Zoliflodacin

Zoliflodacin is used to treat gonorrhea (an infection passed along by sexual contact). Zoliflodacin is in a class of medications called antibacterials. It works by stopping the growth of bacteria.

Zoliflodacin comes as granules to mix with water and take by mouth. Take once as a single dose. If you weigh less than 50 kg (110 lbs), take zoliflodacin on an empty stomach, 1 hour before eating or 2 hours after eating. If you weigh 50 kg (110 lbs) or more, take with food.

Zoliflodacin granules must be mixed with water before taking; do not take the dry granules. Do not mix with other liquids or sprinkle on food. Follow the instructions for mixing carefully.

Take zoliflodacin exactly as directed. Do not take more or less of it than prescribed by your doctor.

To mix zoliflodacin granules, follow these steps:

1. Pour drinking water into the mixing container and fill to the 60 mL line.
2. Shake the packet to move the granules to the bottom of the packet. Cut along the line on the packet with scissors.
3. Add the entire contents of the packet into the mixing container of water.
4. Twist the lid of the container to the right to close and shake well for 60 seconds. Shake until the mixture does not have any clumps.
5. Remove the lid and drink the mixture within 15 minutes after preparation
6. Some medicine will remain in the container. Repeat adding 60mL of water and shaking for 60 seconds.
7. Drink all of the second mixture.

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 zoliflodacin,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with zoliflodacin. Other medications may cause dosing changes or extra monitoring when taken with zoliflodacin. Make sure you have discussed any medications you are currently taking or plan to take before taking zoliflodacin with your doctor and pharmacist.
• tell your doctor if you have or have ever had any medical conditions.
• tell your doctor if you or your partner are pregnant or plan to become pregnant. You may have to take a pregnancy test before starting treatment. Men with female partners should use effective birth control to prevent pregnancy for at least 3 months after your dose. Talk to your doctor about what birth control would work best for you and your partner. If you or your partner become pregnant after taking zoliflodacin, call your doctor immediately. Zoliflodacin may harm the fetus.
• tell your doctor if you are breastfeeding.
• you should know that zoliflodacin may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

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

• headache
• dizziness
• nausea
• diarrhea

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

• itching, rash,
• severe diarrhea (frequent, watery, bloody stools) or stomach cramps for up to 2 months after taking this medication

Zoliflodacin 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). Do not freeze.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all appointments with your doctor and the laboratory.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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