In the U.S.—

In Canada—

• Antiacne agent, systemic
• Antirosacea agent, systemic
• Keratinization stabilizer

Isotretinoin (eye-soe-TRET-i-noyn ) is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines have been tried and have failed to help the acne. Isotretinoin may also be used to treat other skin diseases as determined by your doctor.

Isotretinoin must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Isotretinoin must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for isotretinoin.

This medicine is available only with your doctor's prescription and should be prescribed only by a doctor who has special knowledge of the diagnosis and treatment of severe, uncontrollable cystic acne.

Isotretinoin is available in the following dosage form:

Oral
• Capsules (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For isotretinoin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to isotretinoin, acitretin, etretinate, tretinoin, or vitamin A preparations. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives (such as parabens), or dyes.

Pregnancy—Isotretinoin must not be taken during pregnancy because it causes birth defects in humans. In addition, isotretinoin must not be taken if there is a chance that you may become pregnant during treatment or within 1 month following treatment.

Breast-feeding—It is not known whether isotretinoin passes into breast milk. However, isotretinoin should not be used during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Children may be especially sensitive to the effects of isotretinoin. This may increase the chance of side effects during treatment. Children may have the side effects of back, joint, or muscle pain more often than adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of isotretinoin in the elderly with use in other age groups. However, older people may have a greater risk of problems and adverse effects when taking isotretinoin.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using isotretinoin, it is especially important that your health care professional know if you are using any of the following:

• Acitretin (e.g., Soriatane) or
• Tretinoin, oral (e.g., Vesanoid)—Use of isotretinoin with these medicines may result in an increase in side effects

• Oral contraceptives, progestin-only or “mini pills” (birth control pills) (e.g., Nor-QD, Micronor, Ovrette)—This medication is not an effective form of birth control when used with isotretinoin.

• Tetracyclines, oral (medicine for infection)—Use of isotretinoin with these medicines may increase the chance of a side effect called pseudotumor cerebri, which is a swelling and pressure on the brain

• Alcoholism or excess use of alcohol (or history of) or
• Diabetes mellitus (sugar diabetes) (or a family history of) or
• Family history of high triglyceride (a fat-like substance) levels in the blood or
• Severe weight problems—Use of isotretinoin may increase blood levels of triglyceride (a fat-like substance), which may increase the chance of heart or blood vessel problems in patients who have a family history of high triglycerides, are greatly overweight, are diabetic, or use a lot of alcohol. For persons with diabetes mellitus, use of isotretinoin also may change blood sugar levels

• Anorexia (eating disorder)
• Osteoporosis (brittle bones), childhood or family history of
• Osteomalacia (softening of the bones)
• Other bone disorders or diseases—Isotretinoin should be used with caution. It is not known whether this medicine effects bone loss.

• Kidney disease or
• Lipids in blood, sudden and large increase or
• Liver disease or
• Vitamin A overdose (too much vitamin A in your body)—Isotretinoin should not be used in patients with these medical problems.

• Mental disorders such as mental depression or psychosis—Isotretinoin may make these problems worse.

Isotretinoin comes with patient information. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Isotretinoin must not be taken by women of reproductive age unless two effective forms of contraception (birth control) have been used for at least 1 month before the beginning 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. In addition, you will be asked to sign an informed consent form stating that you understand the above information .

If you are a woman who is able to have children, you must have a pregnancy blood test within 1 week before beginning treatment with isotretinoin to make sure you are not pregnant. Treatment with isotretinoin will then be started within the week, on the second or third day of your next normal menstrual period. In addition, you must have a pregnancy blood test each month while you are taking this medicine and one month after treatment is completed.

Take isotretinoin with food and a full glass of liquid, like water. Taking with food is important for getting the right amount of medicine out of your stomach. Taking with a full glass of liquid will reduce chest or stomach discomfort that may occur from isotretinoin.

It is very important that you take isotretinoin only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Importance of not sharing medication with anyone else because of the risk of birth defects and other serious side effects.

Dosing—

The dose of isotretinoin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of isotretinoin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking isotretinoin.

• For oral dosage form (capsules):
  • For acne:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 1 milligram (mg) per kilogram (kg) (0.23 to 0.45 mg per pound) of body weight a day. It is recommended that the dose per day be divided and not taken all at one time. For adult patients with severe acne, dosage adjustments may be needed and must be determined by your doctor.
    • Children—Use is usually not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits to make sure this medicine does not cause unwanted effects.

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

Importance of checking with your doctor before taking any medications including vitamins, herbal products, or over-the-counter (OTC) medicines. Some of these medicines or nutritional supplements (e.g., St. John's wort) may make your birth control pills not work.

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 health care professional can help you choose the right skin products to reduce skin dryness and irritation.

Do not donate blood to a blood bank while you are taking isotretinoin or for 30 days after you stop taking it. This is to prevent the possibility of a pregnant patient receiving the blood containing the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This decrease 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. Therefore, if you wear contact lenses, your eyes may be more sensitive to them during the time you are taking isotretinoin and for up to about 2 weeks after you stop taking it. To help relieve dryness of the eyes, check with your doctor about using an eye-lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor.

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 should not stop taking this medicine unless the skin irritation becomes too severe. Do not use a sunlamp.

