Microsoft word - labeling.1.14.addendum

Who should not use tr is a condition in which the skin has blackheads, whiteheads, and other pimples. T gel, USP (micr should not use tr help you find out if you ar A r low your doctor' Use other acne medicines with doctor if these side ef T If you become pr T (micr What is the most important information I should know about tr or pharmacist. talking with your doctor; so, if you have any questions or ar clude everything ther leaflet pr cine. Ther Read this information car of tretinoin gel, USP (microsphere) 0.1% relative to baseline levels. Clinical ell your doctor befor edness or peeling.
etinoin gel, USP (micr void sunlight or sunlamps and medicines that may make you mor etinoin gel, USP (micr tion if used on eczema. you pharmacokinetic studies have not been performed with tretinoin gel, USP ovides a summary of the information about etinoin gel, USP (micr e may be new information about this medicine when you get your pr INDICATIONS AND USAGE • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to etinoin gel, USP (micr Tretinoin gel, USP (microsphere) 0.1% and 0.04% is indicated for topical ap- temporarily reduce the amount or frequency of application of the medica- s instructions car egnant while using plication in the treatment of acne vulgaris. The safety and efficacy of the use tion, discontinue use temporarily, or discontinue use all together. Efficacy at etinoin gel, USP (micr of this product in the treatment of other disorders have not been established. reduced frequencies of application has not been established. If a reaction fects bother you.
e is to know about your medicine. This information does not take the place of suggesting sensitivity occurs, use of the medication should be discontin- etinoin gel, USP (micr CLINICAL STUDIES etinoin. See the list of other ingr ued. Excessive skin dryness may also be experienced; if so, use of an e taking medicines that may make you mor 1% and 0.04% Tretinoin Gel, USP etinoin gel, USP (micr Tretinoin gel, USP (microsphere) 0.1%: In two vehicle-controlled studies appropriate emollient during the day may be helpful. tretinoin gel, USP (microsphere) 0.1% applied once daily was significantly • Unprotected exposure to sunlight, including sunlamps, should be mini- mized during the use of tretinoin gel, USP (microsphere) 0.1% and 0.04%, etinoin gel, USP (micr etinoin gel, USP (micr (Microsphere) 0.1% and 0.04% more effective than vehicle in reducing the severity of acne lesion counts. The may make your skin very dry e you start to use your medicine and each time you get mor mean reductions in lesion counts from baseline after treatment for 12 weeks and patients with sunburn should be advised not to use the product until . The medicines you have used in the past might cause too much etinoin gel, USP (micr are shown in the following table: fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable escription medicine that you put on your skin to tr sun exposure due to occupation and those with inherent sensitivity to the etinoin gel, USP (micr Mean Percent Reduction in Lesion Counts sun should exercise particular caution. Use of sunscreen products (SPF Tretinoin gel, USP (microsphere) 0.1% etinoin gel, USP (micr etinoin gel, USP (micr 15) and protective clothing over treated areas are recommended when FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, exposure cannot be avoided. egnant, trying to Tretinoin gel, USP OR INTRAVAGINAL USE. • Weather extremes, such as wind or cold, also may be irritating to patients (microsphere) 0.1% etinoin gel, USP (micr under treatment with tretinoin. edients at the end of this leaflet.
e) 0.1% and 0.04% • Tretinoin gel, USP (microsphere) 0.1% and 0.04% should be kept away "What should I avoid while using tr from the eyes, the mouth, paranasal creases of the nose, and mucous Tretinoin gel, USP (microsphere) 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This Non-inflammatory e sensitive to sunlight. Y • Tretinoin has been reported to cause severe irritation on eczema- only on your doctor' ed, swollen or blister formulation uses methyl methacrylate/glycol dimethacrylate crosspolymer e about something, ask your doctor tous skin and should be used with utmost caution in patients with e sensitive to sunlight. (See porous microspheres to enable inclusion of the active ingredient, tretinoin, in , contact your doctor right away an aqueous gel. Other components of this formulation are purified water, car- bomer 974P, glycerin, disodium EDTA, propylene glycol, sorbic acid, PPG-20 Information for Patients: See Patient Information Leaflet. methyl glucose ether distearate, cyclomethicone and dimethicone copolyol, Total lesion counts ospher escription r until your skin has benzyl alcohol, trolamine, and butylated hydroxytoluene. Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with Tretinoin gel, USP (microsphere) 0.1% was also significantly superior to the Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-di- high concentrations of alcohol, astringents, or spices should be used with vehicle in the investigator's global evaluation of the clinical response. In Study caution because of possible interaction with tretinoin. Avoid contact with the Remove this portion befor #1, thirty-five percent (35%) of patients using tretinoin gel, USP (microsphere) is a member of the retinoid family of compounds, and a metabolite of naturally peel of limes. Particular caution should be exercised with the concomitant use 0.1% achieved an excellent result, as compared to eleven percent (11%) of east feeding.
