Usage
This combination medication is primarily prescribed for the topical treatment of chronic eczematous dermatoses and psoriasis (including localized psoriasis and hard plaques on the soles and palms). It is also used for conditions like fissured feet and cracked heels.
Pharmacological Classification: This is a combination product with multiple classifications: Topical antifungal (Benzoic Acid), Keratolytic (Salicylic Acid, Ichthammol), and Topical corticosteroid (Triamcinolone Acetonide).
Mechanism of Action: Benzoic acid has fungistatic properties. Salicylic acid and ichthammol are keratolytics, softening and removing dry, scaly skin. Triamcinolone acetonide is a corticosteroid with anti-inflammatory and immunosuppressive effects, achieved by inhibiting inflammatory cells and reducing inflammatory mediators.
Alternate Names
Exsora Ointment is a common brand name. Other names include variations of the generic names of the four components.
How It Works
Pharmacodynamics: The combined components offer antifungal, keratolytic, and anti-inflammatory actions. Triamcinolone acetonide, a potent corticosteroid, binds to glucocorticoid receptors, modifying gene expression and inhibiting inflammatory pathways.
Pharmacokinetics: Primarily topical, limiting systemic absorption. However, some absorption can occur with prolonged use or application to large areas, broken skin, or under occlusive dressings. Metabolism and elimination pathways for each component in topical application aren’t fully defined.
Mode of Action: Benzoic acid inhibits fungal growth. Salicylic acid and ichthammol break down keratin, facilitating the removal of the stratum corneum. Triamcinolone acetonide binds to glucocorticoid receptors in the skin, influencing gene expression and impeding inflammatory processes.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Triamcinolone acetonide binds to glucocorticoid receptors. Benzoic acid is believed to interfere with vital fungal cell processes and Salicylic acid increases skin cell turnover. The mechanism of action of Ichtyolammonium is not entirely understood, but appears to be anti-inflammatory and possibly antiseptic.
Elimination Pathways: Systemic elimination of absorbed drug is likely similar to other forms of the constituent drugs, though the exact pathways following topical application haven’t been fully elucidated.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected area two to four times daily, or as directed by a physician. Gently rub into the skin.
Children: Use with caution in children. Consult a physician before use in children younger than 2 years old. Dosage adjustments are often needed based on age and body weight.
Special Cases:
- Elderly Patients: Use cautiously. Monitor for increased systemic absorption and side effects.
- Patients with Renal Impairment: No specific dosage adjustments are typically required. However, caution is advisable.
- Patients with Hepatic Dysfunction: No specific dosage adjustments are usually needed. Caution is recommended.
- Patients with Comorbid Conditions: Exercise caution in patients with diabetes or other metabolic disorders, as topical corticosteroids can affect glucose control.
Clinical Use Cases
This medication is primarily for dermatological use. It is not generally relevant for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Adjustments may be needed depending on individual patient response and tolerability. Consult a physician if no improvement is observed after several weeks or if the condition worsens.
Side Effects
Common Side Effects:
- Burning or warm sensation at the application site
- Itching
- Irritation or allergic skin reactions
- Redness
- Dryness
- Peeling
- Thinning of the skin
Rare but Serious Side Effects:
- Blistering skin
- Stretch marks
- Acne
- Signs of systemic absorption (e.g., changes in blood sugar levels, Cushing’s syndrome) - with prolonged use over large areas
Long-Term Effects:
- Skin atrophy
- Telangiectasia
- Hypopigmentation
Adverse Drug Reactions (ADR):
- Severe allergic reactions (e.g., angioedema, anaphylaxis) - although rare, require immediate medical attention.
Contraindications
- Hypersensitivity to any of the components (benzoic acid, ichthammol, salicylic acid, triamcinolone acetonide)
- Open wounds or broken skin.
- Primary bacterial skin infections.
- Viral skin diseases (herpes simplex, chickenpox).
