Omadacycline

(oh mad" a sye' kleen)

Brand Name(s): Nuzyra^®

WHY is this medicine prescribed?

Omadacycline is used to treat infections caused by bacteria, including pneumonia and certain infections of the skin. Omadacycline is in a class of medications called tetracycline antibiotics. It works by preventing the growth and spread of bacteria.

Antibiotics such as omadacycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Omadacycline comes as a tablet to take by mouth. It is usually taken once a day for 7 to 14 days. Omadacycline should be taken on an empty stomach with water at least 4 hours after having any food or drinks. Then do not eat or drink anything, except water, for at least 2 hours (4 hours for any food or drink that is a dairy product) after taking this medication. Take omadacycline 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 omadacycline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take omadacycline until you finish the prescription, even if you feel better. If you stop taking omadacycline too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What SPECIAL PRECAUTIONS should I follow?

Before taking omadacycline,

• tell your doctor and pharmacist if you are allergic to omadacycline, doxycycline, minocycline, sarecycline, tetracycline, demeclocycline, any other medications, or any of the ingredients in omadacycline tablets. 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. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven) and bismuth subsalicylate. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• be aware that antacids containing magnesium, aluminum, or calcium and iron products interfere with omadacycline, making it less effective. Take omadacycline 4 hours before or after antacids, iron preparations, and vitamin products that contain iron.

• tell your doctor if you have or have ever had intracranial hypertension (pseudotumor cerebri; high pressure in the skull that may cause headaches, blurry or double vision, vision loss, and other symptoms).

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment. Talk to your doctor about the use of effective birth control while taking omadacycline. If you become pregnant while taking omadacycline, call your doctor immediately. Omadacycline can harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking omadacycline and for 4 days after your final dose.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Omadacycline may make your skin sensitive to sunlight. Tell your doctor right away if you get a sunburn.

• you should know that when omadacycline is used during pregnancy or in babies or children up to age 8, it can cause the teeth to become permanently stained or temporarily affect bone growth. Omadacycline should not be used in children under age 8 unless your doctor decides it is needed.

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?

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

• nausea
• vomiting
• diarrhea
• constipation
• difficulty falling asleep or staying asleep
• headache

Some side effects can be serious. If you experience any of these symptoms, stop taking omadacycline and call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• watery or bloody stools, stomach cramps, or fever during treatment or for up to two or more months after stopping treatment
• severe headache, blurred vision, seeing double, or loss of vision

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 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. http://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 (http://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 and the laboratory. Your doctor may order certain lab tests to check your body's response to omadacycline.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the omadacycline, call 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: December 15, 2018.