Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
isotretinoin
Amneal Pharma Australia Pty Ltd
Isotretinoin
Registered
_Isotretinoin AN capsules – Consumer Medicine Information _ _ _ _Isotretinoin AN CMI v3.0 _ _ _ _ _ _Page 1 _ ISOTRETINOIN AN CAPSULES _Isotretinoin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Isotretinoin AN 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 AN capsules against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT ISOTRETINOIN AN IS USED FOR Isotretinoin AN capsules contains the active ingredient isotretinoin. Isotretinoin AN is used to treat acne. Isotretinoin AN 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 AN is used for more severe cases. YOUR DOCTOR, HOWEVER, MAY HAVE PRESCRIBED ISOTRETINOIN AN FOR ANOTHER PURPOSE. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ISOTRETINOIN AN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Isotretinoin AN is not addictive. BEFORE YOU TAKE ISOTRETINOIN AN _WHEN YOU MUST NOT TAKE _ _ISOTRETINOIN AN _ DO NOT TAKE ISOTRETINOIN AN IF: 3. YOU HAVE HAD AN ALLERGIC REACTION TO ISOTRETINOIN AN, VITAMIN A, OTHER RETINOIDS OR ANY OTHER INGREDIENTS OF ISOTRETINOIN AN (LISTED AT THE END OF THIS LEAFLET) 4. YOU ARE TAKING TETRACYCLINE ANTIBIOTICS (SUCH AS AKAMIN®, VIBRAMYCIN®, DOXYCYCLINE HYDROCHLORIDE, DORYX®, FRAKAS®, MINOMYCIN®) 5. YOU HAVE SEVERE LIVER DISEASE 6. YOU HAVE VERY HIGH FAT LEVELS (CHOLESTEROL, TRIGLYCERIDES) IN YOUR BLOOD 7. YOU HA Perskaitykite visą dokumentą
_ _ _ _ _Isotretinoin AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ Doc ID: 68.AN.P.2.0 Page 1 of 11 ISOTRETINOIN AN _ _ _(ISOTRETINOIN TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE: The name of the medicine is isotretinoin. CHEMICAL NAME: is 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-cis-(4,6,8)-trans-nonatetraenoic acid MOLECULAR FORMULA: C 20 H 28 0 2 MOLECULAR WEIGHT: 300.44 CAS REGISTRY NUMBER: _[4759-48-2] _ DESCRIPTION Isotretinoin is related to both retinoic acid and retinol (Vitamin A). Isotretinoin is a yellow - orange to orange crystalline powder that is practically insoluble in water, soluble in methylene chloride, sparingly soluble in ether and slightly soluble in alcohol. It is sensitive to air, heat and light, especially in solution. Isotretinoin AN capsules contain Isotretinoin, yellow beeswax, Disodium edetate, Butylated Hydroxyanisole, dl-alpha-tocopherol, hydrogenated soya oil, Soya oil, hydrogenated vegetable oil (5mg, 10mg and 20mg only), Soya oil – hydrogenated (40mg only). The capsule shell contains Sorbitol solution (70% non-crystallising), Glycerol, Gelatin, Titanium dioxide,purified water, Brilliant scarlet 4R (10mg and 20mg only), Sunset yellow FCF (40mg only), Indigo carmine (20mg only), Iron oxide black (10mg only). PHARMACOLOGY _PHARMACODYNAMICS_ Isotretinoin AN contains isotretinoin; this is a retinoid that inhibits sebaceous gland function and keratinisation. The exact mechanism of action of isotretinoin is unknown. Clinical improvement in cystic acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is reversible and the extent is related to the dose and duration of treatment with Isotretinoin AN and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. PHARMACOKINETICS _ _ _ _ _Isotretinoin AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ Doc ID: 68.AN.P.2.0 Page 2 of 11 ABSORPTION There is considerable interindivi Perskaitykite visą dokumentą