Overview:
Impetigo is a prevalent and contagious bacterial skin infection frequently attributed to Staphylococcus aureus and Streptococcus pyogenes. With its prevalence and impact on individuals, finding effective treatment options is crucial. Ozenoxacin, a topical antibiotic, has emerged as a promising therapeutic agent for impetigo. This article aims to provide an overview of Ozenoxacin, its mechanism of action, clinical efficacy, safety profile, and potential implications in the management of impetigo. This article will delve into the clinical evidence supporting the efficacy and safety of Ozenoxacin in treating impetigo, as well as explore potential considerations such as dosing, drug interactions, and long-term use. By examining the available data and insights, healthcare professionals can comprehensively understand Ozenoxacin's role and impact on impetigo management.
Drug Group:
Ozenoxacin belongs to the class of drugs known as quinolone antibiotics.
Available Doses and Dosage Forms:
Ozenoxacin is topical, specifically as a cream or ointment for external use. Available in one percent strength. Ozenoxacin is available in tubes of 10, 30, and 45 grams. The cream itself is pale yellow. The cream contains 10 mg (milligrams) of Ozenoxacin per gram.
For Patients:
What Is Impetigo?
Impetigo is a highly spreading bacterial skin infection that primarily affects children but can occur in individuals of all ages. Bacteria Staphylococcus aureus or Streptococcus pyogenes (also known as group A streptococcus) are responsible for causing impetigo. Impetigo typically develops when the bacteria enter the skin through a cut, insect bite, or other skin integrity break. The main characteristic of impetigo is the formation of red sores or blisters on the skin, which may be itchy and uncomfortable. These sores can break open and ooze fluid, forming a yellowish-brown crust. The infection is commonly found around the mouth and nose but can occur in any body area exposed to the bacteria.
Impetigo spreads through an infected person's skin or personal items such as towels, clothing, or bedding. It can also spread by scratching the infected area and touching other body parts.
Common symptoms of impetigo include:
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Red sores or blisters, which may burst and develop a honey-colored crust.
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Itching and discomfort around the affected area.
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Swollen lymph nodes near the infected area.
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Fever in some cases, particularly with more severe or extensive infections.
Prompt treatment of impetigo is essential to prevent infection from spreading to others and speed up healing. Treatment typically involves topical antibiotics, such as ointments or creams containing medications like Mupirocin or Ozenoxacin. These are applied directly to the affected areas of the skin. In more severe cases, oral antibiotics may be prescribed if the infection does not respond to the topical treatments.
How Does Ozenoxacin Work?
Ozenoxacin is a topical antibiotic from the class of drugs known as quinolones. Ozenoxacin effectively inhibits the growth and proliferation of bacteria responsible for infections such as impetigo. Specifically, it targets bacteria's DNA (deoxyribonucleic acid) gyrase and topoisomerase IV enzymes. By interfering with these enzymes, Ozenoxacin disrupts the replication and repair of bacterial DNA. This disruption prevents the bacteria from multiplying effectively and repairing their DNA, ultimately leading to their death or growth inhibition. Ozenoxacin is typically formulated as a cream or ointment for topical application. This allows direct application to the affected skin area, ensuring targeted medication delivery. Applying Ozenoxacin directly to the site of infection can effectively combat the bacteria responsible for impetigo while minimizing systemic absorption and potential side effects.
What Is the Dosage of Ozenoxacin?
Ozenoxacin is a topical cream or ointment with one percent strength for external use.
How Effective Is Ozenoxacin?
Ozenoxacin has effectively treated certain bacterial skin infections, such as impetigo. Clinical studies have shown that Ozenoxacin effectively targets the bacteria causing the infection, alleviates symptoms, and supports the healing process of the affected skin. The effectiveness of Ozenoxacin can vary depending on factors such as the specific bacteria involved, the severity of the infection, and individual patient factors. To achieve the best possible outcomes, it is crucial to adhere to the prescribed treatment regimen and complete the entire course of Ozenoxacin medication as directed by the healthcare provider.
What Are the Things to Inform the Doctor Before Taking the Drug?
Before using Ozenoxacin:
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Inform the doctor and pharmacist if there is a history of allergies to Ozenoxacin, other medications, or ingredients in Ozenoxacin cream.
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Notify the doctor and pharmacist about any prescription and non-prescription medications, vitamin tablets, nutritional supplements, or herbal products the patient is taking or planning to take.
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Discuss with the doctor if the patient is pregnant, planning to become pregnant, or breastfeeding. If the patient is pregnant using Ozenoxacin, contact the doctor for further guidance.
How Is Ozenoxacin Administered?
