Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
isotretinoin, Quantity: 20 mg
Southern Cross Pharma Pty Ltd
Isotretinoin
Capsule, soft
Excipient Ingredients: Soya Oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; Gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue FCF; ethanol; purified water; Shellac; strong ammonia solution
Oral
60 capsule
(S4) Prescription Only Medicine
Treatment of severe cystic acne. 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 cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.
Visual Identification: red-orange, size 6, oval, soft gelatin capsules, marked 'P20'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-07-27
________________________________________________________________________________ C: Products/Isotretinoin/Isotretinoin Gx/CMI Page 1 of 4 ISOTRETINOIN GX _contains the active ingredient isotretinoin_ CONSUMER MEDICINE INFORMATION _ _ What is in this leaflet This leaflet answers some common questions about Isotretinoin Gx capsules. 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 Isotretinoin Gx capsules against the benefits they expect it will 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 Isotretinoin Gx is used for Isotretinoin Gx contains the active ingredient isotretinoin. Isotretinoin Gx is used to treat acne. Isotretinoin Gx 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. Isotretinoin Gx is used for more severe cases. YOUR DOCTOR, HOWEVER, MAY HAVE PRESCRIBED ISOTRETINOIN GX FOR ANOTHER PURPOSE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ISOTRETINOIN GX HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Isotretinoin Gx is not addictive. Before you take it _When you must not take it _ DO NOT TAKE ISOTRETINOIN GX IF: 1. YOU ARE PREGNANT, OR FOR AT LEAST ONE MONTH BEFORE YOU PLAN TO FALL PREGNANT If you fall pregnant while taking Isotretinoin Gx 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. 2. YOU ARE BREASTFEEDING Breastfeeding must stop before treatment begins. Do not breastfeed while taking I Read the complete document
AUSTRALIAN PRODUCT INFORMATION ISOTRETINOIN GX (ISOTRETINOIN) CAPSULES 1 NAME OF THE MEDICINE Isotretinoin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isotretinoin Gx 10 mg capsules contain 10 mg Isotretinoin. Isotretinoin Gx 20 mg capsules contain 20 mg Isotretinoin. Excipients with Known effect: Contains Soya oil, hydrogenated soya oil and partially hydrogenated soya oil. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ISOTRETINOIN Gx 10 mg Capsules is a soft gelatin, oval (red-orange, size 3) marked P10; ISOTRETINOIN Gx 20 mg Capsules is a soft gelatin, oval (red-orange, size 6) marked P20 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe cystic acne: 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 cystic acne who are unresponsive to conventional therapy, including systemic antibiotics. 4.2 DOSE AND METHOD OF ADMINISTRATION The therapeutic response to isotretinoin is dose related and varies between patients. This necessitates individual adjustment of dosage according to the response of the condition and the patient's tolerance of the drug. In most cases complete or near complete suppression of acne is achieved with a 16 week course of treatment. All patients should initially receive ISOTRETINOIN Gx at doses up to 0.5 mg/kg/day bodyweight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. It should be noted that transient exacerbation of acne is occasionally seen during this initial period. Satisfactory initial responses have been reported from 0.05 mg/kg/day. Relapse rates on the lower doses are Read the complete document