occurring Vitamin A. Tretinoin has a molecular weight of 300.44. Tretinoin has of topical over-the-counter acne preparations containing benzoyl peroxide, patients on the vehicle control. In Study #2, twenty-eight percent (28%) of the following structure: sulfur, resorcinol, or salicylic acid with tretinoin gel, USP (microsphere) 0.1% patients using tretinoin gel, USP (microsphere) 0.1% achieved an excellent and 0.04%. It also is advisable to allow the effects of such preparations to result, as compared to nine percent (9%) of the patients on vehicle control.
subside before use of tretinoin gel, USP (microsphere) 0.1% or 0.04% Tretinoin gel, USP (microsphere) 0.04%: In two vehicle-controlled clinical studies tretinoin gel, USP (microsphere) 0.04% applied once daily was more Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week effective (p<0.05) than vehicle in reducing the acne lesion counts. The mean dermal study in which CD-1 mice were administered 0.017% and 0.035% reductions in lesion counts from baseline after treatment for 12 weeks are befor (micr cr higher your Y skin, and will not give faster or better r USP (micr mor tor has pr Do not use mor tr noin gel, USP (micr eyes, or open Do not put into your skin. evenly over the entir chin and both cheeks. Spr (about the size of a pea) onto your fingertip. Dab Pump: Fully depr gel, USP (micr gertip. Dab T How should I use tr ou can use a facial cr eam or lotion that will not make your acne worse. Y etinoin gel, USP (micr ube: Squeeze a small amount of formulations of tretinoin, cutaneous squamous cell carcinomas and papillo- shown in the following table: (micr use tr sensitive to sunlight. T you (micr they ar you milk to the baby you e often than your doctor has told you. T CLINICAL PHARMACOLOGY mas in the treatment area were observed in some female mice. These con- centrations are near the tretinoin concentration of these clinical formulations Mean Percent Reduction in Lesion Counts Tretinoin is a retinoid metabolite of Vitamin A that binds to intracellular recep- (0.1% and 0.04%). A dose-related incidence of liver tumors in male mice was escribed. Do not use etinoin gel, USP (micr Tretinoin gel, USP (microsphere) 0.04% once a day in the evening, or as dir skin tors in the cytosol and nucleus, but cutaneous levels of tretinoin in excess of observed at those same doses. The maximum systemic doses associated etinoin gel, USP (micr . However sor etinoin gel, USP ecommended by your doctor physiologic concentrations occur following application of a tretinoin-contain- with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/ Tretinoin gel, USP ing topical drug product. kg/day, respectively. These doses are two and four times the maximum hu- ess the pump twice to dispense a small amount of may make your face mor (microsphere) 0.04% etinoin gel, USP (micr man systemic dose applied topically, when normalized for total body surface may irritate or incr e surface of your face by gently smoothing it etinoin gel, USP (micr Although tretinoin activates three members of the retinoid acid (RAR) nuclear area. The biological significance of these findings is not clear because they eam or lotion each mor α, RARβ, and RARγ) which may act to modify gene expres- , clean your face befor evenly over the entir ell your doctor about all medicines that you ar occurred at doses that exceeded the dermal maximally tolerated dose (MTD) sion, subsequent protein synthesis, and epithelial cell growth and differentia- of tretinoin and because they were within the background natural occurrence tion, it has not been established whether the clinical effects of tretinoin are Non-inflammatory rate for these tumors in this strain of mice. There was no evidence of carci- mediated through activation of retinoic acid receptors, other mechanisms, nogenic potential when 0.025 mg/kg/day of tretinoin was administered topi- etinoin gel, USP (micr on your skin.
