Generic name: isotretinoin (oral) [ EYE-so-TRET-i-noyn ]
Brand names: Absorica, Accutane, Amnesteem, Claravis, Isotretinoin (Eqv-Absorica), ... show all 8 brands Myorisan, Sotret, Zenatane
Drug classes: Miscellaneous antineoplastics, Miscellaneous uncategorized agents
What is Amnesteem?
Amnesteem is available only from a certified pharmacy under a special program called iPLEDGE.
Amnesteem may also be used for purposes not listed in this medication guide.
Amnesteem in just a single dose can cause severe birth defects or death of a baby. Never use Amnesteem if you are pregnant or able to become pregnant.
You must have a negative pregnancy test before taking Amnesteem. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using this medicine and call your doctor at once if you think you might be pregnant.
Before taking this medicine
Amnesteem 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 this medicine if you are pregnant or able to become pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be able to get pregnant. You must have 2 negative pregnancy tests before you start taking Amnesteem, 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 Amnesteem 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.
Stop using Amnesteem 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 this medicine, 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 Amnesteem if you are allergic to it.
Tell your doctor if you have ever had:
depression or mental illness;
heart disease or high cholesterol;
osteoporosis or low bone mineral density;
an eating disorder such as anorexia;
a food or drug allergy; or
Do not breastfeed.
Not approved for use by anyone younger than 12 years old.
How should I take Amnesteem?
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 Amnesteem with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.
Follow all directions about taking Amnesteem with or without food.
Use Amnesteem 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 Amnesteem?
Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.
Do not donate blood while taking Amnesteem 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 Amnesteem 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.
Amnesteem 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 Amnesteem will affect you. Amnesteem may impair your vision, especially at night.
Amnesteem side effects
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).
Amnesteem may cause serious side effects. Stop using Amnesteem and call your doctor at once if you have:
problems with your vision or hearing;
muscle or joint pain, bone pain, back pain;
increased thirst, increased urination;
hallucinations, (see or hearing things that are not real);
symptoms of depression--unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Common side effects of Amnesteem may include:
dryness of your skin, lips, eyes, or nose (you may have nosebleeds);
headache, back pain, joint pain, muscle problems;
skin reactions; or
cold symptoms such as stuffy nose, sneezing, sore throat.
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 other drugs will affect Amnesteem?
Tell your doctor about all your other medicines, especially:
St. John's wort (may make birth control pills less effective);
vitamin or mineral supplements;
progestin-only birth control pills (mini-pills, may not work as well when taken with Amnesteem);
steroid medicine; or
Where can I get more information?
- Your doctor pharmacist can provide more information about Amnesteem.
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.
No reports of permanent liver damage associated with Accutane (isotretinoin) could be found in the literature but temporary increases in liver test abnormalities are estimated to occur in up to 15% of people taking isotretinoin. Significant increases, such as those more than three times the upper limit of normal (ULN) or increases that require people to stop taking Accutane are exceedingly rare and occur in less than 1% of people taking Accutane. Continue reading
Absorica and Accutane both contain isotretinoin, a medicine used to treat very severe acne, but Absorica is more easily absorbed into your body and, unlike Accutane, does not have to be taken with food. Continue reading
Absorica starts to work within 4 weeks but may take up to 20 weeks (5 months) for the full effects to be seen. Within four weeks of taking Absorica, a more than 33% reduction in the overall number of acne lesions was reported. Over 70% of people with severe nodular acne achieved a 90% reduction in the number of their nodular acne lesions after 20 weeks with Absorica. A single course of Absorica for 20 weeks has been shown to result in complete and prolonged remission of acne in many patients. Continue reading
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