Drug Info: I: Isotretinoin (Systemic)

In the U.S.—

In Canada—

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

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

Isotretinoin must not be used to treat women who are ableto bear children unless other forms of treatment have beentried first and have failed. Isotretinoin must not be takenduring pregnancy because it causes birth defects in humans.If you are able to bear children, it is very important thatyou read, understand, and follow the pregnancy warnings forisotretinoin.

This medicine is available only with your doctor'sprescription and should be prescribed only by a doctor whohas special knowledge of the diagnosis and treatment ofsevere, uncontrollable cystic acne.

Isotretinoin is available in the following dosageform:

• Oral
• Capsules (U.S. and Canada)

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

Allergies—Tell your doctor if you haveever 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 toany other substances, such as foods, preservatives (such asparabens), or dyes.

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

Breast-feeding—It is not known whetherisotretinoin passes into breast milk. However, isotretinoinshould not be used during breast-feeding because it may causeunwanted effects in nursing babies.

Children—Children may be especiallysensitive to the effects of isotretinoin. This may increase thechance of side effects during treatment. Children may have theside effects of back, joint, or muscle pain more often thanadults.

Older adults—Many medicines have notbeen studied specifically in older people. Therefore, it maynot be known whether they work exactly the same way they do inyounger adults or if they cause different side effects orproblems in older people. There is no specific informationcomparing use of isotretinoin in the elderly with use in otherage groups. However, older people may have a greater risk ofproblems and adverse effects when taking isotretinoin.

Other medicines—Although certainmedicines should not be used together at all, in other casestwo different medicines may be used together even if aninteraction might occur. In these cases, your doctor may wantto change the dose, or other precautions may be necessary. Whenyou are using isotretinoin, it is especially important thatyour health care professional know if you are using any of thefollowing:

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

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

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

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

• Anorexia (eating disorder)
• Osteoporosis (brittle bones), childhood or family historyof
• Osteomalacia (softening of the bones)
• Other bone disorders or diseases—Isotretinoinshould be used with caution. It is not known whether thismedicine 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 yourbody)—Isotretinoin should not be used in patients withthese medical problems.

• Mental disorders such as mental depression orpsychosis—Isotretinoin may make these problemsworse.

Isotretinoin comes with patient information. It is veryimportant that you read and understand this information. Besure to ask your doctor about anything you do notunderstand.

Isotretinoin must not be taken by women of reproductiveage unless two effective forms of contraception (birthcontrol) have been used for at least 1 month before thebeginning of treatment. Contraception must be continuedduring the period of treatment, which is up to 20 weeks, andfor 1 month after isotretinoin is stopped. Be sure you havediscussed this information with your doctor. In addition, youwill be asked to sign an informed consent form stating thatyou understand the above information .

If you are a woman who is able to have children, you musthave a pregnancy blood test within 1 week before beginningtreatment with isotretinoin to make sure you are notpregnant. Treatment with isotretinoin will then be startedwithin the week, on the second or third day of your nextnormal menstrual period. In addition, you must have apregnancy blood test each month while you are taking thismedicine 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 gettingthe right amount of medicine out of your stomach. Taking witha full glass of liquid will reduce chest or stomachdiscomfort that may occur from isotretinoin.

It is very important that you take isotretinoin only asdirected. Do not take more of it, do not take it moreoften, and do not take it for a longer time than your doctorordered. To do so may increase the chance of sideeffects.

Importance of not sharing medication with anyone elsebecause of the risk of birth defects and other serious sideeffects.

Dosing—

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

The number of capsules that you take depends on thestrength of the medicine. Also, the number of doses you take each day, the time allowedbetween doses, and the length of time you take the medicinedepend on the medical problem for which you are takingisotretinoin.

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

Missed dose—

If you miss a dose of this medicine, take it as soon aspossible. However, if it is almost time for your next dose,skip the missed dose and go back to your regular dosingschedule. 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, orin other damp places. Heat or moisture may cause themedicine to break down.
• Do not keep outdated medicine or medicine no longerneeded. Be sure that any discarded medicine is out of thereach of children.

Your doctor should check your progress at regularvisits to make sure this medicine does not causeunwanted effects.

Isotretinoin causes birth defects in humans if takenduring pregnancy. Therefore, if you suspect that you may havebecome pregnant, stop taking this medicine immediately andcheck with your doctor.

Importance of checking with your doctor before taking anymedications including vitamins, herbal products, orover-the-counter (OTC) medicines. Some of thesemedicines 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, yourskin may become irritated. Also, your acne may seem to getworse before it gets better. Check with your doctor if your skin condition does notimprove within 1 to 2 months after starting this medicine orat any time your skin irritation becomes severe. Fullimprovement continues after you stop taking isotretinoin andmay take up to 6 months. Your health care professional canhelp you choose the right skin products to reduce skindryness and irritation.

