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What you should know before using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Children may be especially sensitive to the effects of isotretinoin. This may increase the chance of side effects during treatment. Children may have the side effects of back, joint, or muscle pain more often than adults.

This medicine should be used with caution in teenagers, especially those with bone problems or diseases.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of isotretinoin in the elderly with use in other age groups. However, older people may have a greater risk of problems and adverse effects when taking isotretinoin.

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Desogestrel
  • Doxycycline
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Levonorgestrel
  • Mestranol
  • Minocycline
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Tetracycline

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcoholism or excess use of alcohol (or history of) or
  • Diabetes mellitus (sugar diabetes) (or a family history of) or
  • Family history of high triglyceride (a fat-like substance) levels in the blood or
  • Severe weight problems—Use of isotretinoin may increase blood levels of triglyceride (a fat-like substance), which may increase the chance of heart or blood vessel problems in patients who have a family history of high triglycerides, are greatly overweight, are diabetic, or use a lot of alcohol. For persons with diabetes mellitus, use of isotretinoin also may change blood sugar levels
  • Anorexia (eating disorder)
  • Osteoporosis (brittle bones), childhood or family history of
  • Osteomalacia (softening of the bones)
  • Other bone disorders or diseases—Isotretinoin should be used with caution. It is not known whether this medicine 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 your body)—Isotretinoin should not be used in patients with these medical problems.
  • Mental disorders such as mental depression or psychosis—Isotretinoin may make these problems worse.

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