Myorisan

MYORISAN
(MY-OR-I-SAN)
(isotretinoin) Capsules

Read the Medication Guide that comes with Myorisan 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 Myorisan?

• Myorisan is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because Myorisan can cause birth defects, Myorisan is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE Program.
• Myorisan 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 Myorisan. Female patients must not get pregnant:

• for 1 month before starting Myorisan
• while taking Myorisan
• for 1 month after stopping Myorisan.

If you get pregnant while taking Myorisan, 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. Myorisan may cause:

• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking Myorisan 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 Myorisan 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 Myorisan, you may also need follow-up mental health care if you had any of these symptoms.

What is Myorisan?

Myorisan 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. Myorisan can cause serious side effects (see “What is the most important information I should know about Myorisan?”). Myorisan 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 Myorisan?

• Do not take Myorisan if you are pregnant, plan to become pregnant, or become pregnant during Myorisan treatment. Myorisan causes severe birth defects. See “What is the most important information I should know about Myorisan?”
• Do not take Myorisan if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Myorisan.

What should I tell my doctor before taking Myorisan?

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

• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Myorisan 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. Myorisan 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 Myorisan. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Myorisan 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 Myorisan. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Myorisan may weaken your bones.
• Corticosteroid medicines . These medicines taken with Myorisan 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 Myorisan 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 Myorisan?

• You must take Myorisan exactly as prescribed. You must also follow all the instructions of the iPLEDGE Program. Before prescribing Myorisan, 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 Myorisan 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 Myorisan at a time. This is to make sure you are following the Myorisan iPLEDGE Program. You should talk with your doctor each month about side effects.
• The amount of Myorisan you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take Myorisan 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Myorisan capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Myorisan 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 two doses at the same time.
• If you take too much Myorisan or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking Myorisan. 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 Myorisan. Female patients who can get pregnant will get a pregnancy test each month.
• Female patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking, and for one month after taking Myorisan. You must access the iPLEDGE system to answer questions about the program requirements and to enter your two 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 Myorisan.

If you have s ex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Myorisan and call your doctor right away.

What should I avoid while taking Myorisan?

• Do not get pregnant while taking Myorisan and for one month after stopping Myorisan. See “What is the most important information I should know about Myorisan?”
• Do not breast feed while taking Myorisan and for one month after stopping Myorisan. We do not know if Myorisan can pass through your milk and harm the baby.
• Do not give blood while you take Myorisan and for one month after stopping Myorisan. If someone who is pregnant gets your donated blood, her baby may be exposed to Myorisan and may be born with birth defects.
• Do not take other medicines or herbal products with Myorisan unless you talk to your doctor. See “What should I tell my doctor before taking Myorisan?”
• Do not drive at night until you know if Myorisan has affected your vision. Myorisan may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your s kin, including waxing, dermabrasion, or laser procedures , while you are using Myorisan and for at least 6 months after you stop. Myorisan 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. Myorisan may make your skin more sensitive to light.
• Do not share Myorisan with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Myorisan?

• Myorisan 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 Myorisan?”
• Myorisan may cause serious mental health problems. See “What is the most important information I should know about Myorisan?”
• serious brain problems. Myorisan can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Myorisan and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea or vomiting
• seizures (convulsions)
• stroke
• skin problems. Skin rash can occur in patients taking Myorisan. In some patients a rash can be serious. Stop using Myorisan 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 Myorisan. Stop taking Myorisan 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. Myorisan 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 Myorisan. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Myorisan if you break a bone.

Stop Myorisan 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.

Myorisan may stop long bone growth in teenagers who are still growing.

• hearing problems . Stop using Myorisan 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. Myorisan may affect your ability to see in the dark. This condition usually clears up after you stop taking Myorisan, but it may be permanent. Other serious eye effects can occur. Stop taking Myorisan 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 Myorisan and after treatment.
• lipid (fats and cholesterol in blood) problems. Myorisan 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 Myorisan treatment is finished.
• serious allergic reactions. Stop taking Myorisan and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Myorisan and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Myorisan 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 Myorisan 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 Myorisan. 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 or VersaPharm Inc. at 1-877-254-4381.

How should I store Myoris an?

• Store Myorisan at 68°-77°F (20° to 25°C). Protect from light.
• Keep Myorisan and all medicines out of the reach of children.

General Information about Myorisan

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Myorisan for a condition for which it was not prescribed. Do not give Myorisan 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 Myorisan. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Myorisan 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 Myorisan?

Active Ingredient: Isotretinoin

Inactive Ingredients : yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, tocopherol, and soybean oil. Gelatin capsules contain gelatin, glycerin, and non-crystallizing sorbitol solution, with the following dye systems: 10 mg - ferric oxide (yellow) and titanium dioxide; 20 mg - titanium dioxide; 30 mg - titanium dioxide and ferric oxide (red); 40 mg - FD&C Yellow No. 6 and titanium dioxide.

