DISTAPH

What it is

Dicloxacillin Viatris is dicloxacillin sodium capsules containing 250 mg or 500 mg dicloxacillin as the active ingredient. Dicloxacillin sodium is a semisynthetic penicillin that resists inactivation by staphylococcal β-lactamase (penicillinase). Penicillinase resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during active multiplication, and all penicillins inhibit the biosynthesis of the bacterial cell wall.

Approved indications

— Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections, including skin and skin structure and wound infections. — Treatment of infected burns. — Treatment of cellulitis. — Treatment of osteomyelitis. — Treatment of pneumonia.

Dosing overview

For mild to moderate infections in adults and children more than 12 years of age: 250 mg, 6 hourly. In more severe infections the dosage may be doubled. The capsules should be administered on an empty stomach, one to two hours before food.

Key safety warnings

Serious, and occasionally fatal, hypersensitivity (anaphylactoid) reactions have occurred in patients receiving penicillin. Serious anaphylactic reactions require immediate emergency treatment with adrenaline (epinephrine). Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including dicloxacillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Dicloxacillin has been associated with cholestatic hepatotoxicity and jaundice. The patterns of liver function test results and biopsy histology are similar to those with flucloxacillin. Despite the reduced frequency of hepatic reactions to dicloxacillin, dicloxacillin should only be used in older patients (55 years or more) when such use is clearly justifiable on clinical grounds. Rare reports have been received during postmarketing surveillance of oesophageal burning, oesophagitis and oesophageal ulceration, particularly after ingestion of dicloxacillin capsules with an insufficient quantity of water and/or before going to bed. To minimise the risk of developing such events, dicloxacillin should be taken with at least 120 mL of water and should NOT be taken in the supine position or immediately before going to bed.

Contraindications

A history of a previous hypersensitivity reaction to any penicillins, or to any component of the formulation.

PBS listing

Distaph 500 mg capsules are listed on the PBS with 3 items, streamlined and restricted access, at an ex-manufacturer price of A$9.35. Distaph 250 mg capsules are listed on the PBS with 2 items, restricted access, at an ex-manufacturer price of A$6.11.

Regulatory history

Distaph 500 mg and 250 mg capsules were first listed on the Australian Register of Therapeutic Goods on 28 October 2014.