ALA-CORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALA-CORT (ALA-CORT).
Topical corticosteroid that induces phospholipase A2 inhibitory proteins, collectively called lipocortins, which inhibit the release of arachidonic acid, thereby reducing prostaglandin and leukotriene synthesis, and exerting anti-inflammatory, antipruritic, and vasoconstrictive effects.
| Metabolism | Topically applied; systemic absorption is minimal but can be increased with use on large areas, occlusive dressings, or damaged skin. Absorbed portion is metabolized primarily in the liver via hepatic microsomal enzymes (CYP3A4) and excreted by the kidneys. |
| Excretion | Primarily hepatic metabolism (approximately 95%) followed by renal excretion of inactive metabolites (<5% unchanged). Biliary/fecal excretion is negligible. |
| Half-life | Terminal elimination half-life: 1–2 hours for hydrocortisone (active component), prolonged in liver disease or with concurrent CYP3A4 inhibitors. |
| Protein binding | Hydrocortisone is approximately 90–95% bound to corticosteroid-binding globulin (CBG, transcortin) and albumin. |
| Volume of Distribution | Apparent volume of distribution (Vd) is approximately 0.4–0.6 L/kg, indicating moderate tissue distribution and limited penetration into CNS. |
| Bioavailability | Topical: Bioavailability is negligible (<1%) through intact skin; may increase (up to 30%) with damaged skin or occlusive dressings. Rectal: Bioavailability is approximately 10–20% via mucosal absorption, with first-pass metabolism reducing systemic exposure. |
| Onset of Action | Topical: Within minutes for relief of inflammation and pruritus; peak effect at 2–4 hours. Rectal (enema/suppository): Onset within 1–2 hours for acute proctitis. |
| Duration of Action | Topical: Duration of anti-inflammatory effect approximately 4–6 hours; requires multiple daily applications. Rectal: Effects last 6–8 hours. |
| Molecular Weight | 448.5 |
Topical: Apply a thin film to affected area 3-4 times daily. Dosage strength: 0.5% cream or ointment.
| Dosage form | CREAM |
| Renal impairment | No adjustment required for topical use; systemic absorption minimal. |
| Liver impairment | No adjustment required for topical use; hepatic metabolism negligible. |
| Pediatric use | Children ≥2 years: Apply a thin film to affected area 2-3 times daily. Use lowest potency preparation; avoid prolonged use. |
| Geriatric use | Use lowest effective dose; monitor for skin atrophy and systemic effects due to thinner skin and increased percutaneous absorption. |
| 1st trimester | Avoid topical corticosteroids, especially potent formulations, due to risk of orofacial clefts (though absolute risk is low). Use only if potential benefit justifies risk. |
| 2nd trimester | May use low-potency corticosteroids for short periods if clearly needed. Avoid prolonged use or large areas. |
| 3rd trimester | May use low-potency corticosteroids for short periods. High-potency formulations may cause fetal growth restriction or adrenal suppression; avoid. |
Clinical note
Comprehensive clinical and safety monograph for ALA-CORT (ALA-CORT).
| Placental transfer | Corticosteroids cross the placenta; degree depends on potency, formulation, and application area. Topical absorption is minimal (<1% systemic) for low-potency agents on intact skin, but increased with high potency or compromised skin. |
| Breastfeeding | Topical corticosteroids are poorly absorbed systemically; low-potency formulations are considered safe during breastfeeding. Avoid application to breast area to prevent infant ingestion. Use low-potency, short-term only. |
■ FDA Black Box Warning
None
| Serious Effects |
Untreated bacterial, fungal, or viral skin infectionsPerioral dermatitisRosaceaHypersensitivity to any component
| Precautions | Systemic absorption may cause reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria with prolonged use, Local adverse reactions: atrophy, striae, telangiectasias, acneiform eruptions, perioral dermatitis, May mask signs of infection, Use with caution in pediatric patients due to increased susceptibility to HPA axis suppression, Avoid use on face, intertriginous areas, and under occlusive dressings unless directed by physician |
| Food/Dietary | No known food interactions with topical ALA-CORT. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: No adequate human studies; animal studies show increased risk of cleft palate. Second/third trimester: Risk of intrauterine growth restriction, adrenal suppression in fetus. Avoid prolonged use. |
| Fetal Monitoring | Monitor maternal blood pressure, blood glucose (especially in diabetics), and signs of infection. Fetal monitoring for growth restriction if prolonged therapy >2 weeks. |
| Fertility Effects | Systemic corticosteroids may impair fertility by disrupting ovulation in women; no data specific to ALA-CORT. |
| Clinical Pearls |
| ALA-CORT (hydrocortisone acetate 2.5% and pramoxine HCl 1%) is a topical corticosteroid with anesthetic. Use for short-term relief of pruritus and inflammation in corticosteroid-responsive dermatoses. Avoid prolonged use on intertriginous or occluded areas. Limit to <2 weeks continuous use in adults to avoid skin atrophy. Not recommended for children <2 years. |
| Patient Advice | Apply a thin layer to affected area no more than 3-4 times daily. · Do not cover with bandages or plastic unless directed by doctor. · Avoid contact with eyes, mouth, or broken skin. · Discontinue and notify doctor if infection, irritation, or no improvement after 7 days. · Do not use for diaper dermatitis or under diapers/occlusive dressings. · Keep out of reach of children. |