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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 modafinil in children below 16 years of age. Safety and efficacy have not been established .
Geriatric
Although appropriate studies on the relationship of age to the effects of modafinil have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of modafinil in the elderly. However, elderly patients may have a slower removal of this medicine from the body, which may require an adjustment of dosage in patients receiving modafinil .
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
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.
- Tolvaptan
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clomipramine
- Cyclosporine
- Desogestrel
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Levonorgestrel
- Mestranol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Triazolam
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.
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:
- Angina (severe chest pain), recent or
- Heart disease or
- Heart attack, recent or
- High blood pressure—Use with caution. It is not known how modafinil will affect these conditions .
- Drug abuse or dependence, history of—Dependence may be more likely to develop .
- Heart problems during the use of other central nervous system (CNS) stimulating medicines, history of—Similar problems may occur when you use modafinil.
- Kidney disease, severe—Higher blood levels of a breakdown product of modafinil may occur. It is not known if this will cause any problems.
- Liver disease, severe—Higher blood levels of modafinil may occur, increasing the chance of having unwanted effects. You will probably receive a lower dose than a patient without liver disease.
- Severe mental illness, history of—Modafinil may cause the illness to return.
