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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established.
This medicine should be used with caution in teenagers, especially those with bone problems or diseases.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients may have a greater risk of problems and side effects when taking isotretinoin.
|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.|
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.
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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
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, severe or
- Diabetes or
- Metabolism disorder, family history of or
- Severe weight problems—Use with caution. May increase risks for more serious problems.
- Anorexia (eating disorder) or
- Epiphyseal closure, premature or
- Osteomalacia (softening of the bones) or
- Osteoporosis (brittle bones), childhood or family history of or
- Other bone disorders or diseases—Use with caution. It is not known whether this medicine affects bone loss.
- Asthma or
- Depression, history of or
- Eye or vision problems or
- Hearing problems or
- Heart disease or
- Hepatitis or
- Hypertriglyceridemia (high triglycerides in the blood) or
- Intestinal disorders, history of or
- Pancreatitis (inflammation of the pancreas) or
- Pseudotumor cerebri (swelling in the brain) or
- Psychosis, history of or
- Vitamin A overdose (too much vitamin A in the body)—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.