Description
Gepotidacin is used to treat uncomplicated urinary tract infections (uUTI). Gepotidacin 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:
- Tablet
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 gepotidacin in children younger than 12 years of age or weighing less than 40 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 gepotidacin in the elderly. However, some elderly patients may be more sensitive to the effects of this medicine than younger adults and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bradycardia (slow heartbeat) or
- Heart attack, recent or
- Heart rhythm problems, including QT prolongation or
- Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Surgery or any medical procedure, planned—Use with caution. May increase risk for more serious side effects.
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. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine after a meal to help prevent stomach upset.
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 (tablets):
- For uncomplicated urinary tract infections:
- Adults and children 12 years of age and older weighing 40 kilograms (kg) or more—1500 milligrams (mg) or two 750 mg tablets 2 times a day (about 12 hours apart) for 5 days.
- Children younger than 12 years of age or weighing less than 40 kg—Use and dose must be determined by your doctor.
- For uncomplicated urinary tract infections:
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 while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause heart rhythm problems, including QT prolongation. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Contact your doctor right away if you have any of these symptoms or any questions.
Check with your doctor right away if you have diarrhea, fainting, increased sweating, increased watering of the mouth, muscle spasms, nausea, slurred speech, stomach pain, trouble speaking, or vomiting. These may be symptoms of cholinergic effects (increased acetylcholine in the nervous system).
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
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:
More common
- Diarrhea
- nausea
Less common
- Itching of the vagina or genitals
- soft feces
- stomach pain
- thick, white vaginal discharge with mild or no odor
- vomiting
Rare
- Changes in patterns and rhythms of speech
- difficulty in breathing or swallowing
- dizziness or lightheadedness
- fast, pounding, or irregular heartbeat or pulse
- feeling of constant movement of self or surroundings
- hot flush
- increased sweating
- muscle spasms
- sensation of spinning
- skin itching, rash, or redness
- slurred speech
- swelling of the face, throat, or tongue
- trouble in speaking
Incidence not known
- Chest tightness
- fainting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual tiredness or weakness
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:
Less common
- Bloated
- excess air or gas in the stomach or intestines
- full feeling
- headache
- passing gas
Rare
- Acid or sour stomach
- belching
- blurred vision
- heartburn
- indigestion
- stomach discomfort or upset
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-80003854
