OZEPRO 1% Cream 5gm

INTRODUCTION

OZEPRO 1% CREAM contains Ozenoxacin which belongs to the group of medicines called Antibiotics. It is used to treat topical impetigo in adults and children aged 2 months and above.

Impetigo is a superficial skin infection mainly affects the infants and children. Symptoms include red sores on the face, nose, mouth or on the arms and legs.

Before applying OZEPRO 1% CREAM, inform your doctor if you have bacterial or fungal infections, contact dermatitis. Consult your doctor for advice.

There is no information on the use of the OZEPRO 1% CREAM in pregnancy. Contact your doctor before applying. OZEPRO 1% CREAM should be used with caution in breastfeeding women as it is not known whether it may pass through the breast milk. Contact your doctor before applying.

OZEPRO 1% CREAM should be used with caution in children aged 2 months to 17 years of age. Contact your doctor before applying.

OZEPRO 1% CREAM should be used with caution in elderly patients (aged above 65 years). Contact your doctor before applying.

The most common side effects of this medicine are irritation and itching at the application site, rosacea and seborrheic dermatitis. Contact your physician if the side effects worsen.

USES OF OZEPRO 1% CREAM

• Used to treat impetigo

HOW OZEPRO 1% CREAM WORKS

OZEPRO 1% CREAM works by inhibiting the bacterial DNA replication enzymes and prevents the bacteria from multiplying, thereby works against the bacteria and reduces the skin infection.

DIRECTIONS FOR USE

Apply OZEPRO 1% CREAM as directed by your physician. It is for external use only. Wash your hands with soap and water and apply a thin layer of the medicine to the affected area of the skin and rub it gently.  

SIDE EFFECTS OF OZEPRO 1% CREAM

HOW TO MANAGE SIDE EFFECTS

Itchy skin:

Avoid hot showers because hot water can irritate the skin. Do not scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the itching worsens.

WARNING & PRECAUTIONS

PREGNANCY

OZEPRO 1% CREAM should be used with caution in pregnancy. Contact your doctor before applying.

BREASTFEEDING

OZEPRO 1% CREAM should be used with caution in breastfeeding women as it is not known whether it may pass through the breast milk. Contact your doctor before applying.

DRIVING AND USING MACHINES

OZEPRO 1% CREAM has no effect on the ability to drive or operate machines.

LIVER

OZEPRO 1% CREAM should be used with caution in in pre-term and full-term jaundiced neonates. Contact your doctor before applying.

ALLERGY

Do not use OZEPRO 1% CREAM if you are allergic to Ozenoxacin, or to any other ingredients of this medicine.

INTERACTIONS

A. Drug-Drug interactions:

Tell your doctor if you are applying or have recently taken any other medicines, including medicines obtained without a prescription, vitamin supplement or herbal products such as:

• ciprofloxacin (medicine used for bacterial infections)

Overdosage:

If you or anyone else accidentally uses too much of OZEPRO 1% CREAM or if you or a child accidentally swallow the medicine, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store OZEPRO 1% CREAM below 30°C

FAQs ABOUT OZEPRO 1% CREAM

What OZEPRO 1% CREAM is and what it is used for?

OZEPRO 1% CREAM contains Ozenoxacin which belongs to the group of medicines called Quinolone antibiotics. It is used for treating topical impetigo in adults and children aged 2 months and above.

Where do you apply OZEPRO 1% CREAM?

OZEPRO 1% CREAM is usually applied to affected skin. Do not apply on the eyes, nose, mouth and mucous membrane.

How OZEPRO 1% CREAM works?

OZEPRO 1% CREAM works by inhibiting the bacterial DNA replication enzymes and prevents the bacteria from multiplying, thereby works against the bacteria and reducing the skin infection.

What is impetigo?

Impetigo is a superficial skin infection mainly affects the infants and children. Symptoms include red sores on the face, nose, mouth or on the arms and legs.

What are the side effects of applying OZEPRO 1% CREAM?

The most common side effects of this medicine are irritation and itching at application site, rosacea and seborrheic dermatitis. Contact your physician if the side effects worsen.

REFERENCES

1. Barbara G. Wells, Joseph T. Dipiro, Terry L. Schwinghammer, Cecily V. Dipiro. Skin and soft tissue infections. Pharmacotherapy Handbook. 9th edition. 2015. Page- 448.

2. Antonio Torreloa, Ramon Grimalt, Xavier Masramon Nuria Albareda Lopez Ilonka Zsolt. Ozenoxacin a new effective and safe topical treatment for impetigo in children and adolescents. Karger Dermatology. 2020. [Accessed on August 2nd 2022] https://www.karger.com/Article/Fulltext/504536

3. Ferrer Internacional, S.A. Health Products Regulatory Authority (HPRA). [Revised in July 2018] [Accessed on August 2nd 2022] https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1744-003-001_24072018095036.pdf

4. Teligent Pharma, Inc. U.S. Food & Drug Administration. [Revised in December 2017] [Accessed on August 2nd 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208945lbl.pdf

5. Ferrer Internacional, S.A. Ozenoxacin. [Revised in May 2017] [Accessed on August 2nd 2022] https://www.cipherpharma.com/wp-content/uploads/2017/12/Ozanex-PM-English.pdf

6. Ferrer Internacional, S.A. Ozenoxacin. [Revised in 2019] [Accessed on August 2nd 2022] https://www.xepicream.com/fileadmin/PageImages/PDF/Xepi_Prescribing_Information.pdf

AUTHOR DETAILS

Written By Dr. Janet.C, Pharm.D
Last updated on 29 Nov 2022 | 03:15 PM(IST)