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Augmentin tabletsAugmentin

Amoxidillin trihydrate - Potassium clavulanate

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

AUGMENTIN 625 mg tablets: Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).

AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).

 

PHARMACEUTICAL FORM

AUGMENTIN 625 mg tablets: A white to off white oval shaped, film coated tablet debossed with 'AC' and a score line on one side and plain on the other side. Approximately 20 mm by 9.5 mm and about 7.5 mm thick. The total nominal weight is 1.080 g.

AUGMENTIN 1 g tablets: White oval film-coated tablets engraved A C.

 

CLINICAL PARTICULARS

Indications

AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.

 

AUGMENTIN oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites:

Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.

Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.

Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections e.g. boils, abscesses, cellulitis, wound infections.

Bone and joint infections e.g. osteomyelitis.

Dental infections e.g. dentoalveolar abscess

Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.

 

A comprehensive list of susceptible organisms is provided in the Pharmacodynamics section.

 

Dosage and Administration

Usual dosages for the treatment of infection

Adults and children over 12 years+

Mild - Moderate infections One AUGMENTIN 625 mg tablet twice daily

Severe infections One AUGMENTIN 1 g tablet twice daily

 

Therapy can be started parenterally and continued with an oral preparation.

 

Dosage in dental infections (e.g. dentoalveolar abscess)

Adults and children over 12 years+: One AUGMENTIN 625 mg tablet two times a day for five days + AUGMENTIN 625 mg and 1 g tablets are not recommended in children of 12 years and under

 

Dosage in renal impairment

Adults:

The AUGMENTIN 1 g tablet should only be used in patients with a glomerular filtration rate of >30 ml/min.

Mild impairment (Creatinine

clearance >30 ml/min)

Moderate impairment ( Creatinine

clearance 10-30 ml/min)

Severe impairment (Creatinine

clearance < 10 ml/min)

No change in dosage

(i.e either one 625 mg tablet twice

daily or one 1 g tablet twice daily

One 625 mg tablet twice daily.

The 1 g tablet should not be

administered.

Not more than one 625 mg

tablet every 24 hours

 

Dosage in hepatic impairment

Dose with caution: monitor hepatic function at regular intervals.

 

Administration
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
 

To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of AUGMENTIN is optimised when taken at the start of a meal.


Treatment should not be extended beyond 14 days without review.


AUGMENTIN is also available as AUGMENTIN intravenous for the short-term treatment of bacterial infections and for prophylaxis against infection which may be associated with major surgical procedures. AUGMENTIN intravenous is described in a separate Pack Insert.


AUGMENTIN is also available as a suspension for three times daily dosing for administration to children under the age of 12 years for the treatment of bacterial infections. AUGMENTIN suspension three times daily is described in a separate Pack Insert.


Contraindications
AUGMENTIN is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.


AUGMENTIN is contraindicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction.


Warnings and Precautions
Before initiating therapy with AUGMENTIN 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 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 may also occasionally result in overgrowth of non-susceptible organisms.

 

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.


Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The clinical significance of these changes is uncertain. AUGMENTIN should be used with caution in patients with evidence of hepatic dysfunction.


Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.


In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Dosage and Administration section.


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 Overdose).

 

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