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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.
Pediatric
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.
Geriatric
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.
Pregnancy
| 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. |
Breastfeeding
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, severe or
- Diabetes mellitus (sugar 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 effects bone loss.
- Asthma 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
- Mental depression, history of or
- Pancreatitis (inflammation of the pancreas) or
- Pseudotumor cerebri (brain problem) or
- Psychosis, history of or
- Vitamin A overdose (too much vitamin A in your body)—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
