Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
isotretinoin, Quantity: 40 mg
Strides Pharma Science Pty Ltd
Isotretinoin
Capsule, soft
Excipient Ingredients: purified water; titanium dioxide; dl-alpha-tocopherol; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; butylated hydroxyanisole; Soya Oil; partially hydrogenated soya oil; sunset yellow FCF; glycerol; disodium edetate; hydrogenated soya oil; Gelatin
Oral
90 capsules, 15 capsules, 30 capsules, 60 capsules
(S4) Prescription Only Medicine
DERMATANE is indicated for the treatment of severe cystic acne and 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 eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.
Visual Identification: Light orange coloured, oval, soft gelatin capsule containing a yellow/orange, opaque, viscous liquid.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-06-08
1 DERMATANE™ DERMATANE™ _contains the active ingredient isotretinoin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Dermatane. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Dermatane against the benefits the medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DERMATANE IS USED FOR Dermatane contains the active ingredient isotretinoin. Dermatane is used to treat acne. Dermatane belongs to a group of medicines called retinoids, which are similar to vitamin A. The retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria, reducing inflammation and opening clogged pores. There are many different types of medicines used to treat acne. Dermatane is used for more severe cases. YOUR DOCTOR MAY HAVE PRESCRIBED DERMATANE FOR ANOTHER PURPOSE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DERMATANE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. DERMATANE is not addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DERMATANE IF: 1. YOU ARE PREGNANT OR FOR AT LEAST ONE MONTH BEFORE YOU INTEND TO BECOME PREGNANT IF YOU FALL PREGNANT WHILE TAKING DERMATANE, THERE IS AN EXTREMELY HIGH RISK OF HAVING A BABY THAT IS SEVERELY DEFORMED. YOU MUST USE EFFECTIVE CONTRACEPTION FOR ONE MONTH BEFORE, DURING AND ONE MONTH AFTER TREATMENT WITH DERMATANE. 2. YOU ARE BREASTFEEDING BREASTFEEDING MUST STOP BEFORE DERMATANE TREATMENT CAN BEGIN. DO NOT BREASTFEED WHILE TAKING DERMATANE. 3. YOU HAVE HAD AN ALLERGIC REACTION TO DERMATANE, VITAMIN A, OTHER RETINOIDS OR ANY INGREDIENTS OF DERMATANE LISTED AT THE END OF THIS LEAFLET 4. YOU ARE TAKING TETRACYCLINE Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – DERMATANE (ISOTRETINOIN) 1 NAME OF THE MEDICINE Isotretinoin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Dermatane 5 mg capsule contains isotretinoin 5 mg Each Dermatane 10 mg capsule contains isotretinoin 10 mg Each Dermatane 20 mg capsule contains isotretinoin 20 mg Each Dermatane 40 mg capsule contains isotretinoin 40 mg Isotretinoin is a yellow or light orange crystalline powder practically insoluble in water, soluble in methylene chloride and slightly soluble in ethanol (96 per cent). It is sensitive to air, heat and light, especially in solution. Excipients with known effect Contains soya bean oil (refined, hydrogenated and partially hydrogenated). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Dermatane 5: Faint pinkish-cream to cream coloured oval, soft gelatin capsules, containing a yellow/orange, viscous liquid. Dermatane 10: Light violet coloured oval soft gelatin capsules, containing a yellow/ orange viscous liquid. Dermatane 20: Maroon coloured oval soft gelatin capsules, containing a yellow/orange viscous liquid. Dermatane 40: Light orange coloured, oval, soft gelatin capsules, containing a yellow/orange, opaque, viscous liquid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Dermatane is indicated for the treatment of severe cystic acne and 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 eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Due to significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics. 4.2 D OSE AND METHOD OF ADMINISTRATION The therapeutic response to isotretinoin is dose related and varies between patients. This necessitate Read the complete document