Brand Names: Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane
Generic Name: isotretinoin (oral)
- What is isotretinoin?
- What are the possible side effects of isotretinoin?
- What is the most important information I should know about isotretinoin?
- What should I discuss with my healthcare provider before taking isotretinoin?
- How should I take isotretinoin?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking isotretinoin?
- What other drugs will affect isotretinoin?
- Where can I get more information?
What is isotretinoin?
Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE.
Isotretinoin may also be used for purposes not listed in this medication guide.
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What are the possible side effects of isotretinoin?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Stop using isotretinoin and call your doctor at once if you have:
- problems with your vision or hearing;
- hallucinations, (see or hearing things that are not real), thoughts about suicide or hurting yourself;
- depressed mood, crying spells, changes in behavior, feeling angry or irritable;
- loss of interest in things you enjoyed before, feeling hopeless or guilty;
- sleep problems, extreme tiredness, trouble concentrating;
- changes in weight or appetite;
- a seizure (convulsions), sudden numbness or weakness;
- muscle weakness, pain in your bones or joints or in your back;
- severe diarrhea, rectal bleeding, bloody or tarry stools;
- pale skin, feeling light-headed or short of breath;
- severe stomach or chest pain, pain when swallowing; or
- dark urine, or jaundice (yellowing of your skin or eyes).
Common side effects may include:
- dryness of your skin, lips, eyes, or nose (you may have nosebleeds).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about isotretinoin?
Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use this medicine if you are pregnant or may become pregnant.
You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.
What should I discuss with my healthcare provider before taking isotretinoin?
Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin, before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
- tubal ligation (tubes tied);
- vasectomy of the male sexual partner;
- an IUD (intrauterine device);
- estrogen-containing birth control pills (not mini-pills); and
- hormonal birth control patches, implants, injections, or vaginal ring.
Secondary forms of birth control include:
- a male latex condom with or without spermicide;
- a diaphragm plus a spermicide;
- a cervical cap plus a spermicide; and
- a vaginal sponge containing a spermicide.
Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.
Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.
You should not use isotretinoin if you are allergic to it.
Tell your doctor if you have ever had:
- depression or mental illness;
- liver disease;
- heart disease or high cholesterol;
- osteoporosis or low bone mineral density;
- an eating disorder such as anorexia;
- a food or drug allergy; or
- an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.
It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
You should not breast-feed while using this medicine.
Isotretinoin is not approved for use by anyone younger than 12 years old.
How should I take isotretinoin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.
Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.
Follow all directions about taking isotretinoin with or without food.
Use this medicine for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.
You may need frequent blood tests.
Never share this medicine with another person, even if they have the same symptoms you have.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.
What should I avoid while taking isotretinoin?
Do not take a vitamin or mineral supplement that contains vitamin A.
Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.
While you are taking isotretinoin and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.
Avoid driving or hazardous activity until you know how this medicine will affect you. Isotretinoin may impair your vision, especially at night.
What other drugs will affect isotretinoin?
Tell your doctor about all your other medicines, especially:
- St. John's wort;
- vitamin or mineral supplements;
- progestin-only birth control pills (mini-pills);
- steroid medicine; or
- a tetracycline antibiotic, including doxycycline or minocycline.
This list is not complete. Other drugs may affect isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about isotretinoin.
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