Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
Memantine hydrochloride
Lupin Australia Pty Limited
Medicine Registered
PRODUCT INFORMATION MEMANTINE-LUPIN TABLETS (LUPIN AUSTRALIA PTY. LTD) NAME OF THE MEDICINE Memantine-LUPIN 5 mg tablets : 5 mg memantine hydrochloride (equivalent to 4.15 mg memantine) Memantine-LUPIN 10 mg tablets : 10 mg memantine hydrochloride (equivalent to 8.31 mg memantine) Memantine-LUPIN 15 mg tablets : 15 mg memantine hydrochloride (equivalent to 12.46 mg memantine) Memantine-LUPIN 20 mg tablets : 20 mg memantine hydrochloride (equivalent to 16.62 mg memantine) DESCRIPTION MEMANTINE HYDROCHLORIDE It is described chemically as 1-amino-3, 5-dimethyl-adamantane hydrochloride Memantine hydrochloride is a colourless crystalline substance with a bitter taste. The solubility of memantine hydrochloride in water at room temperature is about 3.5%. No polymorphic forms have been detected. Molecular formula: C 12 H 21 N.HCl Molecular Weight: 215.77 CAS: 19982-08-2 (free base) 4110-52-1 (hydrochloride salt) Chemical structure: _Memantine-LUPIN tablet _ _Product Information _ _Lupin Australia Pty Ltd _ Page 2 of 18 EXCIPIENTS Silicified cellulose - microcrystalline, Croscarmellose sodium, Talc - purified, Magnesium Stearate. Coating Materials: FOR 5 MG AND 10 MG: Opadry 03B28796 White (contains Hypromellose, Titanium dioxide and Macrogol 400) FOR 15 MG: Opadry 03B82943 Yellow (contains Hypromellose, Titanium dioxide, Macrogol 400 and Iron oxide yellow) FOR 20 MG: Opadry 03B84713 Pink (contains Hypromellose, Titanium dioxide, Macrogol 400 and Iron oxide red) _Memantine-LUPIN tablet _ _Product Information _ _Lupin Australia Pty Ltd _ Page 3 of 18 PHARMACOLOGY PHARMACOLOGICAL ACTIONS: There is increasing evidence that malfunctioning of glutamatergi Przeczytaj cały dokument