Isotretinoin (Accutane®)

WARNING

Isotretinoin must not be used by females who are pregnant or are planning on becoming pregnant. Isotretinoin is associated with a high risk of severe birth defects (malformations present at birth).

If a female does become pregnant while taking isotretinoin, isotretinoin must be stopped immediately and she should see a specialist for further evaluation.

Because of the high risk of severe birth defects, isotretinoin is only approved under a strict distribution program called iPLEDGE. iPLEDGE is a program set up to make sure that isotretinoin is not taken during pregnancy. Additional information about iPLEDGE will be given to you by the prescribing physician. Full details on the iPLEDGE program.

Do not order isotretinoin online. Isotretinoin is only prescribed under strict conditions, which includes signing a consent, monthly visits with the physician to refill the prescription, and monthly pregnancy tests for women.

Isotretinoin is available as a prescription oral treatment. It is available in capsule form.

• Available forms:
  
  
  • Oral treatment:
    
    
    • Capsule / Liquid-filled capsule:
      Available as prescription
      Generic available (US)
  • Brand names:
    
    
    • Absorbica®
    • Accutane®* (Roaccutane® in other countries)
    • Amnesteem®
    • Claravis®
    • Myorisan®
    • Sotret®
    • Zenatane®
      
      *This brand name is no longer available.

• Available in these doses:
  
  
  • Capsule: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

Dosing information:

The starting dose is based on body weight and will be determined by your physician. The dose is normally 0.5 to 1 mg per kg of body weight per day (mg/kg/day), divided into 2 doses. The dose may be adjusted as needed by your physician.

For children younger than 12 years, the use is determined by the physician however, safety studies have not been done in children younger than 12 years.

The duration of isotretinoin treatment is usually 4 to 5 months and can be up to 6 months. The exact treatment duration is determined by your physician.

• Who is it for?
  
  
  • Gender:
    • Males and females
      
  • Severity of acne:
    • Due to the serious nature of this medication, it is only approved for severe acne that does not respond to other treatments.
      
  • Age:
    • Children of 12 years and older, adolescents, and adults
      
  • Other:
    • Recalcitrant nodular acne (a certain type of severe, disfiguring acne) not responding to other treatments

How to use it:

Isotretinoin is an oral treatment, available in capsule form and is usually taken twice a day.

Your physician will prescribe an initial dose of isotretinoin and may increase or decrease the dose depending on the response to treatment and the side-effects.

Take isotretinoin with meals (that contain fat). Swallow the capsule whole with a full glass of water (8 ounces or 250 ml) or other liquid. You should not suck or chew on the capsule.

It may take several weeks or more to see the benefit of isotretinoin on your acne. During the first weeks of treatment, your acne may increase and your skin may become more irritated, which is normal and does not mean that the medication is not working. Talk to your physician if there has been no improvement in your acne after 1 to 2 months of starting isotretinoin. Your acne may continue to improve up to 6 months after stopping the treatment.

Follow the instructions on your prescription carefully and use isotretinoin exactly as prescribed by your physician. Do not change the dose or the frequency of your medication. If you have any questions about the medication or the prescription, ask your physician or pharmacist.

Capsule

In general, capsules should be swallowed whole. Do not break, crush, chew or open the capsules.

All forms of isotretinoin need to be taken with food (preferably containing fat) aside from Absorbica®, which is designed to be taken with or without food (Absorbica® is also better absorbed with a fat-containing meal).

Do not switch between brands of isotretinoin. If you pick up a prescription and the capsules look different, check with your pharmacist or prescribing physician.

Be aware of:

