What is isotretinoin?

• Isotretinoin is a form of vitamin A. It decreases the amount of sebum (oil) that is released by the sebaceous (oil) glands, and it increases that rate at which the skin renews itself.
• Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
• Isotretinoin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my doctor before taking isotretinoin?

• Before taking isotretinoin, tell your doctor if you have
  • a personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there);
  • diabetes;
  • asthma;
  • heart disease;
  • osteoporosis (bone loss) or weak bones;
  • anorexia nervosa;
  • high cholesterol or triglyceride levels (types of fat) in the blood; or
  • liver disease.
• You may not be able to take isotretinoin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Do not take isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking isotretinoin. Isotretinoin is in the FDA pregnancy category X. This means that isotretinoin is known to cause severe birth defects in an unborn baby. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking isotretinoin and notify your doctor.
• It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.

How should I take isotretinoin?

• Take isotretinoin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Isotretinoin is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, isotretinoin can cause serious side effects. Before starting treatment with isotretinoin, discuss with your doctor how bad the acne is, the possible benefits of isotretinoin and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with isotretinoin therapy.
• You will get no more than a 30-day supply of isotretinoin at a time. Your prescription should have a special yellow self-adhesive sticker attached to it. If your prescription does not have this yellow sticker, call your doctor. The pharmacy should not fill the prescription without this sticker.
• Take each dose of isotretinoin with a full glass of water. This will help prevent the medication inside the capsule from irritating the lining of the esophagus. For the same reason, do not chew or suck on the capsule.
• Take isotretinoin twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.
• Take all of the isotretinoin that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with isotretinoin.
• Your doctor may perform blood tests during treatment with isotretinoin to monitor side effects from this medication.
• Due to the serious side effects that may occur with the use of this medication, do not share it with anyone else.
• Store isotretinoin at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of an isotretinoin overdose include vomiting, abdominal pain, flushing of the face, inflammation of the lips, headache, dizziness, and clumsiness.

What should I avoid while taking isotretinoin?

• Do not take vitamin supplements containing vitamin A during treatment with isotretinoin. This could cause increased side effects.
• Do not donate blood while taking isotretinoin and for at least 1 month following the end of treatment. Blood donated while taking isotretinoin may be given to a pregnant woman and be harmful to her baby.
• Do not use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking isotretinoin and for six months following treatment due to the possibility of scarring.
• Avoid exposure to sunlight or UV rays while taking isotretinoin. Isotretinoin may increase the sensitivity of the skin to sunlight and a severe sunburn could result.
• Use caution when driving a vehicle at night. Isotretinoin can cause decreased night vision. The onset of decreased night vision may be sudden.

What are the possible side effects of isotretinoin?

• Stop taking isotretinoin and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • changes in vision, blurred vision, or decreased vision (especially at night);
  • painful or constant dryness of the eyes;
  • depression including feelings of sadness, crying spells, irritability, changes in sleep patterns, unusual tiredness, trouble concentrating, loss of appetite, and/ or suicidal thoughts or other mental problems;
  • stomach, chest, or bowel pain;
  • rectal bleeding, or severe or bloody diarrhea;
  • difficulty or pain when swallowing;
  • new or worsening heartburn;
  • yellowing of the skin or eyes or persistently dark urine;
  • severe headache or dizziness;
  • seizures;
  • nausea and vomiting;
  • joint or muscle pain or bone problems;
  • hearing problems or hearing loss;
  • trouble breathing;
  • fainting;
  • increased thirst or urination;
  • slurred speech or problems moving;
  • leg swelling;
  • increased levels of cholesterol or triglyceride (types of fat) in your blood (detected by blood tests).
• Other, less serious side effects are more likely to occur. Continue to take isotretinoin and talk to your doctor if you experience
  • inflammation, dryness, or cracking of the lips;
  • dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ or difficulty wearing contact lenses;
  • itching; or
  • increased sensitivity of the skin to the sun.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What drug(s) may interact with isotretinoin?

• alcohol
• benzoyl peroxide, salicylic acid, or other drying medicines used for acne
• corticosteroids (example: prednisone)
• medicines for seizures
• orlistat
• other drugs that make you more sensitive to the sun such as sulfa drugs
• progestin-only birth control hormones (examples: 'Minipills' like Aygestin®, Micronor®, Nor-QD® or injectable/implantable products such as Depo-Provera® or Norplant®)
• tetracycline antibiotics (examples: doxycycline, tetracycline)
• vitamins and other supplements containing vitamin A
• warfarin

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.