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The clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for such complications. However, the majority of these abnormalities resolve without interruption of tretinoin or after completion of treatment. Tretinoin has potentially significant toxic side effects in APL patients. Supportive care appropriate for APL patients, e.

Therefore, caution should be exercised when treating patients with the combination of tretinoin and anti-fibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin see Drug Interactions.

As tretinoin is metabolized by the hepatic P system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Medications that generally induce hepatic P enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine.

To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of tretinoin. As with other retinoids, tretinoin must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

No long term carcinogenicity studies with tretinoin have been conducted. A twofold increase in the sister chromatid exchange SCE has been demonstrated in human diploid fibroblasts, but other chromosome aberration assays, including an in vitro assay in human peripheral lymphocytes and an in vivo mouse micronucleus assay, did not show a clastogenic or aneuploidogenic effect.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from tretinoin in nursing infants, mothers should discontinue nursing prior to taking this drug.

Of the total number of subjects in clinical studies of tretinoin, No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Virtually all patients experience some drug related toxicity, especially headache, fever, weakness, and fatigue.

These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage. The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with tretinoin.

APL patients treated with tretinoin have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension and has been observed with or without concomitant leukocytosis.

Some patients have expired due to progressive hypoxemia and multi-organ failure. The management of the syndrome has not been defined rigorously, but high dose steroids given at the first signs of the syndrome appear to reduce morbidity and mortality. Treatment with dexamethasone, 10 mg intravenously administered every 12 hours for 3 days or until resolution of symptoms, should be initiated without delay at the first suspicion of symptoms one or more of the following: fever, dyspnea, weight gain, abnormal chest auscultatory findings or radiographic abnormalities.

Sixty percent or more of patients treated with tretinoin may require high dose steroids because of these symptoms. The majority of patients do not require termination of tretinoin therapy during treatment of the syndrome. Respiratory system disorders were commonly reported in APL patients administered tretinoin. Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported.

Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia.

These symptoms have quickly resolved without apparent residual effects. There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first. Optimal consolidation or maintenance regimens have not been determined. Two-piece hard gelatin capsule with brown opaque cap and dark yellow opaque body, filled with yellow viscous oily suspension.

Imprinted in black ink with stylized barr Available in bottles of capsules NDC Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required.

There is an extremely high risk that a deformed baby will result if you become pregnant while taking tretinoin, in any amount, for even short periods of time. Potentially any exposed fetuses can be affected.

There is also an increased risk of miscarriage. Premature births may also occur. Effective contraception birth control should be discussed with your doctor.

Two forms of reliable contraception must be used during therapy, and must be continued for one month after tretinoin treatment has stopped. If directed by your doctor, two forms of reliable contraception must also be used simultaneously for at least one month before beginning therapy.

It is recommended that you either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. 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. Tretinoin should not be taken by nursing mothers since it is not known whether it is excreted in human milk.

Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from tretinoin, mothers should discontinue nursing prior to taking this drug. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels.

We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Mechanism of Action Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. Pharmacokinetics Tretinoin activity is primarily due to the parent drug.

Pregnancy Category D See boxed WARNINGS 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. Patients Without the t 15;17 Translocation Initiation of therapy with tretinoin may be based on the morphological diagnosis of acute promyelocytic leukemia. Pseudotumor Cerebri Retinoids, including tretinoin, have been associated with pseudotumor cerebri benign intracranial hypertension , especially in pediatric patients.

General Tretinoin has potentially significant toxic side effects in APL patients. Laboratory Tests The patient's hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently.

Drug Interactions Limited clinical data on potential drug interactions are available. Drugs Metabolized By the Hepatic P System As tretinoin is metabolized by the hepatic P system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system.

Vitamin A As with other retinoids, tretinoin must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

Anti-fibrinolytic Agents Such as Tranexamic Acid, Aminocaproic Acid, or Aprotinin Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with tretinoin and anti-fibrinolytic agents. Effect of Food No data on the effect of food on the absorption of tretinoin are available. Carcinogenesis, Mutagenesis and Impairment of Fertility No long term carcinogenicity studies with tretinoin have been conducted.

