Overview page
Medicine name: Accutane is a well known brand for the oral retinoid isotretinoin; equivalent generic products include Oratane and other registered generics.
Isotretinoin constitutes the active ingredient.
Primary use: treatment of severe nodulocystic or treatment-resistant acne. It is a prescription systemic medicine used under clinician supervision.
Common capsule strengths: 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.
Agile navigation: view side effect details at Collateral effects or other treatment options at Equivalent medicines and further options.
Before kicking off, convey important details to your clinician.
Before isotretinoin is prescribed, disclose the following to your prescriber or pharmacist so they can assess safety and ongoing monitoring program needs.
- Pregnancy, pregnancy planning, and breastfeeding are the main subjects.
- Current or past mental health problems including depression, psychosis, or suicide attempts, and relevant family history.
- Liver disease or previous liver enzyme abnormalities.
- High cholesterol or triglyceride levels, or a history of pancreatitis.
- Bone disease such as osteoporosis or conditions affecting bone health.
- Chronic inflammatory disease of the bowel or persistent gastrointestinal symptoms.
- The chronic glucose intolerance called diabetes or glucose intolerance.
- Cardiovascular pathology.
- Allergies to isotretinoin, other retinoids, vitamin A, preservatives or dyes.
If you are unsure about any item, ask your prescriber to clarify. For pregnancy prevention and testing requirements see Access to legal resources in Australia.
Isotretinoin administration guide
Swallow capsules whole with a glass of water and follow the directions on your prescription label. Taking the capsule with food increases absorption and may reduce stomach upset.
Maintain a consistent dosing schedule, for example taking doses at the same time each day. Do not chew or crush capsules and do not take more frequently than prescribed.
Adolescents: clinicians may prescribe isotretinoin for teenagers from about 13 years of age if indicated, with extra observation and tracking.
Overdose risk: in Australia contact the Poisons Information Centre on 13 11 26 or arrive at the nearest emergency department if you suspect an overdose event.
Not taken at scheduled time - what to do
As soon as you forget a dose, take it as soon as you remember, unless the next scheduled dose is due within about four hours. When the next dose is close, skip the forgot to take my dose and follow the standard dosing pattern. Never take a double dose to make up for a dose you missed.
Medicines, supplements and foods that can interact with isotretinoin
Keep from combining.
- High dose vitamin A supplements or multivitamins containing high amounts of vitamin A - risk of hypervitaminosis A.
Use with caution. and discuss with your clinician
- Tetracycline group antibiotics, for example doxycycline or tetracycline - there is a risk of benign intracranial hypertension when combined.
- Orlistat, a weight loss medication - may increase absorption of fat soluble vitamin A related substances.
- A typical systemic corticosteroid, such as prednisone.
- Anti-coagulants such as warfarin - isotretinoin may alter clotting tests and effects.
- Antiepileptic medicines.
- Topical acne treatments that cause skin irritation such as benzoyl peroxide or salicylic acid - use only as advised to limit excessive dryness.
- Beverage with ethanol - can increase liver strain and raise triglyceride levels; limit intake during treatment.
- Herbal products such as St John's wort which may change hormonal contraceptive reliability.
This enumeration is incomplete. Provide a complete list of prescription and non-prescription medicines, supplements and herbal products to your healthcare team. Also report alcohol use and smoking.
Network monitoring, risk mitigation measures and practical advice
- Expect a possible temporary worsening of acne in the first few weeks of treatment.
- Monthly clinical reviews are commonly required to renew prescriptions and assess wellbeing.
- Regular blood tests such as liver function and lipid profile are routine and typically checked before starting and periodically thereafter.
- Do not donate blood while taking isotretinoin and for at least 30 days after the last dose.
- Watch for mood or behavioral changes. Seek urgent medical contact if you experience depression, unusual irritability, aggression or thoughts of self harm.
- Night vision may be reduced; avoid driving at night if vision changes occur and report any visual disturbances promptly.
- Dry eyes and contact lens discomfort are common; artificial tears can help. Protect skin from sun exposure and avoid tanning devices.
- Avoid skin procedures that injure the surface such as waxing, dermabrasion or laser resurfacing during therapy and for several months afterwards due to scarring risk.
- If you have diabetes or prediabetes, discuss glucose continuous oversight with your clinician as lipids and glucose can change during therapy.
For a list of serious adverse events see Off target effects.
Possible reactions to the medication
Seek immediate medical attention
- Signs of allergic reaction such as rash, itching, hives, swelling of face or throat, or breathing difficulties.
