Differin prescribing information.
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Differin prescribing information.
Differin prescribing information.
Differin prescribing information.
AlcoholQ:Can I case alcohol with Benzac AC 2. A:There is no observed interaction between this medication and alcohol. Other General WarningsTalk to your risk ifYou experience swelling or other on your skin after application of this browser, discontinue and talk to your dermatologist. You should avoid exposure of this leaflet to your eyes, sugar, nose or mucous membrane, if taking exposure happens wash it easy.
If you are a consumer or patient please visit this version. Wash affected areas gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes.
Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be reevaluated. Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. 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 and protective clothing over treated areas is recommended when exposure cannot be avoided. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication.
Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of DIFFERIN Gel or discontinue use. Avoid application to cuts, abrasions, eczematous or sunburned skin. As DIFFERIN Gel has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime should be approached with caution.
Because clinical trials are conducted under widely varying conditions, adverse reactions 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 the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in acne subjects who used DIFFERIN Gel once daily for 12 weeks.
In a one-year, open-label safety trial of subjects with acne who received DIFFERIN Gel, the pattern of adverse reactions was similar to the week controlled study. The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Risk Summary Available data from clinical trials with DIFFERIN Gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose MRHD of 2 g resulted in fetal skeletal and visceral malformations see Data. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U. Animal Data No malformations were observed in rats treated with oral adapalene doses of 0. Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6. Risk Summary There are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk see Clinical Considerations. Safety and effectiveness have not been established in pediatric patients below the age of Safety and effectiveness in geriatric patients age 65 and above have not been established.
Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3- 1-adamantyl methoxyphenyl]naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water.
The molecular formula is C 28 H 28 O 3 and molecular weight is Adapalene is represented by the following structural formula. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein.
Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes.
However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. The mean AUC hr was 8. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.
Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. Seventy-eight 78 subjects had plasma adapalene levels evaluated at Weeks 2, 8, and The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0. The highest dose levels are 3. In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed.
Adapalene was not mutagenic or genotoxic in vitro Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay or in vivo mouse micronucleus test. The safety and efficacy of once daily use of DIFFERIN Gel for treatment of acne vulgaris were assessed in one 12 week, multi-center, controlled, clinical trial, conducted in a total of subjects 12 to 52 years of age with acne vulgaris of mild to moderate severity.
All female subjects of child-bearing potential enrolled in the trial were required to have a negative urine pregnancy test at the beginning of the trial and were required to practice a highly effective method of contraception during the trial. Female subjects who were pregnant, nursing or planning to become pregnant were excluded from the trial. An equal number of males The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table:.
Protect from freezing. Keep out of reach of children. Important: For use on the skin only topical. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples. Tell your doctor about all the medicines you takeincluding prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use any other medicine for acne.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. You may use a moisturizer for relief of dry skin or irritation, however you should avoid products that contain alpha hydroxy or glycolic acid.
Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. It may harm them.
If you would like more information, talk with your doctor. Active ingredient: adapalene Inactive ingredients: carbomeredetate disodium, methylparaben, poloxamerpropylene glycol, purified water and sodium hydroxide.
This Patient Information has been approved by the U. Food and Drug Administration. All trademarks are the property of their respective owners. Usual dosage: apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information. Each gram contains: adapalene 0.
For topical use only. Not for ophthalmic, oral, or intravaginal use. Usual dosage: Apply a thin film once a day at nighttime to affected areas. May also contain hydrochloric acid for pH adjustment.
See carton closure for lot number and expiration date. 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 RxImagewe 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: Not for ophthalmic, oral or intravaginal use. Wear sunscreen when sun exposure cannot be avoided 5. Concomitant use of other potentially irritating topical products medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime should be approached with caution.
Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0. The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table: Table 3: Clinical study primary efficacy results at Week 12 DIFFERIN adapalene Gel, 0. Apply a thin film of DIFFERIN Gel to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.
Package insert / prescribing information. Generic name: adapalene. Dosage form: cream. Drug class: Topical acne agents. Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically. See full prescribing information for DIFFERIN (adapalene) Gel, DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years. Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically. DIFFERIN Gel, %, is a retinoid, indicated for the topical treatment of acne *Sections or subsections omitted from the full prescribing information. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A. Labeler - Galderma Laboratories, L. Excretion appears to be primarily by the biliary route.Manufacturer: Galderma. Full Prescribing Info. Differin Gel contains 0. Differin Cream contains 0. Pharmacology: Adapalene is a retinoid-like compound which, in in vivo and in vitro models of inflammation, has been demonstrated to possess anti-inflammatory properties; Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Mechanistically, adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin, not to cytosolic receptor-binding proteins.
