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

Because of the potential for the development of sensitisation following subgingival administration, the treatment area should be closely observed. If signs and/or symptoms of sensitisation (itching, swelling, papules, rubefaction, etc) develop, further therapy should be discontinued.

Warnings and precautions associated with systemically administered minocycline should be considered before periodontal use, especially in patients with hepatic dysfunction, severe renal impairment, and in patients taking other potentially hepatotoxic drugs. (No data is available on the use of DENTOMYCIN in these groups of patients).

However as the dose of minocycline associated with subgingival administration of DENTOMYCIN is significantly lower than the dose with systemic administration, the resulting serum levels are correspondingly much lower.

Although not seen in clinical trials with DENTOMYCIN, systemic use of antibiotic preparations may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs or if an infection caused by minocycline-resistant bacteria or non-sensitive bacteria develops locally, the medication should be discontinued and appropriate therapy instituted.

Tetracyclines depress plasma prothrombin activity. Reduced doses of concomitant anticoagulants may therefore be necessary. The relevance of this statement to DENTOMYCIN has not been established.

Cross-resistance between tetracyclines may develop in micro-organisms, as may cross-sensitisation in patients.

Use in pregnancy

There are no specific data available on the use of DENTOMYCIN in pregnancy.

Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

The use of drugs of the tetracycline class during tooth development (last half of pregnancy) may cause permanent discolouration of the teeth (yellow-grey-brown).This adverse reaction is more common during long term use of the drug but has been observed following repeated short term courses. Enamel hypoplasia has also been reported. DENTOMYCIN should therefore not be used in pregnancy unless considered essential.

Use in lactation

There are no specific data available on the use of DENTOMYCIN during lactation.

Tetracyclines have been found in the milk of lactating women who are taking a drug in this class. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has also been reported.

DENTOMYCIN should therefore not be used during lactation unless considered essential.

Not Applicable.

The most commonly reported adverse event is local irritation, occurring in less than 2% of patients. Adverse reactions associated with the systemic administration of minocycline are thought to be much less likely to occur with the subgingival application of DENTOMYCIN, due to the relatively low serum levels involved. Drug reaction with eosinophilia and systemic symptoms (DRESS) has occurred with systemic administration of minocycline and the possibility of systemic reactions occurring should be considered. If DRESS is suspected, Dentomycin should be discontinued immediately.

Adverse reactions are listed by frequency: very common (≥1/10), common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000); very rare (≤1/10,000), not known (cannot be estimated from available data).

The following undesirable effects have been observed:

Infections and infestations

Frequency not known: Application site abscess.

Dental abscesses were reported in a clinical trial in both DENTOMYCIN and vehicle control group following subgingival scaling and root planing. These are thought to result from the process of treatment rather than the drug therapy.

Immune system disorders

Frequency not known: Hypersensitivity reactions, including angioedema, bronchospasm/dyspnoea, rash, urticaria and pruritus, have been reported in the post-marketing period.

Psychiatric disorders

Uncommon: Mild dysphoria.

Gastrointestinal

Uncommon: Gingival oedema, diarrhoea, stomach discomfort

General and administration site disorders

Common: Application site irritation (e.g. pain, inflammation, erythema, rash)

Frequency not known: Application site ecchymosis.

A single case of ecchymosis was reported in a clinical trial in both DENTOMYCIN and vehicle control group following subgingival scaling and root planing. This was thought to result from the process of treatment rather than the drug therapy.

Reporting of suspected adverse reactions

Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the HPRA homepage. A downloadable report form is also accessible from the HPRA website, which may be completed manually and submitted to the HPRA via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option. FREEPOST HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Not applicable.