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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 10.05.2022
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Adapalene Topical (Clindapene)® Cream is indicated for the topical treatment of acne vulgaris.
Clinical Studies
Two vehicle-controlled clinical studies were conducted in patients 12 to 30 years of age with mild to moderate acne vulgaris, in which Adapalene Topical (Clindapene)® Cream was compared with its vehicle. Patients were instructed to apply their treatment medication once daily at bedtime for 12 weeks. In one study patients were provided with a soapless cleanser and were encouraged to refrain from using moisturizers. No other topical medications, other than Adapalene Topical (Clindapene)® Cream, were to be applied to the face during the studies. Adapalene Topical (Clindapene)® Cream was significantly more effective than its vehicle in the reduction of acne lesion counts. The mean percent reduction in lesion counts from baseline after treatment for 12 weeks are presented in the following table:
MEAN PERCENT REDUCTION IN LESION COUNTS FROM BASELINE TO WEEK 12 | ||||
Efficacy Variable | Study No. 1 | Study No. 2 | ||
Adapalene Topical (Clindapene) Cream, 0.1% N=119 | Cream Vehicle N=118 | Adapalene Topical (Clindapene) Cream, 0.1% N=175 | Cream Vehicle N=175 | |
Non-inflammatory lesions | 34% | 18% | 35% | 15% |
Inflammatory lesions | 32% | 17% | 14% | 6% |
Total lesions | 34% | 18% | 30% | 15% |
The trend in the Investigator's global assessment of severity supported the efficacy of Adapalene Topical (Clindapene) when compared to the cream vehicle.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.5 & 10 Benzoyl Peroxide (Clindapene) (Benzoyl Peroxide (Clindapene) gel) may be used alone topically for mild to moderate acne and as an adjunct in acne treatment regimens which might include retinoic acid products, systemic antibiotics, and/or sulfur and salicylic acid containing preparations. The active ingredient, Benzoyl Peroxide (Clindapene), exerts a desquamative and antibacterial action. It provides mild peeling and keratolytic activity.
Adapalene Topical (Clindapene) (Adapalene Topical (Clindapene)) is a topical medicine (a medication that is applied to the surface of the skin) similar to vitamin A. It helps the skin to renew itself.
Adapalene Topical (Clindapene) is used to treat severe acne in people who are at least 12 years old. It works by decreasing acne formation.
Adapalene Topical (Clindapene) may also be used for purposes not listed in this medication guide.
Benzoyl Peroxide (Clindapene) topical is used to treat acne and may be used for other skin conditions as determined by your doctor.
Benzoyl Peroxide (Clindapene) is available without prescription. Some of the skin products are available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Benzoyl Peroxide (Clindapene) topical is used in certain patients with the following medical conditions:
- Decubital ulcer (bed sores)
- Stasis ulcer (a certain type of ulcer)
Usual Adult Dose for Acne
Adapalene Topical (Clindapene)
Topical 0.1% cream, 0.1% gel, 0.3% gel
Apply to the affected area once a day at bedtime after washing. A thin film should be applied, avoiding eyes, lips, angles of the nose, and mucous membranes.
Lotion: Apply a thin film of lotion to the entire face and other affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of lotion (3 to 4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes.
Usual Pediatric Dose for Acne
Adapalene Topical (Clindapene)
Topical 0.1% cream, 0.1% gel, 0.3% gel
11 years or less: Safety and efficacy have not been established.
12 to 18 years: Apply to the affected area once a day at bedtime after washing. A thin film should be applied, avoiding eyes, lips, angles of the nose, and mucous membranes.
Safety and effectiveness of the lotion formulation in pediatric patients under the age of 12 have not been established.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Adapalene Topical (Clindapene) should not be applied to skin with cuts, abrasions, eczema, or sunburn.
Patients should minimize exposure to sunlight, including sunlamps, and use sunscreens and other protection whenever prolonged exposure is unavoidable. Therapy should be discontinued if sunburn develops, and not resumed until the skin fully recovers. Patients may also have a heightened susceptibility to irritation due to weather extremes (wind or cold).
Adapalene Topical (Clindapene) may cause erythema, dryness, scaling, burning, and itching, which usually begin the first 2 to 4 weeks of therapy but diminish with continued use. Patients who develop excessive irritation should use the medication less frequently, interrupt treatment briefly, or discontinue use totally.
