Usage
Ciclopirox + Fluocinolone acetonide is prescribed for the treatment of fungal skin infections, especially where inflammation, itching, and redness are also present. These infections can include Tinea pedis (athlete’s foot), Tinea cruris (jock itch), Tinea corporis (ringworm), cutaneous candidiasis, and seborrheic dermatitis complicated by fungal infection.
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Pharmacological Classification: This is a combination product containing a synthetic antifungal agent (ciclopirox) and a topical corticosteroid (fluocinolone acetonide).
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Mechanism of Action: Ciclopirox inhibits fungal growth by preventing the formation of the fungal cell’s protective covering. Fluocinolone acetonide reduces inflammation by suppressing the body’s inflammatory response, decreasing the migration of infection-fighting cells, reducing blood vessel dilation, and stabilizing cell membranes.
Alternate Names
No alternate generic names found. Several brand names exist (e.g., Flucort-C, others may vary regionally).
How It Works
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Pharmacodynamics: Ciclopirox disrupts fungal cell membrane synthesis, leading to fungal cell death. Fluocinolone acetonide, a corticosteroid, binds to glucocorticoid receptors, inhibiting inflammatory pathways and reducing symptoms like itching, redness, and swelling.
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Pharmacokinetics: Topical application results in minimal systemic absorption (around 1.3% for ciclopirox). The absorbed portion of fluocinolone acetonide is metabolized primarily in the liver and excreted by the kidneys. Ciclopirox metabolism and elimination are not well-defined for topical application.
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Mode of Action/Receptor Binding/Enzyme Inhibition: Ciclopirox chelates polyvalent cations (iron and aluminum), disrupting essential enzyme function within the fungal cell. Fluocinolone acetonide exerts its anti-inflammatory effects via glucocorticoid receptor binding.
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Elimination Pathways: For the small amount of fluocinolone acetonide absorbed systemically, hepatic metabolism and renal excretion are the primary pathways. Ciclopirox elimination after topical application is not well-characterized.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected area twice daily, usually morning and evening. Treatment duration depends on the infection type and severity, typically ranging from several weeks for Tinea infections to shorter durations for other conditions.
Children:
Use in children under 12 is generally not recommended, as safety and effectiveness have not been established. For certain conditions, such as scalp psoriasis, limited use in children 2 years and older might be considered under strict medical supervision with adjusted dosing.
Special Cases:
- Elderly Patients: As per adult guidelines, monitoring skin for atrophy or other adverse effects with prolonged use is necessary.
- Patients with Renal Impairment: Since systemic absorption is minimal, dosage adjustments are usually unnecessary but caution is advised. Monitor for any systemic side effects.
- Patients with Hepatic Dysfunction: Similar to renal impairment, minimal absorption usually eliminates the need for dose changes. However, caution and monitoring are recommended.
- Patients with Comorbid Conditions: Patients with diabetes, adrenal gland disorders or immune system problems should be monitored closely due to potential for systemic corticosteroid effects with long term or high dose use.
Clinical Use Cases
Ciclopirox + Fluocinolone acetonide is not indicated for:
- Intubation
- Surgical Procedures
- Mechanical Ventilation
- Intensive Care Unit (ICU) Use
- Emergency Situations
Dosage Adjustments
Avoid use on large areas, under occlusive dressings (unless specifically directed by a physician), or for prolonged periods. No specific dosage adjustments are routinely made based on renal/hepatic dysfunction or other metabolic disorders.
Side Effects
Common Side Effects
Burning sensation, irritation, itching, and redness at the application site are common. Dryness or peeling of the skin may also occur.
Rare but Serious Side Effects
Allergic reactions (rash, hives, swelling, difficulty breathing), worsening of infection, skin atrophy, telangiectasia, hypopigmentation, hypertrichosis, and folliculitis. Signs of adrenal suppression (fatigue, weakness, weight loss) can occur with extensive or prolonged use, especially in children.
Long-Term Effects
Skin thinning, striae, and telangiectasia may occur with prolonged use, especially with high potency formulations or under occlusion. Glaucoma and cataracts are potential ocular side effects if applied near the eyes.
Adverse Drug Reactions (ADR)
Any signs of hypersensitivity or severe skin reactions should prompt immediate discontinuation and medical evaluation.
Contraindications
Hypersensitivity to any component. Avoid use on open wounds, cuts, or severely irritated skin. Not for ophthalmic, oral, or intravaginal use.
Drug Interactions
May interact with other topical corticosteroids, enhancing their effects and increasing the risk of adverse effects. Minimal systemic absorption means drug interactions are less likely than with oral or systemic antifungals or corticosteroids.
Pregnancy and Breastfeeding
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Pregnancy Safety Category: Category B (animal studies have not shown fetal harm, but controlled studies in pregnant women are lacking). Topical application poses a low risk due to limited absorption. However, use only if clearly needed and under close medical supervision.
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Breastfeeding: Excretion in breast milk is unknown for topical application, though similar drugs taken orally can be excreted. Avoid applying to the nipple area.
Drug Profile Summary
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Mechanism of Action: Ciclopirox: Inhibits fungal growth by disrupting cell membrane synthesis. Fluocinolone acetonide: Suppresses inflammation via glucocorticoid receptor binding.
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Side Effects: Common: Application site reactions (burning, itching, redness). Serious: Allergic reactions, skin atrophy, adrenal suppression (with prolonged/high-dose use).
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Contraindications: Hypersensitivity, open wounds, ophthalmic/oral/intravaginal use.
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Drug Interactions: Increased risk of side effects with other topical corticosteroids.
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Pregnancy & Breastfeeding: Topical use generally safe but consult a doctor before using.
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Dosage: Apply thin layer twice daily to affected area.
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Monitoring Parameters: Treatment response, skin integrity, signs of adverse reactions, growth in children (with prolonged use).
Popular Combinations
This is already a combination product and is not typically combined with other drugs.
Precautions
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General Precautions: Hypersensitivity, existing skin damage, avoid eyes/mucous membranes, prolonged/extensive use.
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Specific Populations: Children (avoid in <12 years; monitor growth), pregnancy (use with caution if benefit outweighs risk), breastfeeding (avoid nipple area).
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Lifestyle Considerations: No specific restrictions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ciclopirox + Fluocinolone acetonide?
A: Apply a thin layer to affected skin twice daily. Duration varies depending on infection but typically several weeks.
Q2: Can this be used on children?
A: Not generally recommended for children under 12. Limited use in older children for specific conditions under strict medical supervision.
Q3: What are the common side effects?
A: Burning, itching, redness, irritation at the application site.
Q4: Can I use this if I’m pregnant or breastfeeding?
A: Consult your doctor. Topical use is generally considered low risk due to limited absorption but should only be used if clearly needed.
Q5: What should I do if my condition doesn’t improve?
A: Consult your doctor. They may adjust treatment or explore alternative diagnoses.
Q6: Can I cover the treated area with a bandage?
A: Not unless specifically advised by your doctor. Occlusive dressings can enhance absorption and increase the risk of side effects.
Q7: What if I accidentally get it in my eyes?
A: Rinse thoroughly with water and consult a doctor if irritation persists.
Q8: Can I use this with other topical medications?
A: Inform your doctor about all other medications you are using, especially other topical corticosteroids, as this can increase the risk of side effects.
Q9: What if I miss a dose?
A: Apply the missed dose as soon as you remember, then continue with your regular schedule. Don’t apply double the amount to catch up.
