Product description

Accutane (Isotretinoin)

Accutane is used for treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Take Accutane two times a day with a meal, unless your doctor tells you otherwise. Swallow the capsule. Don't suck or chew it. Take it with a full glass of water, milk, or other nonalcoholic liquid. Follow your doctor's instructions carefully.

Depending on your reaction to Accutane, your doctor may need to adjust the dosage upward or downward. If you respond quickly and very well, your doctor may take you off Accutane even before the 15 or 20 weeks are up.

After you finish taking Accutane, there should be at least a 2-month "rest period" during which you are off the drug. This is because your acne may continue to get better even though you are no longer taking the medication. Once the 2 months are up, if your acne is still severe, your doctor may want to give you a second course of Accutane. If you are still growing, your doctor may recommend a longer "rest period."

Avoid consumption of alcoholic beverages.

Read the patient information leaflet available with the product. Do not crush the capsules.

Do not share Accutane with anyone because of the risk of birth defects and other serious side effects.

Accutane is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

If you miss a dose of Accutane, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Accutane at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Accutane out of the reach of children and away from pets.

Safety Information

Do not use Accutane if:

• you are allergic to any ingredient in Accutane;
• you are pregnant, planning to become pregnant, or become pregnant while taking Accutane;
• you are breast-feeding.

• Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not give blood while taking Accutane and for 1 month after stopping taking Accutane.
• Do not drink alcohol while taking Accutane.
• Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.
• To prevent cracking of lips, use a lip moisturizer or balm.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures.
• Accutane may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Accutane . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
• Tell your health care provider if you plan vigorous physical activity (sports) during treatment with Accutane.
• Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Accutane.
• Certain birth control pills (progestin) that do not contain estrogen may not be as effective while you are taking Accutane.
• Diabetes patients - Accutane may affect your blood sugar. Check blood sugar levels closely and ask your health care provider before adjusting the dose of your diabetes medicine.

  Side Effects

  Possible Side Effects
  
  

  Check with your doctor if any of these most common side effects persist or become bothersome:

  • abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums;changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.
  Seek medical attention right away if any of these severe side effects occur:
  • severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; shortness of breath; seizures; severe birth defects; severe diarrhea; severe headache; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.
  More Information
  
  

  Accutane is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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