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 belongs to a group of medicines known as retinoids, which are derivatives of vitamin A. It works by reducing the production of the skin’s natural oil (sebum).

Acne occurs due to an excessive production of sebum from over-active sebaceous glands in the skin. The sebum blocks the sebaceous glands, which prevents the oil from flowing freely out and causes an accumulation of sebum under the skin. The bacteria associated with acne thrive in these conditions. They feed on the sebum, and produce waste products and fatty acids that irritate the sebaceous glands, making them inflamed and causing spots.

Isotretinoin decreases the size and activity of the sebaceous glands in the skin, which reduces the amount of sebum that is produced. This stops the glands becoming blocked, and means bacteria are less likely to thrive. It also reduces the inflammation in the skin.

Isotretinoin can have serious side effects and its use must be supervised by a dermatologist. It is reserved for the treatment of severe acne that has not improved with a course of oral antibiotics, and for acne with cyst formation.

Your acne may worsen at the start of treatment, but this usually subsides within 7 to 10 days of continued treatment. In most cases, complete or near-complete clearing of acne is achieved with a 12 to 16 week course of treatment, and you are likely to remain free of acne for a long time. Repeat courses are not normally recommended, unless a definite relapse is seen after treatment is stopped.


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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.

Headache
Nausea
Blood disorders
Visual disturbances
High blood glucose level (hyperglycaemia)
Inflammation of the pancreas (pancreatitis)
Abnormal reaction of the skin to light, usually a rash (photosensitivity)
Dry skin
Mood changes, strange or abnormal thoughts or depression
Skin darkening
Breathing difficulties due to a narrowing of the airways (bronchospasm)
Increased hair growth (hirsutism)
Hair loss (alopecia)
Itching (pruritis)
Inflammation of the surface of the eye (keratitis)
Dryness of the mucous membranes, eg lips, eyes, nose (causing nosebleeds) and throat (causing hoarseness)
Liver disorders
Pain in the muscles and joints
Inflammatory bowel disease

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 ROACCUTANE with caution in
Alcoholism
Diabetes
Elderly people
History of depression
Lipid metabolism disorder
Obesity
Women who could become pregnant

ROACCUTANE Not to be used in
A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A)
Acne developing in the peroid before puberty (prepubertal acne)
Breastfeeding
Decreased kidney function
Decreased liver function
High levels of fats (lipids) such as cholesterol and triglycerides in the blood (hyperlipidaemia)
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.

Use ROACCUTANE with caution in
Alcoholism
Diabetes
Elderly people
History of depression
Lipid metabolism disorder
Obesity
Women who could become pregnant

Isotretinoin used in combination with tetracycline-type antibiotics, eg minocycline and tetracycline may increase the pressure within the skull, leading to adverse effects. For this reason, tetracycline antibiotics must not be taken at the same time as this medicine.

Combined treatment with isotretinoin and vitamin A may result in a condition similar to vitamin A overdose, which may cause changes in the structure of the bone. High doses of vitamin A (more than the recommended dietary allowance of 4000-5000 iu per day) should therefore be avoided.

The use of other treatments conventionally used for acne, including antibiotics, exfoliants, medicines which loosen the dead skin on the skin surface (keratolytics), or radiation therapy with ultraviolet light, should be avoided while taking isotretinoin. However, non-irritant preparations can be applied to the skin if necessary.

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. ROACCUTANE must not be used during pregnancy as it causes major birth defects. Women of child-bearing potential can only take this medicine if they use effective contraception for one month before, during and for one month after finishing treatment. Treatment must only be started on the second or third day of your menstrual period, and only after a negative pregnancy test. This medicine should not be used by breastfeeding mothers. Discuss this with your doctor.