Adapalene Topical (Clindapene) therapy may render the skin more vulnerable to the irritating effects of astringents, abrasive soaps, skin cleansers, and other facial chemicals and cosmetics that contain alcohol or have a strong drying effect. Concomitant use of these agents with Adapalene Topical (Clindapene) should be approached with caution. Products containing alpha hydroxy or glycolic acids should be avoided.
Adapalene Topical (Clindapene) should not be used around the eyes, mouth, angles of the nose, mucous membranes, or on cut, abraded, or eczematous skin. Contact with the eye may cause an ocular reaction such as swelling, conjunctivitis, and irritation.
Wax epilation should not be performed on Adapalene Topical (Clindapene)-treated skin.
Safety and effectiveness in pediatric patients under the age of 12 years has not been established.
Dialysis
Data not available
Other Comments
Initially, an apparent exacerbation of acne may appear within the first few weeks of treatment due to the action of Adapalene Topical (Clindapene) topical on previously unseen lesions. Therapeutic results are typically noticed after 8 to 12 weeks of treatment.
Wash and dry affected areas prior to application. Apply sparingly one or more times daily.
How supplied
5 Benzoyl Peroxide (Clindapene) (Benzoyl Peroxide (Clindapene) gel) is available in 1.5 oz. (42.5g)
(NDC 0066-0430-15) plastic tubes;
10 Benzoyl Peroxide (Clindapene) (Benzoyl Peroxide (Clindapene) gel) is available in 1.5 oz. (42.5 g)
(NDC 0066-0431-15) plastic tubes.
5 Benzoyl Peroxide (Clindapene) contains 50 mg of Benzoyl Peroxide (Clindapene) per gram and 10 Benzoyl Peroxide (Clindapene) contains 100 mg of Benzoyl Peroxide (Clindapene) per gram.
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F).
Revised October 2006. Mfd for: Dermik Laboratories, a business of sanofi-aventis U.S. LLC., Bridgewater, NJ 08807.
See also:
What is the most important information I should know about Adapalene Topical (Clindapene)?
Adapalene Topical (Clindapene) Gel should not be administered to individuals who are hypersensitive to Adapalene Topical (Clindapene) or any of the components in the vehicle gel.
See also:
What is the most important information I should know about Benzoyl Peroxide (Clindapene)?
There are many brands and forms of Benzoyl Peroxide (Clindapene) available and not all brands are listed on this leaflet.
Do not use Benzoyl Peroxide (Clindapene) topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use Benzoyl Peroxide (Clindapene) topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using Benzoyl Peroxide (Clindapene) topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.
Benzoyl Peroxide (Clindapene) may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.
It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Use Adapalene Topical (Clindapene) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Adapalene Topical (Clindapene). Talk to your pharmacist if you have questions about this information.
- Do not use other medicines on your skin without first discussing it with your doctor.
- Adapalene Topical (Clindapene) is for external use only. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. Exposure of Adapalene Topical (Clindapene) to the eye may cause swelling, redness, and irritation.
- Do not apply Adapalene Topical (Clindapene) to cuts, abrasions, eczematous skin, or sunburned skin.
- Use Adapalene Topical (Clindapene) in the evening before bedtime unless directed otherwise by your doctor.
- Before applying Adapalene Topical (Clindapene), clean the area to be treated with mild soap or soapless cleanser and gently dry.
- Apply a thin film of Adapalene Topical (Clindapene) to the affected and surrounding area. Rub in gently. Wash your hands immediately after using Adapalene Topical (Clindapene).
- A mild sensation of warmth or slight stinging may occur shortly after using Adapalene Topical (Clindapene).
- If you miss a dose of Adapalene Topical (Clindapene), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If several applications are missed, contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Adapalene Topical (Clindapene).
Use Benzoyl Peroxide (Clindapene) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Benzoyl Peroxide (Clindapene) is only to be used on the skin. The kit contains a medicated wash and cream prefilled sponge applicators.
- To use the wash - Shake well before using. Wet the affected area and then apply Benzoyl Peroxide (Clindapene) by gently massaging into the skin for 10 to 20 seconds, working into a lather. Rinse the treated area thoroughly and gently pat dry.
- To use the cream prefilled sponge applicators - Wash the affected area with a mild cleanser. Rinse thoroughly and completely dry the affected area. Firmly squeeze the prefilled sponge applicator until the seal between the applicator and sponge has broken. Apply Benzoyl Peroxide (Clindapene) by rubbing the sponge in small circular motions over the affected area. Dispose of each applicator after a single use.