• Before using isotretinoin, let your physician or pharmacist know if you are allergic to isotretinoin, vitamin A, aspirin, or any of the other ingredients in the capsules.
• Before using isotretinoin, inform your physician about the prescription and non-prescription medications, vitamins (including vitamin A), nutritional supplements, and herbal products you are using/taking. You will find a complete list of drug interactions below.
• Before using isotretinoin, inform your physician if you have attempted, or anyone in your family has thought about or attempted suicide or is currently suffering or has previously suffered from depression or other mental disorders. Isotretinoin may change your behavior, thoughts, or mental health. Your physician needs to be contacted immediately if you have one of the following symptoms: anxiety, sadness, crying spells, loss of interest in activities you used to enjoy, decreased performance at school or work, sleeping irregularities (sleeping more than usual or having trouble falling asleep or staying awake), irritability, anger, aggression, weight changes, changes in appetite, concentrating problems, withdrawal from friends or family, lack of energy, feelings of worthlessness or guilt, thoughts about killing or hurting yourself, acting on dangerous thoughts, or hallucinations (hearing, seeing or smelling things that are not there). Inform your family members about these possible symptoms so they can call your physician if you are unable to ask for help.
• Before using isotretinoin, inform your physician if you or anyone in your family suffers from or has ever suffered from osteoporosis (weak / brittle bones), osteomalacia (weak / soft bones because of lack of vitamin D), or other conditions with weak bones or premature epiphyseal closure (bone growth problem). Isotretinoin may weaken bones or thicken bones abnormally. Isotretinoin may also increase the risk of bone injuries when performing certain types of physical activities. Injuries may also heal more slowly. Ask your physician before participating in hard physical activity such as sports. Furthermore, inform your physician that you are taking isotretinoin if you break a bone.
• Before using isotretinoin, inform your physician if you or anyone in your currently suffers or has ever suffered from asthma, diabetes, high triglyceride (fat) level in the blood, lipid metabolism disorders (difficulty to process fat), pancreatitis (inflammation of the pancreas), anorexia nervosa (eating disorder), severe weight problems, intestinal problems, eye or vision problems, hearing problems, heart or liver disease including hepatitis, kidney disease, pseudotumor cerebri (swelling in the brain), or vitamin A overdose.
• Before using isotretinoin, inform your physician if you drink alcohol. It is not recommended to use isotretinoin with alcohol.
• If you are using isotretinoin, avoid pregnancy during treatment and until one month after stopping isotretinoin (see warning above).
• Before using isotretinoin, you must use two acceptable forms of birth control for one month prior to starting isotretinoin, during your entire course, and for one month after finishing your course. The most effective forms of birth control for women are hormonal contraceptives including birth control pills, patches, shots, vaginal rings, implants, and IUDs (intrauterine devices). One of these forms of birth control needs to be combined with a condom, diaphragm, or cervical cap. If a female has a single male partner and he has had a vasectomy, that counts as one form of birth control. If for any reason you cannot use two forms of birth control or have questions about birth control, ask your physician.
• If you miss a menstrual period or your menstrual period is late, or you have sex without two forms of contraception, stop isotretinoin and contact your physician immediately.
• Isotretinoin interacts with the action of micro-dosed progestin oral contraceptives (“mini pill” such as Ovrette®, Micronor® Nor-QD®) making these pills less reliable. These mini pills are not an acceptable form of birth control while taking isotretinoin.
• Make sure that you inform your physician about all the medications, vitamins, nutritional supplements, and herbal supplements, including St. John’s wort, you are taking if you are using hormonal contraceptives. Medications may interact with the action of hormonal contraceptives making the contraceptive less reliable.
• Before starting isotretinoin, you must have two negative pregnancy tests. After starting the treatment, pregnancy tests need to be repeated monthly until 30 days after taking the last dose.
• If you think that you might be pregnant or if there is any chance whatsoever that you may become pregnant (inadequate contraception) stop isotretinoin and call you physician immediately.
• For males: a very small amount of isotretinoin will be present in your semen while you are taking the treatment. Whether this amount of isotretinoin is harmful to the fetus if your partner becomes pregnant is unknown. Talk to your physician if your partner is pregnant or wants to become pregnant while you are using isotretinoin.
• If you are using isotretinoin, do not breastfeed during treatment and upto 1 month after stopping isotretinoin.
• Do not donate blood while taking isotretinoin or within a month of stopping using isotretinoin. This is to ensure that a pregnant woman does not receive blood containing isotretinoin.
• Isotretinoin may make your skin more sensitive to sunlight so avoid unnecessary direct or prolonged exposure to sunlight, and use of sunlamps or tanning beds. Risk of sunburn and dry skin or irritation is especially present during the first 2 to 3 weeks of treatment. Wear protective clothing, sunglasses and sunscreen (minimal sun protection factor of 15) while taking isotretinoin.
• Isotretinoin may decrease the ability to see in the dark so be careful when driving or operating machinery at night. This may start at any time during your treatment and may still be present after your stopped taking isotretinoin. Talk to your physician about driving or operating machinery while on isotretinoin.
• Isotretinoin may cause your eyes to feel dry. This can make wearing contact lenses uncomfortable during and for a while after stopping treatment. Your physician may prescribe a lubricating solution to relieve dryness of the eyes. If your eyes are inflamed, contact your physician right away.
• Isotretinoin may cause your mouth and nose to feel dry. Sugarless candy or gum, melting ice cubes or a saliva substitute may relieve this feeling. Contact your physician if symptoms continue for more than two weeks because persisting dryness of the mouth increases the chance of dental problems such as tooth decay, gum disease, and fungal infections.
• Isotretinoin may increase the risk of developing scars so avoid hair removal by waxing, laser skin therapy, and dermabrasion when you are on isotretinoin treatment and for 6 months after you have stopped treatment. Ask your physician when it is best to restart these hair removal treatments.
• Isotretinoin may decrease certain types of blood cells causing you to bleed or get infections more easily. Avoid close contact with people who are sick or have infections and wash your hands regularly. Avoid situations where you could be bruised or injured. Be gentle while brushing teeth or flossing and be careful with razors or nail clippers.
• If you are about to undergo surgery (which includes dental surgery), inform your physician or dentist that you use isotretinoin, prior to the procedure.
• If isotretinoin was prescribed for acne, you can continue your regular diet unless your physician advises otherwise.
• Do not share your medication with anyone else, especially because of the risk of birth defects in the babies of pregnant women and other serious side-effects.
• Keep your regular appointments with your physician to track your response to isotretinoin.

