ALKEM-AMOXICLAV

What it is

ALKEM-AMOXICLAV 875mg/125mg Tablets is a combination product containing the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as the potassium salt of clavulanic acid). The tablets are white to off white capsule shaped, biconvex, film coated tablets debossed with AM and CL separated by breakline on one side and 1000 on other side.

Approved indications

ALKEM-AMOXICLAV 875 mg/125 mg tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms: — <cite index="1-4">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

Dosing overview

ALKEM-AMOXICLAV 875mg/125 mg tablets should be taken immediately before or with the first mouthful of food, to minimise potential gastrointestinal intolerance and to optimize absorption. The usual adult dose is one amoxicillin and potassium clavulanate 500mg/125mg tablet every 12 hours. For more severe infections, the dose should be one amoxicillin and potassium clavulanate 875mg/125mg tablet every 12 hours. Treatment should usually be continued for 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Treatment should not exceed 14 days without review.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with *Clostridium difficile* appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Cholestatic hepatitis, which may be severe but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to amoxicillin and potassium clavulanate tablets have occurred predominantly in males and elderly patients and may be associated with prolonged treatment.

Contraindications

Amoxicillin and potassium clavulanate tablets are contraindicated in patients with a history of allergic reaction to β-lactams such as penicillins or cephalosporins. They are also contraindicated in patients with a previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction.

Regulatory history

ALKEM-AMOXICLAV 875mg/125mg amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets was first registered on the Australian Register of Therapeutic Goods on 14 November 2013.