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

Isotretinoin may cause mood or behavior problems, including having thoughts about hurting themselves; check with you doctor right away if unusual mood or behavior problems occur.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. Check with your doctor if these problems are bothersome.

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.

Importance of not removing hair by wax epilation while taking isotretinoin and for 6 months after stopping isotretinoin. Isotretinoin can increase your chance of scarring from wax epilation.

Importance of not having any cosmetic procedures to smooth your skin (e.g., dermabrasion, laser) while taking isotretinoin and for 6 months after stopping isotretinoin. Isotretinoin can increase your chance of scarring from these cosmetic procedures.

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Bone or joint pain;  burning, redness, itching, or other signs of eye inflammation;  difficulty in moving;  nosebleeds;  scaling, redness, burning, pain, or other signs of inflammation of lips;  skin infection or rash 
  
  

• Rare
  • Abdominal or stomach pain (severe);  attempts at suicide or thoughts of suicide (usually stops after medicine is stopped);  back pain;  bleeding or inflammation of gums;  blurred vision or other changes in vision;  changes in behavior;  decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped);  diarrhea (severe) ;  headache (severe or continuing);  mental depression;  nausea and vomiting;  pain or tenderness of eyes;  pain, tenderness, or stiffness in muscles (long-term treatment);  rectal bleeding;  yellow eyes or skin 
  
  

• Incidence not determined
  • Attack, assault, or use of force;  black, tarry stools;  bleeding from sore in mouth;  bloating;  bloody or cloudy urine;  bloody cough;  bone pain, tenderness, or aching;  burning or stinging of skin;  chest pain;  chills;  confusion;  constipation;  convulsions;  cough or hoarseness;  dark-colored urine;  decrease in height;  difficulty breathing;  difficulty in speaking;  difficulty in swallowing;  discharge from eye;  dizziness;  double vision;  ear pain;  excessive tearing;  fainting;  fast, irregular, pounding, or racing heartbeat or pulse;  fever with or without chills;  fractures and/or delayed healing;  general feeling of discomfort or illness;  heartburn;  high blood pressure;  hives;  inability to move arms, legs, or facial muscles;  inability to speak;  indigestion;  inflamed tissue from infection;  irregular yellow patch or lump on skin;  irritation;  joint pain, redness, stiffness, or swelling;  killing oneself;  lack or slowing of normal growth in children ;  loosening of the fingernails;  loss of appetite;  loss of bladder control;  loss or change in hearing;  muscle cramps or spasms;  muscle spasm or jerking of all extremities ;  muscle weakness;  noisy breathing;  pain in ribs, arms, or legs;  pain or burning in throat;  pain or tenderness around eyes and cheekbones;  painful cold sores or blisters on lips, nose, eyes, or genitals;  painful or difficult urination;  pains in chest, groin, or legs, especially calves of legs;  pains in stomach, side, or abdomen, possibly radiating to the back;  pale skin;  pinpoint red spots on skin;  redness or soreness around fingernails;  redness, soreness or itching skin;  sensitivity of eyes to sunlight;  shortness of breath;  skin rash;  slow speech;  sneezing;  sore throat;  sores, ulcers, or white spots on lips or tongue or inside the mouth;  sores, welting or blisters;  stuffy or runny nose;  sudden loss of coordination ;  sudden loss of consciousness;  sudden onset of shortness of breath for no apparent reason;  sudden onset of severe acne on chest and trunk;  sudden onset of slurred speech;  swelling of eyelids, face, lips, hands, lower legs, or feet;  swollen, painful or tender lymph glands in neck, armpit, or groin;  tightness in chest;  unusual bleeding or bruising ;  unusual tiredness or weakness;  unusual weight gain or loss;  use of extreme physical or emotional force;  watery or bloody diarrhea;  wheezing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Crusting of skin;  difficulty in wearing contact lenses (may continue after medicine is stopped);  dryness of eyes (may continue after treatment is stopped);  dryness of mouth or nose;  dryness or itching of skin ;  headache (mild);  increased sensitivity of skin to sunlight;  peeling of skin on palms of hands or soles of feet;  stomach upset ;  thinning of hair (may continue after treatment is stopped) 
  
  

• Incidence not determined
  • Abnormal menstruation;  burning, crawling, itching, numbness, prickling, “pins and needles” or tingling feeling ;  changes in fingernails or toenails;  continuing ringing or buzzing or other unexplained noise in ears ;  dandruff;  darkening of skin;  fatigue;  flushing ;  hair abnormalities;  hair loss;  increased hair growth, especially on the face ;  large amount of triglyceride in the blood;  lightening of normal skin color;  lightening of treated areas of dark skin;  nervousness;  oily skin;  redness of face;  severe sunburn;  skin rash, encrusted, scaly and oozing;  sleeplessness;  stomach burning;  sweating;  trouble sleeping;  unable to sleep;  unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness ;  unusually warm skin of face;  voice changes 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, isotretinoin is used in certain patients with the following medical conditions:

• Folliculitis, gram-negative (bacterial infection of skin on face beginning near the nose)
• Hidradenitis suppurativa (sweat gland problem)
• Rosacea (red skin disorder of the face, usually of the nose and cheeks)
• Thickened or patchy skin disorders, such as keratosis follicularis, palmoplantar keratoderma, lamellar ichthyosis, or pityriasis rubra pilaris

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.