etinoin gel, USP (micr cally to mice (0.1 times the maximum human systemic dose, normalized for etinoin gel, USP (micr because you otection total body surface area). For purposes of comparisons of the animal exposure Mode of Action: Although the exact mode of action of tretinoin is unknown, to systemic human exposure, the maximum human systemic dose applied ease the irritation of your current evidence suggests that the effectiveness of tretinoin in acne is due Total lesion counts topically is defined as 1 gram of tretinoin gel, USP (microsphere) 0.1% applied e likely to be dry and r primarily to its ability to modify abnormal follicular keratinization. Comedones e surface of your face by gently smoothing it into your skin. on . Other acne medicines used with *That is, a mean percent increase of 2% daily to a 50 kg person (0.02 mg tretinoin/kg body weight). form in follicles with an excess of keratinized epithelial cells. Tretinoin promotes . T e using cosmetics and r ected by your doctor etinoin gel, USP (micr ning after washing near your mouth, detachment of cornified cells and the enhanced shedding of corneocytes alk to your doctor about r "What should I avoid while using tr Dermal carcinogenicity testing has not been performed with tretinoin gel, USP from the follicle. By increasing the mitotic activity of follicular epithelia, treti- Tretinoin gel, USP (microsphere) 0.04% was also superior (p<0.05) to the ve- etinoin gel, USP (micr (microsphere) 0.1% or 0.04%. hicle in the investigator's global evaluation of the clinical response. In Study noin also increases the turnover rate of thin, loosely-adherent corneocytes. ou may use cosmetics with #1, fourteen percent (14%) of patients using tretinoin gel, USP (microsphere) ehead, chin, and Through these actions, the comedo contents are extruded and the formation Studies in hairless albino mice suggest that concurrent exposure to tretinoin of the microcomedo, the precursor lesion of acne vulgaris, is reduced. 0.04% achieved an excellent result, as compared to five percent (5%) of pa- may enhance the tumorigenic potential of carcinogenic doses of UVB and tients on the vehicle control. In Study #2, nineteen percent (19%) of patients UVA light from a solar simulator. This effect has been confirmed in a later study Additionally, tretinoin acts by modulating the proliferation and differentiation using tretinoin gel, USP (microsphere) 0.04% achieved an excellent result, as in pigmented mice, and dark pigmentation did not overcome the enhance- ed and cause it to peel.
of epidermal cells. These effects are mediated by tretinoin's interaction with compared to nine percent (9%) of the patients on vehicle control. ment of photocarcinogenesis by 0.05% tretinoin. Although the significance (about the size of a pea) on your fin a family of nuclear retinoic acid receptors. Activation of these nuclear recep- of these studies to humans is not clear, patients should minimize exposure to No studies were conducted comparing the efficacy of tretinoin gel, USP emove cosmetics fr etinoin gel, USP (micr tors causes changes in gene expression. The exact mechanisms whereby sunlight or artificial ultraviolet irradiation sources. tretinoin-induced changes in gene expression regulate skin function are not (microsphere) 0.04% to tretinoin gel, USP (microsphere) 0.1%. There is no evidence that tretinoin gel, USP (microsphere) 0.1% is more efficacious than The mutagenic potential of tretinoin was evaluated in the Ames assay and in tretinoin gel, USP (microsphere) 0.04% or that tretinoin gel, USP (microsphere) the in vivo mouse micronucleus assay, both of which were negative. Pharmacokinetics: Tretinoin is a metabolite of Vitamin A metabolism in man. 0.04% is safer than tretinoin gel, USP (microsphere) 0.1%.
