Drugs List

Therapeutic Indications

Uses

Chronic periodontitis with pocket depth equal or >5mm: adjunctive treatment

Contraindications

Children under 12 years
Acute renal failure

Precautions and Warnings

Children aged 12 to 18 years
Repeated therapy within 6 months
Breastfeeding
Hepatic impairment
Pregnancy
Severe renal impairment

Advise patient to avoid food and drinks for at least 2 hours after dose
Monitor for signs of superinfection with non-susceptible organisms
Possible systemic absorption
Superinfection may occur during therapy
Discontinue if sensitisation occurs
Discontinue if superinfection occurs
Advise to avoid brushing, flossing, mouthwash for 2 hours after dose

Before periodontal use, precautions and warnings associated with systemic administration of minocycline should be considered, especially in patients with severe renal impairment and hepatic impairment, and in those taking concurrent potentially hepatotoxic drugs. No data is available in these groups of patients concerning the use of minocycline dental gel. However, the dose of minocycline given into the periodontium is much lower than the dose given systemically and so serum levels are consequently lower.

Systemic use of antibiotic preparations can lead to an overgrowth of non-susceptible organisms, although clinical trials with minocycline dental gel have not demonstrated this. If superinfection occurs or an infection caused by minocycline-resistant bacterial or non-sensitive bacteria develops locally, treatment with minocycline should be discontinued and the infection should be treated appropriately with other medications.

Pregnancy and Lactation

Pregnancy

Minocycline should not be used during pregnancy unless considered essential.

Schaefer suggests inadvertent first trimester use of tetracyclines occurs frequently, and has not been associated with an increased risk of other congenital malformations. Inadvertent use of tetracyclines, even after the 15th week, is not an indication for termination of the pregnancy or for invasive prenatal diagnostic procedures. The manufacturer suggests because of the tetracycline class effects on tooth development minocycline should not be used in pregnancy unless essential.

Specific data on the use of minocycline on the periodontium in human pregnancy is not available. Animal studies show that tetracyclines cross the placenta, can enter foetal tissue, and can have toxic effects on the developing foetus, including disrupted skeletal development. Embryotoxicity has also occurred in animals treated early in pregnancy.

During tooth development of the foetus (in the last half of pregnancy), tetracyclines may cause permanent discolouration of the teeth (yellow-grey-brown). This reaction is more common during long term therapy, but has also been observed following repeated short term courses. Enamel hypoplasia has also been reported.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Minocycline should not be used during breastfeeding unless considered essential.

Hale suggests that there are other antimicrobials with similar spectrums and because of this the use of minocycline in breastfeeding women is not generally recommended. Short term use, less than 3 weeks, is probably safe, longer therapy should be avoided. The Drugs and Lactation Database (LactMed) suggests harm is not likely in short term use of minocycline.

At the time of writing, specific data on the use of minocycline on the periodontium during lactation is not available.

Tetracyclines have been found in breast milk, and this can lead to permanent tooth discolouration and enamel hypoplasia in the developing infant. Because tetracyclines, in general bind to milk calcium they would have reduced absorption in the infant, minocycline may be absorbed to a greater degree than other older tetracyclines.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angioedema
Bronchospasm
Diarrhoea
Dysphoria
Dyspnoea
Ecchymosis
Gastric upset
Gingival oedema
Irritation (localised)
Pruritus
Rash
Urticaria

Presentation

Oromucosal gel containing minocycline as minocycline hydrochloride dihydrate

Drugs List

Therapeutic Indications

Uses

Chronic periodontitis with pocket depth equal or >5mm: adjunctive treatment

Dosage

For application directly into the periodontal pocket by means of the specially designed applicator.

Administer after scaling and root planning to periodontal pockets with a probing depth of at least 5 mm. Insert the point of the applicator into the pocket to the point of resistance and then release gel into the pocket to the point of overflow.

Between applications to other teeth, wipe the applicator with Ethanol 70% to avoid transfer of bacteria. Each disposable applicator is intended for use on a single patient to treat multiple periodontal pockets, although a new applicator must be used for each session of treatment.

Adults

Elderly

Contraindications

Children under 12 years
Acute renal failure

Precautions and Warnings

Children aged 12 to 18 years
Repeated therapy within 6 months
Breastfeeding
Hepatic impairment
Pregnancy
Severe renal impairment

Advise patient to avoid food and drinks for at least 2 hours after dose
Monitor for signs of superinfection with non-susceptible organisms
Possible systemic absorption
Superinfection may occur during therapy
Discontinue if sensitisation occurs
Discontinue if superinfection occurs
Advise to avoid brushing, flossing, mouthwash for 2 hours after dose

Before periodontal use, precautions and warnings associated with systemic administration of minocycline should be considered, especially in patients with severe renal impairment and hepatic impairment, and in those taking concurrent potentially hepatotoxic drugs. No data is available in these groups of patients concerning the use of minocycline dental gel. However, the dose of minocycline given into the periodontium is much lower than the dose given systemically and so serum levels are consequently lower.

Systemic use of antibiotic preparations can lead to an overgrowth of non-susceptible organisms, although clinical trials with minocycline dental gel have not demonstrated this. If superinfection occurs or an infection caused by minocycline-resistant bacterial or non-sensitive bacteria develops locally, treatment with minocycline should be discontinued and the infection should be treated appropriately with other medications.

Pregnancy and Lactation

Pregnancy

Minocycline should not be used during pregnancy unless considered essential.

Schaefer suggests inadvertent first trimester use of tetracyclines occurs frequently, and has not been associated with an increased risk of other congenital malformations. Inadvertent use of tetracyclines, even after the 15th week, is not an indication for termination of the pregnancy or for invasive prenatal diagnostic procedures. The manufacturer suggests because of the tetracycline class effects on tooth development minocycline should not be used in pregnancy unless essential.

Specific data on the use of minocycline on the periodontium in human pregnancy is not available. Animal studies show that tetracyclines cross the placenta, can enter foetal tissue, and can have toxic effects on the developing foetus, including disrupted skeletal development. Embryotoxicity has also occurred in animals treated early in pregnancy.

During tooth development of the foetus (in the last half of pregnancy), tetracyclines may cause permanent discolouration of the teeth (yellow-grey-brown). This reaction is more common during long term therapy, but has also been observed following repeated short term courses. Enamel hypoplasia has also been reported.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Minocycline should not be used during breastfeeding unless considered essential.

Hale suggests that there are other antimicrobials with similar spectrums and because of this the use of minocycline in breastfeeding women is not generally recommended. Short term use, less than 3 weeks, is probably safe, longer therapy should be avoided. The Drugs and Lactation Database (LactMed) suggests harm is not likely in short term use of minocycline.

At the time of writing, specific data on the use of minocycline on the periodontium during lactation is not available.

Tetracyclines have been found in breast milk, and this can lead to permanent tooth discolouration and enamel hypoplasia in the developing infant. Because tetracyclines, in general bind to milk calcium they would have reduced absorption in the infant, minocycline may be absorbed to a greater degree than other older tetracyclines.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angioedema
Bronchospasm
Diarrhoea
Dysphoria
Dyspnoea
Ecchymosis
Gastric upset
Gingival oedema
Irritation (localised)
Pruritus
Rash
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Dentomycin 2% w/w Periodontal Gel. Henry Schein UK Holdings Ltd. Revised January 2015.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Minocycline Last revised: 10, March 2015
Last accessed: 5, September 2016