Adapalene applied cutaneously is comedolytic in the rhino mouse model and also has effects on the abnormal processes of epidermal keratinization and differentiation, both of which are present in the pathogenesis of acne vulgaris.
The mode of action of adapalene is suggested to be a normalisation of differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Adapalene is superior to reference retinoids in standard anti-inflammatory assays, both in vivo and in vitro. Mechanistically, it inhibits chemotactic and chemokinetic responses of human polymorphonuclear leucocytes and also the metabolism by lipoxidation of arachidonic acid and to pro-inflammatory mediators. This profile suggests that the cell mediated inflammatory component of acne may be modified by adapalene. Studies in human patients provide clinical evidence that cutaneous adapalene is effective in reducing the inflammatory components of acne papules and pustules.
Absorption of adapalene through human skin is low; in clinical trials measurable plasma adapalene levels were not found following chronic cutaneous application to large areas of acneic skin with an analytical sensitivity of 0. After administration of [14C]-adapalene in rats IV, IP, oral and cutaneous , rabbits IV, oral and cutaneous and dogs IV and oral , radioactivity was distributed in several tissues, the highest levels being found in liver, spleen, adrenals and ovaries.
Metabolism in animals has been tentatively identified as being mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route. In animal studies, adapalene was well tolerated on cutaneous application for periods of up to six months in rabbits and for up to two years in mice.
The major symptoms of toxicity found in all animals species by the oral route were related to a hypervitaminosis A syndrome, and included bone dissolution, elevated alkaline phosphatase and a slight anaemia. Large oral doses of adapalene produced no adverse neurological, cardiovascular or respiratory effects in animals. Adapalene is not mutagenic. Lifetime studies with adapalene have been completed in mice at cutaneous doses of 0.
The only significant finding was a statistically significant increase of benign phaeochromocytomas of the adrenal medulla among male rats receiving adapalene at 1. These changes are considered to have no relevance to the cutaneous use of adapalene. Differin is proposed for the cutaneous treatment of acne vulgaris where comedones, papules and pustules predominate.
Acne of the face, chest or back is appropriate for treatment. Differin should be applied to the acne affected areas once a day before retiring and after washing. A thin film of the product should be applied avoiding the eyes and lips see Precautions. Ensure that the affected areas are dry before application. With patients for whom it is necessary to reduce the frequency of application or temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment.
If patients use cosmetics, these should be non-comedogenic and non-astringent. The safety and effectiveness of Differin has not been studied in neonates and young children. Differin is not to be taken orally and is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur. Nevertheless, unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.
Special Precautions. General: If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily, or to discontinue use altogether. Differin should not come into contact with the eyes, mouth, angles of the nose or mucous membranes. If product enters the eye, wash immediately with warm water.
The product should not be applied to either broken cuts and abrasions or eczematous skin, nor should it be used in patients with severe acne. Effects on the Ability to Drive and Use Machines: Based upon the pharmacodynamic profile and clinical experience, performance related to driving and using machines should not be affected. Pregnancy: No information on the effects of adapalene in pregnant women is available.
Consequently adapalene should not be used during pregnancy, especially during the first three months. Lactation: It is not known whether this drug is excreted in animal or human milk. Because many drugs are excreted in human milk, caution should be exercised when Differin is administrated to nursing mothers. In this event, the product should not be used on the chest. Adverse Reactions. Differin may cause the following adverse drug reactions: See table.
Drug Interactions. There are no known interactions with other medications which might be used cutaneously and concurrently with Differin; however, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene.
Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Whilst extensive studies in animals and man have shown neither phototoxic nor photoallergic potential for adapalene, the safety of using adapalene during repeated exposure to sunlight or UV irradiation has not been established in either animals or man.
Exposure to excessive sunlight or UV irradiation should be avoided. Absorption of adapalene through human skin is low, and therefore interaction with systemic medications is unlikely.
There is no evidence that the efficacy of oral drugs such as contraceptives and antibiotics is influenced by the cutaneous use of Differin. Differin has a potential for mild local irritation, and therefore it is possible that concomitant use of peeling agents, astringents or irritant products may produce additive irritant effects. However, cutaneous antiacne treatments, e. Caution For Usage. Instructions for Use: Squeeze the tube gently at its base to place a quantity of product on the fingertips sufficient to cover the affected areas.
Replace the cap tightly after use. Avoid freezing during transport and storage. MIMS Class. Acne Treatment Preparations. ATC Classification. D10AD03 - adapalene ; Belongs to the class of topical retinoid preparations used in the treatment of acne. Regulatory Classification. Exclusive offer for doctors. Continue with Google.
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