WARNING: Do not use ISOTANE if you are pregnant. Do not become pregnant during use, or within one month of stopping treatment with ISOTANE. MAJOR RISK OF BIRTH DEFECTS. Effective birth control must be used. Keep out of reach of children.

Acne Treatment

It is best to talk to your doctor or dermatologist (skin specialist doctor) about the correct treatment for your acne. Some of the treatment options they may give you are mentioned below:

Topical Treatment
For treatment of mild to moderate acne, topical treatment may be given. The most common topical treatment is benzoyl peroxide. This can be bought from your pharmacy with or without a prescription, or your supermarket. Other topical treatments include prescription medicines such as antibiotic lotions. These topical treatments are often sufficient to reduce inflammation and unblock pores. Treatment periods will vary between patients but normally last between 2-4 weeks.
Oral Treatment
For treatment of moderate to severe acne, oral treatment may be given. Isotretinoin, the active ingredient in ISOTANE, is an oral treatment commonly prescribed by doctors and dermatologists. Isotretinoin belongs to a group of medicines called retinoids which are Vitamin A derivatives. It works by reducing the amount of sebum (an oily substance produced by the sebaceous glands in your skin), reducing bacteria, reducing inflammation and opening clogged pores. Other oral treatments for moderate to severe acne include oral antibiotics and hormonal contraceptive pills. Oral antibiotics (e.g. doxycycline, minocycline) work by reducing the amount of bacteria on your skin. Hormonal contraceptive pills help in the regulation of hormones such as the androgens during puberty.

isotane

ISOTANE (isotretinoin) is a prescription medicine used to treat severe forms of acne that are resistant to other treatments. Each capsule contains either 10mg or 20mg of isotretinoin. Common side effects include dryness of the lips, mouth, throat, nose, eyes and skin; skin eruptions, rashes, itching, inflammation, redness, sweating or changes in skin colour, nail inflammation, infection or altered appearance, nosebleeds, tenderness, soreness or stiffness in your bones, joints or muscles, and headache. For a full list of side effects and precautions please refer to the Consumer Medicine Information

Warning to Patients
Do not take ISOTANE if you:
  • are pregnant, or you intend to become pregnant
  • are breast-feeding
  • have had an allergic reaction to ISOTANE, any other retinoids, including Vitamin A or any of the ingredients listed in the Consumer Medicine Information.
  • have kidney or liver disease
  • have an excessive amount of vitamin A in the diet
  • are taking tetracycline antibiotics
  • have very high levels of fat (triglycerides, cholesterol) in your blood
  • are a child under 13 years.
  • Before you start your ISOTANE treatment, please advise your doctor or dermatologist if you;
  • Are depressed (have feelings of deep sadness and unworthiness or feel ‘down’), or have felt this way in the past
  • Have abnormal thoughts or behaviour or a mental illness, or have had them in the past
  • Have thoughts of harming yourself (suicidal thoughts or tendencies) or have had them in the past
  • Before you start your ISOTANE treatment, please advise your doctor or dermatologist if you;
  • Have any other health problems, especially the following: you are considerably overweight; have diabetes, or a history of diabetes in your family; or a history of pancreatitis (inflamed pancreas).
  • Drink large amounts of alcohol
  • Are on the “mini pill”, a progestogen only oral contraceptive pill
  • Are allergic to any other medicines, foods, preservatives or dyes
  • Undertake regular vigorous exercise
Warning to Female Patients
  1. Do not take this medicine if you are pregnant. If you become pregnant while taking ISOTANE, there is an extremely high risk that your baby will be severely deformed. Effective birth control must be used.
  2. Do not breast-feed if you are taking this medicine. The active ingredient in ISOTANE passes into breast milk and there is a possibility that your baby may be affected.
  3. Pregnancy testing should be performed before, during (every month is strongly recommended) and for a month after treatment has finished.
  4. If you become pregnant while taking ISOTANE, stop taking it and tell your doctor immediately.
  5. You must use effective birth control starting at least one month before you begin taking ISOTANE, for the whole time you are taking ISOTANE and for one month after you finish taking ISOTANE. Even if you are infertile or not sexually active, effective birth control is recommended.
  6. If you take further courses of ISOTANE after completing the initial treatment, you must ensure that each time you take ISOTANE you use effective birth control starting at least one month before treatment, for the whole time during treatment and for one month after you have finished taking ISOTANE.
Warning to Male Patients
  1. Do not share your medication with anyone, particularly not females.
  2. Isotretinoin treatment does not appear to damage sperm. Although isotretinoin and its metabolites are present in very low levels in your semen, these levels are considered too low to harm the unborn baby of your female partner. No specific contraceptive precautions are necessary for men.
Where can I find more information about ISOTANE?
For further information about ISOTANE, please refer to the Consumer Medicine Information, or contact your doctor or pharmacist.
Further information can also be obtained from Mylan New Zealand Ltd.
Isotane (isotretinoin) 10 mg, 20mg Capsules are a Prescription Medicine used to treat severe forms of acne that are resistant to other treatments.
WARNING: This medication can cause birth defects. Do not use if you are pregnant or plan to become pregnant. Effective birth control must be used one month before starting Isotane treatment, during treatment and for at least one month after treatment has finished. Do not take if you have an allergy to isotretinoin, other retinoids including vitamin A or any of the excipients; are pregnant or intend to become pregnant; are breastfeeding; have kidney or liver disease; have an excessive amount of vitamin A in your diet; are taking tetracycline antibiotics; have very high levels of fat (triglycerides, cholesterol) in your blood. Tell your doctor if you are depressed or have felt this way in the past; if you have thoughts about harming yourself; drink large amounts of alcohol; are taking the mini-pill; intend to undertake regular vigorous exercise or have any other health problems. Side effects include dryness of the lips, mouth, throat, nose, eyes, genitals or skin; skin eruptions, rashes, redness, sweating; nail inflammation, infection or altered appearance; nosebleeds; tenderness, soreness or stiffness in your bones, joints or muscles; impaired hearing; headache; increased sensitivity to sunlight; hair loss, thinning or increased growth; changes in normal behaviour; blurred vision, decreased night vision; nausea, vomiting, diarrhoea. Medicines have benefits and some may have risks. Consult your doctor to see if Isotane is right for you. Always read the label carefully and use strictly as directed. If symptoms persist or you have side effects, see your health professional. Full Consumer Medicine Information (CMI) is available at www.medsafe.govt. nz. Isotane is fully funded on special authority. Normal doctor’s fees & pharmacy charges apply.Mylan NZ Ltd., Auckland. TAPS NA7865