANTINE HYDROCHLORIDE
10tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets
TORRENT PHARMACEUTICALS LTD
MEMENTOR TABLETS Memantine Hydrochloride 10 mg 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Mementor is used for 2. How Mementor works 3. Before you use Mementor 4. How to use Mementor 5. While you are using it 6. Side effects 7. Storage and Disposal of Mementor 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision WHAT MEMENTOR IS USED FOR? Mementor contains Memantine Hydrochloride. It is used for treatment of patients with moderate to severe Alzheimer’s disease. HOW MEMENTOR WORKS Memantine Hydrochloride belongs to a group of medicines known as anti- dementia medicines. Memory loss in Azheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so called N-methyl-D-aspartate (NMDA) – receptors that are involved in transmitting nerve signals important in learning and memory. Memantine Hydrochloride belongs to group of medicines called NMDA- receptor antagonists. Mementor acts on these NMDA-receptors improving the transmission of nerve signals and memory. BEFORE YOU USE MEMENTOR _When you must not use it_ If you are allergic (hypersensitive) to Memantine hydrochloride, or any other ingredients of mementor film- coated tablets _Before you start to use it_ _Talk to your doctor or pharmacist_ _before taking Memantor_ - If you have a history epileptic seizures - If you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).In these situations the treatment should be carefully supervised, and the clinical benefit of Mementor reassessed by your doctor on a regular basis. If you suffer from renal impairment (kidney problem), your doctor should closely monitor your kidney function and if necessary adapt the Mementor doses accordingly. The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), d Baca dokumen lengkap
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory MEMENTOR TABLETS 10 MG MEMANTINE HYDROCHLORIDE TABLETS BRAND OR PRODUCT NAME MEMENTOR TABLETS 10 MG NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each film coated tablet contains: 10 mg Memantine Hydrochloride equivalent to 8.31 mg Memantine Colours: Titanium Dioxide PRODUCT DESCRIPTION White to off white colored, oval shaped, biconvex, bevel edged, film coated tablets, debossed ‘10’ on one side and breakline on other side. DOSAGE FORM Film coated tablet PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia. Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. PHARMACOKINETICS _Absorption:_ Memantine has an absolute bioavailability of approximately 100%. t max is between 3 and 8 hours. There is no indication that food influences the absorption of memantine. _Distribution:_ Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5-1 μmol) with large inter-individual variations. When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated. The volume of distribution is around 10 l/kg. About 45% of memantine is bound to plasma-proteins. _Biotransformation:_ It is reported that in man, about 80% of the circulating memantine-related material is present as the parent compound. Main human metabolites are N-3,5-dimethyl- gludantan, the isomeric mixture of 4- and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl- adamantane. None of these metabolites exhibit NMDA-antagonistic activity. No cytochrome P 450 catalysed metabolism has been reported Baca dokumen lengkap