Isotretinoin

Jul 26, 2022

Generic name: isotretinoin (oral) [ EYE-so-TRET-i-noyn ]
Brand names: Absorica, Accutane, Amnesteem, Claravis, Isotretinoin (Eqv-Absorica),  … show all 9 brands
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)
Drug classes:  Miscellaneous antineoplastics ,  Miscellaneous uncategorized agents

What is 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.

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.

Before taking this medicine

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 should I take isotretinoin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking isotretinoin with or without food.

Use isotretinoin for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include  headache ,  dizziness ,  vomiting , stomach pain, warmth or tingling in your face, swollen or cracked lips, and  loss of balance  or coordination.

What should I avoid while taking isotretinoin?

Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

While you are taking isotretinoin and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Isotretinoin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid driving or hazardous activity until you know how isotretinoin will affect you. Isotretinoin may impair your vision, especially at night.

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.

Isotretinoin side effects  (more detail)

Isotretinoin dosing information

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
Maximum dose: Up to 2 mg/kg/day
Duration of therapy: Up to 20 weeks

Comments:
-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 weeks

Comments:
-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

Detailed Isotretinoin dosage information

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.

source :: https://www.drugs.com/mtm/isotretinoin.html