Treclin gel should only be used on the skin. When applying Treclin gel, avoid getting it into the eyes, eyelids, lips, and nostrils.
Treclin should not be used in patients who:
- have a history of hypersensitivity to clindamycin and/or tretinoin or any of the excipients or lincomycin
- have regional enteritis, ulcerative colitis, or a history of any antibiotic-associated colitis
- have a personal or familial history of skin cancer
- have a history of acute eczemas, rosacea and perioral dermatitis
- have pustular and deep cystic nodular acne varieties (acne conglobata and acne fulminans)
Special warnings and precautions for use:
- Treclin is not for oral, ophthalmic, intranasal or intravaginal use
- Treclin is not recommended in treatment of mild acne vulgaris
- Treclin should not be used during pregnancy, especially during the first trimester and women not using contraception
- Contact with the mouth, eyes and mucous membranes and injured skin should be avoided
- In the event of accidental contact with the eyes, bathe with large amounts of water.
Antibiotic-associated colitis has been reported with the use of some other topical clindamycin products. This is unlikely to occur with Treclin as plasma levels have been determined and the percutaneous absorption of clindamycin is clinically negligible.
If you notice prolonged diarrhea or suffer from abdominal cramps, treatment with Treclin should be discontinued immediately as the symptoms may indicate antibiotic-associated colitis.
If severe irritation occurs you should discontinue temporarily or reduce the frequency of application.
Treclin should not be applied at the same time as other topical treatments, including cosmetics, as there is a chance of possible incompatibility.
Particular caution should be exercised in using keratolytic agents such as sulfur, salicylic acid, benzoyl peroxide or resorcinol and chemical abrasives.
Do not use any cleansers or scrubbing solutions with a strong drying effect. You should also avoid abrasive soaps, cosmetics, and spices or lime should be used with caution.
Photosensitivity may occur during treatment with Treclin Gel and exposure to sunlight should be limited as much as possible and appropriate sunscreen should be worn.
Avoid using sun-lamps or sunbeds throughout treatment as this product should not be used on sunburnt skin.
Long-term use of clindamycin may cause resistance and overgrowth of non-susceptible dermal bacteria or fungi, although this is rare.
Cross-resistance may occur with other antibiotics such as lincomycin or erythromycin.
Do not use if you are allergic to any of the ingredients listed below above.
Tretinoin causes enhanced permeability for other topically applied medicinal agents.
Fertility, pregnancy, and lactation
Treclin should be given to women of childbearing potential only if effective contraception is used during treatment and for 4 weeks after stopping treatment.
There is not a substantial amount of data regarding the use of Treclin in pregnant women.
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 fetus/new-born child.
Clindamycin has been shown to not be teratogenic in reproduction studies in rats and mice when applied via subcutaneous and oral methods.
Treclin should not be used during pregnancy, especially during the first trimester, and in women who may become pregnant.
There is not adequate data on the effects of tretinoin and clindamycin and the secretion of breast milk following the use of Treclin. It is advised that Treclin is not be used by women who are breastfeeding.
Reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin, revealed no evidence of impaired fertility.
Systemically administered tretinoin severely affects fertility. Available data regarding fertility after topical administration in humans are limited.