Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking this medication. Serious (sometimes fatal) birth defects, miscarriages, and premature births have occurred when this drug has been used during pregnancy.
For female patients, two effective forms of birth control (or complete avoidance of sexual intercourse) must be used for 1 month before starting isotretinoin, during use, and for 1 month after stopping this drug. You must also have monthly pregnancy-avoidance counseling from your doctor. Do not use "minipills" for birth control (non-estrogen-containing pills) since they may not work as well with isotretinoin. If you are late in having your period, or if you have sexual intercourse at any time without using two effective forms of birth control, stop taking this medication and contact your doctor immediately. (See also the Precautions section.)
After December 31, 2005, only patients enrolled in the iPLEDGE program may obtain and use isotretinoin. You will need to register with iPLEDGE and view a video at your doctor's office before receiving your prescription. Only physicians enrolled in iPLEDGE may prescribe isotretinoin, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the iPLEDGE program and for more information about the risks and benefits of using this medication.
For female patients who are able to become pregnant (even if not sexually active), you will need to contact iPLEDGE every month, either through the internet or by telephone, and answer required questions every time you fill your prescription and 1 month after your last dose.
These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your specific regulations.Who should not take Claravis?
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.
Read the Medication Guide provided by your pharmacist before you start using isotretinoin and each time you get a refill. Read and sign a Patient Information/Informed Consent form before you start taking this medication. If you have any questions about isotretinoin, consult your doctor or pharmacist before taking the medication.
Swallow capsules whole. Do not crush or chew them. Isotretinoin is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of isotretinoin state that it should be taken with meals. However, the FDA has indicated that the Absorica brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it.
Dosage is based on your medical condition and response to therapy.
Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of isotretinoin. Do not take more than the recommended dose.
Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if you have any of these unlikely but serious side effects: mental/mood changes (e.g., depression, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling feeling in the skin, quick/severe sunburn (sun sensitivity), back/joint/muscle pain, signs of infection (e.g., fever, persistent sore throat), painful swallowing, peeling skin on palms/soles.
Isotretinoin may infrequently cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting.
Stop taking this medication and tell your doctor immediately if you develop these unlikely but very serious side effects: severe headache, vision changes, ringing in the ears, hearing loss, chest pain, yellowing eyes/skin, dark urine, severe diarrhea, rectal bleeding.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density).
Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.
If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Contact your doctor for more information.
Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy. Skin scarring may occur.
Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis).
Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure). Consult your doctor for more details.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones.
Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain.
This drug must not be used during pregnancy or by those who may become pregnant during treatment. If you become pregnant or think you may be pregnant, inform your doctor immediately. See also Warning section.
You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor immediately.
It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: tetracyclines (e.g., minocycline, tetracycline), vitamin A-type drugs (e.g., acitretin, bexarotene), vitamin A, drugs that cause bone loss (e.g., anti-seizure drugs such as phenytoin, corticosteroids such as prednisone).
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. (See also Warning section.)
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, stomach pain, facial flushing, headache, loss of balance.
Do not allow anyone else to take this medication. It can cause birth defects and other serious health problems.
Laboratory and/or medical tests should be performed (e.g., pregnancy, blood cholesterol/triglyceride levels, liver function, white blood count, eye exams) to monitor for side effects.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 59-86 degrees F (between 15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines out of reach of children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.
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