The edible imprinting ink for all the capsules contains: shellac glaze, dehydrated alcohol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Myorisan is a prescription medication used to treat the most severe form of acne called nodular acne. Myorisan belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.

This medication comes in capsule form and is usually taken twice daily, with food. Myorisan may be taken for four or five months. A longer periods of use is not recommended.

Common side effects of Myorisan include dry skin, chapped lips, dry eyes, or dry nose causing nosebleeds. Myorisan can also cause birth defects, miscarriages, or premature births.

Because Myorisan can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.

Serious side effects have been reported with Myorisan. See “Myorisan Precautions” section.

Common side effects of Myorisan may include the following:

• dry skin
• chapped lips
• dry eyes
• 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.

Tell your doctor if you have any of the following health conditions:

• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Myorisan 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. Myorisan and certain other medicines can interact with each other, sometimes causing serious side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Myorisan falls into category X. Myorisan must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that Myorisan will cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby and early (premature) births. See "Drug Precautions" section.

A program called iPLEDGE has been set up to make sure that pregnant women do not take Myorisan and that women do not become pregnant while taking Myorisan. All patients, including women who cannot become pregnant and men, can get Myorisan 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. Before prescribing Myorisan, your doctor will:

• explain the iPLEDGE program to you
• have you sign the Patient Information/Informed Consent form (for all patients). Female patients who can get pregnant must also sign another consent form.

You will not be prescribed Myorisan if you cannot agree to or follow all the instructions of the iPLEDGE program. Female patients must not get pregnant:

• for 1 month before starting Myorisan
• while taking Myorisan
• for 1 month after stopping Myorisan

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

Isotretinoin 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.

Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE. You must be registered in the program and understand the risks and benefits of taking this medicine.

Isotretinoin may also be used for purposes not listed in this medication guide.

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, 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 isotretinoin and ending 30 days after your last dose. 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 with or without spermicide;

• a diaphragm plus a spermicide;

• a cervical cap plus a spermicide; and

• a vaginal sponge containing a spermicide.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

Stop using isotretinoin 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 isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

You should not use isotretinoin if you are allergic to it.

To make sure isotretinoin is safe for you, tell your doctor if you have:

• a history of depression or mental illness;

• asthma;

• liver disease;

• diabetes;

• heart disease or high cholesterol;

• osteoporosis or low bone mineral density;

• an eating disorder such as anorexia;

• an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease; or

• a food or drug allergy.

It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

It is not known whether isotretinoin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Isotretinoin is not approved for use by anyone younger than 12 years old.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• vitamin or mineral supplements;

• St. John's wort; or

• a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may interact with isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, stop taking this medicine and check with your doctor right away.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant one month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.

Isotretinoin must not be taken by women of reproductive age unless two effective forms of birth control have been used for at least 1 month before the start of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have 2 pregnancy tests before beginning treatment with isotretinoin to make sure you are not pregnant. The second pregnancy test must be taken at least 19 days after the first test and during the first 5 days of the menstrual period immediately prior to beginning treatment. In addition, you must have a pregnancy test each month while you are taking this medicine and 1 month after treatment is completed.

Do not take vitamin A or any vitamin supplement containing vitamin A while taking this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (eg, St. John's wort) may cause your birth control pills to not work as well.

During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop taking isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.

You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop taking it. This is to prevent a pregnant patient from receiving blood that contains the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Also, check with your doctor.

Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are taking isotretinoin and for up to 2 weeks after you stop taking it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.

Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop taking this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

To help isotretinoin work properly, use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

This medicine may increase pressure in your head. This may increase your risk of vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea or vomiting, or seizures.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.

It is very important that you or your child not have any cosmetic procedures to smooth your skin (eg, dermabrasion, laser) while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Isotretinoin may cause some people to have hearing problems within a few weeks after they start taking it. Check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, redness, soreness, or itching skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine contains FD&C Yellow No.5 (tartrazine) which may cause an allergic reaction, including asthma, in some people. This reaction is more often seen in people who also have an allergy to aspirin.

This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.

2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.

3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.

4. Jones H, Blanc D, Cunliffe WJ. 13-cis-retinoic acid and acne. Lancet 2:1048-1049, 1980.

5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980.

6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984.

7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.

8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.

OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.

750-05256

MyorisanTM 
(isotretinoin capsules, USP)
40 mg

Each capsule contains
40 mg isotretinoin, USP.

Rx only

10 capsules
Prescription Pack

PATIENT:
READ INFORMATION CAREFULLY.