Pronunciation: EYE so TRET i noyn
Brand: Absorica, Amnesteem, Claravis, Myorisan, Sotret, Zenatane
10 mg, capsule, gray, imprinted with BARR 934
20 mg, capsule, brown, imprinted with barr, 935
30 mg, capsule, orange, imprinted with barr, 454
40 mg, capsule, orange, imprinted with barr, 936
10 mg, oval, pink, imprinted with ACCUTANE 10 ROCHE
20 mg, oval, maroon, imprinted with ACCUTANE 20 ROCHE
40 mg, oval, yellow, imprinted with ACCUTANE 40 ROCHE
10 mg, oval, brown, imprinted with I10
20 mg, oval, white, imprinted with I20
40 mg, oval, brown, imprinted with I40
10 mg, capsule, yellow, imprinted with V10
10 mg, oval, gray, imprinted with A66
10 mg, gray, imprinted with barr, 935
20 mg, capsule, pink, imprinted with V20
20 mg, oval, brown, imprinted with A67
20 mg, brown, imprinted with barr, 935
30 mg, elliptical, brown, imprinted with RI
30 mg, capsule, pink, imprinted with V30
30 mg, oval, orange, imprinted with A01
40 mg, capsule, orange, imprinted with V40
40 mg, oval, orange, imprinted with A68
40 mg, orange, imprinted with barr, 936
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.
Isotretinoin is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
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.
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:
Secondary forms of birth control include:
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.
Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.
You should not use isotretinoin if you are allergic to it.
Tell your doctor if you have ever had:
You should not breastfeed while using this medicine.
Isotretinoin is not approved for use by anyone younger than 12 years old.
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.
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.
Isotretinoin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Avoid driving or hazardous activity until you know how this medicine will affect you. Isotretinoin may impair your vision, especially at night.
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:
Common side effects may include:
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.
Tell your doctor about all your other medicines, especially:
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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