Used to treat severe acne that has not responded to oral or topical anti-infectives. Indications: Severe recalcitrant nodular acne: Roaccutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. by definition means as opposed to nodules. Because of significant adverse effects associated with its use, Roaccutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. A single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Roaccutane.

Isotretinoin is the acid form of vitamin A. It stimulates cell division in the skin and reduces the production of keratin. It aids skin peeling and prevents the formation of acne lesions (comedones).

Acne is caused by blockage of sebaceous glands. This leads to an accumulation of the skins natural oils (sebum). Bacteria on the skin feed on sebum and produce waste products which further inflame the sebaceous glands, causing acne. Irritant substances can leak into the surrounding skin causing further inflammation.

The action of isotretinoin combats the changes that take place in acne.
Erythromycin is a member of the macrolide family of antibiotics.
It interferes with the production of proteins that bacteria need to multiply and divide. This inhibits the ability of the bacteria to grow (i.e. it has a bacteriostatic action).
By controlling bacterial numbers, the inflammation of acne can be reduced.

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Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Local skin reaction e.g. redness, itchiness, burning
Increased sensitivity to sunlight
Changes in skin pigmentation
Skin peeling
Eye irritation and swelling

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Use Isotrex Gel (Isotretinoin) with caution in
Eczema
Family history of cancer of the skin or lining of the internal body cavities (cutaneous epithelioma)
Limit exposure to sunlight
Sensitive areas such as the neck

Avoid contact with eyes, eyelids and all other mucosal surfaces
Known sensitivity or allergy to any ingredient
Pregnancy

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Skin-peeling agents and skin drying preparations, such as medicated cosmetics, soaps, toiletries and other anti-acne preparations increase the likelihood of dryness and irritation of the skin.
Vitamin A: Supplements of this vitamin increase the risk of adverse effects from isotretinoin. Although when taken orally erythromycin can interact with many medicines, when applied directly to unbroken skin erythromycin is not expected to be absorbed in sufficient quantities to cause interaction problems.

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby.Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used in pregnancy. Seek medical advice from your doctor. There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.