Nursing Mothers It is not known whether this drug is excreted in human milk. Pediatric Use There are limited clinical data on the pediatric use of tretinoin. Geriatric Use Of the total number of subjects in clinical studies of tretinoin, RA-APL Syndrome APL patients treated with tretinoin have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure.

Respiratory System Disorders Respiratory system disorders were commonly reported in APL patients administered tretinoin. Miscellaneous Adverse Events Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported. Additional Adverse Reactions Reported With Tretinoin Cardiovascular Cases of thrombosis both venous and arterial involving various sites e.

Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Blood samples were taken at baseline and immediately prior to treatment on days 1, 5, 10 and On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours, post-treatment. The range of plasma concentrations of tretinoin and its metabolites, cis-retinoic acid and all-transoxo-retinoic acid at baseline and after multiple once daily applications of Tretinoin Gel, 0. Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients.

A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results.

Studies in hairless albino mice with a different formulation suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect was confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight not statistically significant decreases in sperm count and motility were seen at 0. The safety and efficacy of Tretinoin Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two week prospective, multi-center, randomized, controlled trials.

Efficacy results at Week 12 are presented in Table 3. Success on the 6-point Global Severity Score is defined as a score of 0 clear or 1 very mild. In Trial 2, subjects were also required to have at least two grades reduction from baseline for success. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups. Protect from freezing. Keep out of reach of children. Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel.

Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating. Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel. Warn patients of the drying and irritation effects often seen during treatment.

Continue use of the medication if these effects are tolerable. Caution patients against application of Tretinoin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation. Minimize exposure to sunlight, including sunlamps.

Recommend the use of sunscreen products and protective apparel e. Patient Information Tretinoin Gel, 0. Important information: Tretinoin Gel is for use on skin only. Do not get Tretinoin Gel in your mouth, eyes, vagina, or the corners of your nose. Tretinoin Gel is a prescription medicine used on the skin topical to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.

Before using Tretinoin Gel, tell your healthcare provider about all of your medical conditions, including if you:. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use.

Especially tell your healthcare provider if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with Tretinoin Gel. Tretinoin Gel may cause skin irritation, including: skin dryness, burning, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using Tretinoin Gel for a while, decrease the number of times you apply Tretinoin Gel, or completely stop treatment with Tretinoin Gel.

It is not known if Tretinoin Gel is effective when used less than 1 time a day. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the side effects possible with Tretinoin Gel. Call your doctor for medical advice about side effects.

General information about the safe and effective use of Tretinoin Gel. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tretinoin Gel for a condition for which it was not prescribed. Do not give Tretinoin Gel to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tretinoin Gel that is written for health professionals.

Inactive ingredients: benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine. All rights reserved. Food and Drug Administration. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

Approval: Keep away from eyes, mouth, nasal creases, and mucous membranes. Use sunscreen of at least SPF 15 and protective clothing during exposure.

Tretinoin Gel is indicated for topical treatment of acne vulgaris. For topical use only. Not for ophthalmic, oral, or intravaginal use. Gel, 0. Weather extremes, such as wind or cold, also may be irritating to tretinoin-treated skin. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. What is Tretinoin Gel? It is not known if Tretinoin Gel is safe and effective in children under 10 years of age.

What should I tell my healthcare provider before using Tretinoin Gel? Tretinoin Gel contains fish proteins. Tell your healthcare provider if you get hives or itching during treatment with Tretinoin Gel. It is not known if Tretinoin Gel will harm your unborn baby. It is not known if Tretinoin Gel passes into your breast milk.

How should I use Tretinoin Gel? Rinse and pat your skin dry. Gently rub Tretinoin Gel into your skin.

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DailyMed - TRETINOIN capsule, liquid filled

Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission CR.

The exact mechanism of action of tretinoin in APL is unknown. Tretinoin activity is primarily due to the parent drug. In human pharmacokinetics studies, orally administered drug was well absorbed into the systemic circulation, with approximately two-thirds of the administered radiolabel recovered in the urine.

