Isotretinoin Capsules

What is this medication?

ISOTRETINOIN (eye soe TRET i noyn) treats severe acne. It is often prescribed when other acne medications do not work well enough or cannot be tolerated. It belongs to a group of medications called retinoids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Absorica, Absorica LD, Accutane, Amnesteem, Claravis, MYORISAN, Sotret, ZENATANE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anorexia (where people eat too little)
• Asthma (lung or breathing disease)
• Depression
• Diabetes (high blood sugar)
• Heart disease
• High cholesterol
• Inflammatory bowel disease
• Liver disease
• Mental health disease
• Osteoporosis, weak bones
• Suicidal thoughts, plans or attempt
• An unusual or allergic reaction to isotretinoin, vitamin A, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medication. Swallow the capsules whole. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Vitamins and other supplements containing vitamin A

This medication may also interact with the following:

• Alcohol
• Benzoyl peroxide, salicylic acid, or other drying medications used for acne
• Medications for seizures
• Orlistat
• Other medications that make you more sensitive to the sun such as sulfa medications
• Progestin-only birth control hormones
• St. John's Wort
• Steroid medications like prednisone or cortisone
• Tetracycline antibiotics like doxycycline and tetracycline
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

Do not get pregnant while taking this medication and for 1 month after stopping it. Women must have 2 negative pregnancy tests before starting this medication and one each month during treatment, even if not sexually active. Use 2 reliable forms of birth control for 1 month before, during, and for 1 month after stopping this medication. Use birth control pills that contain estrogen. Ones that contain only progestin may not work as well. If you become pregnant, miss a menstrual cycle, or stop using birth control, stop taking this medication. Call your care team. Severe birth defects may occur even if just one dose is taken. Do not breast-feed while taking this medication or for 1 month after stopping treatment.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

This medication can cause serious eye damage. Tell your care team right away if you have changes in your eyesight.

You may experience a flare in your acne during the initial treatment period. You will need to see your doctor or care team monthly to get a new prescription and to check on your progress and for side effects.

Do not have cosmetic procedures such as waxing, dermabrasion, or laser therapy during and for at least 6 months after you stop taking this medication. These procedures can increase the risk of scarring. Check with your care team for advice about when you can have cosmetic procedures.

This medication may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

This medication can make you more sensitive to the sun. Keep out of the sun, If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Do not give blood while taking this medication or for 30 days after stopping it.

This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

This medication can increase cholesterol and triglyceride levels and decrease HDL (the good cholesterol) levels. Your care team may check your cholesterol. It may be necessary to change your diet or take new prescription medications to help lower cholesterol. Alcohol can increase the risk of high cholesterol. Avoid alcoholic drinks while you are taking this medication.

Your care team may tell you to stop taking this medication if you develop muscle problems. If your muscle problems do not go away after stopping this medication, contact your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Hearing loss, ringing in ears
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach pain, rectal bleeding, severe diarrheaSide effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
• Dryness or irritation of the eyes, lips, mouth, or nose
• Joint pain
• Muscle pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.