Percutaneous absorption, as determined by the cumulative excretion of ra- The components of the microspheres have shown potential for genetic toxicity CONTRAINDICATIONS etinoin gel, USP medicines diolabeled drug into urine and feces, was assessed in 44 healthy men and and teratogenesis. EGDMA, a component of the excipient acrylates copolymer, women. Estimates of in vivo bioavailability, mean (SD)%, following both single was positive for induction of structural chromosomal aberrations in the in vitro This drug is contraindicated in individuals with a history of sensitivity reactions and multiple daily applications, for a period of 28 days with the 0.1% gel, were chromosomal aberration assay in mammalian cells in the absence of metabolic to any of its components. It should be discontinued if hypersensitivity to any 0.82 (0.11)% and 1.41 (0.54)%, respectively. The plasma concentrations of activation, and negative for genetic toxicity in the Ames assay, the HGPRT for- of its ingredients is noted. tretinoin and its metabolites, 13-cis-retinoic acid, all-trans-4-oxo-retinoic ward mutation assay, and the mouse micronucleus assay. acid, and 13-cis-4-oxo-retinoic acid, generally ranged from 1 to 3 ng/mL and were essentially unaltered after either single or multiple daily applications In dermal Segment I fertility studies of another tretinoin formulation in rats, Non-Teratogenic Effects not been established. No irritation studies have been performed to compare slight (not statistically significant) decreases in sperm count and motility were tretinoin gel, USP (microsphere) 0.04% with either tretinoin gel, USP (micro- seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied Topical tretinoin has been shown to be fetotoxic in rabbits when administered sphere) 0.1% or tretinoin cream 0.1%.
topically, and normalized for total body surface area), and slight (not statisti- 0.5 mg/kg/day (8 times the maximum human systemic dose applied topi- cally significant) increases in the number and percent of nonviable embryos in cally and normalized for total body surface area), resulting in fetal resorptions The skin of certain sensitive individuals may become excessively red, females treated with 0.25 mg/kg/day (2 times the maximum human systemic and variations in ossification. Oral tretinoin has been shown to be fetotoxic, edematous, blistered, or crusted. If these effects occur, the medication dose applied topically and normalized for total body surface area) and above resulting in skeletal variations and increased intrauterine death in rats when should either be discontinued until the integrity of the skin is restored, were observed. In oral Segment I and Segment III studies in rats with tretinoin, administered 2.5 mg/kg/day (21 times the maximum human systemic dose or the medication should be adjusted to a level the patient can tolerate. decreased survival of neonates and growth retardation were observed at applied topically and normalized for total body surface area). However, efficacy has not been established for lower dosing frequencies doses in excess of 2 mg/kg/day (17 times the human topical dose normalized (see DOSAGE AND ADMINISTRATION Section). for total body surface area). There are, however no adequate and well-controlled studies in pregnant women. True contact allergy to topical tretinoin is rarely encountered. Temporary hy- Dermal fertility and perinatal development studies with tretinoin gel, USP Animal Toxicity Studies: In male mice treated topically with tretinoin gel, USP per- or hypopigmentation has been reported with repeated application of treti- (microsphere) 0.1% or 0.04% have not been performed in any species. (microsphere) 0.1% at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times noin. Some individuals have been reported to have heightened susceptibility escribed by your doctor the maximum human systemic dose after topical administration of tretinoin to sunlight while under treatment with tretinoin. etinoin gel, USP (micr Pregnancy: Teratogenic Effects: Pregnancy Category C. gel, USP (microsphere) 0.1% normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were In a study of pregnant rats treated with topical application of tretinoin gel, observed at the two highest doses. Similarly, in female mice there was a re- USP (microsphere) 0.1% at doses of 0.5 to 1 mg/kg/day on gestation days duction in ovarian weights, but without any underlying pathological changes, Tretinoin gel, USP (microsphere) 0.1% and 0.04% is intended for topical use 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normal- at 5.0 mg/kg/day (21 times the maximum human dose). In this study there only. If medication is applied excessively, no more rapid or better results will be