Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 91.823 mg/mL; potassium clavulanate, Quantity: 13.58 mg/mL
Devatis Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Suspension, powder for
Excipient Ingredients: saccharin sodium; xanthan gum; methyl hydroxybenzoate; succinic acid; colloidal anhydrous silica; silicon dioxide; hypromellose; Flavour
Oral
60 mL
(S4) Prescription Only Medicine
DEVA-AMOXYCLAV 400/57 (amoxicillin and clavulanic acid) oral suspension is indicated in the short term treatment of the following bacterial infections when caused by sensitive organisms (see Microbiology):,Skin and Skin Structure Infections,Urinary Tract Infections (complicated and uncomplicated),Upper Respiratory Tract Infections including sinusitis and otitis media,Lower Respiratory Tract Infections including acute exacerbations of chronic bronchitis and community acquired pneumonia,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to DEVA-AMOXYCLAV 400/57. 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 DEVA-AMOXYCLAV 400/57, should not require the addition of another antibiotic due to the amoxicillin content of DEVA-AMOXYCLAV 400/57.
Visual Identification: White to cream coloured powder; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-12-15
DEVA-AMOXYCLAV 400/57 SUSPENSION PRODUCT INFORMATION (AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE) NAME OF THE MEDICINE DEVA-AMOXYCLAV 400/57 (amoxicillin and clavulanic acid) is a combination product containing the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid). Chemically, amoxicillin is D-(-)- α-amino-p-hydroxybenzylpenicillin. It is susceptible to hydrolysis by β-lactamases. Amoxicillin trihydrate may be represented structurally as: (Chemical formula: C 16 H 19 N 3 O 5 S, 3H 2 O; Molecular weight: 419.4; 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 _Z_ -(2 _R_ ,5 _R_ )-3-(ß- hydroxyethylidene) clavam-2-carboxylate, and may be represented structurally as: (Chemical formula: C 8 H 8 KNO 5 ; Molecular weight: 237.3; CAS – 61177-45-5) DESCRIPTION Amoxicillin trihydrate is a white or almost white, crystalline powder and is slightly soluble in water. A 0.2% solution in water has a pH of 3.5 to 5.5. Potassium clavulanate is supplied in diluted potassium clavulanate, a dry mixture of potassium clavulanate and silicon dioxide. Potassium clavulanate is a white or almost white, hygroscopic, crystalline powder and is freely soluble in water and has a pKa of 2.7 (clavulanic acid). Its experimental partition coefficient is -1.5. A 1% solution in water has a pH of 4.8 to 8.0. DEVA-AMOXYCLAV 400/57 oral suspension also contains hypromellose, silica-colloidal anhydrous (Aerosil 200), saccharin sodium, silicon dioxide (Syloid AL-1 FP), xanthan gum, methyl 1 hydroxybenzoate, succinic acid, Golden Syrup Flavour 501118 AP0551 and Orange 51941 AP0551. The powder in a bottle is diluted with 52 mL water to make up to 60 mL suspension. Each 5 mL of suspension contains Read the complete document