The terminal elimination half-life of tretinoin following initial dosing is 0. There is evidence that tretinoin induces its own metabolism. Plasma tretinoin concentrations decrease on average to one-third of their day 1 values during 1 week of continuous therapy. Time to reach peak concentration was between 1 and 2 hours. The apparent volume of distribution of tretinoin has not been determined. Tretinoin metabolites have been identified in plasma and urine. Cytochrome P enzymes have been implicated in the oxidative metabolism of tretinoin.

Metabolites include cis retinoic acid, 4-oxo trans retinoic acid, 4-oxo cis retinoic acid, and 4-oxo trans retinoic acid glucuronide. Studies with radiolabeled drug have demonstrated that after the oral administration of 2.

The pharmacokinetics of tretinoin have not been separately evaluated in women, in members of different ethnic groups, or in individuals with renal or hepatic insufficiency. The precise cytochrome P enzymes involved in these interactions have not been specified; CYP 3A4, 2C8 and 2E have been implicated in various preliminary reports.

Results are shown in the following table:. The median time to CR was between 40 and 50 days range: 2 to days. Most patients in these studies received cytotoxic chemotherapy during the remission phase.

Ten of 15 pediatric cases achieved CR 8 of 10 males and 2 of 5 females. There were insufficient patients of black, Hispanic or Asian derivation to estimate relative response rates in these groups, but responses were seen in each category. Responses were seen in 3 of 4 patients for whom cytogenetic analysis failed to detect the t 15;17 translocation typically seen in APL.

Tretinoin is for the induction of remission only. Tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids. 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.

Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Gross external, soft tissue and skeletal alterations occurred at doses higher than 0. There are no adequate and well-controlled studies in pregnant women. Although experience with humans administered tretinoin is extremely limited, increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been documented in humans.

Reported defects include abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency.

Some of these abnormalities were fatal. All fetuses exposed during pregnancy can be affected and at the present time there is no antepartum means of determining which fetuses are and are not affected. Effective contraception must be used by all females during tretinoin therapy and for 1 month following discontinuation of therapy. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously, unless abstinence is the chosen method.

If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing or terminating the pregnancy. Initiation of therapy with tretinoin may be based on the morphological diagnosis of acute promyelocytic leukemia. Confirmation of the diagnosis of APL should be sought by detection of the t 15;17 genetic marker by cytogenetic studies. The response rate of other AML subtypes to tretinoin has not been demonstrated; therefore, patients who lack the genetic marker should be considered for alternative treatment.

Retinoids, including tretinoin, have been associated with pseudotumor cerebri benign intracranial hypertension , especially in pediatric patients. Patients with these symptoms should be evaluated for pseudotumor cerebri, and, if present, appropriate care should be instituted in concert with neurological assessment. The clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for such complications.

However, the majority of these abnormalities resolve without interruption of tretinoin or after completion of treatment. Tretinoin has potentially significant toxic side effects in APL patients. Supportive care appropriate for APL patients, e. Therefore, caution should be exercised when treating patients with the combination of tretinoin and anti-fibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin see Drug Interactions.

The ability to drive or operate machinery might be impaired in patients treated with tretinoin, particularly if they are experiencing dizziness or severe headache. The patient's hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently. As tretinoin is metabolized by the hepatic P system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system.

Medications that generally induce hepatic P enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine.

Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with tretinoin and anti-fibrinolytic agents. No data on the effect of food on the absorption of tretinoin are available. The absorption of retinoids as a class has been shown to be enhanced when taken together with food. No long term carcinogenicity studies with tretinoin have been conducted. A twofold increase in the sister chromatid exchange SCE has been demonstrated in human diploid fibroblasts, but other chromosome aberration assays, including an in vitro assay in human peripheral lymphocytes and an in vivo mouse micronucleus assay, did not show a clastogenic or aneuploidogenic effect.

Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Some pediatric patients experience severe headache and pseudotumor cerebri, requiring analgesic treatment and lumbar puncture for relief.

