Isotretinoin

What is Isotretinoin?

• Isotretinoin (Accutane) is a retinoid used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics.

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Isotretinoin

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What are the uses of this medicine?

• Isotretinoin used in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin capsules can cause serious side effects.

Isotretinoin capsules can only be:

• prescribed by healthcare providers that are registered in the iPLEDGE Program.

Limitations of use:

• If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy.

How does this medicine work?

• Isotretinoin is a retinoid, which when administered at the recommended dosage, inhibits sebaceous gland function and keratinization.
• The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with isotretinoin capsules and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.
• The exact mechanism of action of isotretinoin in the treatment of severe recalcitrant nodular acne is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant
• hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred).

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• medications for seizures such as phenytoin (Dilantin)
• medications for mental illness
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others)
• vitamin A supplements

Is this medicine FDA approved?

• Isotretinoin was patented in 1969 and approved for medical use in 1982.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks.
• Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dosage adjustments up to 2 mg/kg/day for isotretinoin capsules in divided doses, as tolerated.
• The safety and effectiveness of once daily dosing with isotretinoin capsules has not been established and is not recommended.
• If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two doses of isotretinoin capsules at the same time.

Administration:

• You will get no more than a 30-day supply of isotretinoin capsules at a time. This is to make sure you are following the isotretinoin capsules iPLEDGE Program.
• Take isotretinoin capsules 2 times a day with or without meals, unless your healthcare provider tells you otherwise.
• Swallow your isotretinoin capsules whole with a full glass of liquid.
• Do not chew or suck on the capsule.
• Isotretinoin capsules can hurt the tube that connects your mouth to your stomach (esophagus) if not swallowed whole.
• If you miss a dose, just skip that dose. Do not take two doses at the same time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg

This medicine is available in fallowing brand namesː

• Absorica
• Accutane
• Amnesteem
• Claravis
• Myorisan
• Sotret
• Zenatane

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry lips
• dry skin
• back pain
• dry eyes
• joint pain
• nose bleeds
• headache
• upper respiratory tract infection (common cold)
• chapped lips or swelling of the lips
• skin reactions
• muscle problems
• eye problems, including decreased vision

Isotretinoin capsules can cause serious side effects, including:

• can harm your unborn baby
• Serious mental health problems
• intracranial hypertension
• serious skin problems
• pancreatitis
• increased blood fat (lipid) levels
• hearing problems
• liver problems, including hepatitis
• bone and muscle problems
• vision problems
• serious allergic reactions
• blood sugar problems, including diabetes

What special precautions should I follow?

• Do not give blood during treatment with isotretinoin capsules and for one month after stopping isotretinoin capsules. If someone who is pregnant gets your donated blood, their baby may be exposed to isotretinoin and may be born with birth defects.
• Do not take other medicines or herbal products with isotretinoin capsules unless you talk to your healthcare provider.
• Do not drive at night until you know if isotretinoin capsules have affected your vision. Isotretinoin 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, during treatment with isotretinoin capsules and for at least 6 months after you stop. Isotretinoin capsules can increase your chance of scarring from these procedures. Check with your healthcare provider for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Isotretinoin capsules may make your skin more sensitive to light.
• Do not share isotretinoin capsules with other people. Isotretinoin capsules can cause birth defects and other serious health problems.
• Isotretinoin may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. Prior to and during therapy assess for these conditions; stop if these conditions occur on therapy.
• Isotretinoin use has been associated with cases of intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use of tetracyclines. Avoid use with concomitant tetracyclines.
• Reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions.
• Acute pancreatitis has been reported with isotretinoin use in patients with either elevated or normal serum triglyceride levels. If occurs, discontinue treatment.
• Elevations of serum triglycerides above 800 mg/dL have been reported with isotretinoin use. Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled.
• Impaired hearing has been reported in patients taking isotretinoin. Discontinue and refer to specialized care.
• Clinical hepatitis has been reported with isotretinoin use. Monitor liver function tests prior to and during therapy.
• Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Discontinue for abdominal pain, rectal bleeding, or severe diarrhea.
• Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure may occur.
• Visual problems should be carefully monitored. If visual symptoms occur, discontinue and refer for an ophthalmological exam.
• Anaphylactic reactions and other allergic reactions have been reported with isotretinoin use. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia
• All patients with isotretinoin overdose should not donate blood for at least 1 month.

Management of overdosage: In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Isotretinoin is contraindicated in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of isotretinoin in pediatric patients less than 12 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: isotretinoin, USP
• Inactive ingredients: sorbitan monooleate, soybean oil, stearoyl polyoxyglycerides, and vitamin E.

Who manufactures and distributes this medicine?

Manufactured For:

• Teva Pharmaceuticals USA, Inc., Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store isotretinoin capsules at room temperature, 68°F to 77°F (20°C to 25°C).
• Protect from light.

• Dailymed label info on Isotretinoin
• FDA Isotretinoin

Isotretinoin Resources
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