Following are the instructions for the usage:
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Use Ozenoxacin only on the skin.
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Before the application of cream, clean and dry the affected area.
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Apply a thin layer of cream to the affected area as directed by the doctor, usually twice a day.
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Cover the treated area with a bandage or gauze if the doctor instructs.
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After applying the medication, remember to wash your hands unless you treat an area on the hands.
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Avoid applying this medication around the eyes, nose, mouth, or inside the vagina. If it accidentally comes into contact with any of these areas, wipe off the cream and rinse thoroughly with plenty of water.
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Unless instructed otherwise by the doctor, avoid applying Ozenoxacin on large areas of the skin.
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Use this medication regularly to maximize its benefits.
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Continue using it for the prescribed duration, even if the symptoms improve within a few days.
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Avoid stopping the medication too early, as this may result in a recurrence of the infection.
What Are the Side Effects of Ozenoxacin?
It is important to remember that the doctor should prescribe Ozenoxacin because it is essential to determine that the benefits outweigh the potential risks of side effects. While serious side effects are rare, they are uncommon among most individuals using this medication.
Prolonged or repeated use of this medication may lead to a new skin infection caused by fungi, yeast, or other bacteria. If there are signs of a new infection, or if the current infection does not improve or worsens, promptly notify the doctor.
Although rare, a severe allergic reaction to this drug may occur. Seek immediate medical assistance if there are symptoms of a severe allergic reaction, such as rash on the skin, itching/swelling (on the face/tongue/throat), severe dizziness, or breathing problems.
Dietary Considerations:
No dietary modifications are required unless advised by the doctor.
Missed Dose:
If someone needs to forget a dose, apply it immediately. However, if it is close to the time for the next scheduled dose, skip the missed dose and stick to the regular dosing routine. It is essential to avoid applying extra cream to compensate for a missed dose.
Overdose:
If any signs or symptoms of an overdose occur, whether through topical application or accidental ingestion, treating the symptoms based on their presentation is recommended. Currently, there is no known specific antidote for Ozenoxacin overdose. Seeking medical assistance is advised in such cases.
Storage:
Store the medication at 20 degrees Celcius to 25 degrees Celcius (68 to 77 degrees Fahrenheit). Excursions outside this range, between 15 degrees Celcius and 30 degrees Celcius (59 to 86 degrees Fahrenheit), are permitted.
For Doctors:
Indication:
Ozenoxacin cream is prescribed for topical impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in patients at least two months old, including adults and pediatric patients.
Dose:
For the treatment, apply a thin layer of cream topically to the affected area twice daily for five days. In adult and pediatric patients twelve years and older, the affected area may be up to 100 cm2 (centimeter square) or two percent of the total body surface area, whichever is less. For pediatric (children) patients younger than 12 years of age, the affected area should not exceed 100 cm2.
Dosing Considerations:
No specific dosing considerations.
What Are the Pharmacological Aspects of Ozenoxacin?
1. Pharmacodynamics: Although the exposure-response relationship for Ozenoxacin after topical application has yet to be specifically studied, it is doubtful to exist due to the negligible systemic exposure following topical application.
2. Mechanism: Ozenoxacin, the active ingredient in Ozenoxacin cream, works by inhibiting DNA (Deoxyribonucleic acid) gyrase and topoisomerase IV enzymes in bacteria, preventing their replication and growth. It primarily targets gram-positive bacteria, including those commonly associated with impetigo. Ozenoxacin cream delivers Ozenoxacin directly to the affected skin area, providing localized treatment without significant systemic absorption.
3. Pharmacokinetics:
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Absorption: Four pharmacokinetic studies were conducted involving 110 patients who used Ozenoxacin cream at varying strengths, including up to two percent concentration (twice the strength of the marketed formulation). Three studies evaluated systemic absorption in healthy individuals and those with impetigo. During these studies, either a single or repeated application of up to one gram of Ozenoxacin cream was administered to intact or abraded skin, covering an area of up to 200 cm2. In 84 out of 86 subjects, no systemic absorption was observed. In two subjects, minimal systemic absorption was detected at 0.489 ng/mL (nanogram per milliliter).
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Distribution: The binding of [14C]- Ozenoxacin to plasma proteins was moderate, ranging from approximately 80 percent to 85 percent, and appeared independent of the concentration. Since clinical studies demonstrated negligible systemic absorption, investigations into human tissue distribution have yet to be conducted.
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Metabolism: Ozenoxacin demonstrated no significant metabolism when exposed to fresh human skin discs, and minimal metabolism was observed in human hepatocytes.
