Accutane

DRUG DESCRIPTION

Isotretinoin, a retinoid, is available as Accutane (isotretinoin) in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:

ACCUTANE® (isotretinoin) Structural Formula Illustration

What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

  • depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
  • sudden numbness or weakness, especially on one side of...

Read All Potential Side Effects and See Pictures of Accutane »

What are the precautions when taking isotretinoin (Accutane)?

Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone...

Read All Potential Precautions of Accutane »


Accutane Consumer (continued)

SIDE EFFECTS: Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have any of these unlikely but serious side effects: mental/mood changes (e.g., depression, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling feeling in the skin, quick/severe sunburn (sun sensitivity), back/joint/muscle pain, signs of infection (e.g., fever, persistent sore throat), painful swallowing, peeling skin on palms/soles.

Isotretinoin may infrequently cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting.

Stop taking this medication and tell your doctor immediately if you develop these unlikely but very serious side effects: severe headache, vision changes, ringing in the ears, hearing loss, chest pain, yellowing eyes/skin, dark urine, severe diarrhea, rectal bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density).

Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely.

If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Contact your doctor for more information.

Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy. Skin scarring may occur.

Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis).

Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure). Consult your doctor for more details.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain.

This drug must not be used during pregnancy or by those who may become pregnant during treatment. If you become pregnant or think you may be pregnant, inform your doctor immediately. See also Warning section.

You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor immediately.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Accutane Patient Information Including Side Effects

Brand Names: Accutane, Amnesteem, Claravis, Sotret

Generic Name: isotretinoin (oral) (Pronunciation: EYE so TRET i noyn)

  • What is isotretinoin (Accutane)?
  • What are the possible side effects of isotretinoin (Accutane)?
  • What is the most important information I should know about isotretinoin (Accutane)?
  • What should I discuss with my healthcare provider before taking isotretinoin (Accutane)?
  • How should I take isotretinoin (Accutane)?
  • What happens if I miss a dose (Accutane)?
  • What happens if I overdose (Accutane)?
  • What should I avoid while taking isotretinoin (Accutane)?
  • What other drugs will affect isotretinoin (Accutane)?
  • Where can I get more information?

What is isotretinoin (Accutane)?

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

What are the possible side effects of isotretinoin (Accutane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

  • depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
  • sudden numbness or weakness, especially on one side of the body;
  • blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
  • hearing problems, hearing loss, or ringing in your ears;
  • seizure (convulsions);
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
  • fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
  • joint stiffness, bone pain or fracture.

Less serious side effects may include:

  • joint pain, back pain;
  • feeling dizzy, drowsy, or nervous;
  • dryness of the lips, mouth, nose, or skin; or
  • cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about isotretinoin (Accutane)?

Isotretinoin can cause severe, life-threatening birth defects. Never use isotretinoin if you are pregnant.

Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin.

Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.

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