CURAM

What it is

Curam is a combination product containing amoxicillin trihydrate and potassium clavulanate. Curam Duo 500/125 tablets contain amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium clavulanate) 125 mg, while Curam Duo Forte 875/125 tablets contain amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium clavulanate) 125 mg. Curam contains the semi-synthetic antibiotic amoxicillin and the beta-lactamase inhibitor potassium clavulanate. Like other penicillins, amoxicillin has a bactericidal effect on sensitive organisms during the stage of active multiplication. However, amoxicillin is susceptible to hydrolysis by beta-lactamases and the addition of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms normally resistant to amoxicillin due to beta-lactamase production.

Approved indications

Curam is indicated for short-term treatment of bacterial infections at the following sites when caused by amoxicillin/clavulanic acid sensitive, beta-lactamase producing organisms: — Skin and skin structure infections. — Urinary tract infections (complicated and uncomplicated). — Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. — Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis.

Dosing overview

The usual adult dose is one Curam Duo 500/125 tablet every 12 hours. For more severe infections, the dose should be one Curam Duo Forte 875/125 tablet every 12 hours. Curam 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 the adult recommendations. Children weighing less than 40 kg should not use amoxicillin/clavulanic acid tablet preparations. Curam Duo Forte 875/125 tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance less than or equal to 30 mL/minute). For moderate impairment (creatinine clearance 10 to 30 mL/minute), Curam Duo 500/125 is one tablet, 12-hourly only. For severe impairment (creatinine clearance < 10 mL/minute), Curam Duo 500/125 is one tablet every 24 hours.

Key safety warnings

Serious and occasionally fatal hypersensitivity (including anaphylactoid and severe cutaneous adverse reactions) 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. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. 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 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. 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.

Contraindications

Curam is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, or with a history of allergic reactions to beta-lactams, such as penicillins, cephalosporins, carbapenems or monobactams. Curam is also contraindicated in patients with a previous history of amoxicillin/clavulanic acid associated jaundice/hepatic dysfunction.

Regulatory history

Curam Duo 500/125 and Curam Duo Forte 875/125 tablet strip packs were first listed on the ARTG on 28 March 2003. Curam Duo 500/125 and Curam Duo Forte 875/125 tablet blister packs were added to the register on 12 September 2012.