What is isotretinoin?

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

Know the basics

What is isotretinoin used for?

Isotretinoin is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). Isotretinoin belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

How should I take isotretinoin?

Swallow capsules whole. Do not crush or chew them. Isotretinoin is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of isotretinoin state that it should be taken with meals. However, the FDA has indicated that the Absorica brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it.

The dosage is based on your medical condition, weight, and response to treatment.

Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of isotretinoin. Do not take more than the recommended dose.

Since isotretinoin can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

How do I store isotretinoin?

Iodine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store iodine in the bathroom or the freezer. There may be different brands of iodine 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 iodine 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.

Know the precautions & warnings

What should I know before using isotretinoin?

Before taking isotretinoin,

  • tell your doctor and pharmacist if you are allergic to isotretinoin, vitamin A, any other medications, or any of the ingredients in isotretinoin capsules. Ask your pharmacist or check the Medication Guide for a list of the inactive ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements you are taking or plan to take. Be sure to mention medications for seizures such as 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); and vitamin A supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you or anyone in your family has thought about or attempted suicide and if you or anyone in your family has or has ever had 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), or other conditions that cause 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), or heart or liver disease. Also tell your doctor if you are overweight or if you drink or have ever drunk large amounts of alcohol.
  • do not breast-feed while you are taking isotretinoin and for 1 month after you stop taking isotretinoin.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Isotretinoin may make your skin sensitive to sunlight.
  • you should know that isotretinoin may cause changes in your thoughts, behavior, or mental health. Some patients who took isotretinoin 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.
  • you should know that isotretinoin may cause your eyes to feel dry and make wearing contact lenses uncomfortable during and after your treatment.
  • you should know that isotretinoin 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.
  • plan to avoid hair removal by waxing, laser skin treatments, and dermabrasion (surgical smoothing of the skin) while you are taking isotretinoin and for 6 months after your treatment. Isotretinoin increases the risk that you will develop scars from these treatments. Ask your doctor when you can safely undergo these treatments.
  • talk to your doctor before you participate in hard physical activity such as sports. Isotretinoin 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 isotretinoin.

Is it safe to take isotretinoin during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this medication during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. This medication 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

Know the side effects

What are the side effects of isotretinoin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

  • depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
  • sudden numbness or weakness, especially on one side of the body;
  • blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
  • hearing problems, hearing loss, or ringing in your ears;
  • seizure (convulsions);
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
  • fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
  • severe blistering, peeling, and red skin rash;
  • joint stiffness, bone pain or fracture.

Less serious side effects may include:

  • joint pain, back pain;
  • feeling dizzy, drowsy, or nervous;
  • dryness of the lips, mouth, nose, or skin;
  • cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

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.

Know the interactions

What drugs may interact with isotretinoin?

Isotretinoin 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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

  • Chlortetracycline, Demeclocycline, Desogestrel, Dienogest, Doxycycline, Drospirenone, Estradiol Cypionate, Estradiol Valerate, Ethinyl Estradiol, Ethynodiol Diacetate, Etonogestrel, Levonorgestrel, Lymecycline, Meclocycline, Medroxyprogesterone Acetate, Mestranol, Methacycline, Minocycline, Norelgestromin, Norethindrone, Norgestimate, Norgestrel, Oxytetracycline, Rolitetracycline, Tetracycline.

Does food or alcohol interact with isotretinoin?

Isotretinoin 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.

  • Ethanol

What health conditions may interact with isotretinoin?

Isotretinoin 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, especially:

  • Alcoholism, severe;
  • Diabetes;
  • Metabolism disorder, family history of;
  • Severe weight problems—Use with caution. May increase risks for more serious problems.
  • Anorexia (eating disorder);
  • Epiphyseal closure, premature;
  • Osteomalacia (softening of the bones);
  • Osteoporosis (brittle bones), childhood or family history of;
  • Other bone disorders or diseases—Use with caution. It is not known whether this medicine affects bone loss.
  • Asthma;
  • Depression, history of;
  • Eye or vision problems;
  • Hearing problems;
  • Heart disease;
  • Hepatitis;
  • Hypertriglyceridemia (high triglycerides in the blood);
  • Intestinal disorders, history of;
  • Pancreatitis (inflammation of the pancreas);
  • Pseudotumor cerebri (swelling in the brain);
  • Psychosis, history of;
  • Vitamin A overdose (too much vitamin A in the body)—Use with caution. May make these conditions worse.
  • Kidney disease;
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Understand the Dosage

The information provided is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist before using this medication.

What is the dose of Isotretinoin for an adult?

Usual Adult Dose for Acne

Severe recalcitrant nodular acne: 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

Usual Adult Dose for Melanoma – Metastatic

Combination therapy with interferon alfa: 60 mg/day, divided in 3 equal doses, for 6 months

Usual Adult Dose for Granuloma Annulare

0.5 to 1 mg/kg/day orally in equally divided doses twice a day

What is the dose of Isotretinoin for a child?

Usual Pediatric Dose for Acne

Severe recalcitrant nodular acne:
12 years or older: 0.5 to 1 mg/kg/day orally in 2 divided doses

Usual Pediatric Dose for Acute Nonlymphocytic Leukemia

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

How is isotretinoin available?

Isotretinoin is available in the following dosage forms and strengths:

Capsule, Oral: 10 mg, 20 mg, 30 mg, 40 mg.

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.

Symptoms of overdose may include the following:

  • Vomiting;
  • Flushing;
  • severe chapped lips;
  • stomach pain;
  • headache;
  • dizziness;
  • loss of coordination.

What should I do if I miss a dose?

If you miss a dose of isotretinoin, 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 30, 2016 | Last Modified: January 4, 2017