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Sotret

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Sotret

PATIENT INFORMATION

Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant)

To be completed by the patient (and her parent or guardian* if patient is under age 18) and signed by her doctor.

Read each item below and initial in the space provided to show that you understand each item and agree to follow your doctor's instructions. Do not sign this consent and do not take isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin if there is anything that you do not understand.

*A parent or guardian of a minor patient (under age 18) must also read and initial each item before signing the consent.

_________________________________________________________________________(Patient's Name)

1.1 understand that there is a very high chance that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. This can happen with any amount and even if taken for short periods of time. This is why I must not be pregnant while taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Initial:______

2.1 understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 1 month after the end of my treatment with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Initial:______

3.1 understand that I must avoid sexual intercourse completely, or I must use 2 separate, effective forms of birth control (contraception) at the same time. The only exceptions are if I have had surgery to remove the uterus (a hysterectomy), or both of ovaries (bilateral oopharectomy) or my doctor has medically confirmed that I am post-menopausal.

Initial:______

4.1 understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include skin patches, shots, under-the-skin implants, vaginal rings, and intrauterine devices (lUDs). Any form of birth control can fail. That is why I must use 2 different birth control methods at the same time, starting 1 month before, during, and for 1 month after stopping therapy every time I have sexual intercourse, even if 1 of the methods I choose is hormonal birth control.

Initial:______

5.1 understand that the following are effective forms of birth control:

Primary forms Secondary forms
•tying my tubes (tubal sterilization)• partner's vasectomy •intrauterine device •hormonal (combination birth control pills, skin patches, shots, under-the-skin implants, or vaginal ring) Barrier forms (always used with spermicide):• male latex condom • diaphragm •cervical capOthera: •vaginal sponge (contains spermicide)

A diaphragm, condom, and cervical cap must each be used with spermicide, a special cream that kills sperm I understand that at least 1 of my 2 forms of birth control must be a primary method.

Initial:______

6.1 will talk with my doctor about any medicines including herbal products I plan to take during my isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin treatment because hormonal birth control methods may not work if I am taking certain medicines or herbal products.

Initial:______

7.1 may receive a free birth control counseling session from a doctor or other family planning expert. My isotretinoin doctor can give me an isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin Patient Referral Form for this free consultation.

Initial:______

8.1 must begin using the birth control methods I have chosen as described above at least 1 month before I start taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Initial:______

9.1 cannot get my first prescription for isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin unless my doctor has told me that I have 2 negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. The second pregnancy test must be done in a lab during the first 5 days of my menstrual period right before starting isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin therapy treatment, or as instructed by my doctor. I will then have 1 pregnancy test; in a lab.

  • every month during treatment
  • at the end of treatment
  • and 1 month after stopping treatment

I must not start taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin until I am sure that I am not pregnant, have negative results from 2 pregnancy tests, and the second test has been done in a lab.

Initial:______

10.1 have read and understand the materials my doctor has given to me, including The iPLEDGE Program Guide for Isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin for Female Patients Who Can Get Pregnant, The iPLEDGE Birth Control Workbook and The iPLEDGE Program Patient Introductory Brochure.

My doctor gave me and asked me to watch the DVD containing a video about birth control and a video about birth defects and isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

I was told about a private counseling line that I may call for more information about birth control. I have received information on emergency birth control.

Initial:______

11.1 must stop taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have sexual intercourse without using my 2 birth control methods at any time.

Initial:______

12. My doctor gave me information about the purpose and importance of providing information to the iPLEDGE program should I become pregnant while taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin or within 1 month of the last dose. If I become pregnant, I agree to be contacted by the iPLEDGE program and be asked questions about my pregnancy. I also understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be given to the maker of isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and government health regulatory authorities.

Initial:______

13.1 understand that being qualified to receive isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin in the iPLEDGE program means that I:

  • have had 2 negative urine or blood pregnancy tests before receiving the first isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin prescription. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I receive another isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin prescription.
  • have chosen and agreed to use 2 forms of effective birth control at the same time. At least 1 method must be a primary form of birth control, unless I have chosen never to have sexual contact with a male (abstinence), or I have undergone a hysterectomy. I must use 2 forms of birth control for at least 1 month before I start isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin therapy, during therapy, and for 1 month after stopping therapy. I must receive counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy.
  • have signed a Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) that contains warnings about the chance of possible birth defects if I am pregnant or become pregnant and my unborn baby is exposed to isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.
  • have been informed of and understand the purpose and importance of providing information to the iPLEDGE program should I become pregnant while taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin or within 1 month of the last dose. I agree to be contacted by the iPLEDGE program and be asked questions about my pregnancy.
  • have interacted with the iPLEDGE program before starting isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control.

