Qupet 1% Cream contains Ozenoxacin, a quinolone antibiotic medicine. It works by inhibiting the protein synthesis responsible for bacterial cell growth. Thus, it kills the bacteria and treats bacterial infections. It is mainly caused by organisms such as Staphylococcus aureus or Streptococcus pyogenes.
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Qupet is indicated for the topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients aged 2 months and older.
Ozenoxacin is a quinolone-class antibacterial agent that exerts its bactericidal activity by inhibiting bacterial DNA synthesis. It specifically targets DNA gyrase A and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, and repair. Ozenoxacin demonstrates potent bactericidal activity against S. aureus and S. pyogenes.
Pharmacokinetic evaluations involving 110 subjects assessed systemic absorption using various strengths of ozenoxacin cream, including concentrations up to 2% (twice the marketed strength). Studies included both healthy volunteers and patients with impetigo, with single or repeated applications of up to 1 g of cream over intact or abraded skin (up to 200 cm²).
No measurable systemic absorption was detected in 84 out of 86 participants
Minimal absorption at the limit of detection (0.489 ng/mL) was observed in only 2 subjects
Ozenoxacin exhibits moderate plasma protein binding (approximately 80–85%), which appears independent of drug concentration. Due to negligible systemic exposure, tissue distribution studies in humans have not been conducted.
The drug is not metabolized by human skin and undergoes only minimal hepatic metabolism, as demonstrated in studies using human hepatocytes.
Excretion pathways in humans have not been studied, as systemic absorption following topical use is clinically insignificant.
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
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
Clinical studies included limited numbers of patients aged ≥65 years
Available data do not suggest differences in efficacy or safety compared to younger adults
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
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
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
Prolonged use may result in overgrowth of non-susceptible bacteria or fungi
If secondary infection occurs, discontinue therapy and initiate appropriate treatment
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
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