Drug interactions:

Some drugs interact with isotretinoin and should not be used together with isotretinoin. However, your physician may prescribe other drugs together with isotretinoin which may cause a slight interaction, and in this case precautions are necessary.

Inform your physician or pharmacist about all the prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take before starting isotretinoin. Also inform your physician or pharmacist of the skin products you use including soaps, cleansers, moisturizers, and cosmetics.

Full list of drug interactions (From PubMed and Medline Plus):

• Chlortetracycline
• Demeclocycline
• Desogestrel
• Dexamethasone
• Dienogest
• Doxycycline
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Levonorgestrel
• Lymecycline
• Meclocycline
• Medroxyprogesterone Acetate
• Mestranol
• Methacycline
• Methylprednisolone
• Minocycline
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oxytetracycline
• Phenytoin
• Prednisone
• Rolitetracycline
• Tetracycline
• Vitamin A supplements

What if I overdose?

In case of overdose, contact an emergency facility or call the American Association of Poison Control Centers at 1 (800) 222-1222 (available 24/7).

If immediate assistance is necessary because the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened, call 911 at once.

Information can also be found online at https://www.poisonhelp.org/help

Symptoms of overdose:

• Vomiting
• Flushing (sudden redness of the face)
• Severe chapped lips
• Stomach pain
• Headache
• Dizziness
• Loss of coordination

What if I miss a dose?

As soon as you recall that you have missed a dose, take the missed dose. However, skip the missed dose if it is almost time for your next dose and continue with your prescribed dosing schedule. Do not increase the quantity or frequency of dosing to make up for the missed dose.

Storage:

Store your medication in the container that the pharmacist provided and keep it out of reach and out of sight of children. Many containers can be opened by children. Keep the container tightly closed. Always lock safety caps and immediately place the medication in a safe location that is up and away from the sight of young children, to prevent poisoning (www.upandaway.org).

Store the medication at room temperature. Keep the medication away from excessive heat and moisture – do not store in the bathroom. Do not freeze isotretinoin.

Disposal:

Do not keep outdated medication and medication that you no longer use. Unneeded medications should be disposed of in a way that pets, children, and other people cannot consume them. Do not flush the medication down the toilet. Contact your pharmacist to learn about the availability of a medicine take-back program in your neighborhood, or get in touch with your local garbage/recycling department to ensure safe disposal. If you do not have access to a take-back program, you can find more information on safe disposal of medication on the FDA website: (https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm)

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