New Drug : XEPI (ozenoxacin)

:

Xepi 

(ozenoxacin)

Xepi Is Manufactured by: The Medimetricks

The Approbation Status: Approved In December 2017

Additional treatments: Impetige

Therapeutic Use: Dermatology and infectious diseases 

• Information About Xepi (ozenoxacin) :

Xepi (ozenoxacin) is an antimicrobial-quinolone.

Xepi is primarily recommended in adult and pediatric patients aged 2 months or older for the prevention of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Xepi shall be supplied as a topical administration ointment. Topically add a thin layer of Xepi to the infected area twice daily for 5 days. For adult and pediatric patients aged 12 years and older, or 2 percent of the total body surface region, the affected region can be up to 100 cm2 and not exceed 100 cm2 for pediatric patients aged less than 12 years. 

• XEPI Drug For ?

XEPI is a drug used to treat impetigo caused by certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients Two months of age and older.

Impetigo is a infectious bacterial infection of the skin that occurs mainly in infants. 

• How To Use ?

XEPI's a cream thing. Apply twice daily for 5 days in a thin layer to the areas of the skin where the impetigo is present. 

• Benefits of XEPI :

Most patients diagnosed with XEPI improved impetigo signs and symptoms and didn't need extra antimicrobial treatment relative to those infected with placebo cream. 

• Clinical Results of XEPI :

FDA Approval

Xepi FDA clearance was based on two multi-center, randomised, double-blind , placebo-controlled clinical trials performed in 723 participants two months of age and older with an impaired body surface area of up to 100 cm2 and randomized to Xepi or placebo for participants 2 months to 11 years of age not reaching 2 per cent. Subjects administered Xepi or placebo twice daily for a duration of 5 days.Subjects of active skin illness, skin inflammation, clinical proof of secondary infection, or chronic signs and symptoms of infection ( fever) have been removed from these trials. In both trials, Xepi showed dominance over placebo over pre-specified clinical and bacteriological endpoints when administered topically twice everyday for 5 days. Bacterial performance, described as bacterial eradication or presumed eradication, was observed in 90.8 percent of patients receiving Xepi compared with 69.8 percent of patients receiving placebo (p<0.0001) at the conclusion of therapy. Xepi was found to have outstanding antibacterial activity against s. Aureus and s, guy. Pyogens, including s-resistant methicillin. Aureus, MRSA. .

• XEPI Side Effects

The negative effects correlated with the use of Xepi can involve, but are not limited to:

• Rosacea were
• Seborrheic skin dermatitis

Adverse reactions (rosacea and seborrheic dermatitis) have been reported in 1 adult patient treated with XEPI who reported dermatitis during trials. 

• Mechanism of Action:

Xepi is an antifungal quinolone (ozenoxacin). The mechanism of action involves bacterial DNA enzyme, DNA gyrase A and topoisomerase IV inhibitors. Ozenoxacin against the aureus and pyogenes organism have been demonstrated to be bactericidal.