What is this medicine?
ISOTRETINOIN (eye soe TRET i noyn) treats severe acne that has not responded to other therapy like antibiotics.
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What should I tell my health care provider before I take this medicine?
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They need to know if you have any of these conditions:
-heart disease
-high blood cholesterol or triglycerides
-inflammatory bowel disease
-liver disease
-mental problems, such as depression, psychosis, attempted suicide, or a family history of mental problems
-osteoporosis, osteomalacia, or other bone disorders
-pancreatitis
-an unusual or allergic reaction to isotretinoin, vitamin A or related drugs, parabens, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
-breast-feeding
How should I use this medicine?
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Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Do not chew or suck on the capsules. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
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If you miss a dose, skip that dose. Do not take double or extra doses. If you take more than your prescribed dose, call your doctor or poison control center right away.
What may interact with this medicine?
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Do not take this medicine with any of the following medications:
-vitamins and other supplements containing vitamin A
This medicine may also interact with the following medications:
-alcohol
-benzoyl peroxide, salicylic acid, or other drying medicines used for acne
-medicines for seizures
-orlistat
-other drugs that make you more sensitive to the sun such as sulfa drugs
-progestin-only birth control hormones
-st. john's wort
-steroid medicines like prednisone or cortisone
-tetracycline antibiotics like doxycycline and tetracycline
-warfarin
What should I watch for while using this medicine?
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You may experience a flare in your acne during the initial treatment period. You will need to see your doctor or health care professional monthly to get a new prescription and to check on your progress and for side effects.
To receive this medicine, you, your doctor and your pharmacy must be registered in the iPLEDGE program. You may only receive up to a 30 day supply of this medicine at one time. You will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females will need to have 2 negative pregnancy tests before starting this medicine and then monthly pregnancy tests during treatment, even if you are not sexually active. Use 2 reliable forms of birth control together for 1 month prior to, during, and for 1 month after stopping this medicine. Avoid using birth control pills that do not contain estrogen. They may not work while you are taking this medicine. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking this medicine. If you are pregnant, report it to FDA MedWatch at 1-800-FDA-1088 and the iPLEDGE pregnancy registry at 1-866-495-0654. Severe birth defects may occur even if just one dose is taken. Do not breast-feed while taking this medicine or for 1 month after stopping treatment.
Do not give blood while taking this medicine and for 30 days after completion of treatment to avoid exposing pregnant women to this medicine through the donated blood.
Some patients have become depressed or developed serious mental problems while taking this medicine or soon after stopping. Stop taking this medicine if you start feeling depressed or have thoughts of violence or suicide. Contact your doctor.
This medicine can increase cholesterol and triglyceride levels and decrease HDL (the good cholesterol) levels. Your health care provider will monitor these levels and recommend appropriate therapy, including changes in diet or prescription drugs, if necessary. Alcohol can increase the risk of developing high cholesterol or high blood lipids. Avoid alcoholic drinks while you are taking this medicine.
If you wear contact lenses, they may feel uncomfortable. If your eyes get dry, check with your eye doctor. This medicine may decrease your night vision or cause other changes in vision. If you experience any change in vision, stop taking this medicine and see an eye doctor.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Cosmetic procedures to smooth your skin including waxing, dermabrasion, or laser therapy should be avoided during therapy and for at least 6 months after you stop because of the possibility of scarring. Check with your health care provider for advice about when you can have cosmetic procedures.
This medicine may affect your blood sugar levels. If you have diabetes check with your doctor or health care professional if you notice any change in your blood sugar tests.
What side effects may I notice from receiving this medicine?
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Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-breathing problems
-changes in menstrual cycle
-changes in vision, like blurred or double vision or decreased night vision
-chest pain
-depression
-dizziness
-fainting
-hearing loss or ringing in the ears
-hives, skin rash
-increased irritability, anger, aggression or thoughts of violence
-increased urination and/or thirst or dark urine
-irregular heartbeat
-loss of interest in usual activities
-muscle or joint pain
-muscle weakness with or without pain
-nausea and vomiting
-severe diarrhea
-severe headache
-severe stomach pain
-slurred speech or trouble swallowing
-start to have thoughts about hurting yourself
-swelling of face or mouth
-unusual bruising or bleeding
-yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
-chapped lips
-dry mouth, nose or skin
-flushing
-hair loss, increased fragility of hair
-headache (mild)
Where should I keep my medicine?
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Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
Information on use before, during and after pregnancy.
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FIRST Trimester
Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.
SECOND Trimester
Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.
THIRD Trimester
Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.
Lactation
Avoid - This drug is known to cause harm to infants when taken by nursing mothers.
