Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Therapeutic classification: Antibacterial for Systemic Use
ATC code: J01AA08
Minocycline Capsules contain the active ingredient minocycline as minocycline hydrochloride, a semi-synthetic derivative of tetracycline.
Minocycline inhibits protein synthesis in susceptible bacteria. In common with other tetracyclines it is primarily bacteriostatic and has a similar spectrum of activity to other tetracyclines.
The general MIC breakpoint to identify organisms susceptible to minocycline is ≥ 0.5 mg/l. All organisms for which the MIC of minocycline is ≥ 1 mg/l are considered resistant (European Committee on Antimicrobial Susceptibility Testing (EUCAST), 2004).
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable. Minocycline is usually active in vitro against Propionibacterium acnes, which is implicated in the pathogenesis of acne.
Bacterial resistance to the tetracyclines is now common in some species and usually involves cross-resistance between the different tetracyclines.
After a single 100 mg dose of Minocycline Capsules administered to fasting male subjects a maximum concentration of 608 (± 162) ng/ml was achieved at 3.2 (± 1.1) hours after dosing and was eliminated with a plasma half life of 18.4 ± 6.2 hours. When administered to male subjects in the fed state a maximum concentration of 750.9 (± 223.8) ng/ml was achieved at 3.7 (± 1.3) hours after dosing and was eliminated with a plasma half life of 18.8 ± 3.1 hours.
There is no other relevant information from pre-clinical studies that has not already been mentioned in the preceding sections.
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