ALPHACLAV DUO

What it is

ALPHACLAV DUO 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). Two strengths are available: ALPHACLAV DUO VIATRIS 500/125 (containing 500 mg amoxicillin and 125 mg clavulanic acid per tablet) and ALPHACLAV DUO FORTE VIATRIS 875/125 (containing 875 mg amoxicillin and 125 mg clavulanic acid per tablet). Both are film coated tablets.

Approved indications

ALPHACLAV DUO is indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms: — 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 infections

Dosing overview

For adults, the usual dose is one ALPHACLAV DUO VIATRIS 500/125 tablet every 12 hours. For more severe infections, the dose should be one ALPHACLAV DUO FORTE VIATRIS 875/125 tablet every 12 hours. Tablets should be taken immediately before or with the first mouthful of food, to minimise potential gastrointestinal intolerance and to optimise absorption. 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. Children weighing 40 kg and more should be dosed according to adult recommendations. It is recommended that amoxicillin and clavulanic acid suspensions be used for children weighing less than 40 kg.

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. If an allergic reaction occurs, ALPHACLAV DUO therapy should be discontinued and the appropriate therapy instituted. 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 by 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. Hepatic events subsequent to amoxicillin and clavulanic acid tablets have occurred predominantly in males and elderly patients and may be associated with prolonged treatment.

Contraindications

History of allergic reaction to β-lactams such as penicillins or cephalosporins is a contraindication. Previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction is a contraindication. ALPHACLAV DUO FORTE VIATRIS 875/125 tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤30 mL/min).

Regulatory history

ALPHACLAV DUO VIATRIS 500/125 and ALPHACLAV DUO FORTE VIATRIS 875/125 were first registered on the Australian Register of Therapeutic Goods (ARTG) on 17 January 2017.