ized for total body surface area after topical administration of tretinoin gel, was a dose-related increase in the plasma concentration of tretinoin 4 hours obtained and marked redness, peeling, or discomfort may occur. Oral inges- ed at 20°-25°C (68°-77°F) [See USP Contr USP (microsphere) 0.1%) some alterations were seen in vertebrae and ribs of after the first dose. A separate toxicokinetic study in mice indicates that sys- tion of large amounts of the drug may lead to the same side effects as those offspring. In another study, pregnant New Zealand white rabbits were treated temic exposure is greater after topical application to unrestrained animals associated with excessive oral intake of Vitamin A. etinoin gel, USP (micr with tretinoin gel, USP (microsphere) 0.1% at doses of 0.2, 0.5, and 1.0 mg/ than to restrained animals, suggesting that the systemic toxicity observed is kg/day, administered topically for 24 hours a day while wearing Elizabethan probably related to ingestion. Male and female dogs treated with tretinoin gel, DOSAGE AND ADMINISTRATION collars to prevent ingestion of the drug. There appeared to be increased inci- USP (microsphere) 0.1% at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or olamine, and butylated hydr Tretinoin gel, USP (microsphere) 0.1% and 0.04% should be applied once oducts, Randolph, NJ 07869 dences of certain alterations, including domed head and hydrocephaly, typical 25 times the maximum human systemic dose after topical administration of . Do not allow anyone else to use this medicine. Medicines ar a day, in the evening, to the skin where acne lesions appear, using enough of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/ tretinoin gel, USP (microsphere) 0.1% normalized for total body surface area, to cover the entire affected area lightly. Application of excessive amounts of for a condition for which it was not pr day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the respectively) for 90 days showed no evidence of reduced testicular or ovarian etinoin gel, USP (micr gel may result in "caking" of the gel, and will not provide incremental efficacy. etinoin gel, USP (micr maximum human systemic dose of tretinoin after topical administration of tret- weights or pathological changes. inoin gel, USP (microsphere) 0.1% normalized for total body surface area. In a A transitory feeling of warmth or slight stinging may be noted on application. repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, Nursing Mothers: It is not known whether this drug is excreted in human In cases where it has been necessary to temporarily discontinue therapy or e information about tr T 1-800-FDA-1088.
these effects were not seen, but a few alterations that may be associated with milk. Because many drugs are excreted in human milk, caution should be to reduce the frequency of application, therapy may be resumed or the fre- tretinoin exposure were seen. Other pregnant rabbits exposed topically for six exercised when tretinoin gel, USP (microsphere) 0.1% or 0.04% is adminis- quency of application increased as the patient becomes able to tolerate the etinoin gel, USP (micr hours to 0.5 or 0.1 mg/kg/day tretinoin while restrained in stocks to prevent tered to a nursing woman. treatment. Frequency of application should be closely monitored by careful escribed for conditions not mentioned in patient information leaflets. Do not use edient opylene glycol, sorbic acid, PPG-20 methyl glucose ether distearate, cyclomethicone and ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 observation of the clinical therapeutic response and skin tolerance. Efficacy ed by DPT Laboratories, San Antonio, TX 78215 mg/kg/day) the maximum human systemic dose after topical administration Pediatric Use: Safety and effectiveness in children below the age of 12 have has not been established for less than once daily dosing frequencies. of tretinoin gel, USP (microsphere) 0.1% adjusted for total body surface area, not been established. but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin Geriatric Use: Safety and effectiveness in a geriatric population have not During the early weeks of therapy, an apparent exacerbation of inflammatory in non tretinoin gel, USP (microsphere) formulations was not teratogenic in been established. Clinical studies of tretinoin gel, USP (microsphere) did not lesions may occur. If tolerated, this should not be considered a reason to etinoin gel, USP (micr rats and rabbits when given in doses of 42 and 27 times the maximum human General Information about tr This medicine is for your use only sometimes pr tr The dium EDT dimethicone copolyol, benzyl alcohol, tr Tretinoin gel, USP (micr Temperatur You can ask your doctor or pharmacist for the information about written for health pr CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MA EFFECTS TO FDA A Distributed by Spear Dermatology Pr include sufficient numbers of subjects aged 65 and over to determine whether discontinue therapy. e dispensing systemic dose after topical administration of tretinoin gel, USP (microsphere) they respond differently from younger subjects. 