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F.A.Q. Section

Sotret® Gel


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Sotret® Gel

Sotret® Gel is a topical treatment for severe acne. It has potent keratolytic and anti-inflammatory properties and works by unclogging the pores and making skin less oily. Sotret® Gel is a retinoid formulation developed for adults and children over 12 years of age.

Other names for this medication:
Isotrex® Gel, Isotrexin Gel, Roaccutane Gel

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Sotret® Gel is manufactured by Sun Pharma. This is a topical medication indicated for severe recalcitrant nodular acne (also known as cystic or nodulocystic acne). This gel has potent keratolytic, exfoliating, and comedolytic properties. Sotret® Gel is recommended for patients who failed to respond to milder acne treatments. The active ingredient of Sotret® Gel is Isotretinoin. This is a first-generation anti-acne retinoid, derivative of vitamin A.

Recalcitrant nodular acne is a severe inflammatory skin condition characterized by blocked pores, big, red, and painful bumps, large cysts and nodules with a diameter of 5 mm or greater, and lesions beneath the skin that are painful even without touch. It occurs as an immune system reaction to P. acnes (Propionibacterium acnes) bacteria overabundance in the skin. P. acnes need clogged pores being a positive environment to proliferate and live in. Skin pores get blocked when sebaceous gland produces too much skin sebum (oil) that mixes with dead skin cells residue forming a pore-filling substance.

Sotret® Gel can be indicated off-label for keratosis follicularis, lamellar ichthyosis, pityriasis rubra pilaris, and some types of cancer (chronic myelogenous leukemia, neuroblastoma, recurrent cervical cancer (combined with interferon alfa), advanced squamous cell head and neck cancer etc.).

MOA (mechanism of action):

Isotretinoin cures acne by reducing skin oiliness and follicular hyperkeratinization (dead epithelial cells built up in the pores). It inhibits skin sebum production by reducing the size of sebaceous glands (microscopic organs producing skin oil) while inhibiting keratinization and thereby removing the residue dead skin cells.


Sotret® Gel is for external use only. Do not apply to your eyes, mouth, inside of the nose, private parts, and any other mucosal surface. Sotret® Gel is normally applied 1-2 times daily, usually for 6-8 weeks at least. In case your acne has not improved after 8 weeks of treatment, discontinue the Sotret® Gel use and seek medical advice.

How to use Sotret® Gel:

1. Wash your hands and the affected areas with mild soap or cleanser, pat dry.

2. Apply a thin layer of the gel to the affected areas with your finger tips.

3. Gently rub until the gel is mostly absorbed.

4. Wash your hands after the gel application.


Do not let Sotret® Gel collect in folds of the skin, such as where your nose meets your face.

Do not apply Sotret® Gel to the irritated, itchy, cracked or burnt skin (sunburns and windburns included).

Due to the flammable nature of Sotret® Gel, avoid smoking or being near an open flame while you are applying Sotret® Gel and immediately after you have used it.

Do not apply Sotret® Gel to the open wounds or cuts.

Do not cover the Sotret® Gel application site with occlusive bandages or other covering.

Patients should avoid prolong sunlight (UV) exposure while using Sotret® Gel.

Do not use Sotret® Gel in combination with harsh skin products, medicated soaps and shampoos, products with drying effect on the skin, peeling agents, products containing alcohol, spices or lime.

Do not get permanent wave solutions and waxing products on skin being treated with Sotret® Gel.

Do not apply skin moisturizers or makeup to the skin being treated with Sotret® Gel 1 hour before and after the gel application.

Patients should use sunscreens (min. SPF 15) and protective clothing while using Sotret® Gel.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not apply a double dose.


Do not exceed the doctor's recommended dose. If an overdose occurs and you are feeling unwell, you should seek emergency medical attention or contact your healthcare provider immediately.


Store at a room temperature from 20 and 25 degrees C (68 and 77 degrees F) away from moisture and heat. Throw away the tube after the expiration date. Keep away from children.

Side effects

The most common side effects associated with the use of Sotret® Gel are:

  • itchy skin
  • burning or stinging sensation
  • redness
  • skin rash
  • contact dermatitis
  • exacerbation of the psoriasis
  • dry skin
  • lightening of the skin

Side effects occurrence does not only depend on the medication you are using, but also on your overall health and other factors.


Do not apply Sotret® Gel if you are allergic to Isotretinoin.

Do not apply Sotret® Gel if you have a history of severe allergic reactions associated with the use of retinoids or vitamin A.

Do not apply Sotret® Gel if you are allergic to any of the other ingredients comprised in Sotret® Gel.

Do not use Sotret® Gel if you or any of your family members have ever had an epidermal tumor.

Do not use Sotret® Gel if you are taking any acne medications (benzoyl peroxide, adapalene, sulfur, salicylic acid), antihistamines (azelastine), Vitamin A, corticosteroids (fluticasone, beclomethasone), antibiotics (clindamycin, erythromycin, tetracyclines), antipruritics (cholestyramine), diarrhea drugs (colestipol), obesity drugs (orlistat), photosensitizing agents (porfimer, verteporfin), antidepressants (hypericum perforatum) or anticoagulant (warfarin).

Do not use Sotret® Gel if you have psychotic disorders, eczema, rosacea or perioral dermatitis.

Do not use Sotret® Gel if you have skin cancer, skin photosensitivity disorder, sunburn or sunlight (UV) exposure.

Do not drive or operate machinery while using Sotret® Gel at night, as it decreases night vision.

Do not use Sotret® Gel in combination with any other acne medications.

Do not apply Sotret® Gel if you have sunburn, windburn or skin irritation with redness, peeling or itching.

Do not use Sotret® Gel in children under 12 years of age.

Sotret® Gel is strictly prohibited in women who are pregnant, plan to have a baby or are breastfeeding.

Frequently asked questions

Q: Is Sotret® Gel safe for teenagers?

A: Sotret® Gel is considerably safe for the use in patients over 12 years of age, as long as used for prescribed condition and at prescribed doses.

Q: Can Sotret® Gel be used in pregnant women?

A: Sotret® Gel is strictly prohibited in women who are pregnant, plan to have a baby or are breastfeeding.

Q: Can I treat photodamage of the skin with Sotret® Gel?

A: No. Sotret® Gel is contraindicated for use on photodamaged skin. It should be used only to treat severe acne.

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