Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
roxithromycin, Quantity: 300 mg
Southern Cross Pharma Pty Ltd
Roxithromycin
Tablet, film coated
Excipient Ingredients: hyprolose; povidone; propylene glycol; purified talc; sodium starch glycollate type A; hypromellose; sodium starch glycollate type B; maize starch; magnesium stearate; colloidal anhydrous silica; poloxamer; glucose; titanium dioxide
Oral
5 tablets
(S4) Prescription Only Medicine
Adults: Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Visual Identification: White to off-white, round, convex film coated tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-04-10
C:Products/Roxi/CMI 17feb12 scp 17/2/12 Page 1 of 4 ROXITHROMYCIN SCP ROXITHROMYCIN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking roxithromycin against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT ROXITHROMYCIN IS USED FOR Roxithromycin is used to treat infections in different parts of the body caused by bacteria. For example: acute pharyngitis (sore throat and discomfort when swallowing) tonsillitis sinusitis acute bronchitis (infection of the bronchi causing coughing) pneumonia (lung infection characterised by fever, malaise, headache) skin and soft tissue infections non gonoccocal urethritis impetigo (bacterial infection causing sores on the skin) Roxithromycin is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection. Roxithromycin, like other antibiotics, does not work against viral infections such as the flu. YOUR DOCTOR MAY HAVE PRESCRIBED ROXITHROMYCIN FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Roxithromycin is not addictive. BEFORE YOU TAKE ROXITHROMYCIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ROXITHROMYCIN IF: 1. you have an allergy to: roxithromycin or any other macrolide antibiotic eg., azithromycin, clarithromycin or erythromycin. any of the ingredients listed at the end of this leaflet (see Product description) Some of the symptoms of an allergic reaction may include shortness of breath, whe Soma hati kamili
C:Products/Roxi/PI 17feb12 scp 17/2/12 Page 1 of 9 PRODUCT INFORMATION ROXITHROMYCIN SCP NAME OF THE MEDICINE ACTIVE INGREDIENT: Roxithromycin CHEMICAL NAMES:_ _ (3_R_, 4_S_, 5_S_, 6_R_, 7_R_, 9_R_, 11_S_, 12_R_, 13_S_, 14_R_)-4-[(2,6-dideoxy-3-_C_-methyl-3-O- methyl-α- L -_ribo_-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-10-[(_E_)-[(2- methoxyethoxy)-methoxy]imino]-3,5,7,9,11,13,-hexamethyl-6-[(3,4,6-trideoxy-3- (dimethylamino)-β- D -_xylo_-hexopyranosyl)oxy]-oxacyclotetradecan-2-one. STRUCTURAL FORMULA: _ _ MOLECULAR FORMULA: C 41 H 76 N 2 O 15 . MOLECULAR WEIGHT: 837.07 CAS REGISTRY NUMBER: 80214-83-1 _ _ DESCRIPTION Roxithromycin is a semi-synthetic macrolide antibiotic. Each Roxithromycin film- coated tablet contains either 150 mg or 300 mg of roxithromycin as the active ingredient. ROXITHROMYCIN SCP tablets also contain the following inactive ingredients: maize starch, hydroxypropylcellulose, silica – colloidal anhydrous, sodium starch glycollate, poloxamer, povidone, magnesium stearate, talc – purified, propylene glycol, glucose, titanium dioxide and hypromellose. C:Products/Roxi/PI 17feb12 scp 17/2/12 Page 2 of 9 PHARMACOLOGY MICROBIOLOGY: Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. It binds to the 50S subunit of the 70S ribosome, thereby disrupting bacterial protein synthesis. A prolonged postantibiotic effect has been observed with roxithromycin. Whilst the clinical significance of this remains uncertain, it supports the rationale for once daily dosing. Although clinical data have demonstrated the efficacy and safety of once daily dosing in adults, these have not been demonstrated in children. At plasma concentrations achieved with the recommended therapeutic doses, roxithromycin has been demonstrated to have _in vitro_ and clinical activity against the following microorganisms: _Streptococcus pneumoniae, Strep. pyogenes, _ _Mycoplasma pneumoniae, Moraxella catarrhalis, Ureaplasma urealyticum _and_ _ _Chlamydia_ sp. Roxithromycin has been demo Soma hati kamili