Description
Zoliflodacin is used to treat a sexually transmitted disease called uncomplicated urogenital gonorrhea. Zoliflodacin works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
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
Appropriate studies have not been performed on the relationship of age to the effects of zoliflodacin in children younger than 12 years of age or weighing less than 35 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zoliflodacin 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
Proper Use
Take this medicine only 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.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
For patients weighing 50 kilograms (kg) or more: Take this medicine with food.
For patients weighing 35 kilograms (kg) to less than 50 kg: Take this medicine on an empty stomach, 1 hour before or 2 hours after a meal.
To use:
- Do not use if the packet or mixing container looks damaged.
- Do not take this medicine in the dry form. Always mix the granules with water before taking. Do not mix with other liquids or sprinkle on food.
- Wash and dry your hands before and after using this medicine.
- Pour 60 milliliters (mL) of drinking water into the container.
- Shake the packet. Carefully cut the packet along the line. Add the entire packet into the mixing container. Turn the lid clockwise to secure onto the mixing container. Shake the container for at least 60 seconds. The mixture should look cloudy. Do not stir or mix it in any other way. Continue shaking until all clumps are gone.
- Turn the lid counter-clockwise to remove it from the mixing container. Drink all of the mixture within 15 minutes of preparing. If it has been more than 15 minutes, do not take the mixture and prepare a new dose.
- Add another 60 mL of water into the container. Shake the mixture and drink it right away to make sure you get the full dose.
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.
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 (granules for suspension):
- For uncomplicated urogenital gonorrhea:
- Adults and children 12 years of age and older weighing 35 kilograms (kg) or more—3 grams (g) or 1 packet once a day.
- Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
- For uncomplicated urogenital gonorrhea:
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 very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are female and able to get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine together with efavirenz (Sustiva®) or rifampin (Rifadin®).
This medicine may decrease sperm count and may be harmful to testicles in some males and may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty in breathing or swallowing, fast heartbeat, skin itching, rash, or redness, or swelling of the face, throat, or tongue.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chills
- cough
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- hot flush
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- stomach cramps, pain, or tenderness
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- watery or bloody diarrhea
Incidence not known
- Difficulty in swallowing
- skin itching, rash, or redness
- swelling of the face, throat, or tongue
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
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
- dizziness
- general feeling of discomfort or illness
- lack or loss of strength
- loss or thinning of the hair
- muscle or joint pain
- nausea
- night sweat
- sleepiness
- swelling of the eyelid
- trouble sleeping
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.
DRG-80008586
