Isotretinoin

Generic name: Isotretinoin (oral)
Dosage form: oral capsule (10 mg; 20 mg; 25 mg; 30 mg; 35 mg; 40 mg; micronized 16 mg; micronized 24 mg; micronized 32 mg; micronized 8 mg)

Usage of Isotretinoin

Isotretinoin is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE.

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

Isotretinoin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Isotretinoin may cause serious side effects. Stop using isotretinoin and call your doctor at once if you have:

problems with your vision or hearing;

muscle or joint pain, bone pain, back pain;

increased thirst, increased urination;

hallucinations, (see or hearing things that are not real);

symptoms of depression--unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;

signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);

severe stomach problems--severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or

increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects of isotretinoin may include:

dryness of your skin, lips, eyes, or nose (you may have nosebleeds);

vision problems;

headache, back pain, joint pain, muscle problems;

skin reactions; or

cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Before taking Isotretinoin

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant or able to become pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be able to get pregnant. You must have 2 negative pregnancy tests before you start taking isotretinoin, before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

tubal ligation (tubes tied);

vasectomy of the male sexual partner;

an IUD (intrauterine device);

estrogen-containing birth control pills (not mini-pills); and

hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

a male latex condom with or without spermicide;

a diaphragm plus a spermicide;

a cervical cap plus a spermicide; and

a vaginal sponge containing a spermicide.

Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use isotretinoin if you are allergic to it.

Tell your doctor if you have ever had:

depression or mental illness;

asthma;

liver disease;

diabetes;

heart disease or high cholesterol;

osteoporosis or low bone mineral density;

an eating disorder such as anorexia;

a food or drug allergy; or

an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for use by anyone younger than 12 years old.

How to use Isotretinoin

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a dayMaximum dose: Up to 2 mg/kg/dayDuration of therapy: Up to 20 weeksComments:-Patients should take some formulations of this drug with food.-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Usual Pediatric Dose for Acne:

12 years or older:-Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day-Maximum dose: 2 mg/kg/day-Duration of therapy: Up to 20 weeksComments:-Patients should take some formulations of this drug with food.-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Warnings

Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use isotretinoin if you are pregnant or able to become pregnant.

You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.

What other drugs will affect Isotretinoin

Tell your doctor about all your other medicines, especially:

phenytoin;

St. John's wort (may make birth control pills less effective);

vitamin or mineral supplements;

progestin-only birth control pills (mini-pills, may not work as well when taken with isotretinoin);

steroid medicine; or

a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may affect isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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