Usage
- Medical Conditions: This topical combination medication is primarily prescribed for inflammatory and dry skin conditions, such as:
- Corticosteroid-responsive dermatoses (e.g., eczema)
- Moderate to severe plaque-type psoriasis
- Dry, scaly skin (xerosis)
- Ichthyosis vulgaris
- Lichen planus
- Pharmacological Classification:
- Ammonium lactate: Keratolytic, emollient, humectant
- Clobetasol propionate: Corticosteroid (super-potent)
- Mechanism of Action: Ammonium lactate increases skin hydration and promotes exfoliation of dead skin cells. Clobetasol propionate, a corticosteroid, binds to glucocorticoid receptors, suppressing the inflammatory cascade and reducing redness, itching, and swelling.
Alternate Names
- No internationally recognized non-proprietary name (INN) exists for this combination.
- Brand Names: Lacsoft C, Covate Soft, Topinate-AL Gel (Note: Brand names may vary regionally.)
How It Works
- Pharmacodynamics: Clobetasol reduces inflammation by inhibiting the production of inflammatory mediators (prostaglandins, leukotrienes). Ammonium lactate moisturizes and softens the skin by increasing hydration and promoting exfoliation.
- Pharmacokinetics:
- Absorption: Clobetasol propionate, when applied topically, has minimal systemic absorption. Absorption increases if applied to thinner skin (face, groin, axillae), broken skin, or under occlusion.
- Metabolism: Primarily hepatic.
- Elimination: Renal and biliary.
- Mode of Action: Clobetasol exerts its anti-inflammatory effects by binding to glucocorticoid receptors in skin cells, modulating gene transcription, and suppressing inflammatory pathways. Ammonium lactate’s keratolytic action is due to the lactic acid component, which breaks down keratin, facilitating exfoliation.
- Receptor Binding/Enzyme Inhibition: Clobetasol binds to glucocorticoid receptors. Ammonium lactate does not have specific receptor binding or enzyme inhibition properties relevant to its therapeutic effect.
- Elimination Pathways: Clobetasol is primarily metabolized in the liver and excreted via the kidneys and bile. Ammonium lactate, after minimal systemic absorption, is likewise metabolized and excreted.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected skin area twice daily (morning and night). Do not apply to the face, groin, or underarms for more than five consecutive days unless directed by a physician.
Children: Use in children under 12 years of age is not recommended. Adolescents (12-17 years): Follow adult guidelines, using with caution and under close medical supervision.
Special Cases:
- Elderly Patients: Use with caution and for limited periods due to increased risk of skin thinning and systemic absorption.
- Patients with Renal Impairment: Close monitoring is advised.
- Patients with Hepatic Dysfunction: Close monitoring is advised.
- Patients with Comorbid Conditions: Use cautiously in patients with diabetes (monitor for hyperglycemia) and other systemic diseases.
Clinical Use Cases
The available sources do not list dosages for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations, as the preparation is intended for topical dermatological use.
Dosage Adjustments
Dose adjustments may be required in specific patient populations (elderly, hepatic/renal impairment) and should be determined based on individual patient assessment.
Side Effects
Common Side Effects:
- Burning, stinging, itching at the application site
- Skin dryness, irritation, redness
- Folliculitis (inflammation of hair follicles)
- Hypertrichosis (excessive hair growth)
- Hypopigmentation (skin lightening)
Rare but Serious Side Effects:
- Skin atrophy (thinning)
- Telangiectasia (spider veins)
- Striae (stretch marks)
- Allergic contact dermatitis
- Systemic absorption (Cushing’s syndrome – rare)
Long-Term Effects:
- Skin atrophy, telangiectasia, and striae can become permanent with prolonged use.
- Risk of hypothalamic-pituitary-adrenal (HPA) axis suppression with prolonged use or use over large areas.
