Oteseconazole

Oteseconazole is used to reduce the number of recurrent vaginal yeast infections in women who are not able to become pregnant. This includes women who are postmenopausal (women who have experienced a change of life; end of menstrual periods) and women who have had surgery to remove their uterus and/or both ovaries or have had a tubal ligation ('tubes tied,' surgery to prevent pregnancy). Oteseconazole is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Oteseconazole comes as a capsule to take by mouth with food. It is usually taken as 4 capsules at one time on day 1, then as 3 capsules at one time on day 2, and then as 1 capsule once a week starting on day 14 for 11 weeks. Oteseconazole may also be taken as 1 capsule once daily for 7 days in a row, followed by 1 capsule once a week starting on day 15 for 11 weeks. Take oteseconazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oteseconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, dissolve, or crush them.

Take oteseconazole until you finish the prescription, even if you feel better. Do not stop taking oteseconazole without talking to your doctor. If you stop taking oteseconazole too soon or skip doses, your infection may come back after a short time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking oteseconazole,

• tell your doctor and pharmacist if you are allergic to oteseconazole, any other medications, or any of the ingredients in oteseconazole capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Oteseconazole should not be taken by patients who are pregnant or who may become pregnant or who are breast-feeding. Oteseconazole may harm the baby if it is used by women who are pregnant or are breastfeeding. If you become pregnant while taking oteseconazole, call your doctor immediately.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Oteseconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• indigestion
• hot flushes

Oteseconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vivjoa^®