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GlaxoSmithKline (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 495 5000
Fax: +353 1 4955225
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5225
Summary of Product Characteristics last updated on medicines.ie: 04/01/2016
SPC Augmentin Intravenous 1.2g

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 04/01/2016 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Dec-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

QRD and Minor administrative updates
Section 4.8 – includes addition of AE reporting details
Section 5.1 – includes update to include Staphylococcus spp. resistance category
Updated on 17/07/2015 and displayed until 04/01/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to address of the MA Holder
Updated on 16/04/2015 and displayed until 17/07/2015
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Apr-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.6 – change to the description of the colour of the reconstituted solution
Updated on 11/03/2015 and displayed until 16/04/2015
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   27-Feb-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 9 - Common MR Renewal Date added - 19 October 2014
Updated on 06/01/2014 and displayed until 11/03/2015
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   20-Nov-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to Section 1
Updated on 02/01/2014 and displayed until 06/01/2014
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   20-Nov-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes to:

Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects

Updated on 06/08/2013 and displayed until 02/01/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   05-Jul-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial contains Amoxicillin sodium amoxicillin equivalent to 500  mg of Amoxicillinamoxicillin and potassium

 clavulanate equivalent to 100  mg of clavulanic acid.

 

For athe full list of excipients, see section 6.1.

 

 

 

4.3       Contraindications

 

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1.

 

 

6.2     Incompatibilities

 

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Augmentin should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions.

 

 If Augmentin is prescribed concurrentlyconcomitantly with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because of loss of activity of the aminoglycoside can occur under these conditions.

           

Augmentin issolutions should not stable inbe mixed with infusions containing glucose, dextran or bicarbonate.  Reconstituted solutions of Augmentin should therefore not be added to such infusions but may be injected into the drip tubing over a period of three to four minutes.

 

This medicinal product must not be mixed with other medicinal products except those listed in section 6.6.

 

 

6.3     Shelf life

 

Unopened: Powder in vials

 

2 years

 

OnceReconstituted vials (for intravenous injection or before dilution for infusion)

 

The reconstituted and added to infusions:

 

            Intravenous Infusion                                                           Stability period at 25°C

           

            solution (1 vial with 10 ml of Water for Injections BP                4 hrPh.Eur.) should be used or diluted immediately, within 20 minutes.

            Sodium Chloride Intravenous

Diluted for intravenous infusion BP (0.9% w/v)             4 hr

            Sodium Lactate Intravenous infusion BP (M/6)                                     4 hr

            Compound Sodium Chloride Injection BPC 1959 (Ringer’s)                   3 hr

            Compound Sodium Lactate Intravenous

            Infusion BP (Ringer-Lactate: Hartmann’s)                                             3 hr

 

            Potassium Chloride and Sodium Chloride Intravenous infusion BP        3 hr

 

           

Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours at 5 C.  From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately. 

 

Intravenous infusions of amoxicillin/clavulanic acid may be given in a range of different intravenous fluids.  Satisfactory antibiotic concentrations are retained at 5 °C and at room temperature (25°C) in the recommended volumes of the following infusion fluids.  If reconstituted and maintained at room temperature (25°C), infusions should be completed within the times stated in the table below.

 

Intravenous infusion

Stability period at 25C

Water for Injection Ph.Eur.

3 hours

0.9% w/v Sodium Chloride intravenous infusion (9 mg/ml)

3 hours

Compound Sodium Chloride Injection 1959 (Ringer's)

2 hours

Compound Sodium Lactate Intravenous Infusion (Ringer-Lactate:Hartmann's)

2 hours

0.3% w/v Potassium Chloride and 0.9% w/v Sodium Chloride Intravenous Infusion (3 mg/ml and 9 mg/ml)

2 hours

 

For storage at 5°C, the reconstituted solution shouldsolutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injection Ph. Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours.  Thereafter, the infusion should be administered immediately after reaching room temperature.

 

            Intravenous Infusion                                                     Storage period 5°C

           

            Water for Injections BP                                                             8 hr

            Sodium Chloride Intravenous infusion BP (0.9% w/v)                8 hr

The stability of Augmentin IV solutions is concentration dependent.  In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly. 

 

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate.  Reconstituted solutions of amoxicillin/clavulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

 

6.4       Special precautions for storage

 

Vials: Do not store above 25°C.  Keep the container tightly closed.

Store in a dry placethe original package in order to protect from moisture.

 

For storage detailsconditions after reconstitution of reconstituted solutionsthe medicinal product, see section 6.3.

 

6.5       Nature and contents of container

 

10 mL, clear, Type IClear glass 10 ml or 25 mL, Ph.Eur. ml vials (Type I or Type III glass vials) with chlorobutyl rubber stopper and sealing ring

 

PackPacks of 1, 5 or 10 in a carton.vials

Not all pack sizes may be marketed.