Increased caution is recommended in the treatment of pediatric patients. Of the total number of subjects in clinical studies of tretinoin, No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Virtually all patients experience some drug related toxicity, especially headache, fever, weakness, and fatigue. These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage.

The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with tretinoin. APL patients treated with tretinoin have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure.

This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension and has been observed with or without concomitant leukocytosis. Some patients have expired due to progressive hypoxemia and multi-organ failure. The management of the syndrome has not been defined rigorously, but high dose steroids given at the first signs of the syndrome appear to reduce morbidity and mortality.

Treatment with dexamethasone, 10 mg intravenously administered every 12 hours for 3 days or until resolution of symptoms, should be initiated without delay at the first suspicion of symptoms one or more of the following: fever, dyspnea, weight gain, abnormal chest auscultatory findings or radiographic abnormalities.

Cases of thrombosis both venous and arterial involving various sites e. Rare cases of vasculitis, predominantly involving the skin, have been reported. In case of overdose with tretinoin, reversible signs of hypervitaminosis A headache, nausea, vomiting, mucocutaneous symptoms can appear. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia.

Imprinted in black ink with stylized barr Available in bottles of capsules NDC Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. There is an extremely high risk that a deformed baby will result if you become pregnant while taking tretinoin, in any amount, for even short periods of time. Potentially any exposed fetuses can be affected. There is also an increased risk of miscarriage.

Premature births may also occur. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight not statistically significant decreases in sperm count and motility were seen at 0.

Keep out of reach of children. Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel. Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating. Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel.

Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel e. Patient Information Tretinoin Gel, 0. Important information: Tretinoin Gel is for use on skin only. Do not get Tretinoin Gel in your mouth, eyes, vagina, or the corners of your nose. Tretinoin Gel is a prescription medicine used on the skin topical to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tretinoin Gel for a condition for which it was not prescribed. Do not give Tretinoin Gel to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Tretinoin Gel that is written for health professionals. Inactive ingredients: benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging.

Approval: Keep away from eyes, mouth, nasal creases, and mucous membranes. Use sunscreen of at least SPF 15 and protective clothing during exposure. Tretinoin Gel is indicated for topical treatment of acne vulgaris. For topical use only. Not for ophthalmic, oral, or intravaginal use.

Gel, 0. Weather extremes, such as wind or cold, also may be irritating to tretinoin-treated skin. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.

What is Tretinoin Gel? It is not known if Tretinoin Gel is safe and effective in children under 10 years of age. What should I tell my healthcare provider before using Tretinoin Gel? Tretinoin Gel contains fish proteins. Tell your healthcare provider if you get hives or itching during treatment with Tretinoin Gel.

It is not known if Tretinoin Gel will harm your unborn baby. It is not known if Tretinoin Gel passes into your breast milk. How should I use Tretinoin Gel? Rinse and pat your skin dry. Gently rub Tretinoin Gel into your skin. Using too much Tretinoin Gel may irritate or increase the irritation of your skin, and will not give faster or better results.

What should I avoid while using Tretinoin Gel? Skin treated with Tretinoin Gel may dry out or get wind burned more easily. Talk to your healthcare provider about ways to manage skin irritation.

What are the possible side effects of Tretinoin Gel? How should I store Tretinoin Gel? Keep Tretinoin Gel and all medicines out of the reach of children. General information about the safe and effective use of Tretinoin Gel Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. What are the ingredients of Tretinoin Gel?

❾-50%}

- 5.1 Skin Irritation

Tretinoin should not be taken by nursing mothers since it is not known whether it is excreted in human milk. Do not use Tretinoin Gel for a condition for which it was not prescribed. There are no well-controlled trials in pregnant women treated with Tretinoin Gel.

The patient's hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently.

The absorption of retinoids as a class has been shown to be enhanced when taken together with food. No long term carcinogenicity studies with tretinoin have been conducted.

A twofold increase in the sister chromatid exchange SCE has been demonstrated in human diploid fibroblasts, but other chromosome aberration assays, including an in vitro assay in human peripheral lymphocytes and an in vivo mouse micronucleus assay, did not show a clastogenic or aneuploidogenic effect.

