Augmentin Tablets

Amoxicillin, clavulanate potassium.

Each 1-g and 625-mg tablet contains amoxicillin trihydrate 875 mg and 500 mg, respectively and clavulanate potassium 125 mg.
Excipients/Inactive Ingredients: Magnesium stearate, sodium starch glycolate, colloidal silicon dioxide, cellulose microcrystalline, titanium dioxide, hydroxypropyl methylcellulose 5 and 15 cps, polyethylene glycol 4000, polyethylene glycol 6000 and silicone oil.

Pharmacology: Pharmacodynamics: Resistance to many antibiotics is caused by bacterial enzyme which destroy the antibiotic before it can act on the pathogen. The clavulanate in AUGMENTIN anticipates this defence mechanism by blocking the β-lactamase enzymes, thus, rendering the organisms susceptible to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body. Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as AUGMENTIN, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.
AUGMENTIN is bactericidal to a wide range of organisms including: Gram-Positive: Aerobes: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *coagulase negative staphylococci (including Staphylococcus epidermidis), Corynebacterium spp, Bacillus anthracis, Listeria monocytogenes.
Anaerobes: Clostridium spp, Peptococcus spp, Peptostreptococcus.
Gram-Negative: Aerobes: *Haemophilus influenzae,*Escherichia coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella spp, *Moraxella catarrhalis, *Salmonella spp, *Shigella spp, Bordetella pertussis, Brucella spp, *Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.
Anaerobes: *Bacteroides spp, including fragilis.
*including β-lactamase producing strains resistant to ampicillin and amoxicillin.

AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The β-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other β-lactam antibiotics.
AUGMENTIN oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: Upper respiratory infection [including ears, nose and throat (ENT)] eg, tonsillitis, sinusitis, otitis media.
Lower respiratory infection eg, acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.
Genitourinary tract infections eg, cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections eg, boils, abscesses, cellulitis, wound infection.
Bone and joint infections eg, osteomyelitis.
Dental infections eg, dentoalveolar abscess.
Other infections eg, septic abortion, puerperal sepsis, intra-abdominal sepsis.
For comprehensive list of susceptible organisms (see Pharmacology: Pharmacodynamics under Actions).

Treatment of Infection: Adult and Children 12 years⁺: Mild to Moderate Infections: Usual Dose: One 625 mg tablet twice daily. Severe Infections: One 1 g tablet twice daily.
Therapy can be started parenterally and continued with an oral preparation.
Dental infections (eg, Dentoalveolar Abscess): Adult and Children 12 years⁺: One 625 mg tablet 2 times daily for 5 days.
⁺AUGMENTIN 625 mg and 1 g are not recommended in children ≤12 years.
Renal Impairment: Adults: AUGMENTIN 1 g tablet should only be used in patients with glomerular filtration rate of >30 mL/min (see Table).


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Hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
Administration: Tablet should be swallowed whole without chewing. If required, tablets may be broken in ½ and swallowed without chewing.
To minimize potential gastrointestinal intolerance, administer at the start of the meal. The absorption of AUGMENTIN is optimized when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
AUGMENTIN is also available as AUGMENTIN IV for the short-term treatment of bacterial infections and for prophylaxis against infection which may be associated with major surgical procedures. AUGMENTIN IV is described in a separate pack insert.
AUGMENTIN is also available as a suspension for 3 times daily dosing for administration to children <12 years for the treatment of bacterial infections. AUGMENTIN suspension 3 times daily is described in a separate pack insert.

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte balance.
Amoxicillin crystalluria in some cases leading to renal failure has been observed (see Precautions).
AUGMENTIN can be removed from the circulation by haemodialysis.

Hypersensitivity to β-lactams eg, penicillins and cephalosporins. History of AUGMENTIN-associated jaundice/hepatic dysfunction.

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 Contraindications).
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 anticoagulation therapy.
Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The clinical significance of these changes is uncertain but 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 6 weeks after treatment has ceased. In patients with renal impairment, AUGMENTIN dosage should be adjusted as recommended in Dosage & Administration.
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).
Effects on the Ability to Drive or Operate Machinery: Adverse effects on the ability to drive or operate machinery have not been observed.
Use in pregnancy & lactation: Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have shown no teratogenic effects. In a single study in women with pre-term, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with AUGMENTIN may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
AUGMENTIN may be administered during the period of lactation. With the exception of the risk and sensitisation, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.

Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have shown no teratogenic effects. In a single study in women with pre-term, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with AUGMENTIN may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
AUGMENTIN may be administered during the period of lactation. With the exception of the risk and sensitisation, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.

Data from large clinical trials were used to determine the frequency of very common to rare adverse effects. The frequencies assigned to all other adverse effects (ie, those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.
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 Precautions).
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: Adults: Very Common: Diarrhoea.
Common: Nausea, vomiting.
Children: Common: Diarrhoea, nausea, vomiting.
All Populations: 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 aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) has been noted in patients treated with β-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. These events have been very rarely reported in children.
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. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
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).

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with AUGMENTIN may result in increased and prolonged blood levels of amoxicillin, but not of clavulanic acid.
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 AUGMENTIN and allopurinol.
In common with other broad spectrum antibiotics, AUGMENTIN may reduce the efficacy of oral contraception and patients should be warned accordingly.

Store at temperatures not above 30°C.
Shelf-Life: 24 months.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.