                                             

6.6       Special precautions for disposal and other handling

 

For single use only. Discard any unused solution.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

Preparation of solutions for intravenous injection

 

Water for Injection Ph. Eur. is the normal solvent.  Augmentin 500/100 mg should be dissolved in 10  ml of solvent.  This yields approximately 10.5 ml of solution for single-dose use.  A transient pink colouration may or may not develop during reconstitution.  Reconstituted solutions are normally colourless or a pale straw colour. 

 

Augmentin should be administered within 20 min of reconstitution.

 

           

Preparation of solutions for intravenous infusion

 

Augmentin vials are not suitable for multi-dose use.

 

Augmentin should be reconstituted as described above for injection.  Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette. 

 

 

 

Updated on 07/06/2012 and displayed until 06/08/2013
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   08-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Date of first authorisation should be 1985 not 2000
Updated on 10/12/2010 and displayed until 07/06/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   15-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to the following -

Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION, Section 4.1 -Therapeutic indications, Section 4.2 - Posology and method of administration, Section 4.3 - Contraindications, Section 4.4 - Special warnings and precautions for use, Section 4.5 - Interaction with other medicinal products and other forms of interaction, Section 4.6 - Pregnancy and lactation, Section 4.7 - Effects on ability to drive and use machines, Section 4.8 - Undesirable effects, Section 4.9 - Overdose, Section 5.1 - Pharmacodynamic properties, Section 5.2 - Pharmacokinetic properties, Section 5.3 - Preclinical safety data, Section 6.3 - Shelf life, Section 6.4 - Special precautions for storage, Section 6.6 - Special precautions for disposal

Updated on 21/11/2008 and displayed until 10/12/2010
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

(New text marked in red)

6.6       Instructions for Use/Handling

 

To reconstitute dissolve in 10 ml Water for Injections (final volume 10.5 ml). Reconstituted solutions are normally colourless; however a transient pink colour may appear during reconstitution.

Updated on 30/10/2008 and displayed until 21/11/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/10/2006 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.4 Special Warnings and Special Precautions for Use

Before initiating therapy with amoxicillin-clavulanate, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity (see contra indications).

‘Augmentin’ should be used with caution in patients with evidence of hepatic dysfunction and with care in patients with renal dysfunction when dosage should be adjusted (see 4.2 Posology and Method of Administration).

Amoxicillin-clavulanate should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Prolonged use of an anti-infective agent may result in superinfection by microorganisms including candida resistant to that anti-infective.

The presence of clavulanic acid in amoxicillin-clavulanate may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.

Each 1.2g vial of ‘Augmentin’ contains 1.0 mmol of potassium and 3.1 mmol of sodium. If the parenteral administration of high doses is necessary, the sodium content must be taken into account in patients on a sodium restricted diet.

In patients with reduced urine output crystalluria has been observed very rarely, predominantly with parenteral therapy. During administration of high doses of amoxicillin it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdosage).

4.5 Interaction with Other Medicaments and Other Forms of Interaction

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving ‘Augmentin’. ‘Augmentin’ should be used with care in patients on anti-coagulation therapy.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and allopurinol.

In common with other antibiotics, amoxicillin-clavulanate may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

The presence of clavulanic acid in amoxicillin-clavulanate may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.

Updated on 22/06/2006 and displayed until 16/10/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4     

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy.  During the administration of high doses of Amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of Amoxicillin crystalluria (see Overdosage).

 

Section 4.8 (whole section rearranged & just crystalluria added)     

Data from large clinical trials was used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency :-

very common >1/10

common >1/100 and <1/10

 uncommon >1/1000 and <1/100

rare >1/10,000 and <1/1000

very rare <1/10,000. 

 

Infections and infestations      

Common           Mucocutaneous candidiasis

 

Blood and lymphatic system disorders

Rare     Reversible leucopenia (including neutropenia) and thrombocytopenia

Very rare         Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see Section 4.4 Special warnings and special precautions for use)

 

Immune system disorders

Very Rare        Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis

 

Nervous system disorders

Uncommon       Dizziness, headache

Very Rare        Reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

 

Gastrointestinal disorders

Very common    Diarrhoea

Common            Nausea, vomiting

Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal.

 

Uncommon          Indigestion

Very Rare           Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). 

 

Hepatobiliary disorders

Uncommon       A moderate rise in AST and/or ALT and Alkaline Phosphatases has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown.

Very Rare        Hepatitis and cholestatic jaundice. These events have been noted with other penicillins and cephalosporins.

Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.

 

Signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased.  These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported.

 

Skin and subcutaneous tissue disorders

Uncommon       Skin rash, pruritus, urticaria

Rare     Erythema multiforme

Very Rare        Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP)

If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.

 

Renal and urinary disorders

Very rare         Interstitial nephritis, crystalluria (see Overdosage)

 

Section 4.9

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses.  A regular check of patency should be maintained.

Updated on 01/06/2006 and displayed until 22/06/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 25/01/2006 and displayed until 01/06/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 25/01/2006 and displayed until 25/01/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 19/06/2003 and displayed until 25/01/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Potassium clavulanate
   Amoxicillin sodium