Qupet 1% Cream 10g Tube

✔️ Administration

Apply a thin layer of ozenoxacin cream to the affected area twice daily for 5 days

Maximum treatment area:

Adults and children ≥12 years: up to 100 cm²

Children <12 years: up to 2% of total body surface area, not exceeding 100 cm²

Wash your hands thoroughly after application

For topical use only

Not intended for oral, ophthalmic, intranasal, or intravaginal use

The treated area may be covered with a sterile gauze or bandage if necessary

Pediatric Use

Safety and efficacy have been established in children aged 2 months to 17 years

Clinical trials included 251 pediatric patients, with dosing up to 0.5 g applied twice daily for 5 days

Safety profile in pediatric patients was similar to that observed in adults

Use in infants younger than 2 months has not been established

Geriatric Use

Clinical studies included limited numbers of patients aged ≥65 years

Available data do not suggest differences in efficacy or safety compared to younger adults

✔️ Side Effects

In clinical trials involving 362 adult and pediatric patients (aged ≥2 months), Qupet was generally well tolerated.

Rare adverse reactions reported included rosacea and seborrheic dermatitis, each occurring in one adult patient

Overall adverse event rates were comparable to placebo and retapamulin ointment

✔️ Pregnancy & Lactation

Pregnancy

There are no adequate human data to assess the risk of ozenoxacin use during pregnancy

Systemic absorption following topical administration is negligible, and fetal exposure is not expected

Animal studies using oral ozenoxacin in pregnant rats and rabbits revealed no developmental toxicity, even at exposures exceeding 10,000 times the maximum human plasma concentration observed after topical use

Lactation

No data are available on the presence of ozenoxacin in human breast milk

Due to minimal systemic absorption, exposure of a breastfed infant is unlikely

The benefits of breastfeeding should be weighed against the mother’s clinical need for treatment

✔️ Precautions & Warnings

Prolonged use may result in overgrowth of non-susceptible bacteria or fungi

If secondary infection occurs, discontinue therapy and initiate appropriate treatment

✔️ Storage:

Store at 20°C–25°C (excursions permitted between 15°C and 30°C)

Protect from light and moisture

Keep out of reach of children