INTRODUCTION

ACNEDAP PLUS contains a combination of Adapalene and Dapsone, which belongs to the group of medicines called topical retinoids and sulfonamide antibiotics. It is used in the treatment of skin acne. Acne is a condition of the skin when the root of your hair (hair follicle) or skin pores gets clogged by oil or dead skin, which becomes prone to bacterial infection resulting in pimples, blackheads and spots or scars.

Adapalene is a form of vitamin A (retinoid) that acts as an antiacne agent by binding directly to the receptors of the skin which increases the rate of cell regeneration and decreases oil secretion preventing clogging of the hair follicles and pores. It also reduces swelling and inflammation. Dapsone is an antibiotic with a structure similar to PABA (para-aminobenzoic acid) that kills bacteria by competitively substituting PABA, a nutrient that bacteria use to generate folic acid for growth and survival. Before recommending ACNEDAP PLUS, your doctor may advise you to have tests to understand your existing condition for planning effective treatment methods. Stay well hydrated and protect your skin from exposure to sunlight or UV light.

Do not apply ACNEDAP PLUS if you are allergic to adapalene or dapsone or have bruises, cuts or burns on the skin, It should be used with caution and inform your doctor if have any disorder of the digestive system (colitis), a disorder of the immune system, anemia or G6PD deficiency. The common side effects of using ACNEDAP PLUS may include dry skin, burning, itching, redness or irritative sensation of the skin and peeling of the skin.

USES OF ACNEDAP PLUS

• Treats acne

HOW ACNEDAP PLUS WORKS

ACNEDAP PLUS is a combination of Adapalene (Retinoid) and Dapsone (Sulfonamide). Adapalene, a form of vitamin A, works as an antiacne agent by attaching directly to the skin's receptors, which increases cell regeneration and decreases oil secretion preventing blockage of the hair follicles and pores It also reduces swelling/inflammation of the skin. Dapsone is an antibiotic with a structure similar to PABA (para-aminobenzoic acid) that kills bacteria by competitively substituting PABA, a nutrient that bacteria use to generate folic acid for growth and survival.

DIRECTIONS FOR USE

Apply ACNEDAP PLUS as advised by your doctor. It is for external use on the skin. Avoid applying ACNEDAP PLUS around or onto your eyes, including eyelids.

SIDE EFFECTS OF ACNEDAP PLUS

HOW TO MANAGE SIDE EFFECTS

Dry Skin:

Drink plenty of water and stay well hydrated. Use moisturizer recommended by your doctor.

Headache:

Take rest and get adequate sleep, stay hydrated. Consult your doctor immediately if the symptoms persist or worsen.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Inform your physician, if you are taking or using,

• Medicated soap for skin, other cosmetic products with a high concentration of alcohol, astringents, sulfur etc
• Resorcinol – use for itching or irritation of the skin and scalp, loss of hair, dandruff etc
• Salicylic acid – used for skin acne, dandruff, etc
• Trimethoprim-Sulfamethoxazole – used to treat bacterial infection
• Topical Benzoyl Peroxide – used to treat acne
• Paracetamol – used to relieve pain
• Phenytoin – used to prevent and control fits/seizures

B. Drug-Food interaction:

The interaction of foods with ACNEDAP PLUS is not known. Consult your doctor for diet advice.

Overdosage:

• In case of using ACNEDAP PLUS in excess than recommended, you may experience dryness, scaling, redness and discomfort of the skin. Contact your doctor immediately if the symptoms are worsening or persists.

SYNOPSIS

MORE INFORMATION

• Keep out of reach from children
• Store at room temperature
• Keep away from sunlight

FAQs ABOUT ACNEDAP PLUS

Can ACNEDAP PLUS be used for skin acne?

Yes. The ingredient adapalene is a form of vitamin A, which decreases swelling, inflammation and treats acne scars. Dapsone helps to fight against bacterial skin infections.

Can ACNEDAP PLUS cause peeling of skin?

Yes. The side effects of using ACNEDAP PLUS may include dryness of the skin, burning, itching, redness of the skin, skin irritation, scaling or peeling of the skin

Can ACNEDAP PLUS cause dryness of the skin?

Yes. ACNEDAP PLUS can cause dryness of your skin. Stay hydrated and apply the moisturizer recommended by your doctor.

Can I use moisturizer while using ACNEDAP PLUS?

Yes. Moisturizer recommended by your doctor can be used while using this medicine.

Can ACNEDAP PLUS be used in children?

ACNEDAP PLUS should be used with caution in children less than 12 years of age, Consult your doctor for advice.

REFERENCES

1. KD. Tripathi. Drugs act on skin and mucous membranes & antimicrobial drugs. Essentials of medical pharmacology. 8th Edition. 2019. Page – 953 to 954, 756.

2. Laurence Brunton, Bruce Chabner, Bjorn Knollman. Drug metabolism, & Chemotherapy of microbial disease. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th Edition. 2006. Page-138, 1563.

3. Ahluwalia, Gurpreet,Warner, Chen, Yang. World Intellectual Property Organization (WIPO) [Revised on 3rd February 2011] [Accessed on 28th March 2022] https://patentimages.storage.googleapis.com/14/10/c8/62b9e22da2470d/WO2011014627A1.pdf

4. Alan B. Fleischer, Jr, MD, Winston-Salem, NC, Zoe D. Draelos, MD, William Abramovits, MD, David M. Pariser, MD. Adapalene. Journal of American Academy of Dermatology (JAAD). Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4%, or vehicle gel for the treatment of acne vulgaris [Revised on 1st February 2007] [Accessed on 28th March 2022] https://www.jaad.org/article/S0190-9622(06)02976-8/fulltext#relatedArticles

5. John P. Cunha, DO, FACOEP. RxList. Aczone_dapzone_vs_differin. [Accessed on 28th March 2022] https://www.rxlist.com/aczone_dapzone_vs_differin/drugs-condition.htm

6. Allergan, Inc. U.S. National Library Of Medicine (NIH). aczone- dapsone gel. [Revised on May 2018] [Accessed on 28th March 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b7d605cf-bf84-461b-939b-1f773a4cba65&type=display

7. Alembic Pharmaceuticals, Inc. National Library of Medicine (NIH). Adapalene gel [Revised on November 2021] [Accessed on 26th March 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a3b6f3c3-d615-4b00-a76f-134b75e30a50&type=display

8. Galderma Laboratories, L.P. Adapalene gel. [Revised on February 2018] [Accessed on 26th March 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a0031324-92a6-4c11-90e2-c2818f7278ec&type=display