Correctly identifying contraindications and adjusting medication strategies based on different physiological states are key to ensuring the safe use of Zoliflodacin.

I. Absolute Contraindications

1. Hypersensitivity to any component of this product

(1) Patients with known hypersensitivity to Zoliflodacin or any of its excipients (such as colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, etc.) are prohibited from using this product.

(2) If you have previously experienced severe rash, pruritus, or anaphylactic shock with other antibacterial agents, you must proactively inform your physician so that a professional cross-sensitivity risk assessment can be performed.

2. Concurrent use of specific enzyme inducers

(1) This product is primarily metabolized by hepatic CYP3A4 enzymes. Concomitant use of moderate to strong CYP3A4 inducers such as rifampicin, efavirenz, phenytoin, carbamazepine, etc., will significantly accelerate the in vivo clearance of this product, leading to a substantial decrease in plasma concentrations, thereby weakening or abolishing the therapeutic effect.

(2) Therefore, this product should not be used during the administration of the above-mentioned drugs.

II. Use with Caution after Thorough Risk Assessment

1. Avoid use in pregnant women

(1) Animal studies have shown that administration of this product during the organogenesis period in pregnant animals resulted in fetal malformations and increased embryo-fetal loss.

(2) Although there are no human pregnancy data available, based on existing evidence, use during pregnancy should be avoided whenever possible.

(3) Women of childbearing potential must have a negative pregnancy test before starting treatment.

2. Weighing benefits and risks in breastfeeding women

(1) It is unknown whether this product is excreted in human milk.

(2) If used during lactation, it may theoretically affect the infant's intestinal flora.

(3) It is recommended that, under medical guidance, the decision to temporarily discontinue breastfeeding or choose an alternative regimen be made by considering the benefits of breastfeeding to the infant and the necessity of treatment to the mother.

3. Contraceptive requirements for men planning to conceive

Male patients with female partners of childbearing potential are advised to maintain effective contraception for at least 3 months after taking the medication to reduce potential embryo-fetal risks.

III. Special Age and Physiological Status Groups

1. Applicable for adolescents meeting weight criteria

(1) This product has been confirmed to be suitable for adolescent patients aged 12 years and older with a body weight of at least 35 kg.

(2) Based on adult clinical study data and pharmacokinetic simulations, exposure levels in this population are comparable to those in adults, and no dose adjustment is required.

2. Not applicable for underweight or younger children

(1) For children under 12 years of age or weighing less than 35 kg, the safety and efficacy of this product have not been established and should not be used.

(2) Parents should not administer this drug to children on their own; alternative treatment options appropriate for that age group should be sought.

3. Limited data in elderly patients

(1) The number of elderly patients aged 65 years and older enrolled in clinical trials was insufficient to determine whether their response differs from that of younger patients.

(2) If elderly patients truly require this medication, they should be closely monitored under the guidance of an experienced physician, with preparations for adverse reaction surveillance in place.