INTRODUCTION

AIRET 0.50% CREAM contains Isotretinoin which belongs to the group of medicines called Retinoids. It is used in adults and adolescents to treat acne vulgaris. Acne is an inflammatory skin condition characterized by spots, oily skin, nodular lesions etc. on the face, chest, and back, which can be painful.

Your doctor might advise you to avoid using sunlamps and spending a long time in the sun while using AIRET 0.50% CREAM and to use sunscreen product and protective clothing to prevent sunburn.

AIRET 0.50% CREAM is not recommended for use if you or any of your family members have skin cancer. Before using AIRET 0.50% CREAM, inform your doctor if you have any allergies, or other skin problems like eczema, red skin, broken blood vessels and tiny pimples usually on the central area of the face, or redness and soreness around the mouth.

AIRET 0.50% CREAM is not recommended for use in pregnant women, women planning a pregnancy or breastfeeding women. Use a reliable method of contraception while you are using AIRET 0.50% CREAM to prevent pregnancy. It is not for use in children so, consult your child’s doctor for advice.

The most common side effects of using AIRET 0.50% CREAM are skin redness, flaking, pain, itching, irritation, tenderness, etc. If any of the symptoms get worse, consult your doctor.

USES OF AIRET 0.50% CREAM

• Used in adults and adolescents to treat acne vulgaris

HOW AIRET 0.50% CREAM WORKS

AIRET 0.50% CREAM reduces acne by making your skin less oily, loosening blackheads and whiteheads and stopping new blackheads, whiteheads and spots from forming, and lowering the number of red, inflamed acne spots.

DIRECTIONS FOR USE

Use AIRET 0.50% CREAM as advised by your physician. It is for external use only. Use it once daily at night time over all of the affected areas. Avoid getting it on your mouth, lips, and eyes. Do not use AIRET 0.50% CREAM on any irritated areas of the skin (Ex. cuts, grazes, sunburn, or broken skin).

Your doctor will decide the right dose and duration of therapy for you according to your age, body weight and disease condition. Do not stop taking AIRET 0.50% CREAM unless your doctor advises you to stop.

SIDE EFFECTS OF AIRET 0.50% CREAM

HOW TO MANAGE SIDE EFFECTS

Skin rash:

Avoid hot showers because hot water can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash persists.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using AIRET 0.50% CREAM, inform your doctor if you are taking any of the following medicines:

• other medicines used to treat acne (Ex. benzoyl peroxide, niacinamide)

Overdosage:

In case you or anybody else accidentally use too much of AIRET 0.50% CREAM, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep AIRET 0.50% CREAM out of reach of children
• Store below 25°C

FAQs ABOUT AIRET 0.50% CREAM

Can AIRET 0.50% CREAM be used on babies?

No. AIRET 0.50% CREAM is used for adults and adolescents, and is not recommended for use in children. Consult your child’s doctor for advice. The doctor will determine an appropriate dose or select a suitable alternative treatment for your child.

What if I forget to apply a dose of AIRET 0.50% CREAM?

If you forget to apply a dose of AIRET 0.50% CREAM, do it as soon as you remember. However, omit the missed dose if it's almost time for the next one. Do not use the medicine two times to make up for the missed dose.

Can AIRET 0.50% CREAM be stopped?

Do not stop using AIRET 0.50% CREAM or change the dose until your doctor tells you to stop, unless you experience any unwanted effects, worsening of your condition or any new symptoms. Contact your doctor in such a case.

Can I go out in the sun during AIRET 0.50% CREAM treatment?

During treatment with AIRET 0.50% CREAM, avoid using sunlamps and spending a long time in the sun. Use a sunscreen product and wear protective clothing to prevent sunburn. Consult your doctor for further queries.

Is AIRET 0.50% CREAM safe to use in pregnancy?

AIRET 0.50% CREAM is not recommended for use in pregnant women and women planning a pregnancy. Use a reliable method of contraception while you are using AIRET 0.50% CREAM to prevent pregnancy. If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before using it. Inform your doctor if you become pregnant during treatment with AIRET 0.50% CREAM.

REFERENCES

1. KD Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Medical Pharmacology, 7th edition 2013. Page- 894.

2. Chalker, D.K., Lesher Jr, J.L., Smith Jr, J.G., Klauda, H.C., Pochi, P.E., Jacoby, W.S., Yonkosky, D.M., Voorhees, J.J., Ellis, C.N., Matsuda-John, S. and Shalita, A.R. Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: results of a multicenter, double-blind investigation. Journal of the American Academy of Dermatology, August 1987. [Accessed on 14th October 2022] https://www.jaad.org/article/S0190-9622(87)70200-X/fulltext

3. B.R. Hughes, J.F.B. Norris, W.J. Cunliffe. A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne. May 1992. [Accessed on 14th October 2022] https://academic.oup.com/ced/article-abstract/17/3/165/6629262?redirectedFrom=fulltext

4. GlaxoSmithKline NZ Limited. Isotrex gel (Isotretinoin 0.05%). [Revised in September 2013]. [Accessed on 14th October 2022] https://www.nps.org.au/assets/medicines/7d895c8e-4b4d-4310-b4c5-a53300ff566e.pdf

5. Central Drugs Standard Control Organization (CDSCO). [Accessed on 14th October 2022] https://cdscoonline.gov.in/CDSCO/Drugs