COCLAVMOX 500/125, amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium) 125 mg tablets strip pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

amoxicillin trihydrate, Quantity: 573.892 mg; potassium clavulanate, Quantity: 151.917 mg

Disponível em:

Micro Labs Pty Ltd

DCI (Denominação Comum Internacional):

amoxicillin trihydrate,potassium clavulanate

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: magnesium stearate; isopropyl alcohol; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; dichloromethane; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose

Via de administração:

Oral

Unidades em pacote:

Alu/Alu strip packs of 10 tablets packed in monocarton

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

COCLAVMOX 500/125 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.

Resumo do produto:

Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 06' on one side and plain on other side.; Container Type: Strip Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Licence status A

Data de autorização:

2017-08-07

Características técnicas

COCLAVMOX TABLETS
1
AUSTRALIAN
PRODUCT
INFORMATION-
COCLAVMOX
875/125
AND
COCLAVMOX 500/125 (AMOXICILLIN AND CLAVULANIC ACID) FILM-COATED
TABLETS
1.
NAME OF THE MEDICINE
Amoxicillin (as trihydrate) and clavulanic acid (as potassium).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COCLAVMOX
tablets
are
combination
products
containing
the
semisynthetic
antibiotic,
amoxicillin (as the trihydrate) and the β-lactamase inhibitor,
potassium clavulanate (as the
potassium salt of clavulanic acid).
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 glycol,
purified talc, ethylcellulose.
3.
PHARMACEUTICAL FORM
COCLAVMOX 500 /125 tablets contain amoxicillin (as trihydrate) 500 mg
and clavulanic acid
(as potassium clavulanate) 125 mg. White colored capsule shaped film
coated tablet debossed
with ‘Ɩ 06’ on one side and plain on other side.
COCLAVMOX 875 /125 tablets contain amoxicillin (as trihydrate) 875 mg
and clavulanic acid
(as potassium clavulanate) 125 mg. White colored capsule shaped film
coated tablet debossed
with ‘Ɩ 07’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COCLAVMOX 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 (uncomplicated and complicated)
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 Infection
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.
COCLAVMOX TABLETS
2
However, when there is