Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 1004.31 mg; potassium clavulanate, Quantity: 151.917 mg
Arrotex Pharmaceuticals Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Tablet, film coated
Excipient Ingredients: isopropyl alcohol; magnesium stearate; dichloromethane; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose
Oral
10 tablets
(S4) Prescription Only Medicine
COCLAVMOX 875/125 tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology):,Urinary Tract Infections (complicated and uncomplicated),Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis.,Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.,Skin and Skin Structure infections.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.
Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-08-07
COCLAVMOX 875/125 AND COCLAVMOX 500/125 TABLETS AMOXICILLIN AND CLAVULANIC ACID TABLETS PRODUCT INFORMATION NAME OF THE MEDICINE COCLAVMOX tablets are combination products containing the semisynthetic antibiotic, amoxicillin (as trihydrate), and the β-lactamase inhibitor, potassium Clavulanate (as the potassium salt of clavulanic acid). Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4– hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2- carboxylic acid trihydrate. It is susceptible to hydrolysis by β -lactamases. Amoxicillin trihydrate may be represented structurally as: CAS – 61336-70-7. Clavulanic acid is produced by the fermentation of _Streptomyces clavuligerus_ . It is an irreversible inhibitor of many β-lactamase enzymes except type 1 (Richmond). It is a β - lactam compound with only weak antibacterial activity. Chemically potassium clavulanate is potassium (2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo- 4-oxa-1-azabicyclo[3.2.0]-heptane-2- carboxylate , and may be represented structurally as: CAS – 61177-45-5. MOLECULAR FORMULA : Amoxicillin trihydrate: C 16 H 19 N 3 O 5 S.3H 2 0 Potassium clavulanate: C 8 H 8 KNO 5 MOLECULAR WEIGHT : Amoxicillin trihydrate: 419.4 Potassium clavulanate: 237.3 DESCRIPTION Amoxicillin trihydrate is a white to almost white, crystalline powder, slightly soluble in water, very slightly soluble in ethanol (96%), practically insoluble in fatty oils. It dissolves in dilute acids and dilute solutions of alkali hydroxides. It having pKa 9.48 & log P is 0.76. Potassium clavulanate is white to almost white, crystalline powder, hygroscopic, freely soluble in water, slightly soluble in alcohol, and very slightly soluble in acetone. It having pKa 2.7 & log P is -1.16. COCLAVMOX 875/125 & COCLAVMOX 500/125 tablets also contain the inactive ingredients: Microcrystalline cellulose, magnesium stearate, sodium starch glycollate Type A and colloidal anhydrous silica. The tablet coating contains hypromellose, titanium dioxide, propylene Lees het volledige document