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RETIN-A MICRO is a brand name for Tretinoin, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
RETIN-A MICRO tretinoin gel (microsphere) should be applied once a day, to acne-prone skin areas, after washing with mild, non-medicated soap and dry skin gently. The gel may be applied at any time during the day or at bedtime. Use only a sufficient quantity of medication to cover the entire affected area lightly.
Application of excessive amounts of gel may result in “caking” of the gel and will not provide incremental efficacy. A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed, or the frequency of application increased as the patient becomes able to tolerate the treatment.
Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. RETIN-A MICRO (microsphere) applied once daily is effective in reducing the severity of acne and reducing the number of lesions.
Efficacy has not been established for less than once daily dosing frequencies. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This may be due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.
Therapeutic results may be noticed after two weeks, but more than four weeks of therapy are required before consistent beneficial effects are observed. Patients in clinical trials were treated for 12 weeks. Patients treated with RETIN-A MICRO (microsphere) may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
Patients treated with RETIN-A MICRO (microsphere) should use effective sunscreens with a minimum SPF of 15 as well as protective clothing when exposure to sun cannot be avoided. PrRETIN-A MICRO® Product Monograph Page 10 of 21 PHARMACEUTICAL INFORMATION Drug Substance Common Name: Tretinoin Chemical Name: 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclo-hexen-1-yl) -2,4,6,8, -no natetraenoic acid.
44 g/mol Physicochemical Properties Description: Tretinoin is a yellow to orange crystalline powder having a characteristic odor.
Solubility:
It is practically insoluble in water and propylene glycol, insoluble in glycerin, and slightly soluble in chloroform and ethanol. 8C. PrRETIN-A MICRO® Product Monograph Page 11 of 21 DRUG PRODUCT Composition RETIN-A MICRO tretinoin gel (microsphere) is a low irritancy formulation.
This formulation uses patented acrylates copolymer porous microspheres (MICROSPONGE System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel, without the use of oils or organic solvents like ethanol or acetone, which themselves can contribute to irritation.
RETIN-A MICRO tretinoin gel (microsphere) is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted. WARNINGS General The skin of certain sensitive individuals may become excessively dry, red, swollen, or blistered.
If these effects occur, the medication should be either discontinued until the integrity of the skin is restored or the medication should be adjusted temporarily to a level the patient can tolerate. Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful.
RETIN-A MICRO tretinoin gel (microsphere) should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. ] Use in Pregnancy: Topical tretinoin should be used by women of childbearing years only after contraceptive counselling.
It is recommended that topical tretinoin should not be used by pregnant women. There have been isolated reports of birth defects among babies born to women exposed to topical tretinoin during pregnancy. To date, there have been no adequate and well-controlled prospective studies performed in pregnant women and the teratogenic blood level of tretinoin is not known.
However, a well-conducted retrospective cohort study of babies born to women exposed to topical tretinoin during the first trimester of pregnancy found no excess birth defects among these babies when compared with babies born to women in the same cohort who were not similarly exposed.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It is a member of the retinoid family of compounds and an endogenous metabolite of Vitamin A. 04% w/w strength, Glycerin, Disodium EDTA, Propylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Sorbic Acid, PPG-20 Methyl Glucose Ether Distearate, Cyclomethicone and Dimethicone Copolyol, Benzyl Alcohol, Trolamine, and Butylated Hydroxytoluene.
STABILITY AND STORAGE RECOMMENDATIONS Keep container closed when not in use. Store between 15o C - 25o C. Protect pump containers from heat. 1% w/w are supplied as 50 g pumps and 2 g tubes (samples). 04% w/w This leaflet is part III of a three-part “Product Monograph” published when RETIN-A-MICRO was approved for sale in Canada and is designed specifically for Consumers.
This leaflet is a summary and will not tell you everything about RETIN-A MICRO. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION What the medication is used for:
RETIN-A MICRO contains tretinoin which is related to Vitamin A. RETIN-A MICRO is effective against: blackheads, whiteheads, and inflammatory lesions of acne such as papules and pustules. It is applied to the skin.
