WHAT IS Accutane/Isotretinoin?

• Accutane/Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
• Accutane/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.
• Accutane/Isotretinoin may also be used for purposes other than those listed in this medication guide.

WHAT HAPPENS IF I OVERDOSE?

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

WHAT DRUG(S) MAY INTERACT WITH Accutane/Isotretinoin?

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

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 SHOULD I DISCUSS WITH MY DOCTOR BEFORE TAKING Accutane/Isotretinoin?

• It is not known whether Accutane/isotretinoin passes into breast milk. Do not take Accutane/isotretinoin without first talking to your doctor if you are breast-feeding a baby.
• You may not be able to take Accutane/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 Accutane/isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking Accutane/isotretinoin. Accutane/Isotretinoin is in the FDA pregnancy category X. This means that Accutane/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 Accutane/isotretinoin and notify your doctor.
• Before taking Accutane/isotretinoin, tell your doctor if you have
  • high cholesterol or triglyceride levels (types of fat) in the blood; or
  • anorexia nervosa;
  • liver disease.
  • 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);
  • heart disease;
  • osteoporosis (bone loss) or weak bones;
  • diabetes;
  • asthma;

HOW SHOULD I TAKE Accutane/Isotretinoin?

• Your doctor may perform blood tests during treatment with Accutane/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.
• Take all of the Accutane/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 Accutane/isotretinoin.
• You will get no more than a 30-day supply of Accutane/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 Accutane/isotretinoin twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.
• Accutane/Isotretinoin is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, Accutane/isotretinoin can cause serious side effects. Before starting treatment with Accutane/isotretinoin, discuss with your doctor how bad the acne is, the possible benefits of Accutane/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 Accutane/isotretinoin therapy.
• Store Accutane/isotretinoin at room temperature away from moisture and heat.
• Take each dose of Accutane/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 Accutane/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.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Accutane/Isotretinoin?

• Stop taking Accutane/isotretinoin and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
  • increased levels of cholesterol or triglyceride (types of fat) in your blood (detected by blood tests).
  • changes in vision, blurred vision, or decreased vision (especially at night);
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • rectal bleeding, or severe or bloody diarrhea;
  • nausea and vomiting;
  • severe headache or dizziness;
  • difficulty or pain when swallowing;
  • stomach, chest, or bowel pain;
  • seizures;
  • fainting;
  • leg swelling;
  • painful or constant dryness of the eyes;
  • slurred speech or problems moving;
  • yellowing of the skin or eyes or persistently dark urine;
  • hearing problems or hearing loss;
  • joint or muscle pain or bone problems;
  • trouble breathing;
  • 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;
  • new or worsening heartburn;
  • increased thirst or urination;
• Other, less serious side effects are more likely to occur. Continue to take Accutane/isotretinoin and talk to your doctor if you experience
  • increased sensitivity of the skin to the sun.
  • inflammation, dryness, or cracking of the lips;
  • itching; or
  • dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ or difficulty wearing contact lenses;
• 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 SHOULD I AVOID WHILE TAKING Accutane/Isotretinoin?

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

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.