Usage
Fluocinolone acetonide + Neomycin is prescribed for corticosteroid-responsive dermatoses with secondary bacterial infection. This includes conditions like eczema, dermatitis (atopic, seborrheic, contact, etc.), psoriasis, and prurigo, when these are infected or at risk of bacterial infection.
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Pharmacological Classification: This is a combination drug containing a topical corticosteroid (fluocinolone acetonide) and a topical antibiotic (neomycin).
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Mechanism of Action: Fluocinolone acetonide reduces inflammation and itching by suppressing the immune response and constricting blood vessels in the skin. Neomycin inhibits bacterial protein synthesis, thus preventing bacterial growth.
Alternate Names
This combination drug does not have an international nonproprietary name (INN).
- Brand Names: Neo-Synalar, Synalar N, Fluonid-N, Skinalar-N (and others, depending upon region).
How It Works
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Pharmacodynamics: Fluocinolone acetonide exerts its anti-inflammatory, antipruritic, and vasoconstrictive effects locally. Neomycin acts locally to kill bacteria or inhibit their growth. Systemic absorption is minimal with topical application, reducing the likelihood of systemic side effects.
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Pharmacokinetics:
- Absorption: Both drugs are minimally absorbed through intact skin. Broken skin, prolonged use, or application to large areas can increase absorption.
- Metabolism: Fluocinolone acetonide is primarily metabolized in the liver. Neomycin is not significantly metabolized.
- Elimination: Fluocinolone metabolites are excreted primarily in the urine, with some in the bile. Neomycin is excreted primarily unchanged by the kidneys.
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Mode of Action: Fluocinolone acetonide binds to glucocorticoid receptors in the skin, leading to decreased production of inflammatory mediators. Neomycin binds to the 30S subunit of bacterial ribosomes, inhibiting protein synthesis.
Dosage
Standard Dosage
Adults: Apply a thin film to the affected area two to four times daily. Treatment duration should generally not exceed seven days.
Children: Use with caution in children. Apply a thin film to the affected area, typically two times daily. Minimize the amount used and the duration of treatment. Pediatric dosing should be determined by a physician.
Special Cases:
- Elderly Patients: Use the lowest effective dose for the shortest duration possible due to increased risk of skin thinning.
- Patients with Renal Impairment: Monitor for potential nephrotoxicity with prolonged use or high doses, although topical application poses minimal risk.
- Patients with Hepatic Dysfunction: Use with caution in patients with severe liver disease, though topical application poses minimal risk.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes as topical corticosteroids can increase blood sugar levels.
Clinical Use Cases
This medication is intended for topical use on the skin and is not suitable for the clinical use cases listed (intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations).
Dosage Adjustments
Dosage adjustments might be needed based on patient response, severity of condition, and location of application. Always consult a doctor to determine the appropriate dose and treatment duration.
Side Effects
Common Side Effects
Burning, itching, irritation, dryness, skin thinning, acne-like eruptions, hypopigmentation, hypertrichosis, allergic contact dermatitis.
Rare but Serious Side Effects
Hypersensitivity reactions, skin atrophy, striae, telangiectasia, perioral dermatitis, secondary infection. Signs of systemic absorption (Cushing’s syndrome, HPA axis suppression) can occur with prolonged use, especially in children. Neomycin can cause ototoxicity (hearing loss) and nephrotoxicity (kidney damage) with systemic absorption, though this is rare with topical use.
Long-Term Effects
Skin atrophy, striae, telangiectasia, hypopigmentation, hypertrichosis, increased risk of skin infections.
Adverse Drug Reactions (ADR)
Allergic reactions (anaphylaxis, angioedema), skin necrosis, contact dermatitis.
Contraindications
Hypersensitivity to fluocinolone acetonide or neomycin. Viral skin infections (herpes simplex, varicella zoster, vaccinia), fungal skin infections, tuberculosis of the skin, rosacea, acne, perioral dermatitis, anogenital pruritus, napkin eruptions. Perforated eardrum (if applying near the ear).
Drug Interactions
No significant drug interactions are expected with topical application. Concurrent use of other topical corticosteroids on the same area should be avoided.
Pregnancy and Breastfeeding
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Pregnancy Safety Category: Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid prolonged use or application to large areas.
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Breastfeeding: Topically applied fluocinolone acetonide is present in breast milk in small amounts. Caution should be exercised when administering to nursing women. Avoid applying to the nipple/areola area to prevent infant ingestion.
Drug Profile Summary
- Mechanism of Action: Fluocinolone acetonide: Anti-inflammatory, antipruritic, vasoconstrictive. Neomycin: Inhibits bacterial protein synthesis.
- Side Effects: Burning, itching, irritation, dryness, skin thinning, acne-like eruptions, allergic contact dermatitis. Rarely: Skin atrophy, striae, secondary infection.
- Contraindications: Hypersensitivity, viral/fungal/tuberculous skin infections, rosacea, acne, perioral dermatitis.
- Drug Interactions: None significant with topical use.
- Pregnancy & Breastfeeding: Use with caution. Avoid prolonged use or application to large areas during pregnancy. Avoid application to the nipple/areola area during breastfeeding.
- Dosage: Apply thinly bid-qid for up to 7 days.
- Monitoring Parameters: Monitor for signs of infection, skin atrophy, and systemic absorption.
Popular Combinations
Fluocinolone acetonide is sometimes combined with other antifungals (like miconazole or clotrimazole) for treating dermatoses with combined bacterial and fungal infections.
Precautions
- General Precautions: Avoid prolonged use, large areas of application, occlusive dressings. Do not use on broken skin or open wounds.
- Specific Populations: Use with caution in children and the elderly. Consult a physician before using during pregnancy or breastfeeding.
- Lifestyle Considerations: No specific lifestyle considerations.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Fluocinolone acetonide + Neomycin?
A: Apply a thin film to the affected area 2-4 times daily, usually for no more than 7 days. Adjust the frequency and duration as needed based on the severity of the condition and patient response. Pediatric and geriatric patients may require lower doses and shorter treatment durations.
Q2: What are the common side effects?
A: Common side effects include burning, itching, irritation, dryness, and skin thinning at the application site.
Q3: Can it be used during pregnancy or breastfeeding?
A: Use with caution during pregnancy and breastfeeding. Consult a physician before use. Avoid application to large areas or for prolonged periods during pregnancy. Avoid applying to the nipple/areola area during breastfeeding.
Q4: What conditions does this medication treat?
A: It treats corticosteroid-responsive skin conditions with secondary bacterial infections, such as infected eczema, dermatitis, or psoriasis.
Q5: How does it work?
A: Fluocinolone acetonide reduces inflammation, while neomycin combats bacterial infection.
Q6: Are there any drug interactions I should be aware of?
A: Significant drug interactions are unlikely with topical use.
Q7: What should I do if I miss a dose?
A: Apply the missed dose as soon as you remember. If it’s almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not apply extra to make up for a missed dose.
A: Contact your doctor if your condition worsens, you experience an allergic reaction, or if you develop any new or unusual symptoms. Also, consult your doctor if your condition does not improve after 7 days of treatment.
Q9. What are the contraindications to Fluocinolone + Neomycin?
A: Hypersensitivity to either ingredient; viral skin infections (e.g., herpes, chickenpox); tuberculous or fungal skin lesions; rosacea, acne; perioral dermatitis. Perforated eardrum if used near the ear.