What it does:
This medicine works by causing the outer layer of the skin to grow more rapidly, which decreases the amount of the protein “keratin” in the skin. As a result, the surface layer of the skin becomes thinner and pores are less likely to become blocked, reducing the occurrence of whiteheads, blackheads and pimples.
When it should not be used:
Do not use if you have an allergy to RETIN-A or any of the ingredients.
What the medicinal ingredient is:
Tretinoin What the important nonmedicinal ingredients are: Other components of this formulation are Purified Water, Carbomer, Glycerin, Disodium EDTA, Propylene Glycol, Propylene Glycol Dicaprylate/Dicaprate, Sorbic Acid, PPG-20 Methyl Glucose Ether Distearate, Cyclomethicone and Dimethicone Copolyol, Benzyl Alcohol, Trolamine, and Butylated Hydroxytoluene.
1% w/w strengths. It is supplied as a topical gel in a 50 g pump. WARNINGS AND PRECAUTIONS BEFORE you use RETIN-A MICRO talk to your doctor or pharmacist if: You are pregnant or might become pregnant. If you are female of child-bearing age, you should only use Retin- A Micro after consulting your doctor and seeking advice for contraceptive counselling.
If you become pregnant, discontinue use of RETIN-A MICRO and consult your doctor. You are breastfeeding. It is not known if RETIN-A MICRO can pass through your milk to the baby. You are planning to be in the sun. You are using or plan to use any other medicine for your acne at the same time as […]
Oral tretinoin has been shown to be teratogenic and fetotoxic in rats when given in doses 1000 and 500 times the topical human dose, respectively. In nine (9) out of ten (10) teratology studies of topical tretinoin conducted in rats and rabbits using several formulations, there has been no evidence of teratogenicity.
In one (1) out of ten (10) studies there was an increase in fetal malformations; however, a clear causal relationship of topical tretinoin in these findings could not be established. In a repeat of this study, there were no fetal malformations.
Topical tretinoin can produce treatment-related fetal effects (delayed ossification of bones and an increase in supernumerary ribs). 0 mg/kg/day (200 times the recommended clinical dose). ] Nursing Mothers It is not known whether RETIN-A MICRO (microsphere) is excreted in human milk.
Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Since many drugs are excreted in human milk, caution should be exercised when tretinoin is administered to a nursing mother.
PRECAUTIONS General Precautions RETIN-A MICRO tretinoin gel (microsphere) is for external use only. Although recent studies have shown that RETIN-A MICRO (microsphere) does not cause phototoxicity or photoallergy, unprotected exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A MICRO (microsphere).
Patients with sunburn should be advised not to use the product until fully recovered because of the possibility of a heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to their occupation and those with inherent sensitivity to the sun should exercise particular caution.
Use of sunscreen products (at least SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided. ] Local Irritation Excessive skin dryness may be experienced; if so, use of an appropriate emollient during the day may be helpful.
The skin of certain sensitive individuals may become excessively dry, red, swollen, or blistered. If these effects occur, the medication should be either discontinued until the integrity of the skin is restored or the medication should be adjusted temporarily to a level the patient can tolerate.
RETIN-A MICRO (microsphere) should be kept away from the eyes, the mouth, angles of the nose and mucous membranes. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.
Medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin.
Avoid contact with the peel of limes. g. plucking, electrolysis, depilatories) but should avoid these procedures at night before applying RETIN-A MICRO (microsphere) as they might result in skin irritation. Weather extremes, such as wind or cold, also may be irritating to patients being treated with tretinoin.
Drug Interactions Caution should be exercised with the simultaneous use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO (microsphere). It also is advisable to allow the effects of such preparations to subside before use of RETIN-A MICRO (microsphere) is begun.
Concomitant topical medication medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin.
Avoid contact with the peel […]