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APX-DICLOXACILLIN (Micro Labs Pty Ltd)

Product name
APX-DICLOXACILLIN
Date registered
Evaluation commenced
Decision date
Approval time
119 (255 working days)
Active ingredients
Dicloxacillin sodium
Registration type
New generic medicine
Indication

Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).

Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin.

Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.

Important Note: When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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