- Severe head pain sensations, visual changes including blurred or double vision, or loss of night vision.
- Chest pain, fainting or irregular heartbeat.
- Hearing loss or persistent ringing in the ears..
- Severe abdominal ache, persistent vomiting or symptoms suggesting pancreatitis.
- Marked mood changes including depression, withdrawal from usual activities or thoughts of self harm.
- Very dark urine, extreme thirst, or a large increase in urination.
- Severe muscle weakness or unexplained severe muscle or joint pain.
- Bruising or bleeding with no identifiable trigger and yellowing of the skin or eyes which may indicate liver injury.
- Changes to menstrual cycle.
Common but usually manageable
- Dry, cracked lips and very dry skin.
- The mouth feels dry and nasal dryness that can cause nosebleeds.
- Mild i am having a headache or temporary increase in hair shedding.
- Pipe flushing or skin sensitivity.
If minor effects persist or interfere with daily life, report them to your prescriber for advice on symptom relief or dose adjustment.
Encrypted efficient storage helps minimize clutter and maximize space.
- Medicines must be stored in a place inaccessible to children and out of view.
- Store at room temperature between 15 to 30 C (59 to 86 F), away from direct heat and moisture.
- Do not use capsules beyond the expiry date and follow pharmacist advice for disposal.
Alternative drugs and similar pharmaceutical options
If isotretinoin is unsuitable, several other strategies may be considered depending on acne type and severity. Discuss options with your general practitioner or dermatologist.
- Other isotretinoin brands and generics: Roaccutane (older brand), Oratane and PBS-listed generics - similar efficacy, price and formulation differences may exist.
- Topical retinoids such as adapalene or tretinoin - effective for comedonal acne and maintenance therapy.
- Benzoyl peroxide preparations - antibacterial and keratolytic, often used in combination therapy.
- Oral antibiotics like doxycycline or minocycline for inflammatory acne; usually used for limited durations.
- Hormonal treatments for suitable patients such as combined oral contraceptives or spironolactone to reduce androgen driven oil production.
- Other systemic retinoids such as acitretin are mainly used for different skin conditions and have different pregnancy preventive precautions.
For approximate cost differences see Competitive price comparisons in Australia.
AUD inflation-adjusted prices in Australia - rough guide
The following are indicative ranges. Actual cost varies with brand, dose, pharmacy, PBS status and your concession or safety net position.
- Isotretinoin (Accutane, Oratane, generics) - often PBS subsidised for qualifying severe acne. PBS patient co-payment is commonly around AUD 30 to 32 per script; concession holders pay about AUD 7 to 8. Private prescriptions may cost approximately AUD 60 to 120 per month depending on dose and manufacturer.
- Doxycycline - frequently PBS listed; many private scripts cost around AUD 10 to 25 per month.
- Topical adapalene or tretinoin - typical retail price about AUD 25 to 60 per tube.
- Benzoyl peroxide products - roughly AUD 8 to 25 depending on product size and strength.
- Combined oral contraceptives - about AUD 10 to 30 per month depending on brand and PBS listing.
- Spironolactone - approximate cost AUD 10 to 20 per month for commonly used doses.
Check with local pharmacies in conjunction with the PBS website for current subsidy and price list details.
Understanding status of lawful authorization affecting access in Australia
- Regulatory category: isotretinoin is prescription only (Schedule 4) and is regulated by the Therapeutic Goods Administration.
- Pregnancy risk: classified as contraindicated in pregnancy. Do not take if pregnant; strict pregnancy prevention requirements apply.
- Contraception and testing: people able to become pregnant are normally required to have negative pregnancy tests before starting, monthly during treatment, and for a period after stopping. Two reliable forms of contraception are generally recommended starting at least one month before treatment, during treatment and for at least one month afterwards.
- PBS criteria: subsidy is commonly restricted to severe nodulocystic acne that has failed a different path care options. Prescribers follow PBS eligibility rules and clinical guidelines.
- Environmental monitoring: regular clinical reviews and pathology checks (liver enzymes, lipids) are standard practice.
- Blood donation: not allowed while on therapy and for a minimum of 30 days after the final dose.
- Personal importation: under TGA rules a person may import a limited supply of a prescription medicine for personal use if conditions are met, including holding a valid Australian prescription. Importing isotretinoin without meeting these conditions is not recommended and may be unlawful.
Regulatory requirements can change; rely on your prescriber and pharmacist for the most current obligations and safety steps.
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