- Rosacea and acne.
- Perioral dermatitis.
Drug Interactions
- Topical salicylic acid and triamcinolone may increase absorption of other topically applied medicines; concomitant use of other topical medications on the same area should, therefore, be avoided unless directed by a doctor.
- No other clinically significant drug interactions have been formally established. However, with extended or excessive use over large areas or broken skin, sufficient triamcinolone acetonide absorption may potentially give rise to interactions with CYP3A4 inducers/inhibitors, anticoagulants, NSAIDs, antidiabetics, and live vaccines.
Pregnancy and Breastfeeding
Pregnancy Safety Category: Not formally assigned. Use during pregnancy only if clearly needed and under close medical supervision. Potential fetal risks are not well-established, though animal studies suggest potential harm. Triamcinolone acetonide’s effects on nursing infants are not fully known. However, due to the potential for adverse effects on the infant, it should be used cautiously during breastfeeding, limiting application and avoiding the breast area to prevent direct infant exposure.
Drug Profile Summary
- Mechanism of Action: Antifungal, keratolytic, and anti-inflammatory.
- Side Effects: Common: burning, itching, dryness, irritation, redness. Serious: blistering, stretch marks, systemic effects.
- Contraindications: Hypersensitivity, open wounds, some skin infections, viral skin diseases, rosacea.
- Drug Interactions: Other topical medications (increased absorption possible), some systemic drugs (with high systemic absorption of topical product)
- Pregnancy & Breastfeeding: Use with caution if clearly needed under medical supervision. Avoid breast area.
- Dosage: Adults and children: Apply thinly to the affected area 2-4 times/day. Adjust for children.
- Monitoring Parameters: Monitor the treated area for local reactions, especially with prolonged or extensive use. If used in diabetics, monitor glucose.
Popular Combinations
Not typically combined with other topical medications for the same condition unless specifically directed by a physician, due to potential interactions and increased risk of side effects.
Precautions
- General Precautions: Evaluate for any pre-existing skin conditions or allergies. Use cautiously over large areas, broken skin, or for prolonged periods.
- Pregnant Women: Use only if clearly needed and under direct medical supervision.
- Breastfeeding Mothers: Use cautiously, avoiding the breast area.
- Children & Elderly: Use with caution. Monitor for adverse reactions, especially with long-term use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Benzoic Acid + Ichtyolammonium + Salicylic Acid + Triamcinolone Acetonide?
A: Adults: Apply thinly 2-4 times/day. Children: Consult a physician, as adjustments are often needed.
Q2: Can this ointment be used on the face?
A: Use with caution on the face, especially near the eyes and mouth. Prolonged use can lead to skin thinning.
Q3: What if I accidentally get the ointment in my eyes?
A: Rinse thoroughly with water and consult a physician if irritation persists.
Q4: Can I use this ointment while pregnant or breastfeeding?
A: Use during pregnancy or breastfeeding only if essential and under a doctor’s supervision. If breastfeeding, avoid applying to the breast area.
Q5: How long does it take to see results?
A: It may take several weeks to notice improvement. Consult a physician if no improvement or worsening occurs.
Q6: Can I use cosmetics after applying the ointment?
A: Avoid cosmetics on the treated area, as they can interfere with the medication’s effectiveness.
Q7: What are the signs of a serious allergic reaction?
A: Watch for hives, difficulty breathing, swelling of the face, lips, tongue, or throat, or dizziness. Seek immediate medical help if these occur.
Q8: Can I cover the treated area with a bandage?
A: Unless directed by a physician, avoid using occlusive dressings, as they can increase systemic absorption and the risk of side effects.
Q9: My skin is very dry after using the ointment. What can I do?
A: Applying a non-medicated moisturizer to unaffected areas can help manage dryness.
Q10: Can I use other topical treatments with this ointment?
A: Generally, other topical treatments should be avoided on the same area, unless prescribed by a doctor, due to potential interactions.