Gepotidacin

Gepotidacin is an antibiotic used to treat urinary tract infections caused by specific bacteria in females who are at least 12 years old and weigh at least 88 lbs (40 kg).

Your doctor will do tests to confirm that gepotidacin is the right treatment for you.

Gepotidacin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each gepotidacin dose is usually taken twice per day (about 12 hours apart) for 5 days. You should take 2 tablets for your full dose.

Take after a meal to lower the chances of gepotidacin upsetting your stomach.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Gepotidacin will not treat a viral infection (flu or a common cold).

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

You may need medical tests to check your heart function.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have any allergies.

You should not use gepotidacin if you are allergic to it.

Tell your doctor if you have or have ever had:

• a heart rhythm disorder like slow heartbeats or long QT syndrome (in you or a family member) or if you take heart rhythm medication;
• a heart attack;
• low levels of potassium in your blood;
• a planned surgery or a medical procedure;
• diarrhea caused by infection; or
• severe liver or kidney disease (or if you are on dialysis).

It is not known if gepotidacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gepotidacin on the baby.

Ask a doctor if it is safe to breastfeed while using gepotidacin.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may feel faint while taking gepotidacin. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Gepotidacin may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• fainting, muscle spasm, trouble speaking, shortness of breath, increased salivation or sweating, irregular heartbeats, seizures;
• severe nausea and vomiting; or
• bronchospasm (wheezing, chest tightness, trouble breathing).

Common side effects of gepotidacin may include:

• nausea, vomiting, diarrhea or soft stools;
• stomach pain, gas;
• headache, dizziness; or
• yeast infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Urinary Tract Infection:

Females weighing at least 40 kg: 1500 mg orally twice a day (about 12 hours apart) for 5 daysComments:-To reduce the development of drug-resistant bacteria and maintain effectiveness, use this drug only for proven or strongly suspected infections caused by susceptible bacteria.-Select or modify antibacterial therapy based on culture and susceptibility data. If unavailable, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.Use: For the treatment of female patients weighing least 40 kg with uncomplicated urinary tract infections caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis

Usual Pediatric Dose for Urinary Tract Infection:

Females 12 years or older: -Weight at least 40 kg: 1500 mg orally twice a day (about 12 hours apart) for 5 daysComments:-To reduce the development of drug-resistant bacteria and maintain effectiveness, use this drug only for proven or strongly suspected infections caused by susceptible bacteria.-Select or modify antibacterial therapy based on culture and susceptibility data. If unavailable, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.Use: For the treatment of female patients weighing least 40 kg with uncomplicated urinary tract infections caused by the following susceptible microorganisms: E coli, K pneumoniae, C freundii complex, S saprophyticus, and E faecalis

If you forget to take a dose, take it as soon as you remember. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines work less effectively.

Gepotidacin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems (such as heart rhythm), high blood pressure, depression, mental illness, cancer, malaria, or HIV.

This list is not complete. Other drugs may affect gepotidacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.