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Adapalene (Topical Route) Side Effects - Mayo Clinic - Before Using
These teratogenic changes included cleft palate, microphthalmia, exophthalmos, encephalocele, skeletal abnormalities, umbilical hernia, and kidney abnormalities.
Other reported clinical experience has not identified differences in responses between elderly and younger patients. There are no data on the presence of topical adapalene or its metabolite in human milk, the effects on the breast-fed infant, or the effects on milk production.
Adapalene is poorly absorbed through human intact skin and has low systemic exposure; however, it is possible that topical administration of large amounts of drug could result in sufficient systemic absorption to produce detectable quantities in human milk. To minimize potential exposure to the breast-fed infant via breast milk, use adapalene on the smallest area of skin and for the shortest duration possible while breast-feeding. Avoid application to areas with increased risk for potential ingestion by or ocular exposure to the breast-fed infant.
Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. Aminolevulinic Acid: Moderate Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
Methoxsalen: Moderate Use methoxsalen and adapalene together with caution; the risk of severe burns or phototoxicity may be additive.
If concurrent use is necessary, closely monitor patients for signs or symptoms of skin toxicity. Photosensitizing agents topical : Moderate Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution. Porfimer: Major Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive.
Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. Salicylic Acid: Moderate Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided.
Sodium Thiosulfate; Salicylic Acid: Moderate Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Verteporfin: Moderate Use caution if coadministration of verteporfin with adapalene is necessary due to the risk of increased photosensitivity.
Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein.
Adapalene reportedly penetrates deeply into the hair follicle. As a result of its actions, adapalene modulates cell differentiation and keratinization.
Adapalene also possesses potent antiinflammatory and comedolytic properties. Adapalene is applied topically to the skin. The distribution and metabolism of absorbed adapalene is unknown. Excretion appears to be primarily by the biliary route. Following application, absorption through human skin is low. PDR Search. Required field. Your Name Your name is required. Recipient's Email Separate multiple email address with a comma Please enter valid email address Recipient's email is required.
In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription over-the-counter [OTC] medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:.
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin. Do not use this medicine in or around the eyes, lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidently gets on these areas, wash with water at once. Apply the medicine to clean, dry areas of the skin affected by acne.
Rub in gently and well. Wash your hands afterwards to remove any medicine that may remain on them. To help clear up your acne completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a short time. If you stop using this medicine too soon, your acne may return or get worse. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. During the first 3 weeks you are using adapalene, your acne may seem to get worse before it gets better. Full improvement should be seen within 12 weeks, especially if you use the medicine every day.
You should not stop using adapalene if your acne seems worse at first, unless irritation or other symptoms become severe. Check with your doctor if your acne does not improve within 8 to 12 weeks.
Do not apply any topical product to the same area where you are using adapalene, unless otherwise directed by your doctor. If applied to the same area treated with adapalene, the following products may cause mild to severe irritation of the skin:. Your doctor may ask you to use other topical products, such as benzoyl peroxide, clindamycin, or erythromycin, during your treatment with adapalene.
Applying the products at different times of the day will lessen the chance of causing skin irritation. If your skin becomes too dry or red at any time, discuss with your doctor whether you should continue using adapalene. Applying creams, lotions, or moisturizers as needed helps lessen these skin problems. During treatment with this medicine, avoid getting too much sun on treated areas and do not use sunlamps.
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Topical agent for the tx of acne vulgaris; causes less skin irritation and is more effective than the highest concentration of tretinoin gel 0.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. For topical administration only. Not for oral, ophthalmic, or intravaginal use. Administered topically in the evening before going to bed. Instruct patient to wash face with a non-medicated soap, then apply a thin film of the cream, lotion, or gel to cover the entire face; avoid eyes, lips, and mucous membranes.
Differin: - Protect from freezing - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F - Store in a cool, well ventilated, dry place - Store in original container Differin Pump: - Protect from freezing - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F Plixda: - Store at controlled room temperature between 68 and 77 degrees F.
Topical adapalene is for external use only. Avoid contact with the eyes, lips, angles of the nose and other mucous membranes. Apply only to affected areas; accidental exposure to unaffected skin may cause irritation. Do not apply to skin that is cut or is affected with seborrheic dermatitis, eczema, a skin abrasion, or sunburn.
As with other retinoids, avoid the use of waxing as a depilatory method. Avoid the use of other potentially irritating topical products. If sun exposure cannot be avoided during topical adapalene therapy, sunscreen products and physical sun blocks protective clothing, hats are recommended for protection of treated areas.
Sunlight UV exposure may potentiate the effects of adapalene. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using topical adapalene. Weather extremes, such as wind or cold, also may be irritating to patients receiving adapalene.
No information is available on the relationship of age to the effects of adapalene in pediatric patients. Safety and efficacy in children less than 12 years of age have not been established. Available data regarding the use of adapalene during pregnancy are insufficient to establish a drug-associated risk of major birth defects, miscarriages, or other adverse maternal or fetal outcomes.
