Product Description:

• This medication 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).
•  It 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.

• 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 at least 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.

Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies:

• This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems.
• Some people who are allergic to peanuts may also be allergic to soy.

Talk to your pharmacist for more details:

• Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), mental/mood problems (such as depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density).
• Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.
• This medication may make you more sensitive to the sun.
• Limit your time in the sun.
• Avoid tanning booths and sunlamps.
• Use sunscreen and wear protective clothing when outdoors.
• Tell your doctor right away if you get sunburned or have skin blisters/redness.
• Isotretinoin can affect your night vision.
• Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.
• If you wear contact lenses, you may not tolerate them as well as usual while using this medication.
• Contact your doctor for more information.
• Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy.
• Skin scarring may occur.
• Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis).
• Limited information suggests isotretinoin may cause some bone loss effects.
• Playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones.
• Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure).
• Consult your doctor for more details.
• Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones.
• Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain.
• This drug must not be used during pregnancy or by those who may become pregnant during treatment.
• If you become pregnant or think you may be pregnant, inform your doctor right away.
• See also Warning section.
• Since this drug 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.
• You must have two negative pregnancy tests before starting this medication.
• You must have a monthly pregnancy test during treatment with isotretinoin.
• If the test is positive, you must stop taking this medication and consult your doctor right away.
• It is unknown if this medication passes into breast milk.
• However, similar drugs pass into breast milk.
• Breast-feeding while using this drug is not recommended.
• Ask your doctor when you can breast-feed after stopping treatment.
• Consult your doctor before breast-feeding.

• isotretinoin