Accutane (Isotretinoin) is prescribed by your veterinarian to treat a variety of dermatologic related conditions including Canine Lamellar Ichthyosis, Cutaneus T-cell Lymphoma, Sebaceous Adenitis in Poodles, Comedo Syndrome in Schnauzers and Feline Acne.
Generic Name: isotretinoin (oral) (EYE so TRET i noyn)
Brand Names: Accutane, Amnesteem, Claravis, Sotret
Directions:
Cautions: All customers who order this product may called for additional review by our pharmacist prior to the order being shipped.
What is Accutane?
Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.
Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.
Accutane may also be used for other purposes not listed in this medication guide.
Important information about Accutane
Accutane can cause severe, life-threatening birth defects. Never use Accutane if you are pregnant.
Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin.
Accutane is available only under a special program called iPLEDGE. It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States.
Do not take vitamin supplements containing vitamin A while you are taking isotretinoin. Do not donate blood while taking Accutane and for at least 30 days after you stop taking it.
What should I discuss with my healthcare provider before taking Accutane?
Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant.
To make sure you can safely take Accutane, tell your doctor if you have any of these other conditions:
- a personal or family history of depression or mental illness;
- heart disease, high cholesterol or triglycerides;
- osteoporosis or other bone disorders;
- an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease;
- diabetes;
- asthma;
- an eating disorder (anorexia nervosa); or
- liver disease.
Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are 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 of child-bearing potential.
Even women who have had their tubes tied are required to use birth control while taking Accutane.
You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, 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 Accutane and ending 30 days after you stop taking it. 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 plus spermicidal foam or gel;
- a diaphragm plus spermicidal foam or gel;
- a cervical cap plus spermicidal foam or gel; and
- a vaginal sponge containing spermicide.
Stop using Accutane 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 Accutane, call the iPLEDGE pregnancy registry at 1-866-495-0654.
It is not known whether isotretinoin passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.
How should I take Accutane?
Take Accutane exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Each prescription of Accutane must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of Accutane at one time.
Always take Accutane with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible. Take Accutane with food or milk. Take this medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.
To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.
Never share this medicine with another person, even if they have the same symptoms you have. Store Accutane at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
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 under the skin, swelling of the lips, and loss of balance or coordination.
What should I avoid while taking Accutane?
Do not take vitamin supplements containing vitamin A while you are taking Accutane.
Do not donate blood while taking Accutane and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of Accutane.
Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking Accutane and for at least 6 months after you stop taking it. Scarring may result.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Accutane can make your skin more sensitive to sunlight and sunburn may result. Accutane may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.
Accutane side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Accutane: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Accutane and call your doctor at once if you have any of these serious side effects:
- depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
- sudden numbness or weakness, especially on one side of the body;
- blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
- hearing problems, hearing loss, or ringing in your ears;
- seizure (convulsions);
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
- fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
- severe blistering, peeling, and red skin rash; or
- joint stiffness, bone pain or fracture.
Less serious Accutane side effects may include:
- joint pain, back pain;
- feeling dizzy, drowsy, or nervous;
- dryness of the lips, mouth, nose, or skin; or
- cracking or peeling skin, itching, rash, changes in your fingernails or toenails.
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.
See also: Accutane side effects (in more detail)
What other drugs will affect Accutane?
Before taking Accutane, tell your doctor if you are also taking:
- steroids (prednisone and others);
- seizure medication such as phenytoin (Dilantin); or
- a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).
This list is not complete and other drugs may interact with Accutane. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about Accutane.
- 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
- Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Warning
CAUTIONS: In order to purchase Accutane you must be a member of the iPLEDGE program. PLEASE NOTE: WE WILL SELL ACCUTANE TO MALE CUSTOMERS ONLY. All customers who order this product may be called for additional review by our pharmacist prior to the order being shipped. This is because of the S.M.A.R.T. program (System to Manage Accutane Related Teratogenicity) which is required by the FDA for female patients due to the risk of birth defects in the offspring of women taking this medication in pregnancy. Logistically we are unable to comply with the necessary strict controls. In order to purchase Accutane you must be a member of the iPLEDGE program.
