Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Topical treatment of acne vulgaris when comedones, papules and pustules are present.

Contraindications

Children under 12 years
Concurrent ultraviolet light therapy
Sunburn
Pregnancy

Precautions and Warnings

Atopy
Females of childbearing potential
Breastfeeding

Contains hydroxybenzoate
Some formulations contain butylated hydroxy toluene (E321)
Avoid administration to eczematous or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with nostrils or mouth
Avoid other topical preparations
Before applying, wash treatment area with soap and water. Dry thoroughly
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Do not apply to broken or denuded skin
Do not apply to periorbital skin
If accidental contact with eyes or mucous membranes - rinse with cool water
May cause irritation when applied to sensitive skin
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue therapy if marked diarrhoea occurs
Reduce application frequency/temporarily discontinue if irritation occurs
Do not exceed recommended dosages and frequency of administration
Usual treatment period is up to 12 weeks
Avoid other topical acne therapies and exfoliants: may cause irritation
Female: Contraception required during and for 1 month after treatment
Advise patient on appropriate sun protection methods
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patients that maximal therapeutic benefit will take several weeks

Clindamycin with tretinoin gel should not be applied at the same time as other topical preparations (including cosmetics) because of possible incompatibility and interaction with tretinoin. Particular caution should be exercised in the use of keratolytic agents. If the patient has been treated with such preparations, the effect of the peeling agents must subside before any commencement of clindamycin and tretinoin gel.

Some medicated cleansers and scrubbing solutions have a strong drying effect. They should not be used in patients receiving clindamycin and tretinoin gel. Abrasive soaps, soaps as well as spices or lime should be used with caution.

Pregnancy and Lactation

Pregnancy

Clindamycin with tretinoin gel is contraindicated in pregnancy.

Clindamycin
A limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/new-born child. Clindamycin was not teratogenic in reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin.

Tretinoin
Tretinoin is a well-known human teratogen following systemic administration but the available data after topical administration in pregnant women is limited. Congenital malformations, some of which are consistent with those observed in retinoic acid embryopathy, have been reported after topical use, but a causal association has yet to be established. Because some absorption does occur, it is not possible to exclude a teratogenic risk (Briggs 2011).

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

Use clindamycin with tretinoin gel with caution in breastfeeding.

It is not known whether clindamycin or tretinoin are excreted in human breast-milk following topical use.

Clindamycin and tretinoin are poorly absorbed after topical administration and are considered a low risk to the infant. Ensure that the infant's skin does not come into contact with treated areas of skin.

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

Acne
Application site reaction
Bleeding skin
Burning sensation (local)
Dermatitis
Desquamation
Dry skin
Erosion
Erythema
Erythema at application site
Exfoliative rash
Eye irritation
Gastro-enteritis
Headache
Herpes simplex
Hypersensitivity reactions
Hypothyroidism
Irritation at application site
Macular rash
Nausea
Pain
Photosensitivity
Pruritus
Rash
Seborrhoea
Sensation of warmth
Skin depigmentation
Skin discolouration
Skin exfoliation
Skin irritation
Sunburn

Presentation

Topical gel containing clindamycin and tretinoin

Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Topical treatment of acne vulgaris when comedones, papules and pustules are present.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Children under 12 years
Concurrent ultraviolet light therapy
Sunburn
Pregnancy

Precautions and Warnings

Atopy
Females of childbearing potential
Breastfeeding

Contains hydroxybenzoate
Some formulations contain butylated hydroxy toluene (E321)
Avoid administration to eczematous or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with nostrils or mouth
Avoid other topical preparations
Before applying, wash treatment area with soap and water. Dry thoroughly
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Do not apply to broken or denuded skin
Do not apply to periorbital skin
If accidental contact with eyes or mucous membranes - rinse with cool water
May cause irritation when applied to sensitive skin
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue therapy if marked diarrhoea occurs
Reduce application frequency/temporarily discontinue if irritation occurs
Do not exceed recommended dosages and frequency of administration
Usual treatment period is up to 12 weeks
Avoid other topical acne therapies and exfoliants: may cause irritation
Female: Contraception required during and for 1 month after treatment
Advise patient on appropriate sun protection methods
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patients that maximal therapeutic benefit will take several weeks

Clindamycin with tretinoin gel should not be applied at the same time as other topical preparations (including cosmetics) because of possible incompatibility and interaction with tretinoin. Particular caution should be exercised in the use of keratolytic agents. If the patient has been treated with such preparations, the effect of the peeling agents must subside before any commencement of clindamycin and tretinoin gel.

Some medicated cleansers and scrubbing solutions have a strong drying effect. They should not be used in patients receiving clindamycin and tretinoin gel. Abrasive soaps, soaps as well as spices or lime should be used with caution.

Pregnancy and Lactation

Pregnancy

Clindamycin with tretinoin gel is contraindicated in pregnancy.

Clindamycin
A limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/new-born child. Clindamycin was not teratogenic in reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin.

Tretinoin
Tretinoin is a well-known human teratogen following systemic administration but the available data after topical administration in pregnant women is limited. Congenital malformations, some of which are consistent with those observed in retinoic acid embryopathy, have been reported after topical use, but a causal association has yet to be established. Because some absorption does occur, it is not possible to exclude a teratogenic risk (Briggs 2011).

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

Use clindamycin with tretinoin gel with caution in breastfeeding.

It is not known whether clindamycin or tretinoin are excreted in human breast-milk following topical use.

Clindamycin and tretinoin are poorly absorbed after topical administration and are considered a low risk to the infant. Ensure that the infant's skin does not come into contact with treated areas of skin.

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

Acne
Application site reaction
Bleeding skin
Burning sensation (local)
Dermatitis
Desquamation
Dry skin
Erosion
Erythema
Erythema at application site
Exfoliative rash
Eye irritation
Gastro-enteritis
Headache
Herpes simplex
Hypersensitivity reactions
Hypothyroidism
Irritation at application site
Macular rash
Nausea
Pain
Photosensitivity
Pruritus
Rash
Seborrhoea
Sensation of warmth
Skin depigmentation
Skin discolouration
Skin exfoliation
Skin irritation
Sunburn

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: April 2014

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.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on April 22, 2014.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com Accessed on April 22, 2014.

Summary of Product Characteristics: Treclin 1%/0.025 gel. Meda Pharmaceuticals Ltd. Revised March 2014.

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
Clindamycin. Last revised: September 07, 2013
Tretinoin. Last revised: September 07, 2013
Last accessed: April 22, 2014.