There are limited clinical data on the pediatric use of tretinoin. Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Some pediatric patients experience severe headache and pseudotumor cerebri, requiring analgesic treatment and lumbar puncture for relief. Increased caution is recommended in the treatment of pediatric patients. Of the total number of subjects in clinical studies of tretinoin, No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Virtually all patients experience some drug related toxicity, especially headache, fever, weakness, and fatigue.

The majority of patients do not require termination of tretinoin therapy during treatment of the syndrome. Respiratory system disorders were commonly reported in APL patients administered tretinoin.

Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported. Cases of thrombosis both venous and arterial involving various sites e. Rare cases of vasculitis, predominantly involving the skin, have been reported. In case of overdose with tretinoin, reversible signs of hypervitaminosis A headache, nausea, vomiting, mucocutaneous symptoms can appear. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia.

Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first. Optimal consolidation or maintenance regimens have not been determined.

Two-piece hard gelatin capsule with brown opaque cap and dark yellow opaque body, filled with yellow viscous oily suspension.

Premature births may also occur. Effective contraception birth control should be discussed with your doctor. Two forms of reliable contraception must be used during therapy, and must be continued for one month after tretinoin treatment has stopped.

If directed by your doctor, two forms of reliable contraception must also be used simultaneously for at least one month before beginning therapy. It is recommended that you either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. 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.

Tretinoin should not be taken by nursing mothers since it is not known whether it is excreted in human milk.

DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.

View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Mechanism of Action Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. Pharmacokinetics Tretinoin activity is primarily due to the parent drug.

Distribution The apparent volume of distribution of tretinoin has not been determined. Metabolism Tretinoin metabolites have been identified in plasma and urine. Excretion Studies with radiolabeled drug have demonstrated that after the oral administration of 2. Special Populations The pharmacokinetics of tretinoin have not been separately evaluated in women, in members of different ethnic groups, or in individuals with renal or hepatic insufficiency. Pregnancy Category D See boxed WARNINGS 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.

Patients Without the t 15;17 Translocation Initiation of therapy with tretinoin may be based on the morphological diagnosis of acute promyelocytic leukemia.

Pseudotumor Cerebri Retinoids, including tretinoin, have been associated with pseudotumor cerebri benign intracranial hypertension , especially in pediatric patients.

Vitamin A As with other retinoids, tretinoin must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated. Anti-fibrinolytic Agents Such as Tranexamic Acid, Aminocaproic Acid, or Aprotinin Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with tretinoin and anti-fibrinolytic agents. Effect of Food No data on the effect of food on the absorption of tretinoin are available.

Carcinogenesis, Mutagenesis and Impairment of Fertility No long term carcinogenicity studies with tretinoin have been conducted. Nursing Mothers It is not known whether this drug is excreted in human milk. Pediatric Use There are limited clinical data on the pediatric use of tretinoin. Geriatric Use Of the total number of subjects in clinical studies of tretinoin, RA-APL Syndrome APL patients treated with tretinoin have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure.

Hematologic Rare cases of thrombocytosis have been reported. Skin Genital ulceration. Miscellaneous Adverse Events Rare cases of vasculitis, predominantly involving the skin, have been reported. Tretinoin Capsules are available as: 10 mg: Two-piece hard gelatin capsule with brown opaque cap and dark yellow opaque body, filled with yellow viscous oily suspension. Tallman MS, et al. Clinical description of 44 patients with acute promyelocytic leukemia who developed retinoic acid syndrome.

Longauer M. Drug Safety Report No. Patients who develop pruritus or urticaria should contact their healthcare provider. Because clinical trials are conducted under prescribing conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies 14 ].

There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment.

In some subjects, the skin-related adverse reactions persist throughout the treatment period. The following adverse reactions have been identified during post-approval use of Tretinoin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There are no well-controlled trials in pregnant women treated with Tretinoin Gel. Tretinoin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tretinoin Gel at doses of 0. Possible tretinoin-associated teratogenic effects craniofacial abnormalities hydrocephaly , asymmetrical thyroids, variations in ossification, and increased supernumerary ribs were noted in the fetuses of Tretinoin Gel treated animals.