For all patients:
Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects (physical problems that are present at birth).
A program called iPLEDGE has been set up to make sure that pregnant women do not take isotretinoin and that women do not become pregnant while taking isotretinoin. All patients, including women who cannot become pregnant and men, can get isotretinoin only if they are registered with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE and fill the prescription at a pharmacy that is registered with iPLEDGE. Do not buy isotretinoin over the internet.
You will receive information about the risks of taking isotretinoin and must sign an informed consent sheet stating that you understand this information before you can receive the medication. You will need to see your doctor every month during your treatment to talk about your condition and the side effects you are experiencing. At each visit, your doctor may give you a prescription for up to a 30-day supply of medication with no refills. You must have this prescription filled within 7 days. If you do not have your prescription filled within 7 days and you are a woman who can become pregnant, you will not be able to get isotretinoin until it is time for your next office visit, 23 days after the 7 days have passed. If you are a man or if you are a woman who cannot become pregnant, you will need to visit your doctor again to talk about the safe use of isotretinoin and to get a new prescription. You may have the new prescription filled right away.
Tell your doctor if you do not understand everything you were told about isotretinoin and the iPLEDGE program or if you do not think you will be able to keep appointments or fill your prescription on schedule every month.
Your doctor will give you an identification number and card when you start your treatment. You will need this number to fill your prescriptions and to get information from the iPLEDGE website and phone line. Keep the card in a safe place where it will not get lost. If you do lose your card, you can ask for a replacement through the website or phone line.
Do not donate blood while you are taking isotretinoin and for 1 month after your treatment.
Do not share isotretinoin with anyone else, even someone who has the same symptoms that you have.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with isotretinoin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs), the manufacturer's website, or the iPLEDGE program website (http://www.ipledgeprogram.com) to obtain the Medication Guide.
Talk to your doctor about the risks of taking isotretinoin.
For female patients:
If you can become pregnant, you will need to meet certain requirements during your treatment with isotretinoin. You need to meet these requirements even if you have not started menstruating (having monthly periods) or have had a tubal ligation ('tubes tied'; surgery to prevent pregnancy). You may be excused from meeting these requirements only if you have not menstruated for 12 months in a row and your doctor says you have passed menopause (change of life) or you have had surgery to remove your uterus and/or both ovaries. If none of these are true for you, then you must meet the requirements below.
You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You can also have a free visit with a doctor or family planning expert to talk about birth control that is right for you. You must use these two forms of birth control at all times unless you can promise that you will not have any sexual contact with a male for 1 month before your treatment, during your treatment, and for 1 month after your treatment.
If you choose to take isotretinoin, it is your responsibility to avoid pregnancy for 1 month before, during, and for 1 month after your treatment. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.
If you plan to use oral contraceptives (birth control pills) while taking isotretinoin, tell your doctor the name of the pill you will use. Isotretinoin interferes with the action of microdosed progestin ('minipill') oral contraceptives (Ovrette, Micronor, Nor-QD). Do not use this type of birth control while taking isotretinoin.
If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, rings, or intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive.
You must have two negative pregnancy tests before you can begin to take isotretinoin. Your doctor will tell you when and where to have these tests. You will also need to be tested for pregnancy in a laboratory each month during your treatment, when you take your last dose and 30 days after you take your last dose.
You will need to contact the iPLEDGE system by phone or the internet every month to confirm the two forms of birth control you are using and to answer two questions about the iPLEDGE program. You will only be able to continue to get isotretinoin if you have done this, if you have visited your doctor to talk about how you are feeling and how you are using your birth control and if you have had a negative pregnancy test within the past 7 days.
Stop taking isotretinoin and call your doctor right away if you think you are pregnant, you miss a menstrual period, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the iPLEDGE program, the manufacturer of isotretinoin, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby's health will be used to help doctors learn more about the effects of isotretinoin on unborn babies.
For male patients:
A very small amount of isotretinoin will probably be present in your semen when you take prescribed doses of this medication. It is not known if this small amount of isotretinoin may harm the fetus if your partner is or becomes pregnant. Tell your doctor if your partner is pregnant, plans to become pregnant, or becomes pregnant during your treatment with isotretinoin.
