Isotretinoin Oral capsule
What is this medicine?
ISOTRETINOIN (eye soe TRET i noyn) treats severe acne that has not responded to other therapy like antibiotics.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
high blood cholesterol or triglycerides
inflammatory bowel disease
mental problems, such as depression, psychosis, attempted suicide, or a family history of mental problems
osteoporosis, osteomalacia, or other bone disorders
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
How should I use this medicine?
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.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
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?
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:
benzoyl peroxide, salicylic acid, or other drying medicines used for acne
medicines for seizures
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
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
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?
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
changes in menstrual cycle
changes in vision, like blurred or double vision or decreased night vision
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
loss of interest in usual activities
muscle or joint pain
muscle weakness with or without pain
nausea and vomiting
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):
dry mouth, nose or skin
hair loss, increased fragility of hair
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
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.
March 21, 2017
U.S. FDA-approved Package Insert