- If you notice Benzoyl Peroxide (Clindapene) or a white residue remaining on your skin after application, you may be applying too much.
- Wash your hands immediately before and after using Benzoyl Peroxide (Clindapene).
- Continue to use Benzoyl Peroxide (Clindapene) for the full course of treatment even if your condition improves. Do not miss any doses.
- If you miss a dose of Benzoyl Peroxide (Clindapene), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Benzoyl Peroxide (Clindapene).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Acne vulgaris: Treatment of acne vulgaris.
Off Label Uses
Rosacea
Topical Adapalene Topical (Clindapene) for the management of rosacea has been studied in a limited number of patients, with data suggesting it may be a useful alternative to topical metronidazole in patients with papulopustular rosacea.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Benzoyl Peroxide (Clindapene) is used to treat acne and blackheads and spots.
See also:
What other drugs will affect Adapalene Topical (Clindapene)?
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
See also:
What other drugs will affect Benzoyl Peroxide (Clindapene)?
Do not use Benzoyl Peroxide (Clindapene) and sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.
Avoid using other topical products on the same area at the same time unless directed to do so by your doctor. They may interfere with the effects or absorption of Benzoyl Peroxide (Clindapene) and sulfur topical.
Do not cover the area after applying Benzoyl Peroxide (Clindapene) and sulfur topical. Doing so could cause too much medicine to be absorbed by your body and could be harmful.
Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.
Avoid contact with clothing and hair. Benzoyl Peroxide (Clindapene) may cause bleaching.
Avoid combining PABA-containing sunscreens and Benzoyl Peroxide (Clindapene) and sulfur topical. Temporary skin discoloration may occur if they are used together.
See also:
What are the possible side effects of Adapalene Topical (Clindapene)?
Applies to Adapalene Topical (Clindapene) topical: topical cream, topical gel/jelly, topical lotion, topical solution, topical swab
In addition to its needed effects, some unwanted effects may be caused by Adapalene Topical (Clindapene) topical (the active ingredient contained in Adapalene Topical (Clindapene)). In the event that any of these side effects do occur, they may require medical attention.
Severity: Moderate
If any of the following side effects occur while taking Adapalene Topical (Clindapene) topical, check with your doctor or nurse as soon as possible:
More common: - especially during the first month of use
- Burning sensation or stinging of skin
- dryness and peeling of skin
- itching of skin
- redness of skin
Minor Side Effects
Some of the side effects that can occur with Adapalene Topical (Clindapene) topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Rare - more common during the first month of use
- Worsening of acne
See also:
What are the possible side effects of Benzoyl Peroxide (Clindapene)?
Applies to Benzoyl Peroxide (Clindapene) topical: topical bar, topical cream, topical foam, topical gel/jelly, topical liquid, topical lotion, topical pad, topical soap, topical solution
In addition to its needed effects, some unwanted effects may be caused by Benzoyl Peroxide (Clindapene) topical (the active ingredient contained in Benzoyl Peroxide (Clindapene)). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Benzoyl Peroxide (Clindapene) topical:
Less common or rare:
- Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling
- skin rash
- Difficult breathing
- fainting
- hives
- itching
- swelling of the eyes, face, lips, or tongue
- tightness in the throat
If any of the following symptoms of overdose occur while taking Benzoyl Peroxide (Clindapene) topical, get emergency help immediately:
Symptoms of overdose:
- Burning, itching, scaling, redness, or swelling of skin (severe)
Minor Side Effects
Some of the side effects that can occur with Benzoyl Peroxide (Clindapene) topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
- Dryness or peeling of the skin (may occur after a few days)
- feeling of warmth, mild stinging, and redness of the skin
Adapalene Topical (Clindapene) is a topical retinoid primarily used in the treatment of acne and is also used (off-label) to treat keratosis pilaris as well as other skin conditions. It is currently marketed by Galderma under the trade names Adapalene Topical (Clindapene) in some countries, and Adaferin in India. [Wikipedia]
Benzoyl Peroxide (Clindapene) (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl Peroxide (Clindapene) is used as an acne treatment (in combination or as a single agent), for bleaching flour, hair and teeth, for cross-linking polyester resins, and many other uses. It is on the World Health Organization’s List of Essential Medicines, the most important medications needed in a basic health system.