These findings were not observed in control animals. Other maternal and reproductive parameters in the Tretinoin Gel treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Tretinoin Gel applied daily to a 50 kg person.

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses 8 times the clinical dose based on body surface area comparison. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tretinoin Gel is administered to a nursing woman. Safety and effectiveness in children below the age of 10 have not been established.

Safety and effectiveness in a geriatric population have not been established. Clinical studies of Tretinoin Gel did not include any subjects over age 65 to determine whether they respond differently from younger subjects.

Tretinoin Gel, 0. Chemically, tretinoin is all- trans -retinoic acid, also known as all- E -3,7-dimethyl 2,6,6-trimethyl cyclohexenyl -2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds, and a metabolite of Vitamin A. Tretinoin has a molecular weight of Other components of this formulation are benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine.

The contribution to efficacy of individual components of the vehicle has not been evaluated. Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients.

Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

Success on the 6-point Global Severity Score is defined as a score of 0 clear or 1 very mild. In Trial 2, subjects were also required to have at least two grades reduction from baseline for success. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Protect from freezing. Keep out of reach of children. Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel.

Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable. Caution patients against application of Tretinoin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation. Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel e. Patient Information Tretinoin Gel, 0.

Important information: Tretinoin Gel is for use on skin only. Do not get Tretinoin Gel in your mouth, eyes, vagina, or the corners of your nose. Tretinoin Gel is a prescription medicine used on the skin topical to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. Before using Tretinoin Gel, tell your healthcare provider about all of your medical conditions, including if you:.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use. Especially tell your healthcare provider if you use any other medicines to treat your acne, including medicated cleansers or soaps.

Using other topical acne products may increase the irritation of your skin when used with Tretinoin Gel. Tretinoin Gel may cause skin irritation, including: skin dryness, burning, redness, excessive flaking or peeling.

If you are a consumer or patient please visit this version. Patients with acute promyelocytic leukemia APL are at high risk in general and can have severe adverse reactions to tretinoin. Tretinoin should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and in a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise.

Use of tretinoin requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure.

The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of tretinoin. The management of the syndrome has not been defined rigorously, but high dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. The majority of patients do not require termination of tretinoin therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of tretinoin therapy should be considered.

Rapidly evolving leukocytosis is associated with a higher risk of life threatening complications. If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high dose steroids should be initiated immediately. Teratogenic Effects. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. If, nonetheless, it is determined that tretinoin represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence is the chosen method.

When possible, tretinoin therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment. It is available in a 10 mg gelatin capsule for oral administration.

Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, vitamin E, and white wax beeswax. The ingredients in the capsule shell include black iron oxide, red iron oxide, titanium dioxide and yellow iron oxide. Chemically, tretinoin, USP is all- trans retinoic acid and is related to retinol Vitamin A and has the following chemical name: 3,7-Dimethyl 2,6,6-trimethyl cyclohexenyl -2,4,6,8-nonatetraenoic acid.

It is a yellow to light orange crystalline powder, and has the following structural formula:. Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo.

In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission CR.

Tretinoin metabolites have been identified in plasma and urine. Cytochrome P enzymes have been implicated in the oxidative metabolism of tretinoin. Metabolites include cis retinoic acid, 4-oxo trans retinoic acid, 4-oxo cis retinoic acid, and 4-oxo trans retinoic acid glucuronide. Studies with radiolabeled drug have demonstrated that after the oral administration of 2.

Most patients in these studies received cytotoxic chemotherapy during the remission phase. Ten of 15 pediatric cases achieved CR 8 of 10 males and 2 of 5 females. There were insufficient patients of black, Hispanic or Asian derivation to estimate relative response rates in these groups, but responses were seen in each category.

Responses were seen in 3 of 4 patients for whom cytogenetic analysis failed to detect the t 15;17 translocation typically seen in APL. Tretinoin is for the induction of remission only. Tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.

