DENTOMYCIN Periodontal gel Ref.[49989] Active ingredients: Minocycline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Henry Schein UK Holdings Limited, Medcare House, Centurion Close Gillingham Business Park, Gillingham Kent, ME8 0SB, United Kingdom

5.1. Pharmacodynamic properties

Minocycline hydrochloride has in vitro antibacterial activity against a wide range of gram-negative and gram-positive organisms thought to be related to periodontal disease, including Porphyromonas gingivalis (formerly Bacteroides gingivalis), Prevotella intermedia (formerly Bacteroides intermedius) and Actinobacillus actinomycetemcomitans, as well as Wolinella recta, Peptostreptococcus spp, Fusobacterium nucleatum and Eikenella corrodens and Spirochaetes.

5.2. Pharmacokinetic properties

In a pharmacokinetic study, concentrations of minocycline in gingival crevicular fluid remained at clinically-effective levels for a minimum of three days following the administration of 0.05g gel (1mg minocycline) into periodontal pockets.

Serum levels after subgingival administration and even after direct oral administration of 0.5g gel (10mg minocycline) were only in the range of 0.1-0.2μg/ml. These levels are much lower than the serum levels which would be associated with the normal oral dose of 100-200mg/day minocycline used in systemic therapy. To demonstrate this, DENTOMYCIN following the fourth application has a Cmaxa (mean) of 0.10 μg/ml, whereas MINOCIN 50 mg Tablets administered 12 hourly result in steady state levels Cmax (mean) of 2.08 μg/ml and Cminb (mean) of 1.09 μg/ml.

a Cmax = maximum serum concentration.
b Cmin = minimum serum concentration.

5.3. Preclinical safety data

Nothing of further relevance to the prescriber.

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