AMOXYCLAV GENERICHEALTH

What it is

AmoxyClav generichealth is a combination product containing the semisynthetic antibiotic, amoxicillin (as trihydrate) and the β-lactamase inhibitor, potassium clavulanate (as potassium salt of clavulanic acid). Two strengths are available: AmoxyClav generichealth 875/125, containing 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt, and AmoxyClav generichealth 500/125, containing 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. The 875/125 strength is a white elongated capsule shaped film-coated tablet, while the 500/125 strength is a white, oval shaped, film-coated tablet.

Approved indications

AmoxyClav generichealth 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

The usual adult dose is one AmoxyClav generichealth 500/125 tablet every 12 hours. For more severe infections, the dose should be one AmoxyClav generichealth 875/125 tablet every 12 hours. AmoxyClav generichealth 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. AmoxyClav generichealth 875/125 tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤30 mL/min). For AmoxyClav generichealth 500/125 in mild renal impairment (creatinine clearance >30 mL/min), no change in dosage is required. In moderate impairment (creatinine clearance 10–30 mL/min), one tablet should be given 12 hourly. In severe impairment (creatinine clearance <10 mL/min), one tablet should be given every 24 hours.

Key safety warnings

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse 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. If an allergic reaction occurs, AmoxyClav generichealth 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. Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate. DIES is an allergic reaction with the leading symptom of protracted vomiting (1–4 hours after administration of amoxicillin/clavulanate) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock. 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 clavulanic acid tablets have occurred predominantly in males and elderly patients and may be associated with prolonged treatment.

Contraindications

AmoxyClav generichealth is contraindicated in patients with a history of allergic reaction to β-lactams (for example, penicillins or cephalosporins), or to any of the tablet ingredients. It is also contraindicated in patients with a previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction.

Regulatory history

AmoxyClav generichealth 875/125 and 500/125 were first approved on 31 August 2016. Both strengths were listed on the Australian Register of Therapeutic Goods on 17 January 2017 under licence category RE (relating to registered listed medicines).