0.1% normalized for total body surface area, respectively, (assuming a 50 Therapeutic results may be noticed after two weeks, but more than seven kg adult applied a daily dose of 1.0 g of 0.1% gel topically). At these topical ADVERSE REACTIONS weeks of therapy are required before consistent beneficial effects are ob- doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed. Irritation Potential Patients treated with tretinoin gel, USP (microsphere) 0.1% or 0.04% may use Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, ham- Acne clinical trial results: In separate clinical trials for each concentration with cosmetics, but the areas to be treated should be cleansed thoroughly before sters, and subhuman primates. Tretinoin was teratogenic in Wistar rats acne patients treated with tretinoin gel, USP (microsphere) 0.1% or 0.04%, the medication is applied. when given orally or topically in doses greater than 1 mg/kg/day (8 times analysis over the 12 week period showed that cutaneous irritation scores for the maximum human systemic dose normalized for total body surface area). erythema, peeling, dryness, burning/stinging, or itching peaked during the Remove this portion befor However, variations in teratogenic doses among various strains of rats have initial 2 weeks of therapy, decreasing thereafter. eactions can usually Tretinoin Gel, USP (Microsphere) 0.1% tube: ell your doctor if these been reported. In the cynomolgus monkey, which metabolically is more similar 20g (NDC 66530-250-20) and 45g (NDC 66530-250-45). alk to your doctor about ed, or crusted with these our doctor may ask you etinoin gel, USP (micr to humans than other species in its handling of tretinoin, fetal malformations Approximately half of the patients treated with tretinoin gel, USP (microsphere) etinoin gel, USP (micr may work better for some etinoin gel, USP (micr were reported for doses of 10 mg/kg/day or greater, but none were observed 0.04% had cutaneous irritation at Week 2. Of those patients who did experi- Tretinoin Gel, USP (Microsphere) 0.1% pump: fects may go away or bother eatment. Some patients also at 5 mg/kg/day (83 times the maximum human systemic dose normalized for ence cutaneous side effects, most had signs or symptoms that were mild 50g (NDC 66530-250-50). otect you fr ned mor e those that contain astringents, total body surface area), although increased skeletal variations were observed in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, etinoin gel, USP (micr at all doses. Dose-related increases in embryolethality and abortion also were 2=moderate, and 3=severe). Less than 10% of patients experienced moder- Tretinoin Gel, USP (Microsphere) 0.04% tube: ospher even after your acne impre) . If you do get sunbur is skin irritation. This can include skin eatment. These r oblem, talk to your doctor reported. Similar results have also been reported in pigtail macaques. ate cutaneous irritation and there was no severe irritation at Week 2.
20g (NDC 66530-251-20) and 45g (NDC 66530-251-45). important to continue otected. Do not use sunlamps. for a few weeks. T Topical tretinoin in animal teratogenicity tests has generated equivocal results. In studies on tretinoin gel, USP (microsphere) 0.04%, throughout the treat- Tretinoin Gel, USP (Microsphere) 0.04% pump: ed, swollen, blister een with a SPF 15 rating or higher sunlight.
There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin ment period the majority of patients experienced some degree of irritation 50g (NDC 66530-251-50).
in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum hu- (mild, moderate, or severe) with 1% (2/225) of patients having scores indica- egular application of ed, swollen, or blister eactions happen to about half of the people using etinoin gel, USP (micr man systemic dose normalized for total body surface area). Anomalies (hu- tive of a severe irritation rating; and 1.3% (3/225) of patients treated with treti- Storage Conditions: Store at 20°-25°C (68°-77°F) [See USP Controlled merus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also noin gel, USP (microsphere) 0.04% discontinued treatment due to irritation, you should be pr ned mor Room Temperature]. been reported when 10 mg/kg/day was topically applied. Supernumerary ribs which included dryness in one patient and peeling and urticaria in another.
