Zoliflodacin is a novel oral antibacterial agent, with its indications precisely focused on specific types of infections.

I. Indication Scope

1. Applicable Infection Types

(1) Zoliflodacin is approved for the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae.

(2) "Uncomplicated" means that the infection is confined to the local urogenital tract, such as the urethra or cervix, without spreading to the blood or other tissues or organs, and without complications such as pelvic inflammatory disease or epididymitis.

2. Target Population

(1) It is indicated for adults and adolescent patients aged 12 years and older with a body weight of at least 35 kg.

(2) Both age and weight criteria must be met simultaneously; neither alone is sufficient.

II. Necessary Preparations Before Administration

1. Pregnancy Testing for Females of Childbearing Potential

(1) For women of childbearing potential, a pregnancy test must be performed before drug administration, and treatment may only commence after a negative result is confirmed.

(2) This precaution is based on embryotoxic effects observed in animal studies, and despite the lack of human data, it requires careful attention.

2. Screening for Concomitant Medication Contraindications

(1) Before treatment, patients should thoroughly inform their physician of all current medications, especially CYP3A4 enzyme inducers such as rifampicin, efavirenz, carbamazepine, and phenytoin.

(2) These drugs accelerate the metabolic clearance of zoliflodacin, leading to subtherapeutic plasma concentrations and potential treatment failure.

3. Inquiry About Allergy History

(1) Patients with a history of hypersensitivity to zoliflodacin or any of its excipients are strictly prohibited from using this product.

(2) If a patient has previously experienced severe rash, pruritus, or anaphylactic reactions to other antibacterial agents, this should also be disclosed to the physician for evaluation of cross‑sensitivity risk.

III. Important Precautions During and After Treatment

1. Strict Adherence to Preparation and Administration Instructions

(1) This product is an oral suspension granule and must be reconstituted with drinking water for oral administration.

(2) Do not use milk, fruit juice, or other liquids; do not swallow dry granules or sprinkle them on food.

(3) The reconstituted suspension must be consumed within 15 minutes, including the second rinse water, to ensure the full dose is ingested.

2. Timing of Dosing Based on Body Weight

(1) For patients weighing 35 kg to less than 50 kg: take on an empty stomach, i.e., at least 1 hour before a meal or 2 hours after a meal.

(2) For patients weighing 50 kg or more: take with food to optimize drug absorption.

3. Monitoring for Adverse Reaction Signals

After a single dose, seek medical attention promptly if any of the following occur: frequent watery or bloody diarrhea (which may indicate Clostridioides difficile infection and can occur up to two months after drug discontinuation); rash, pruritus, or facial swelling suggestive of allergic reactions; persistent severe headache or dizziness that interferes with daily activities.

4. Fertility‑Related Protective Measures

For male patients: if their partner is of childbearing potential, effective contraceptive measures must be used for at least 3 months after taking the drug.

5. Avoiding Misuse and Resistance Risk

(1) This product should only be used for confirmed bacterial infections.

(2) Misuse not only provides no benefit to the current condition but also accelerates the development of bacterial resistance, thereby undermining the future therapeutic efficacy of this agent and other related antibacterial drugs.