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

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

Isotretinoin may cause dryness of the eyes. Therefore, ifyou wear contact lenses, your eyes may be more sensitive tothem during the time you are taking isotretinoin and for upto about 2 weeks after you stop taking it. To help relievedryness of the eyes, check with your doctor about using aneye-lubricating solution, such as artificial tears. If eyeinflammation occurs, check with your doctor.

Isotretinoin may cause dryness of the mouth and nose. Fortemporary relief of mouth dryness, use sugarless candy orgum, melt bits of ice in your mouth, or use a salivasubstitute. However, if dry mouth continues for more than 2weeks, check with your medical doctor or dentist. Continuingdryness of the mouth may increase the chance of dentaldisease, including tooth decay, gum disease, and fungusinfections.

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

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

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

Isotretinoin may cause bone or muscle problems, includingjoint 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 supplementcontaining vitamin A while taking this medicine, unlessotherwise directed by your doctor. To do so may increase thechance of side effects.

Importance of not removing hair by wax epilation whiletaking isotretinoin and for 6 months after stoppingisotretinoin. Isotretinoin can increase your chance ofscarring from wax epilation.

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

For diabetic patients:

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

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

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

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

• Rare
  • Abdominal or stomach pain (severe); attempts atsuicide or thoughts of suicide (usually stops aftermedicine is stopped); back pain; bleeding orinflammation of gums; blurred vision or other changesin vision; changes in behavior; decreased vision aftersunset or before sunrise (sudden or may continue aftermedicine is stopped); diarrhea (severe) ; headache(severe or continuing); mental depression; nausea andvomiting; pain or tenderness of eyes; pain, tenderness,or stiffness in muscles (long-term treatment); rectalbleeding; yellow eyes or skin
  
  

• Incidence not determined
  • Attack, assault, or use of force; black, tarrystools; bleeding from sore in mouth; bloating; bloodyor cloudy urine; bloody cough; bone pain, tenderness,or aching; burning or stinging of skin; chest pain;chills; confusion; constipation; convulsions; cough orhoarseness; 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 racingheartbeat or pulse; fever with or without chills;fractures and/or delayed healing; general feeling ofdiscomfort or illness; heartburn; high blood pressure;hives; inability to move arms, legs, or facial muscles;inability to speak; indigestion; inflamed tissue frominfection; irregular yellow patch or lump on skin;irritation; joint pain, redness, stiffness, orswelling; killing oneself; lack or slowing of normalgrowth in children ; loosening of the fingernails; lossof appetite; loss of bladder control; loss or change inhearing; muscle cramps or spasms; muscle spasm orjerking of all extremities ; muscle weakness; noisybreathing; pain in ribs, arms, or legs; pain or burningin throat; pain or tenderness around eyes andcheekbones; painful cold sores or blisters on lips,nose, eyes, or genitals; painful or difficulturination; pains in chest, groin, or legs, especiallycalves of legs; pains in stomach, side, or abdomen,possibly radiating to the back; pale skin; pinpoint redspots on skin; redness or soreness around fingernails;redness, soreness or itching skin; sensitivity of eyesto sunlight; shortness of breath; skin rash; slowspeech; sneezing; sore throat; sores, ulcers, or whitespots on lips or tongue or inside the mouth; sores,welting or blisters; stuffy or runny nose; sudden lossof coordination ; sudden loss of consciousness; suddenonset of shortness of breath for no apparent reason;sudden onset of severe acne on chest and trunk; suddenonset of slurred speech; swelling of eyelids, face,lips, hands, lower legs, or feet; swollen, painful ortender lymph glands in neck, armpit, or groin;tightness in chest; unusual bleeding or bruising ;unusual tiredness or weakness; unusual weight gain orloss; use of extreme physical or emotional force;watery or bloody diarrhea; wheezing
  
  

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

• More common
  • Crusting of skin; difficulty in wearing contactlenses (may continue after medicine is stopped);dryness of eyes (may continue after treatment isstopped); dryness of mouth or nose; dryness or itchingof skin ; headache (mild); increased sensitivity ofskin to sunlight; peeling of skin on palms of hands orsoles of feet; stomach upset ; thinning of hair (maycontinue after treatment is stopped)
  
  

• Incidence not determined
  • Abnormal menstruation; burning, crawling, itching,numbness, prickling, “pins and needles” ortingling feeling ; changes in fingernails or toenails;continuing ringing or buzzing or other unexplainednoise in ears ; dandruff; darkening of skin; fatigue;flushing ; hair abnormalities; hair loss; increasedhair growth, especially on the face ; large amount oftriglyceride in the blood; lightening of normal skincolor; lightening of treated areas of dark skin;nervousness; oily skin; redness of face; severesunburn; skin rash, encrusted, scaly and oozing;sleeplessness; stomach burning; sweating; troublesleeping; unable to sleep; unusual drowsiness,dullness, tiredness, weakness or feeling ofsluggishness ; unusually warm skin of face; voicechanges
  
  

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.

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

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

Other than the above information, there is no additionalinformation relating to proper use, precautions, or sideeffects for these uses.