Generic Name: Accutane Brand Name(s): Generics only. No brands available.

Uses

What is Accutane® (isotretinoin) used for?

Accutane® is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

Accutane® is used to treat severe nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics.

How should I take Accutane® (isotretinoin)?

Accutane® comes as a capsule to take by mouth, twice a day with meals for 4 to 5 months at a time. Swallow the capsules whole with a full glass of liquid. Do not chew or suck on the capsules.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Take Accutane® exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

How do I store Accutane® (isotretinoin)?

Accutane® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Accutane® in the bathroom or the freezer. There may be different brands of Accutane® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Accutane® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Accutane® (isotretinoin)?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Accutane® or other medications.
  • You have any other illnesses, disorders, or medical conditions.

Do not breast-feed while you are taking Accutane® and for 1 month after you stop taking Accutane®.

Avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Accutane® may make your skin sensitive to sunlight.

Accutane® may cause changes in your thoughts, behavior, or mental health. Some patients who took Accutane® have developed depression or psychosis (loss of contact with reality), have become violent, have thought about killing or hurting themselves, and have tried or succeeded in doing so. You or your family should call your doctor right away if you experience any of the following symptoms: anxiety, sadness, crying spells, loss of interest in activities you used to enjoy, poor performance at school or work, sleeping more than usual, difficulty falling asleep or staying asleep, irritability, anger, aggression, changes in appetite or weight, difficulty concentrating, withdrawing from friends or family, lack of energy, feelings of worthlessness or guilt, thinking about killing or hurting yourself, acting on dangerous thoughts, or hallucinations (seeing or hearing things that do not exist). Be sure that your family members know which symptoms are serious so that they can call the doctor if you are unable to seek treatment on your own.

Accutane® may cause your eyes to feel dry and make wearing contact lenses uncomfortable during and after your treatment.

Accutane® may limit your ability to see in the dark. This problem may begin suddenly at any time during your treatment and may continue after your treatment is stopped. Be very careful when you drive or operate machinery at night.

Avoid hair removal by waxing, laser skin treatments, and dermabrasion (surgical smoothing of the skin) while you are taking Accutane® and for 6 months after your treatment. Accutane® increases the risk that you will develop scars from these treatments. Ask your doctor when you can safely undergo these treatments.

Accutane® may cause the bones to weaken or thicken abnormally and may increase the risk of certain bone injuries in people who perform some types of physical activity. If you break a bone during your treatment, be sure to tell all your healthcare providers that you are taking Accutane®.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Accutane® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Accutane®. Accutane® is pregnancy risk category X, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur from Accutane® (isotretinoin)?

Consult your doctor at once if these following side effects bother you:

  • Red, cracked, and sore lips
  • Dry skin, eyes, mouth, or nose
  • Nosebleeds
  • Changes in skin color
  • Peeling skin on the palms of the hands and soles of the feet
  • Changes in the nails
  • Slowed healing of cuts or sores
  • Bleeding or swollen gums
  • Hair loss or unwanted hair growth
  • Sweating
  • Flushing
  • Voice changes
  • Tiredness
  • Cold symptoms
  • Headache
  • Blurred vision
  • Dizziness
  • Nausea
  • Vomiting
  • Seizures
  • Slow or difficult speech
  • Weakness or numbness of one part or side of the body
  • Stomach pain
  • Chest pain
  • Difficulty swallowing or pain when swallowing
  • New or worsening heartburn
  • Diarrhea
  • Yellowing of the skin or eyes
  • Dark colored urine
  • Back, bone, joint or muscle pain
  • Difficulty hearing
  • Painful or constant dryness of the eyes
  • Unusual thirst
  • Frequent urination
  • Trouble breathing

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Accutane® (isotretinoin)?

Accutane® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug, such as:

  • Tetracyclines (e.g., minocycline, tetracycline)
  • Vitamin A-type drugs (e.g., acitretin, bexarotene)
  • Phenytoin (Dilantin)
  • Medications for mental illness
  • Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
  • Tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others)
  • Vitamin A supplements

Does food or alcohol interact with Accutane® (isotretinoin)?

Accutane® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Accutane® (isotretinoin)?

Accutane® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

These health conditions are:

  • Suicide thought
  • Depression
  • Mental illness
  • Diabetes
  • Asthma
  • Osteoporosis (a condition in which the bones are fragile and break easily)
  • Osteomalacia (weak bones due to a lack of vitamin D or difficulty absorbing this vitamin)
  • Other conditions causing weak bones
  • A high triglyceride (fats in the blood) level
  • A lipid metabolism disorder (any condition that makes it difficult for your body to process fats)
  • Anorexia nervosa (an eating disorder in which very little is eaten)
  • Heart or liver disease
  • Overweight

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Accutane® (isotretinoin).

What is the dose of Accutane® (isotretinoin) for an adult?

Acne

The recommended dose is 0.5 to 1 mg/kg/day orally in 2 divided doses; patients whose disease is very severe with scarring or is primarily manifested on the trunk may require up to 2 mg/kg/day.

Granuloma Annulare

The recommended dose is 0.5 to 1 mg/kg/day orally in equally divided doses twice a day.

What is the dose of Accutane® (isotretinoin) for a child?

Acne
12 years or older: The recommended dose is 0.5 to 1 mg/kg/day orally in 2 divided doses.

Acute Nonlymphocytic Leukemia

1 month or older: The recommended dose is 100 mg/m2/day orally, given as a single dose, for 4 weeks.

How is Accutane® (isotretinoin) available?

Accutane® is available in the following dosage forms and strengths:

  • Capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Accutane®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: May 16, 2017 | Last Modified: May 16, 2017

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