Before Using This Medicine

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 isotretinoin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to isotretinoin, acitretin, etretinate, tretinoin, or vitamin A preparations. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives (such as parabens), or dyes.

Pregnancy—Isotretinoin must not be taken during pregnancy because it causes birth defects in humans. In addition, isotretinoin must not be taken if there is a chance that you may become pregnant during treatment or within 1 month following treatment .

Breast-feeding—It is not known whether isotretinoin passes into breast milk. However, isotretinoin should not be used during breast-feeding because it may cause unwanted effects in nursing babies.

Children—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.

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

Older adults—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.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using isotretinoin, it is especially important that your health care professional know if you are using any of the following:

• Acitretin (e.g., Soriatane) or
• Tretinoin, oral (e.g., Vesanoid)—Use of isotretinoin with these medicines may result in an increase in side effects

• Oral contraceptives, progestin-only or “mini pills” (birth control pills) (e.g., Nor-QD, Micronor, Ovrette)—This medication is not an effective form of birth control when used with isotretinoin.

• Tetracyclines, oral (medicine for infection)—Use of isotretinoin with these medicines may increase the chance of a side effect called pseudotumor cerebri, which is a swelling and pressure on the brain

Other medical problems—The presence of other medical problems may affect the use of isotretinoin. 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.