CARMOL HC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CARMOL HC (CARMOL HC).
Carmol HC is a combination of urea (a keratolytic) and hydrocortisone (a corticosteroid). Urea softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation and enhancing penetration of hydrocortisone. Hydrocortisone suppresses inflammation by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
| Metabolism | Hydrocortisone is primarily metabolized in the liver via reduction, primarily by 5α- and 5β-reductases and 3α-hydroxysteroid dehydrogenase. Urea is not metabolized and is excreted unchanged in urine. |
| Excretion | Primarily renal excretion of metabolites (40-60%) as glucuronide and sulfate conjugates; <10% unchanged; biliary/fecal elimination accounts for <20%. |
| Half-life | 1-2 hours (hydrocortisone acetate); clinical effects persist longer due to local anti-inflammatory action; tissue half-life not well defined. |
| Protein binding | Highly bound to corticosteroid-binding globulin (CBG) and albumin, about 90-95%. |
| Volume of Distribution | 0.3-0.5 L/kg (hydrocortisone); reflects distribution into total body water and tissues. |
| Bioavailability | Topical: variable, dependent on skin integrity and formulation, approximately 1-7% systemically absorbed; oral/buccal: not applicable for CARMOL HC as it is a topical product. |
| Onset of Action | Topical: 4-6 hours for reduction of inflammation and pruritus; effects may be noted earlier with application to thinner skin. |
| Duration of Action | Effects persist for 8-12 hours after topical application; duration depends on formulation and skin condition. |
Apply a thin film to affected area twice daily; topical, not for ophthalmic or oral use.
| Dosage form | CREAM |
| Renal impairment | No adjustment required due to minimal systemic absorption. |
| Liver impairment | No adjustment required due to minimal systemic absorption. |
| Pediatric use | Apply a thin film to affected area twice daily; use lowest potency and shortest duration possible; avoid use in children <2 years unless directed by physician. |
| Geriatric use | Apply a thin film to affected area twice daily; use lowest potency and shortest duration due to increased risk of skin atrophy and systemic absorption. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CARMOL HC (CARMOL HC).
| Breastfeeding | Minute amounts of topical hydrocortisone may be absorbed into breastmilk, but no adverse effects reported. M/P ratio not available. Avoid application to breast or nipple to prevent infant ingestion. Generally considered compatible with breastfeeding with caution. |
| Teratogenic Risk | Hydrocortisone is a corticosteroid. Topical use during pregnancy is generally considered low risk for teratogenicity, but systemic absorption can occur with extensive use. First trimester: limited data suggest no significant increase in congenital anomalies; however, high-dose systemic corticosteroids are associated with oral clefts (odds ratio ~3.4). Second/third trimester: prolonged use may increase risk of intrauterine growth restriction, preterm birth, and adrenal suppression in the neonate. Avoid long-term, high-potency, or large surface area applications. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to any component of the formulation","Untreated bacterial, fungal, viral, or parasitic skin infections (e.g., herpes simplex, varicella, tuberculosis)"]
| Precautions | ["Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with potential for glucocorticosteroid insufficiency after withdrawal.","Use with caution on large areas, under occlusive dressings, or in patients with impaired hepatic function.","Pediatric patients may be more susceptible to systemic toxicity due to larger skin surface-to-body-weight ratio.","Local adverse reactions including burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration, secondary infection, skin atrophy, striae, and miliaria."] |
| Food/Dietary | No known food interactions. Take with or without food. No dietary restrictions required. |
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| Fetal Monitoring | For prolonged or extensive use during pregnancy: monitor fetal growth via serial ultrasound for growth restriction. Newborns exposed in utero to prolonged high-dose corticosteroids should be monitored for adrenal suppression (e.g., hypoglycemia, hypotension). |
| Fertility Effects | No known adverse effects on fertility from topical hydrocortisone at typical doses. |
| Clinical Pearls | CARMOL HC combines 1% hydrocortisone acetate with 10% urea in an emollient base. The urea enhances hydration and keratolytic effect, improving steroid penetration in hyperkeratotic conditions. Avoid use on acutely inflamed, infected, or eroded skin. Limit continuous use to 2 weeks; monitor for skin atrophy and HPA axis suppression, especially in children or on large surface areas. |
| Patient Advice | Apply a thin layer to affected areas only; avoid use on face, groin, or axillae unless directed. · Do not cover with bandages or diapers unless instructed; occlusive dressings increase absorption. · Discontinue and inform your doctor if irritation, infection, or worsening occurs. · Do not use continuously for more than 2 weeks without medical evaluation. · Avoid contact with eyes, mouth, or open wounds; wash hands after application. |