Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 574 mg (Equivalent: amoxicillin, Qty 500 mg); potassium clavulanate, Quantity: 149 mg (Equivalent: clavulanic acid, Qty 125 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose
Oral
10 tablets
(S4) Prescription Only Medicine
Short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. Skin and skin structure infections. Urinary tract infections (uncomplicated and complicated). Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility APX-AMOXICILLIN/CLAVULANIC ACID 500/125 tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to APX-AMOXICILLIN/CLAVULANIC ACID 500/125 tablets should not require the addition of another antibiotic due to the amoxycillin content of APX-AMOXICILLIN/CLAVULANIC ACID 500/125 tablets.
Visual Identification: OFF-WHITE, OVAL BICONVEX, FILM-COATED TABLETS, SCORED ON BOTH SIDES.; Container Type: Strip Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2021-04-22
APX-AMOXICILLIN/CLAVULANIC ACID 500/125; APX-AMOXICILLIN/CLAVULANIC ACID 875/125 1 APX- AMOXICILLIN/CLAVULANIC ACID 500/125; APX- AMOXICILLIN/CLAVULANIC ACID 875/125 _amoxicillin trihydrate and potassium clavulanate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APX- Amoxicillin/Clavulanic acid 500/125 and APX-Amoxicillin/Clavulanic acid 875/125. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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 APX- AMOXICILLIN/ CLAVULANIC ACID 500/125 AND APX- AMOXICILLIN/ CLAVULANIC ACID 875/125 ARE USED FOR This medicine contains two active ingredients. One of these ingredients is a type of penicillin called amoxicillin and the other is potassium clavulanate. It is used to treat a wide range of infections in the body caused by bacteria. These infections may affect the chest (bronchitis or pneumonia), bladder (cystitis), sinuses (sinusitis), the ears (otitis media) or the skin. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There is no evidence that this medicine is addictive. _HOW IT WORKS _ APX-Amoxicillin/Clavulanic acid 500/125 and APX- Amoxicillin/Clavulanic acid 875/125 work by killing the bacteria that cause these infections. It will not work against infections caused by viruses such as colds or the flu. BEFORE YOU TAKE APX-AMOXICILLIN/ CLAVULANIC ACID 500/125 OR APX- AMOXICILLIN/ CLAVULANIC ACID 875/125 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • amoxicillin trihydrate or pota Read the complete document
Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION APX-AMOXICILLIN/CLAVULANIC ACID 500/125 AND APX- AMOXICILLIN/CLAVULANIC ACID 875/125 (AMOXICILLIN TRIHYDRATE/POTASSIUM CLAVULANATE) TABLETS 1. NAME OF THE MEDICINE Amoxicillin trihydrate and Potassium clavulanate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION APX-Amoxicillin/Clavulanic acid 500/125 and APX-Amoxicillin/Clavulanic acid 875/125 tablet preparations are a combination products containing amoxicillin trihydrate and potassium clavulanate. APX-Amoxicillin/Clavulanic acid 500/125 tablets contain amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium clavulanate) 125 mg. APX-Amoxicillin/Clavulanic acid 875/125 tablets contain amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium clavulanate) 125 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM APX-Amoxicillin/Clavulanic acid 500/125 tablets: Off-white, oval, biconvex, film-coated and scored on both sides. APX-Amoxicillin/Clavulanic acid 875/125 tablets: White to pale yellow, oblong, biconvex, film-coated and scored on both sides. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Short-term treatment of bacterial infections at the following sites when caused by amoxicillin/clavulanic acid sensitive, beta-lactamase producing organisms: • Skin and skin structure infections. • Urinary tract infections (complicated and uncomplicated). • Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. • Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin/clavulanic acid tablet preparations. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaini Read the complete document