Usage
Clobetasol + Gentamicin + Miconazole is a combination topical medication prescribed for inflammatory skin conditions with bacterial and/or fungal infections. These conditions include infected eczema, inflamed ringworm (tinea corporis), inflamed jock itch (tinea cruris), inflamed athlete’s foot (tinea pedis), and other mixed skin infections with secondary inflammation.
This medication combines drugs from three pharmacological classifications:
- Corticosteroid: Clobetasol propionate is a highly potent corticosteroid.
- Antibiotic: Gentamicin sulfate is an aminoglycoside antibiotic.
- Antifungal: Miconazole nitrate is an imidazole antifungal.
Mechanism of Action:
- Clobetasol: Reduces inflammation by suppressing the immune response, decreasing the production of inflammatory mediators like prostaglandins and leukotrienes. It also constricts blood vessels, further reducing swelling and redness.
- Gentamicin: Inhibits bacterial protein synthesis, leading to bacterial death or growth retardation.
- Miconazole: Inhibits ergosterol synthesis, a crucial component of fungal cell membranes. This disruption creates holes in the fungal membranes, causing leakage of cell contents and fungal death.
Alternate Names
This triple combination medication does not have a universally recognized international nonproprietary name (INN). The combination is often referred to by the names of its components. Several brand names exist, depending on the region and manufacturer. Some examples might include Cosvate-GM, Clobacin GM and Sonaderm-GM.
How It Works
Pharmacodynamics:
- Clobetasol: Exerts its anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects by binding to glucocorticoid receptors in skin cells.
- Gentamicin: Binds to the 30S subunit of bacterial ribosomes, inhibiting protein synthesis.
- Miconazole: Inhibits the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, blocking ergosterol biosynthesis.
Pharmacokinetics:
- Absorption: Minimal systemic absorption occurs when applied topically to intact skin. Absorption increases with application to broken skin, large surface areas, or under occlusive dressings.
- Metabolism: Clobetasol is primarily metabolized in the liver. Gentamicin is not metabolized. Miconazole is extensively metabolized in the liver.
- Elimination: Clobetasol metabolites are excreted primarily in the urine and bile. Gentamicin is excreted unchanged primarily in the urine. Miconazole metabolites are excreted in urine and feces.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected skin area twice daily. Gently rub until absorbed. Treatment should generally not exceed two consecutive weeks, and the total dosage should not exceed 50g per week.
Children: Use in children under two years of age is not recommended. For children older than two years, follow adult dosing guidelines, but exercise caution and limit the duration of treatment.
Special Cases:
- Elderly Patients: Follow adult dosing guidelines. Monitor for potential side effects related to skin thinning.
- Patients with Renal Impairment: Caution is advised due to the nephrotoxic potential of gentamicin, especially with prolonged or high-dose use.
- Patients with Hepatic Dysfunction: Monitor for potential adverse effects due to the hepatic metabolism of clobetasol and miconazole.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes, glaucoma, cataracts, adrenal gland problems, or liver problems.
Clinical Use Cases
This medication is primarily intended for topical dermatological use and is not generally applicable in clinical settings such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Adjustments may be needed for patients with renal or hepatic impairment, as described above. Prolonged use should be avoided.
Side Effects
Common Side Effects
Burning, stinging, itching, dryness, skin irritation, redness, rash, peeling, and hypopigmentation at the application site.
Rare but Serious Side Effects
Allergic contact dermatitis, skin atrophy, telangiectasia (spider veins), striae (stretch marks), folliculitis, hypertrichosis (excessive hair growth), and secondary infections. Systemic absorption can lead to hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and other systemic corticosteroid side effects.
Long-Term Effects
Skin thinning, striae, telangiectasia, and hypopigmentation.
Adverse Drug Reactions (ADR)
Severe allergic reactions, including anaphylaxis and angioedema. Systemic toxicity from gentamicin (nephrotoxicity, ototoxicity) is rare with topical use.
Contraindications
Hypersensitivity to any of the components, rosacea, acne vulgaris, perioral dermatitis, primary cutaneous viral infections (e.g., herpes simplex, chickenpox), perianal and genital pruritus, and otitis externa with perforated eardrum.
Drug Interactions
Clobetasol: Few drug interactions are known.
Miconazole: May interact with oral anticoagulants like warfarin. May increase the levels of some medications metabolized by CYP3A4 and CYP2C9.
Gentamicin: Concurrent use with other nephrotoxic or ototoxic drugs should be avoided.
Pregnancy and Breastfeeding
Safety during pregnancy and breastfeeding has not been established. Use only if clearly needed and under close medical supervision. Avoid application to large areas or for prolonged durations.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Use with caution; potential risk to fetus/infant.
- Dosage: See above.
- Monitoring Parameters: Skin integrity, signs of infection, local and systemic side effects, HPA axis function with prolonged use.
Popular Combinations
This medication is itself a popular combination for treating mixed skin infections with inflammation. Combining it with other topical agents is generally not recommended without medical supervision.
Precautions
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General Precautions: Avoid contact with eyes, mucous membranes, and broken skin. Do not use with occlusive dressings unless directed by a physician. Wash hands after application.
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Specific Populations: See “Dosage” and “Pregnancy and Breastfeeding” sections.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Gentamicin + Miconazole?
A: Apply a thin layer to affected skin twice daily. Do not exceed 50g/week or use for longer than two weeks without medical advice.
Q2: Can this cream be used on the face?
A: Use on the face is generally not recommended due to the risk of skin atrophy, telangiectasia, and perioral dermatitis. If used on the face, limit application to a maximum of five days.
Q3: Can I use this cream for acne?
A: No, it is not recommended for acne and may worsen the condition.
Q4: Is it safe to use during pregnancy?
A: Safety during pregnancy and breastfeeding is not fully established. Consult a doctor before using.
Q5: What should I do if I accidentally swallow the cream?
A: Seek immediate medical attention. While topical application results in minimal systemic absorption, ingestion can lead to more significant exposure.
Q6: Can I use this cream for a long time?
A: Prolonged use is not recommended due to the risks of skin atrophy, HPA axis suppression, and the development of antibiotic resistance.
Q7: Can I cover the treated area with a bandage?
A: Occlusive dressings are generally not recommended as they increase systemic absorption. Use only if specifically directed by a physician.
Q8: What are the signs of an allergic reaction to this cream?
A: Severe itching, redness, swelling, hives, difficulty breathing, or dizziness. Seek immediate medical attention if these occur.
Q9: How should I store this medication?
A: Store in a cool, dry place away from direct sunlight and out of the reach of children.
