Generic Name: Isotretinoin
Examples include Accutane and Claravis
Do not use Claravis if you are a woman who is pregnant, planning to become pregnant, or breast-feeding. Serious birth defects can occur in pregnant women who are using Claravis . Increased risks of miscarriage and premature births have been reported. Claravis can only be dispensed through a special program. You must watch a videotape on contraceptive methods and completely abstain from sexual intercourse or practice 2 forms of birth control beginning 1 month before, during, and for 1 month after use of Claravis . You must have 2 negative urine or blood pregnancy tests before you may begin taking Claravis . The second test must be done in a lab. You must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before you receive your refill of Claravis . If you do not have regular menstrual cycles or you have unprotected sex at any time within 1 month before, during, or 1 month after use of Claravis , your doctor or other health care provider will give you special instructions regarding how to take your pregnancy tests. After discussing this medication with your health care provider, you must read, initial, and sign a consent form before taking Claravis . Do not sign the consent form if there is anything you do not understand. Additional negative pregnancy tests will be required every month during treatment.
Claravis is used for:
Treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.
Claravis is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.
Do NOT use Claravis if:
- you are allergic to any ingredient in Claravis
- you are pregnant, planning to become pregnant, or become pregnant while taking Claravis
- you are breast-feeding
- you do not understand the possible risks of Claravis or you are not able to follow all of the instructions in the medication guide
- you are taking tetracycline antibiotics or vitamin A-type medicines (eg, etretinate, vitamin A)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Claravis :
Some medical conditions may interact with Claravis . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are woman and unable to use 2 effective forms of birth control or avoid sexual intercourse
- if you have diabetes, a family history of diabetes, high blood cholesterol or triglyceride levels, psychiatric disorders, suicidal thoughts, liver disease, pancreatitis, a bone loss condition (eg, osteoporosis), decreased bone density, an eating disorder, severe diarrhea, rectal bleeding, hearing problems, ringing in the ears, or stomach pain
Some MEDICINES MAY INTERACT with Claravis . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Tetracyclines because the risk of increased pressure in the brain may be increased
- St. John's wort because an increased risk of failure of hormonal contraceptives (eg, birth control pills) may occur
- Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of Claravis 's side effects
- Corticosteroids (eg, prednisone) or phenytoin because the risk of their side effects may be increased by Claravis
- Progestin-only birth control (eg, "mini-pill") because its effectiveness may be decreased by Claravis
This may not be a complete list of all interactions that may occur. Ask your health care provider if Claravis may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Claravis :
Use Claravis as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Claravis comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Claravis refilled.
- Take Claravis by mouth with food.
- Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat.
- For best results, take Claravis regularly. Taking Claravis at the same time each day will help you remember to take it.
- Claravis can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor's instructions before you can take Claravis . This will be necessary each time you refill your prescription.
- You will get no more than a 30-day supply of Claravis at a time to be sure you check in with your doctor each month to discuss side effects.
- If you miss a dose of Claravis , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Claravis .
Important safety information:
- Claravis may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Claravis with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- A sudden decrease in night vision may occur while you are taking Claravis . Use caution when driving at night and avoid driving at night if you experience decreased night vision.
- If you wear contact lenses, you may have difficulty wearing them during and after therapy.
- Do not give blood while taking Claravis and for 1 month after stopping taking Claravis .
- Do not drink alcohol while taking Claravis .
- Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.
- To prevent cracking of lips, use a lip moisturizer or balm.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Claravis and for at least 6 months after you stop. Claravis can increase your chance of scarring from these procedures.
- Claravis may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Claravis . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Some patients, while taking Claravis or soon after stopping it, have become depressed or developed serious mental problems. Stop using Claravis and tell your health care provider right away if you have any of these symptoms: feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; having thoughts about taking your own life or hurting yourself (suicidal thoughts).
- Tell your health care provider if you plan vigorous physical activity (sports) during treatment with Claravis .
- Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Claravis .
- Certain birth control pills (progestin-only pills, "mini pills") that do not contain estrogen may not be as effective while you are taking Claravis .
- You should not take the herbal supplement St. John's wort because it makes birth control pills less effective.
- Diabetes patients - Claravis may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- LAB TESTS, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Claravis . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Claravis should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not become pregnant. Claravis can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Claravis and call your health care provider. Do not breast-feed while taking Claravis and for 1 month after stopping Claravis . Claravis may pass through your milk and harm the baby.
Possible side effects of Claravis :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums;changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; shortness of breath; seizures; severe birth defects; severe diarrhea; severe headache; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.Proper storage of Claravis :
Store Claravis at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Claravis out of the reach of children and away from pets.
- If you have any questions about Claravis , please talk with your doctor, pharmacist, or other health care provider.
- Claravis is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Claravis . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Claravis Prescribing Information (FDA)
- Claravis Advanced Consumer (Micromedex) - Includes Dosage Information
- Accutane Consumer Overview
- Accutane Prescribing Information (FDA)
- Accutane Detailed Consumer Information (PDR)
- Amnesteem Prescribing Information (FDA)
- Sotret Prescribing Information (FDA)