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Sotret

Generic Name: isotretinoin (EYE-soe-TRET-i-noyn)
Brand Name: Examples include Claravis and Sotret

Do not use Sotret if you are pregnant, may become pregnant, or if you are planning to become pregnant. Serious and sometimes fatal birth defects can occur if Sotret is taken during pregnancy. Any fetus exposed during pregnancy could be harmed. There is no accurate way to tell if an exposed fetus has been harmed. Increased risks of miscarriage and premature births have been reported. Sotret 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 Sotret. You must have 2 negative urine or blood pregnancy tests before you may begin taking Sotret. 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 Sotret. 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 Sotret, 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 Sotret. 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.


Sotret 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.

Sotret 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 Sotret if:

  • you are allergic to any ingredient in Sotret or to vitamin A
  • you are pregnant, may become pregnant, or if you are planning to become pregnant
  • you are breast-feeding
  • you do not understand the possible risks of Sotret or you are not able to follow all of the instructions in the Medication Guide
  • you are taking tetracycline antibiotics (eg, doxycycline) 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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Sotret:

Some medical conditions may interact with Sotret. 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 a personal or family history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you have a personal or family history of asthma, diabetes, high blood cholesterol or triglyceride levels, heart disease, liver problems, bone loss (osteoporosis) or other bone problems (eg, weak bones), or an eating disorder (eg, anorexia)
  • if you have a history of hearing problems (eg, ringing in the ears, hearing loss), stomach or bowel problems (eg, severe stomach pain, rectal bleeding, persistent or severe diarrhea), pancreas problems (eg, pancreatitis), or irregular menstrual periods
  • if you are taking medicines that may decrease bone strength (eg, corticosteroids, such as prednisone; medicines for seizures, such as phenytoin)

Some MEDICINES MAY INTERACT with Sotret. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Tetracyclines (eg, doxycycline) 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 Sotret's side effects
  • Progestin-only birth control (eg, "mini-pill") because their effectiveness may be decreased by Sotret

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sotret 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 Sotret:

Use Sotret as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sotret comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sotret refilled.
  • Some brands of Sotret should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Sotret 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 Sotret regularly. Taking Sotret at the same time each day will help you remember to take it.
  • Sotret 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 Sotret. This will be necessary each time you refill your prescription.
  • You will get no more than a 30-day supply of Sotret at a time to ensure you check in with your doctor each month to discuss side effects.
  • If you miss a dose of Sotret, 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 Sotret.

Important safety information:

  • Sotret may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sotret with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose or take Sotret for longer than prescribed without checking with your doctor. Doing so will not improve your condition faster and may increase your risk for side effects.
  • A sudden decrease in night vision may occur while you are taking Sotret. 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 donate blood while taking Sotret and for 1 month after you stop taking Sotret.
  • Do not drink alcohol while taking Sotret.
  • 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 Sotret and for at least 6 months after you stop taking it. Sotret can increase your chance of scarring from these procedures.
  • Sotret may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sotret. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Some patients have become depressed or developed serious mental or mood problems while taking Sotret. Stop using Sotret and tell your health care provider right away if you have any new, worsened, or sudden symptoms, such as 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; or having thoughts about taking your life or hurting yourself (suicidal thoughts).
  • Sotret may cause decreased bone strength in some patients. Patients who play vigorous impact sports may be at increased risk of bone problems (eg, fractures). Discuss any questions or concerns with your doctor.
  • Women who may become pregnant 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 Sotret.
  • Do not use progestin-only pills or "minipills" (pills that do not contain estrogen) for birth control because they may not work as well with Sotret. Ask your doctor or pharmacist if you are not sure what type of birth control pills you are using.
  • Women who use hormonal birth control should avoid the use of the herbal supplement St. John's wort because it may decrease the effectiveness of hormonal birth control.
  • Diabetes patients - Sotret 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 Sotret. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sotret may affect normal growth in some CHILDREN. Caution is advised when using Sotret in children; they may be more sensitive to its effects. Consult your doctor for more details.
  • Sotret should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Sotret if you are pregnant. It has been shown to cause serious birth defects, miscarriage, early birth, or death of the fetus. Avoid becoming pregnant while you are taking it. 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 Sotret and call your doctor right away. It is not known if Sotret is found in breast milk. Do not breast-feed while taking Sotret and for 1 month after stopping Sotret.

Possible side effects of Sotret:

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:

Chapped lips; dizziness; drowsiness; dry eyes, mouth, or skin; dry nose that may lead to nosebleeds; headache; temporary worsening of acne.

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); abnormal hair growth; bleeding, redness, or swelling of the gums; bone pain; change in the amount of urine produced; chest pain; dark urine; difficult or painful swallowing; excessive thirst; fainting; fast heartbeat; hearing problems or ringing in the ears; joint or back pain; muscle pain or weakness; nausea; new or worsening heartburn; new or worsening mental, mood, or behavior changes (eg, bizarre, aggressive, or violent behavior; depression); red patches or bruises on the legs or arms; red, swollen, blistered, or peeling skin; seizures; severe headache; shortness of breath; stomach pain or tenderness; suicidal thoughts or actions; swollen glands; symptoms of increased pressure in the brain (eg, eye pressure, nausea, vomiting, vision changes); symptoms of infection (eg, fever, chills, sore throat); symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); symptoms of stomach or bowel problems (eg, severe stomach or bowel pain, rectal bleeding, persistent or severe diarrhea); tightness in the lungs; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; voice changes; vomiting; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.

Proper storage of Sotret:

Store Sotret 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 Sotret out of the reach of children and away from pets.

General information:

  • If you have any questions about Sotret, please talk with your doctor, pharmacist, or other health care provider.
  • Sotret 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Sotret or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sotret. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sotret. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Sotret.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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