Description
Oveporexton is used to treat narcolepsy type 1 (narcolepsy with cataplexy). Narcolepsy is uncontrollable desire for sleep or a sudden attack of deep sleep. Cataplexy is a sudden onset of muscle weakness.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 oveporexton in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oveporexton in the elderly.
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
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Insomnia (trouble sleeping) or
- Overactive bladder, history of—Use with caution. May make these conditions worse.
- Kidney disease, mild to moderate or
- Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food at the same time each day.
Swallow the table whole with water. Do not chew, crush, or split it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For narcolepsy type 1:
- Adults—1 or 2 milligrams (mg) when you wake up, then 1 or 2 mg 3 to 5 hours later. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For narcolepsy type 1:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine together with itraconazole (Sporanox®).
This medicine may increase your risk of insomnia (trouble sleeping). If your condition does not improve or if they get worse more than 7 days. Tell your doctor right away.
This medicine may cause bladder problems. Check with your doctor right away if you have increased need to urinate or passing urine more often.
This medicine may increase creatine phosphokinase. Tell your doctor right away if you have dark urine, unexplained muscle pain, or weakness, especially during vigorous physical activity or if you also take certain medicines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Chills
- cough
- diarrhea
- fever
- general feeling of discomfort or illness
- headache
- increased need to urinate
- joint pain
- loss of appetite
- muscle aches and pains
- passing urine more often
- runny nose
- shivering
- sore throat
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Increased watering of the mouth
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- pain in the mouth or throat
- stomach pain
Rare
- Skin rash
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011976
