Clinical studies of Tretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. Topical use may induce severe local erythema and peeling at the site of application. Avoid frequent washings and harsh scrubbing.Call your doctor for medical advice about side effects. Although no definite pattern of teratogenicity and no causal association have been established from these cases, five of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The medications you have used in the past might cause unnecessary redness or peeling.To get the best results with tretinoin cream therapy, it is necessary to use it properly. However, investigations in this area are continuing.There have been reports that, in some patients, areas treated with Tretinoin developed a temporary increase or decrease in the amount of skin pigment (color) present. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from Tretinoin Capsules in nursing infants, mothers should discontinue nursing prior to taking this drug.There are limited clinical data on the pediatric use of Tretinoin Capsules. Supportive care appropriate for APL patients, eg, prophylaxis for bleeding, prompt therapy for infection, should be maintained during therapy with Tretinoin Capsules.There is a risk of thrombosis (both venous and arterial) which may involve any organ system, during the first month of treatment (see The ability to drive or operate machinery might be impaired in patients treated with Tretinoin Capsules, particularly if they are experiencing dizziness or severe headache.Microdosed progesterone preparations (“minipill”) may be an inadequate method of contraception during treatment with Tretinoin Capsules.The patient’s hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently.Limited clinical data on potential drug interactions are available.As Tretinoin Capsules are metabolized by the hepatic P450 system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Some of these abnormalities were fatal. Molecular genetic studies were not conducted in these cases, but it is likely they represent cases with a masked translocation giving rise to PML/RARα. Liver function test results should be carefully monitored during treatment and consideration be given to a temporary withdrawal of Tretinoin Capsules if test results reach >5 times the upper limit of normal values. Not available in select states including MA, MT, NH, NY, and TX, due to state regulations regarding the ability of physicians to dispense prescription drug products in their offices. Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. Adverse effects of tretinoin cream have been reversible upon discontinuation of therapy (see If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Patients undergoing therapy should be closely observed for signs of respiratory compromise and/or leukocytosis (see boxed WARNINGS). A dose-related incidence of liver tumors in male mice was observed at those same doses. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with Tretinoin. h�23V0P03U01Q03Q042R���w�/�+r��3S���� Efficacy at reduced frequencies of application has not been established. Carcinogenesis, Mutagenesis and Impairment of FertilityTHIS LEAFLET TELLS YOU ABOUT TRETINOIN CREAM ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. It is recommended that you either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. Just stick to the special plan your doctor has laid out for you and be patient. Birth control must be used even if you think you cannot become pregnant, unless you have had a hysterectomy.If you are pregnant or become pregnant while on tretinoin therapy or during the month after treatment has stopped, immediately contact your doctor to discuss the desirability of continuing the pregnancy.YOU MUST NOT TAKE Tretinoin Capsules IF YOU ARE A NURSING MOTHER.Tretinoin Capsules should not be taken by nursing mothers since it is not known whether it is excreted in human milk. Tretinoin Capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.Tretinoin has teratogenic and embryotoxic effects in mice, rats, hamsters, rabbits and pigtail monkeys, and may be expected to cause fetal harm when administered to a pregnant woman.