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Excretion: Human excretion studies have yet to be conducted due to the minimal systemic absorption observed in clinical studies.
Toxicity:
Long-term animal studies to assess the potential carcinogenic effects of Ozenoxacin have yet to be conducted. Ozenoxacin showed no genotoxicity in vitro when tested for gene mutation and chromosomal effects in the Ames test and mouse lymphoma cell assay. Additionally, no genotoxic effects were observed in an in vivo rat micronucleus test, demonstrating systemic exposure. In oral administration studies, male and female rats treated with Ozenoxacin doses up to 500 mg/kg/day (milligrams per kilogram of body weight per day), which is approximately 8500 and 16,000 times, respectively, the maximum human plasma concentration observed with the application of Ozenoxacin one percent cream, did not experience any adverse effects on mating or fertility.
Clinical Studies:
The safety and effectiveness of Ozenoxacin for treating impetigo were assessed in two double-blind, placebo-controlled clinical trials (Trial 1, NCT01397461, and Trial 2, NCT02090764). 723 subjects aged two months and older, with an affected body surface area of up to hundreds cm2 (not exceeding two percent for subjects aged two months to 11 years), were randomly assigned to receive either Ozenoxacin or a placebo. The treatment involved applying Ozenoxacin or the placebo twice daily for five days. Subjects with underlying skin conditions, skin trauma, evidence of secondary infection, or systemic signs and any symptoms of infection were excluded from the studies.
The clinical success of the treatment was evaluated based on the absence or reduction of clinical signs and symptoms at the end of therapy (days six to seven). These included the absence of exudates or pus, crusting, tissue warmth, and pain, as well as mild or improved erythema or inflammation and the absence of blistering, itching or pain, and crusting. In Trial 1, Ozenoxacin achieved clinical success in 34.8 percent of subjects compared to 19.2 percent in the placebo group. In Trial 2, the success rates were 54.4 percent for Ozenoxacin and 37.9 percent for the placebo. These differences in success rates between Ozenoxacin and placebo were statistically significant (p = 0.002 and p = 0.001 for Study 1 and Study 2, respectively).
The most commonly identified bacteria in the study were S. aureus and S. pyogenes. In subjects with baseline presence of S. aureus or S. pyogenes, Ozenoxacin demonstrated clinical success rates of 37.6 percent and 39.7 percent, respectively, in Trial 1. In Trial 2, the success rates for Ozenoxacin were 57.4 percent for S. aureus and 78.9 percent for S. pyogenes. The corresponding success rates for the placebo group were lower in all cases.
Overall, the results from these trials support the effectiveness of Ozenoxacin in achieving clinical success in treating impetigo, particularly against S. aureus and S. pyogenes infections.
Warnings and Precautions:
Extended use of Ozenoxacin cream has the potential to lead to the growth of bacteria and fungi that are not susceptible to its effects. If such infections occur during treatment, it is advised to discontinue the use of Ozenoxacin and implement suitable supportive measures.
What Are the Drug Interactions of Ozenoxacin?
It is essential to be aware that drug interactions can impact the effectiveness of the medications or potentially increase the risk of severe side effects. This information may not cover all possible drug interactions. A thorough record of all the products the patient might use is recommended. This includes prescription and non-prescription drugs and herbal products and shares it with the healthcare provider and pharmacist. Any changes to the medication regimen should only be made with the doctor's approval. It is better to only start, stop, or alter the dosage of any medicines with proper medical guidance.
Specific Considerations:
Pregnancy: There is a lack of data on using Ozenoxacin in pregnant women. However, due to the negligible systemic absorption of Ozenoxacin following topical application, it is unlikely that maternal use of Ozenoxacin will result in fetal exposure to the drug. Animal studies with oral Ozenoxacin did not show significant adverse effects on fetal development.
Lactation: No information is available regarding the presence of Ozenoxacin in human milk. However, the negligible systemic absorption of Ozenoxacin suggests that breastfeeding is unlikely to result in the exposure of the infant to Ozenoxacin. The benefits of breastfeeding and the clinical need for Ozenoxacin should be considered.
Pediatric Use: Ozenoxacin is safe and effective in pediatric patients aged two months to 17 years, based on adequate and well-controlled studies. The safety profile of Ozenoxacin in pediatric patients is comparable to that observed in adults. The use of Ozenoxacin in pediatric patients younger than two months of age has yet to be established.
Geriatric Use: Due to the limited number of subjects aged 65 and older included in clinical studies, it is unknown if there are any differences in the response to Ozenoxacin compared to younger subjects. However, no notable differences in responses between the elderly and younger patients have been reported in other clinical experiences.