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. Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Gross external, soft tissue and skeletal alterations occurred at doses higher than 0. There are no adequate and well-controlled studies in pregnant women. Although experience with humans administered tretinoin is extremely limited, increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been documented in humans.

Reported defects include abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency. Some of these abnormalities were fatal. All fetuses exposed during pregnancy can be affected and at the present time there is no antepartum means of determining which fetuses are and are not affected.

Effective contraception must be used by all females during tretinoin therapy and for 1 month following discontinuation of therapy. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously, unless abstinence is the chosen method. If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing or terminating the pregnancy.

Initiation of therapy with tretinoin may be based on the morphological diagnosis of acute promyelocytic leukemia. Confirmation of the diagnosis of APL should be sought by detection of the t 15;17 genetic marker by cytogenetic studies. The response rate of other AML subtypes to tretinoin has not been demonstrated; therefore, patients who lack the genetic marker should be considered for alternative treatment.

Retinoids, including tretinoin, have been associated with pseudotumor cerebri benign intracranial hypertensionespecially in pediatric patients.

Patients with these symptoms should be evaluated for pseudotumor cerebri, and, if present, appropriate care should be instituted in concert with neurological assessment. The clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for such complications.

Medications that generally induce hepatic P enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital.

Medications that generally inhibit hepatic P enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine. To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of tretinoin. As with other retinoids, tretinoin must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

See FDA-Approved Patient Labeling (Patient Information). The patient should be instructed to: Cleanse the treatment area thoroughly, before treatment with a. See FDA-Approved Patient Labeling (Patient Information) Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel. See FDA-Approved Patient Labeling (Patient Information). The patient should be instructed to: Cleanse the treatment area thoroughly, before treatment with a. INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) % is indicated as an adjunctive agent (see second bullet. Maintenance of. It is recommended that you either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. Non-Inflammatory Facial Lesions. Rinse and pat your skin dry. Success on the 6-point Global Severity Score is defined as a score of 0 clear or 1 very mild.

If you are a consumer or patient please visit this version. Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris. Tretinoin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Tretinoin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy. Patients treated with Tretinoin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

When treating with Tretinoin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid.

Allow the effects of such preparations to subside before use of Tretinoin Gel has begun. Each gram of Tretinoin Gel contains 0. The skin of certain individuals may become dry, red, or exfoliated while using Tretinoin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together.

Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions. Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Tretinoin Gel.

Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Tretinoin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish.

Patients who develop pruritus or urticaria should contact their healthcare provider. Because clinical trials are conducted under prescribing conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two randomized, controlled trials, subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies 14 ]. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.

Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects, the skin-related adverse reactions persist throughout the treatment period. The following adverse reactions have been identified during post-approval use of Tretinoin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Tretinoin Gel at doses of 0. Possible tretinoin-associated teratogenic effects craniofacial abnormalities hydrocephaly , asymmetrical thyroids, variations in ossification, and increased supernumerary ribs were noted in the fetuses of Tretinoin Gel treated animals.

Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.

Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic effects on fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

A total of pediatric subjects aged 10 to 16 years treated with Tretinoin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. Safety and effectiveness in a geriatric population have not been established. Clinical studies of Tretinoin Gel did not include any subjects over age 65 to determine whether they respond differently from younger subjects.

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients. A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results.

This effect was confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay. All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight not statistically significant decreases in sperm count and motility were seen at 0.

The safety and efficacy of Tretinoin Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two week prospective, multi-center, randomized, controlled trials. Efficacy results at Week 12 are presented in Table 3. Success on the 6-point Global Severity Score is defined as a score of 0 clear or 1 very mild. In Trial 2, subjects were also required to have at least two grades reduction from baseline for success.

The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups. Protect from freezing. Keep out of reach of children.

Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel. Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating. Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel. Warn patients of the drying and irritation effects often seen during treatment.

Tretinoin Gel is a prescription medicine used on the skin topical to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. Before using Tretinoin Gel, tell your healthcare provider about all of your medical conditions, including if you:. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use.

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