MOXICLAV 1g Tablet

Infections at the following sites when caused by amoxicillin-clavulanate-susceptible organisms:

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

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

- Genito-urinary tract infections e.g. cystitis (especially when recurrent or complicated -excluding prostatitis), urethritis, pyelonephritis, female genital infections.

- Skin and soft tissue infections in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis.

- Bone and joint infections e.g. osteomyelitis, where more prolonged therapy may be appropriate.

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

Dose

Dosage depends on the age, weight and renal function of the patient and the severity of the infection.

Dosages are expressed throughout in terms of amoxicillin-clavulanate content except when doses are stated in terms of an individual component.

Usual dosages for the treatment of infection

Adults and children over 12 years of age only

- Mild to moderate infections: 875/125 mg given twice daily.

- Severe infections (including chronic and recurrent urinary tract infections and those of the lower respiratory tract): 875/125 mg given 3 times daily.

Elderly: No adjustment needed; dose as for adults. If there is evidence of renal impairment, dose should be adjusted as for renally impaired adults.

See the package insert about the details below:

- Renal impairment

- Haemodialysis

- Hepatic impairment

Mode of administration

For oral use.

To minimize potential gastrointestinal intolerance, administer at the start of a meal. The absorption of amoxicillin-clavulanate is optimised when taken at the start of a meal.

Treatment should not be extended beyond 14 days without review.

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

Hypersensitivity to the active substances, to penicillins or a history of related beta lactam sensitivity, such as to cephalosporin antibiotics, or to any of the excipients of the formulation.

A history of penicillin associated jaundice or hepatic dysfunction.

Very common

- Diarrhoea (in adults).

Common

- Mucocutaneous candidiasis,

- Nausea, vomiting,

- Diarrhoea, nausea, vomiting (in children).

Uncommon

- Skin rash, pruritus,

- Urticaria,

- Indigestion,

- Dizziness,

- Headache

- A moderate rise in AST and/or ALT and alkaline phosphatases.

Rare

- Reversible leucopenia (including neutropenia) and thrombocytopenia,

- Erythema multiforme.

Very rare

- Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding time and prothrombin time.

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

- Reversible hyperactivity and convulsions,

- Mucocutaneous candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis),

- Black hairy tongue,

- Hepatitis and cholestatic jaundice,

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

- Interstitial nephritis, crystalluria.

See the package insert about the details below:

- Allopurinol

- Anticoagulants

- Oral contraceptives

- Probenecid

This product should only be used in pregnancy or lactation if considered essential by the physician.

Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parenterally administered amoxicillin-clavulanate have shown no teratogenic effects.

In a single study in women with preterm, 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.

Warnings

In moderate to severe renal impairment dosage adjustment is required.

Caution should be exercised in administration to patients with hepatic impairment or evidence of hepatic dysfunction.

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.

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. The possibility of cross sensitivity in patients known to be hypersensitive to cephalosporins should be considered.

Precautions

Moxiclav should be administered with extreme caution to patients with infectious mononucleosis due to the increased risk of erythematous rash developing.

Prolonged usage of Moxiclav, as with any antibiotic, may result in the overgrowth of non-susceptible micro-organisms.

Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors.

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms.

Amoxicillin is, however, susceptible to degradation by beta-lactamases and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.

Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in micro-organisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated beta-lactamases frequently responsible for transferred drug resistance. It is generally less effective against chromosomally-medicated type 1 beta-lactamases.

The presence of clavulanic acid in amoxicillin-clavulanate formulations protects amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins. Thus amoxicillin-clavulanate possesses the distinctive properties of a broad spectrum antibiotic and a beta-lactamase inhibitor.