দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
Roxithromycin
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
Rulide and Rulide D PI CCDSv5 PIv6 8 Apr 13 _ _ _Page 1 _ PRODUCT INFORMATION RULIDE ® & RULIDE ® D NAME OF THE MEDICINE Rulide Tablets Rulide D Tablets NON-PROPRIETARY NAME Roxithromycin CHEMICAL STRUCTURE Roxithromycin has the following structural formula: The empirical formula for roxithromycin is C 41 H 76 N 2 O 15 . Its molecular weight is 837.07. CAS NUMBER Chemical Abstracts Number: [80214-83-1] DESCRIPTION Roxithromycin is a semi-synthetic macrolide antibiotic. It is a white crystalline powder. Roxithromycin is very slightly soluble in water, freely soluble in acetone, in alcohol and in methylene chloride. It is slightly soluble in dilute hydrochloric acid. Rulide tablets contain 150mg or 300mg of roxithromycin. Rulide D tablets contain 50mg of roxithromycin. Rulide tablets also contain hydroxypropylcellulose, poloxamer, povidone, colloidal anhydrous silica, magnesium stearate (470), purified talc (553), maize starch, hypromellose, anhydrous glucose, titanium dioxide (171) and propylene glycol (1520). Rulide D tablets also contain microcrystalline cellulose, crospovidone, magnesium stearate, fumaric acid, colloidal anhydrous silica, sodium saccharin, methacrylic acid copolymer, sodium hydroxide, purified talc, sodium lauryl sulfate, Macrogol 6000, triethyl citrate and liquorice and strawberry flavours. Rulide and Rulide D PI CCDSv5 PIv6 8 Apr 13 _ _ _Page 2 _ PHARMACOLOGY PHARMACOKINETICS Absorption Roxithromycin is absorbed after oral administration with an absolute bioavailability of approximately 50%. Peak plasma concentrations following administration of 150mg and সম্পূর্ণ নথি পড়ুন