País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
donepezil hydrochloride monohydrate, Quantity: 5.22 mg (Equivalent: donepezil hydrochloride, Qty 5 mg)
Dr Reddys Laboratories Australia Pty Ltd
donepezil hydrochloride monohydrate
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; macrogol 400
Oral
28, 100, 120, 30, 14, 56, 98
(S4) Prescription Only Medicine
Treatment of mild, moderate and severe Alzheimer's disease.
Visual Identification: White, round, biconvex, film coated tablets debossed 'DNP' on one side and '5' on opposite side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
DONEPEZIL-DRLA TABLETS PRODUCT INFORMATION NAME OF THE MEDICINE Active: Donepezil hydrochloride monohydrate CAS Number: 120011-70-3 . HCl. . H 2 O DESCRIPTION Donepezil hydrochloride monohydrate is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in _n_-hexane. Chemical Name: (_RS_)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl]- methylpiperidine hydrochloride monohydrate. Molecular formula: C 24 H 29 NO 3 HCl.H 2 O Molecular Weight: 433.97 Excipient: Lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, hyprolose, magnesium stearate. The film coating contains macrogol 400, hypromellose, titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a colouring agent. ACTIONS Specific and reversible acetylcholinesterase inhibitor. PHARMACOLOGY It has been demonstrated that Alzheimer’s disease is associated with a relative decrease in the activity of the cholinergic system in the cerebral cortex and other areas of the brain. Studies suggest that donepezil hydrochloride exerts its therapeutic effect by enhancing cholinergic function in the central nervous system. This is Product Information for Donepezil-DRLA V3 Product Information for Donepezil-DRLA –V3 2 of 34 accomplished by increasing the concentration of acetylcholine through reversible inhibition of acetylcholinesterase. PHARMACODYNAMICS Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain. Donepezil hydrochloride was found _in_ _ _ _vitro _ to be over 1,000 times more potent an inhibitor of this enzyme than of butyrylcholinesterase, an enzyme which is present mainly outside the central nervous system. In patients with Alzheimer’s dementia participating in clinical trials, administration of single daily doses of donepezil hydrochloride 5 or 10 mg produced steady-state inhibition of acetyl Leia o documento completo