Usage
This combination medication is prescribed for topical treatment of superficial skin infections caused by bacteria and fungi, such as:
- Dermatophytosis (ringworm, athlete’s foot, jock itch)
- Bacterial skin infections (impetigo, infected eczema)
- Inflammatory skin conditions with secondary infections (e.g., eczema, dermatitis complicated by bacterial or fungal infection)
Pharmacological Classification:
This is a combination product containing:
- Corticosteroid (Mometasone) - Anti-inflammatory
- Quinolone antibiotic (Ofloxacin) - Antibacterial
- Nitroimidazole antibiotic (Ornidazole) - Antibacterial and antiprotozoal
- Allylamine antifungal (Terbinafine) - Antifungal
Mechanism of Action:
- Mometasone: Reduces inflammation by suppressing the release of inflammatory mediators.
- Ofloxacin: Inhibits bacterial DNA gyrase, essential for bacterial DNA replication.
- Ornidazole: Damages bacterial DNA and inhibits protein synthesis.
- Terbinafine: Inhibits squalene epoxidase, an enzyme in fungal cell membrane synthesis.
Alternate Names
- Mometasone/Ofloxacin/Ornidazole/Terbinafine
- Keto 4S Cream (brand name in some regions)
How It Works
Pharmacodynamics:
- Mometasone: Potent corticosteroid reducing inflammation by suppressing inflammatory mediators.
- Ofloxacin: Inhibits bacterial DNA gyrase, hindering DNA replication.
- Ornidazole: Damages bacterial DNA and inhibits protein synthesis, leading to bacterial cell death.
- Terbinafine: Inhibits squalene epoxidase, disrupting fungal cell membrane formation.
Pharmacokinetics:
Topical application limits systemic absorption. Minimal amounts of each drug may be absorbed systemically. Primarily eliminated through hepatic metabolism.
Mode of Action:
- Mometasone: Binds to glucocorticoid receptors, modulating gene expression and reducing inflammatory responses.
- Ofloxacin: Inhibits bacterial topoisomerase II (DNA gyrase) and topoisomerase IV.
- Ornidazole: Forms reactive metabolites that damage bacterial DNA.
- Terbinafine: Inhibits squalene epoxidase, leading to ergosterol depletion and fungal cell death.
Elimination Pathways:
Primarily hepatic metabolism for all four components, followed by excretion.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected area once or twice daily.
Children:
Not recommended for children under 12 years of age unless directed by a physician. Safety and efficacy have not been established in younger children.
Special Cases:
- Elderly Patients: Use with caution due to potentially increased systemic absorption.
- Patients with Renal Impairment: Use cautiously. Systemic absorption may necessitate dosage adjustment.
- Patients with Hepatic Dysfunction: Use cautiously. Systemic absorption may necessitate dosage adjustment.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes, adrenal gland disorders, or other skin conditions.
Clinical Use Cases
This medication is not indicated for systemic use and is not relevant to scenarios such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dosage adjustments should be made based on individual patient response and tolerability. Renal and hepatic impairment may necessitate dose reduction due to potential systemic absorption.
Side Effects
Common Side Effects
- Burning sensation
- Itching
- Redness
- Irritation at the application site
- Dry skin
Rare but Serious Side Effects
- Allergic reactions (rash, hives, swelling)
- Skin atrophy
- Telangiectasia
- Hypopigmentation
- Striae
Long-Term Effects
Prolonged use of topical corticosteroids can lead to skin thinning, striae, and telangiectasia.
Adverse Drug Reactions (ADR)
Severe allergic reactions require immediate medical attention.
Contraindications
- Hypersensitivity to any of the components
- Viral skin infections (herpes, varicella)
- Untreated parasitic infections
- Open wounds, deep cuts, scrapes (unless directed by a physician)
Drug Interactions
- Topical corticosteroids (e.g., betamethasone)
- Other antibiotics (e.g., gentamicin)
- Other antifungals (e.g., ketoconazole, clotrimazole)
Pregnancy and Breastfeeding
Consult a physician before use during pregnancy or breastfeeding.
Drug Profile Summary
- Mechanism of Action: See “Mechanism of Action” above.
- Side Effects: Burning, itching, redness, irritation, dryness; rarely: allergic reactions, skin atrophy, telangiectasia, hypopigmentation, striae.
- Contraindications: Hypersensitivity, viral skin infections, untreated parasitic infections, open wounds.
- Drug Interactions: Topical corticosteroids, other antibiotics, antifungals.
- Pregnancy & Breastfeeding: Consult physician.
- Dosage: Apply thin layer once or twice daily; adjust for renal/hepatic impairment.
- Monitoring Parameters: Monitor for local skin reactions and signs of systemic absorption.
Popular Combinations
This formulation itself is a popular combination, addressing mixed bacterial and fungal infections with concurrent inflammation.
Precautions
- General Precautions: Screen for allergies, metabolic disorders, organ dysfunction.
- Pregnant Women: Consult a physician before use.
- Breastfeeding Mothers: Consult a physician before use.
- Children & Elderly: Not recommended for children under 12; use with caution in the elderly due to increased systemic absorption.
- Lifestyle Considerations: Avoid alcohol consumption while using ornidazole.
FAQs (Frequently Asked Questions)
A: Apply a thin layer to the affected skin once or twice a day. Adjust dosage based on patient response and renal/hepatic function. Not recommended for children under 12.
Q2: What are the common side effects?
A: Common side effects include burning, itching, redness, irritation, and dry skin at the application site.
Q3: Can I use this cream during pregnancy?
A: Consult your doctor before using this cream if you are pregnant or breastfeeding.
Q4: What skin infections can this combination treat?
A: This cream treats dermatophytosis (ringworm, athlete’s foot, jock itch), bacterial infections (impetigo, infected eczema), and inflammatory skin conditions with secondary infections.
Q5: How long does it take for the cream to work?
A: The duration of treatment varies depending on the infection’s severity and individual response. Continue the full course as prescribed, even if symptoms improve.
Q6: Can this cream be used on open wounds?
A: No, do not apply this cream to open wounds, deep cuts, or scrapes unless specifically directed by your physician.
Q7: What should I do if the cream accidentally gets in my eyes?
A: Rinse your eyes thoroughly with water. If irritation persists, consult a doctor.
Q8: Are there any drug interactions I should be aware of?
A: Inform your doctor about all other medications you are using, including topical corticosteroids, antibiotics, and antifungals, to avoid potential interactions.
Q9: Can I use this cream if I have diabetes?
A: Use this medication with caution if you have diabetes, adrenal gland disorders, or other skin conditions. Consult your physician for guidance.
Q10: What is the role of each component in this combination?
A: Mometasone reduces inflammation, ofloxacin and ornidazole combat bacteria, and terbinafine targets fungal infections.