e than seven weeks of using etinoin gel, USP (micrtr have been a consistent finding in rats when dams were treated topically or In studies on tretinoin gel, USP (microsphere) 0.1%, no more than 3% of pa- etinoin gel, USP (micr may dry out or get windbur . If the discomfort is a pr for a while, change the amount of orally with retinoids. tients had cutaneous irritation scores indicative of a severe irritation rating; etinoin gel, USP (micr There are no adequate and well-controlled studies in pregnant women. treti- although, 6% (14/224) of patients treated with tretinoin gel, USP (microsphere) etinoin gel, USP (micr ou should talk to your doctor about the use of all skin car oves by 4 weeks after starting tr noin gel, USP (microsphere) 0.1% and 0.04% should be used during preg- 0.1% discontinued treatment due to irritation. Of these 14 patients, four had etinoin gel, USP (micr etinoin gel, USP (micrtr nancy only if the potential benefit justifies the potential risk to the fetus. severe irritation after 3 to 5 days of treatment, with blistering in one patient. until your skin is completely back to normal. T our doctor may change your dose of . If this happens to you, it is just your skin getting used to ol you should continue r our skin may become very dry etinoin gel, USP (micr With widespread use of any drug, a small number of birth defect reports as- Results in studies of subjects without acne: In a half-face comparison trial fects possible with sociated temporally with the administration of the drug would be expected conducted for up to 14 days in women with sensitive skin, but without acne, e you see the full benefit.
e skin irritation or skin irritation that will not go away by chance alone. Thirty human cases of temporally associated congenital tretinoin gel, USP (microsphere) 0.1% was statistically less irritating than may make you get sunbur ospher Manufactured by DPT Laboratories, San Antonio, TX 78215 ovement right away malformations have been reported during two decades of clinical use of topi- tretinoin cream 0.1%. In addition, a cumulative 21 day irritation evaluation in a wide etinoin gel, USP (micr . This usually impr cal tretinoin. Although no definite pattern of teratogenicity and no causal as- subjects with normal skin showed that tretinoin gel, USP (microsphere) 0.1% Distributed by Spear Dermatology Products, Randolph, NJ 07869 esults after two weeks, but mor sociation has been established from these cases, five of the reports describe had a lower irritation profile than tretinoin cream 0.1%. The clinical significance , you may notice new pimples. At this stage, it is and call your doctor etinoin gel, USP (micr the rare birth defect category holoprosencephaly (defects associated with of these irritation studies for patients with acne is not established. Compa- etinoin gel, USP (micr e using, or change the times that you use oducts that may dry or irritate your skin. Such pr e) etinoin gel, USP (micr edness or peeling.
ning, stinging, itching, dryness, and peeling. Some of these side ef incomplete midline development of the forebrain). The significance of these rable effectiveness of tretinoin gel, USP (microsphere) 0.1% and tretinoin otect your skin if you must be in sunlight a lot.
spontaneous reports in terms of risk to the fetus is not known. cream 0.1% has not been established. The lower irritancy of tretinoin gel, until your doctor instructs otherwise.
e the possible side ef e not all the side ef USP (microsphere) 0.1% in subjects without acne may be attributable to the clothing, eated with fects become a pr properties of its vehicle. The contribution to decreased irritancy by the methyl e may be some mild discomfort or peeling during the early weeks of tr methacrylate/glycol dimethacrylate crosspolymer porous microspheres has etinoin gel, USP (micr void cold weather and wind as much as possible and use clothing to pr oducts. If you get sever etinoin gel, USP (micr You may not see impr patients than for others. Keep using may notice some r spher Early in therapy USP (micr Once your acne is under contr spher What should I avoid while using tr Spend as little time as possible in the sun. Use a daily sunscr tective ar gel, USP (micr tr how to pr A alcohol, or spices and include certain medicated soaps, shampoos and hair permanent solutions. A contact with the peel of limes. Y pr (micr while using A medicated soap and wash gently and pat dry Talk could cause r A brief feeling of warmth or stinging may be normal when you apply (micr The most common side ef redness, bur you less after you have used side ef However been pr Ther notice that their skin begins to take on a blush. These r tr USP (micr be lessened by following instructions car Call your doctor right away if your face becomes very dry to stop using spher These ar ask your doctor or pharmacist.

Source: http://www.spearpharma.com/wp-content/uploads/2013/07/TretinoinMicrosphereGel.pdf