Description
Oteseconazole is used to reduce the risk of fungal or yeast infections, including vulvovaginal candidiasis that keeps coming back in female patients who are unable to get pregnant with a history of vulvovaginal candidiasis. It may be used alone or together with other medicine (eg, fluconazole). This medicine works by killing the fungus or yeast, or preventing its growth.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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
Use of oteseconazole in pre-teen females who have started their menstrual period is not recommended. Safety and efficacy have not been established in pre-teen females who have not started their menstrual period.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oteseconazole 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. 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.
- Alpelisib
- Seladelpar
- Talazoparib
- Topotecan
- Ubrogepant
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:
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
Proper Use
Take this medicine exactly 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.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Swallow the capsule whole. Do not chew, crush, dissolve, or open it.
It is best to take this medicine with food.
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 (capsules):
- For vulvovaginal candidiasis (Vivjoa™ only):
- Adults and pre-teen females who have started their menstrual period—600 milligrams (mg) taken as a single dose on Day 1, followed by 450 mg taken as a single dose on Day 2. Then, 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 to 12) on Day 14.
- Pre-teen females who have started their menstrual period—Use is not recommended.
- Children—Use and dose must be determined by your doctor.
- For vulvovaginal candidiasis (Vivjoa™ and fluconazole):
- Adults and pre-teen females who have started their menstrual period—150 milligrams (mg) once a day on Days 1, 4, and 7. Followed by, 150 mg once a day for 7 days on Days 14 to 20. Then, 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 to 14) on Day 28.
- Pre-teen females who have started their menstrual period—Use is not recommended.
- Children—Use and dose must be determined by your doctor.
- For vulvovaginal candidiasis (Vivjoa™ only):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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 important that your doctor check your progress at regular visits to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
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:
Less common
- Burning while urinating
- difficult or painful urination
- heavy non menstrual vaginal bleeding
- hot flush
- longer or heavier menstrual periods
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
- Headache, severe and throbbing
Less common
- Acid or sour stomach
- belching
- heartburn
- indigestion
- nausea
- stomach discomfort, upset, or pain
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.
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