During clinical trials women of childbearing potential initiated treatment only after negative pregnancy tests were obtained. However, 2 women receiving the topical lotion and 6 women receiving the topical gel became pregnant during adapalene clinical trials.
Pregnancy outcomes for these 8 women were: 3 healthy full term deliveries, 2 premature deliveries, 2 elective pregnancy terminations, and 1 lost to follow-up. These teratogenic changes included cleft palate, microphthalmia, exophthalmos, encephalocele, skeletal abnormalities, umbilical hernia, and kidney abnormalities. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
There are no data on the presence of topical adapalene or its metabolite in human milk, the effects on the breast-fed infant, or the effects on milk production.
Adapalene is poorly absorbed through human intact skin and has low systemic exposure; however, it is possible that topical administration of large amounts of drug could result in sufficient systemic absorption to produce detectable quantities in human milk.
To minimize potential exposure to the breast-fed infant via breast milk, use adapalene on the smallest area of skin and for the shortest duration possible while breast-feeding. Avoid application to areas with increased risk for potential ingestion by or ocular exposure to the breast-fed infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. Aminolevulinic Acid: Moderate Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
Methoxsalen: Moderate Use methoxsalen and adapalene together with caution; the risk of severe burns or phototoxicity may be additive. If concurrent use is necessary, closely monitor patients for signs or symptoms of skin toxicity. Photosensitizing agents topical : Moderate Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution. Porfimer: Major Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity.
Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. Salicylic Acid: Moderate Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation.
Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided. Sodium Thiosulfate; Salicylic Acid: Moderate Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation.
Verteporfin: Moderate Use caution if coadministration of verteporfin with adapalene is necessary due to the risk of increased photosensitivity. Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive.
Adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Adapalene reportedly penetrates deeply into the hair follicle.
As a result of its actions, adapalene modulates cell differentiation and keratinization. Adapalene also possesses potent antiinflammatory and comedolytic properties. Adapalene is applied topically to the skin. The distribution and metabolism of absorbed adapalene is unknown. Excretion appears to be primarily by the biliary route.
Following application, absorption through human skin is low. PDR Search. Required field. Your Name Your name is required. Recipient's Email Separate multiple email address with a comma Please enter valid email address Recipient's email is required. Thank you. Your email has been sent. Jump to Section.
Related Drug Information Drug Summary. Topical dosage 0. Adults, Adolescents, and Children 12 years and older. Topical Route. Back to top.
The following selected adverse reactions occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus. Severe skin irritation or skin dryness. Overall, Differin Gel has superior tolerability compared to other retinoid acne treatments that don't contain adapalene. Common side effects include dryness. may occur during the first weeks of using Differin Gel %. These side effects usually decrease with continued use Differin Gel %. CLASSES. Topical Retinoids for Acne. DEA CLASS. Rx, OTC. DESCRIPTION. Topical agent for the tx of acne vulgaris; causes less skin irritation and is more. No information is available on the relationship of age to the effects of adapalene in pediatric patients. For topical administration only. Do not apply any topical product to the same area where you are using adapalene, unless otherwise directed by your doctor.Drug information provided by: IBM Micromedex. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.
For non-prescription products, read the label or package ingredients carefully. Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of adapalene in children up to 12 years of age with use in other age groups. In teenagers, adapalene is not expected to cause different side effects or problems than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of adapalene in the elderly with use in other age groups.
Older adults are not likely to develop acne. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.
Tell your healthcare professional if you are taking any other prescription or nonprescription over-the-counter [OTC] medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:.
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin. Do not use this medicine in or around the eyes, lips, or inside of the nose. Spread the medicine away from these areas when applying.
If the medicine accidently gets on these areas, wash with water at once. Apply the medicine to clean, dry areas of the skin affected by acne.
Rub in gently and well. Wash your hands afterwards to remove any medicine that may remain on them. To help clear up your acne completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a short time.
If you stop using this medicine too soon, your acne may return or get worse. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. During the first 3 weeks you are using adapalene, your acne may seem to get worse before it gets better.
Full improvement should be seen within 12 weeks, especially if you use the medicine every day. You should not stop using adapalene if your acne seems worse at first, unless irritation or other symptoms become severe. Check with your doctor if your acne does not improve within 8 to 12 weeks. Do not apply any topical product to the same area where you are using adapalene, unless otherwise directed by your doctor. If applied to the same area treated with adapalene, the following products may cause mild to severe irritation of the skin:.
Your doctor may ask you to use other topical products, such as benzoyl peroxide, clindamycin, or erythromycin, during your treatment with adapalene. Applying the products at different times of the day will lessen the chance of causing skin irritation.
If your skin becomes too dry or red at any time, discuss with your doctor whether you should continue using adapalene. Applying creams, lotions, or moisturizers as needed helps lessen these skin problems.
During treatment with this medicine, avoid getting too much sun on treated areas and do not use sunlamps. Since your skin may be more prone to sunburn or skin irritation, use sunscreen or sunblocking lotions regularly with a sun protection factor SPF of 15 or more.
Wear protective clothing against sun, wind, and cold weather. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:. Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.
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