Initial:______

My doctor has answered all my questions about isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and I understand that it is my responsibility not to get pregnant 1 month before, during isotret (isotret (isotretinoin capsules) inoin capsules) inoin treatment, or for 1 month after I stop taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Initial:______

I now authorize my doctor_______________________to begin my treatment with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Patient Signature:__________________________________________Date:_____________

Parent/Guardian Signature (if under age 18):_______________________Date:___________

Please print: Patient Name and Address___________________________________________

_____________________________________Telephone_____________________________

I have fully explained to the patient,_________________, the nature and purpose of the treatment described above and the risks to

female patients of childbearing potential. I have asked the patient if she has any questions regarding her treatment with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and have answered those questions to the best of my ability.

Doctor Signature:________________________________________Date:______________

PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.

Patient Information/Informed Consent (for all patients):

To be completed by patient (and parent or guardian if patient is under age 18) and signed by the doctor.

Read each item below and initial in the space provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement.

Do not sign this agreement and do not take isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin if there is anything that you do not understand about all the information you have received about using isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

1.1,__________________________________________________________________, (Patient's Name) understand that isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin is a medicine used to treat severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.

Initials:______

2. My doctor has told me about my choices for treating my acne.

Initials:______

3.1 understand that there are serious side effects that may happen while I am taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant)].

Initials:______

4.1 understand that some patients, while taking isotretinoin or soon after stopping isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, "anxious" or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotret (isotret (isotretinoin capsules) inoin capsules) inoin becoming aggressive or violent. No one knows if isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin caused these behaviors or if they would have happened even if the person did not take isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. Some people have had other signs of depression while taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin (see #7 below).

Initials:______

5. Before I start taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7 below), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.

Initials:______

6. Before I start taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.

Initials:______

7. Once I start taking isotretinoin, I agree to stop using isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. I:

  • Start to feel sad or have crying spells
  • Lose interest in activities I once enjoyed
  • Sleep too much or have trouble sleeping
  • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • Have a change in my appetite or body weight
  • Have trouble concentrating
  • Withdraw from my friends or family
  • Feel like I have no energy
  • Have feelings of worthlessness or guilt
  • Start having thoughts about hurting myself or taking my own life (suicidal thoughts)
  • Start acting on dangerous impulses
  • Start seeing or hearing things that are not real

Initials:______

8.1 agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin, to check my progress, and to check for signs of side effects.

Initials:______

9. Isotret (isotret (isotretinoin capsules) inoin capsules) inoin will be prescribed just for me — I will not share isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin with other people because it may cause serious side effects, including birth defects.

Initials:______

10.1 will not give blood while taking isotretinoin or for 1 month after I stop taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. I understand that if someone who is pregnant gets my donated blood, her baby may be exposed to isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin and may be born with serious birth defects.

Initials:______

11.1 have read The iPLEDGE Program Patient Introductory Brochure, and other materials my provider gave me containing important safety information about isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. I understand all the information I received.

Initials:______

12. My doctor and I have decided I should take isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin. I understand that I must be qualified in the iPLEDGE program to have my prescription filled each month. I understand that I can stop taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin at any time. I agree to tell my doctor if I stop taking isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Initials:______

I now allow my doctor__________________________to begin my treatment with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Patient Signature:_________________________________________Date:_____________

Parent/Guardian Signature (if under age 18):_____________________Date:____________

Patient Name (print)__________________________________________________________

Patient Address_________________________________Telephone (_______._______.____)

I have:

  • fully explained to the patient,_________________________, the nature and purpose of isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin treatment, including its benefits and risks
  • given the patient the appropriate educational materials, The iPLEDGE Program Patient Introductory Brochure and asked the patient if he/she has any questions regarding his/her treatment with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin
  • answered those questions to the best of my ability

Doctor Signature:__________________________________________Date:_____________

PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.

MEDICATION GUIDE

SOTRET®
(Isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin Capsules, USP)

Read the Medication Guide that comes with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Sotret (isotretinoin capsules) ?

  • Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
  • Because Sotret (isotretinoin capsules) can cause birth defects, Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
  • Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may cause serious mental health problems.

1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Female patients must not get pregnant:

  • for 1 month before starting Sotret (isotretinoin capsules)
  • while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules)
  • for 1 month after stopping Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) .

If you get pregnant while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) , stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

  • FDA MedWatch at 1-800-FDA-1088, and
  • the iPLEDGE pregnancy registry at 1-866-495-0654

2. Serious mental health problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may cause:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.

Stop Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

  • start to feel sad or have crying spells
  • lose interest in activities you once enjoyed
  • sleep too much or have trouble sleeping
  • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • have a change in your appetite or body weight
  • have trouble concentrating
  • withdraw from your friends or family
  • feel like you have no energy
  • have feelings of worthlessness or guilt
  • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  • start acting on dangerous impulses
  • start seeing or hearing things that are not real

After stopping Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) , you may also need follow-up mental health care if you had any of these symptoms.

What is Sotret (isotretinoin capsules) ?

Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can cause serious side effects (see "What is the most important information I should know about Sotret (isotretinoin capsules) ?"). Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can only be:

  • prescribed by doctors that are registered in the iPLEDGE program
  • dispensed by a pharmacy that is registered with the iPLEDGE program
  • given to patients who are registered in the iPLEDGE program and agree to do everything required in the program

What is severe nodular acne?

Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.

Who should not take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?

  • Do not take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) if you are pregnant, plan to become pregnant, or become pregnant during Sotret (isotretinoin capsules) treatment. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) causes severe birth defects. See "What is the most important information I should know about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?"
  • Do not take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) if you are allergic to anything in it. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) .

What should I tell my doctor before taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?

Tell your doctor if you or a family member has any of the following health conditions:

Tell your doctor if you are pregnant or breastfeeding. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

  • Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Taking both together may increase your chance of getting side effects.
  • Tetracycline antibiotics. Tetracycline antibiotics taken with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can increase the chances of getting increased pressure in the brain.
  • Progestin-only birth control pills (mini-pills). They may not work while you take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Ask your doctor or pharmacist if you are not sure what type you
  • are using.
  • Dilantin (phenytoin). This medicine taken with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may weaken your bones.
  • Corticosteroid medicines. These medicines taken with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may weaken your bones.
  • St. John's Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

How should I take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?

  • You must take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) , your doctor will:
  • explain the iPLEDGE program to you
  • have you sign the Patient Information/Informed Consent (for all patients). Female patients who can get pregnant must also sign another consent form.

You will not be prescribed Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) if you cannot agree to or follow all the instructions of the iPLEDGE program.

  • You will get no more than a 30-day supply of Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) at a time. This is to make sure you are following the Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) iPLEDGE program. You should talk with your doctor each month about side effects.
  • The amount of Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
  • Take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
  • If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
  • If you take too much Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) or overdose, call your doctor or poison control center right away.
  • Your acne may get worse when you first start taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . This should last only a short while. Talk with your doctor if this is a problem for you.
  • You must return to your doctor as directed to make sure you don't have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Female patients who can get pregnant will get a pregnancy test each month.
  • Female patients who can get pregnant must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . You must access the iPLEDGE system to answer questions about the program requirements and to enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1 -866-495-0654.

You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) .

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away.

What should I avoid while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?

  • Do not get pregnant while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and for 1 month after stopping Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . See "What is the most important information I should know about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?"
  • Do not breast feed while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and for 1 month after stopping Sotret (isotretinoin capsules) . We do not know if Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can pass through your milk and harm the baby.
  • Do not give blood while you take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and for 1 month after stopping Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . If someone who is pregnant gets your donated blood, her baby may be exposed to Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and may be born with birth defects.
  • Do not take other medicines or herbal products with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) unless you talk to your doctor. See "What should I tell my doctor before taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?"
  • Do not drive at night until you know if Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) has affected your vision. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may decrease your ability to see in the dark.
  • Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and for at least 6 months after you stop. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may make your skin more sensitive to light.
  • Do not share Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Sotret (isotretinoin capsules) ?

  • Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See "What is the most important information I should know about Sotret (isotret (isotretinoin capsules) inoin capsules) ?"
  • Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may cause serious mental health problems. See "What is the most important information I should know about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) ?"
  • serious brain problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away if you get any of these signs of increased brain pressure:
  • skin problems. Skin rash can occur in patients taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . In some patients a rash can be serious. Stop using Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like "pink eye"), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
  • stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Sotret (isotretinoin capsules) . Stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor if you get:
    • severe stomach, chest or bowel pain
    • trouble swallowing or painful swallowing
    • new or worsening heartburn
    • diarrhea
    • rectal bleeding
    • yellowing of your skin or eyes
    • dark urine
  • bone and muscle problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard physical activity during treatment with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Tell your doctor if you get:
    • back pain
    • joint pain
    • broken bone. Tell all healthcare providers that you take Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) if you break a bone.

Stop Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.

Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may stop long bone growth in teenagers who are still growing.

  • hearing problems. Stop using Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
  • vision problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may affect your ability to see in the dark. This condition usually clears up after you stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) , but it may be permanent. Other serious eye effects can occur. Stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and after treatment.
  • lipid (fats and cholesterol in blood) problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) treatment is finished.
  • serious allergic reactions. Stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
  • blood sugar problems. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
  • decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
  • The common, less serious side effects of Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.

These are not all of the possible side effects with Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . Your doctor or pharmacist can give you more detailed information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Sotret (isotret (isotretinoin capsules) inoin capsules) ?

  • Store Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from light.
  • Keep Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) and all medicines out of the reach of children.

General Information about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules)

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) for a condition for which it was not prescribed. Do not give Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) that is written for health care professionals. You can also call iPLEDGE program at 1 -866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients in Sotret (isotretinoin capsules) ?

Active Ingredient: Isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin.

Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 30 mg - FD&C Yellow No. 6, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No.10, and titanium dioxide.

Revised: February 2010

Last reviewed on RxList: 9/27/2010
This monograph has been modified to include the generic and brand name in many instances.

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