Oteseconazole

WHY is this medicine prescribed?

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.

HOW should this medicine be used?

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.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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.

What should I know about STORAGE and DISPOSAL of 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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 20, 2024.