Contraindications
- Hypersensitivity to clobetasol, ammonium lactate, or any other ingredient
- Rosacea, perioral dermatitis
- Viral, bacterial, fungal, or parasitic skin infections at the application site
- Tuberculosis of the skin
Drug Interactions
- Other topical corticosteroids: Increased risk of side effects
- Immunosuppressants: Potentiated immunosuppression
- CYP3A4 inducers (e.g., rifampin, phenytoin): Decreased clobetasol efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): Increased clobetasol levels and side effects
Pregnancy and Breastfeeding
- Pregnancy: Use only if the potential benefit outweighs the potential risk to the fetus. Avoid use during the first trimester. Topical corticosteroids should not be used extensively on pregnant women, in large amounts, or for prolonged periods.
- Breastfeeding: Consult a physician. Caution should be used when clobetasol propionate is administered to a nursing woman. Systemic absorption is minimal with topical application, but it’s unknown if clobetasol is excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Clobetasol: potent topical corticosteroid; Ammonium Lactate: keratolytic and moisturizer.
- Side Effects: Burning, stinging, itching, skin atrophy, hypopigmentation, hypertrichosis.
- Contraindications: Hypersensitivity, rosacea, perioral dermatitis, skin infections.
- Drug Interactions: Other topical steroids, immunosuppressants, CYP3A4 inducers/inhibitors.
- Pregnancy & Breastfeeding: Consult a physician. Caution advised.
- Dosage: Adults and children over 12: Apply thinly twice daily. Avoid facial/groin use > 5 days.
- Monitoring Parameters: Monitor for local skin reactions and signs of systemic absorption (Cushing’s syndrome).
Popular Combinations
Ammonium lactate is often used in combination with corticosteroids (such as clobetasol propionate) or with salicylic acid for additive effects.
Precautions
- General Precautions: Evaluate for existing skin infections before use. Avoid application to broken or damaged skin. Do not use under occlusive dressings unless directed by a physician. Wash hands after application.
- Specific Populations (See above sections on dosage, pregnancy, and breastfeeding for more information).
- Lifestyle Considerations: Avoid excessive sun exposure, tanning beds, and UV light. Limit alcohol consumption, as it may exacerbate some skin conditions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ammonium Lactate + Clobetasol?
A: Adults and children over 12: Apply a thin layer to affected skin twice daily. Do not use on the face, groin, or axillae for more than 5 days unless directed by a physician. Not recommended for children under 12.
Q2: What are the common side effects?
A: Common side effects include burning, stinging, itching, dryness, redness, and folliculitis at the application site.
Q3: Can this medication be used during pregnancy or breastfeeding?
A: Consult a physician. Use with caution if the potential benefit outweighs the risk. Limited data are available regarding fetal and neonatal effects.
Q4: What are the contraindications to using this medication?
A: Contraindications include hypersensitivity, rosacea, perioral dermatitis, and viral, bacterial, fungal, or parasitic skin infections at the application site.
Q5: How does ammonium lactate enhance the effect of clobetasol?
A: Ammonium lactate enhances the effects of clobetasol through its moisturizing and keratolytic effects, softening and improving the skin’s permeability to clobetasol.
Q6: Are there any drug interactions I should be aware of?
A: Yes. It can interact with other topical corticosteroids, immunosuppressants, and drugs that affect CYP3A4 enzyme activity.
Q7: What should I do if my condition does not improve after using this medication?
A: Consult your physician. Your condition may require alternative or additional treatments.
Q8: Can I use this medication on my face?
A: Use on the face should not exceed 5 consecutive days unless directed by a physician, due to the risk of skin atrophy and other side effects.
Q9: What should I do if I experience severe burning or irritation at the application site?
A: Discontinue use and consult your physician. This may indicate an adverse reaction or inappropriate use.
Q10: How long can I use this medication?
A: Use should be limited to the shortest effective duration. Prolonged use can lead to skin atrophy, telangiectasia, striae, and potentially HPA axis suppression. Your physician will determine the appropriate duration of treatment based on your individual condition and response.
