Patient Information on EPIDUO (adapalene and benzoyl peroxide gel)

Manufactured by: Galderma Laboratories, L.P.

Use of Epiduo: we all suffer from acne now and then.  Acne is a very common problem, especially among younger people. Acne means the development of red spots, pimples, and blemishes on the skin. The skin of the face, arms and back are the sites which usually get affected. Despite the fact that they vanish all alone yet now and again can get pustulated and erupt, this emits and deserts a dreadful scar. You may wonder why these horrid bulges get formed on the body, well the answer is simple. Due to the blockage of the sebaceous glands present in our skin which is responsible for the production of oil gets infected by the adjacent germs. Also, pubescence doesn’t help the condition either… hormones, for example, androgens increase during the adolescence and triggers these glands to produce more sebum.

And here comes the Epiduo gel for the treatment of acne vulgaris in patients of 12 years and more. It is manufactured as an aqueous based gel containing 25 mg of benzoyl peroxide and 1 mg of Adapalene.

Administration: the right way of applying the gel is given below;

  • Wash your hands every time before applying the gel.
  • Take out a very small quantity of the gel and apply it on the skin having pimples.
  • Repeat this process once daily after washing.
  • When on treatment with Epiduo, do not subject to waxing or epilating.
  • Ensure you don not insert it into the eyes, nose or mouth. The gel should not be applied in the vagina for any comparable condition.
  • Place the container in a cool and dry place which will not come in contact to direct light and will be away from the children’s reach.

Use in other populaces:

  • Pregnancy: it falls in the category Abstain from using this medicament during pregnancy as none trials or tests have been conducted with Epiduo gel neither in animals nor in human.
  • Breast-feed: should not be used during the lactating period as it is not known whether the agents present in this gel get secreted into the mother’s milk or not.
  • Pediatrics: not safe for youngsters less than 12 years old.
  • Geriatrics: more studies need to be conducted to determine the effectiveness and safety in older patients.

Warnings:

  • Application of this gel should be avoided in the case of hypersensitivity to the ingredients used in it.
  • During the first few weeks of initiation of the application of the gel can cause your skin to burn, sting, dry or itch. Try using a moisturizer to abate these reactions. If you feel that these impacts are deteriorating, end the gel and counsel your skin expert.
  • You should not apply the gel more than one time a day or in larger quantities.
  • Do not apply the gel on the areas of the skin which are broken, scratched, wounded, burnt, or bleeding.
  • Avoid using Epiduo with medicated soaps, lotions or cosmetics, which could otherwise prompt more intense irritation.
  • Stay away or protect your skin from coming in direct contact with the sunlight and sunlamps. Use sunscreen and wear proper protection for it.
  • Attempt to go less outside when the climate is extremely cool or excessively hot as the atmosphere furthest points can also play a role in irritating your skin.
  • The contents of Epiduo gel can fade the color of the clothes and hair.

Interactions with other medicines:

You should not apply other preparations for acne with Epiduo as it could cause severe irritation and inflammation of the skin.

Adverse reactions: most of the side effects appear on the skin, such as scarring, redness, allergic reaction, burning, stinging, blistering, swelling, sunburns, rash, discoloration, dryness of the skin. Apart from the skin-related side effects, Epiduo can also cause eye infection, swelling of the eyelids, scratchy and irritation in the throat.

Toxicology: toxicology provided details regarding Epiduo gel in general are not present but rather such tests have been led by the individual agents. Following results were found in animals;

  • Benzoyl peroxide: does not itself cause tumors but rather acts as a marker or supporter to other carcinogens (cancer causing substances). It was also found to be able to cause changes in the DNA of the human lung cells.
  • Adapalene: it did not transform the reproductive functioning of the rats and mice and also didn’t cause any genetic aberrations in them but it did cause tumors in the adrenal glands of the male rats.

Mode of performance:

  • Adapalene: exact method how it fights acne is not determined. But it brings down inflammation by acting upon the retinoic receptors and suppressing the inflammatory processes.
  • Benzoyl peroxide: it targets the bacteria infecting the skin and glands by releasing free oxygen radicals that scavenge these bugs.

Absorption and secretion: benzoyl peroxide on assimilation from the skin is initially changed into benzoic acid. Benzoyl peroxide and adapalene are excreted through the urine and bile, respectively.

Before using Epiduo inform your doctors: if you are pregnant or had a delivery and if breast-feeding.

Ingredients: adapalene and benzoyl peroxide, purified water, sorbitan oleate, edetate disodium, glycerin, isohexadecane, acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, poloxamer 124, polysorbate 80, propylene glycol.

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