HYDROCORTISONE IN ABSORBASE
Clinical safety rating: avoid
CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.
Glucocorticoid receptor agonist that modulates gene expression, leading to anti-inflammatory, immunosuppressive, and vasoconstrictive effects.
| Metabolism | Primarily hepatic via CYP3A4, also local metabolism in skin; major metabolite is 6β-hydroxycortisol. |
| Excretion | Renal: primarily as 17-hydroxycorticosteroids and 17-ketosteroids; <5% unchanged. Biliary/fecal: minimal. Metabolites conjugated with glucuronide or sulfate. |
| Half-life | Terminal elimination half-life: 1-2 hours (plasma cortisol); biological half-life (duration of action) 8-12 hours due to intracellular receptor effects. |
| Protein binding | 90-95% bound to corticosteroid-binding globulin (CBG, transcortin) and albumin. CBG affinity high, albumin low capacity. |
| Volume of Distribution | 0.4-0.6 L/kg; distributes into total body water; crosses placenta and blood-brain barrier. |
| Bioavailability | Oral: 25-50% (first-pass metabolism); IM: 100% (assuming normal muscle perfusion); rectal: variable (low); topical: minimal systemic absorption (<1% with intact skin, higher with damaged skin or occlusion). |
| Onset of Action | IV: rapid (minutes); IM: 1-2 hours for adrenocortical insufficiency; oral: 1-2 hours; topical: 2-4 hours for anti-inflammatory effect. |
| Duration of Action | IV/IM/oral: 8-12 hours (adrenal suppression); topical: 4-6 hours for anti-inflammatory effect; duration extended by Absorbase base via enhanced penetration. |
Topical: Apply a thin layer to affected area 2-4 times daily.
| Dosage form | OINTMENT |
| Renal impairment | No dose adjustment required for topical use. |
| Liver impairment | No dose adjustment required for topical use. |
| Pediatric use | Apply sparingly to affected area 1-2 times daily for up to 7 days; avoid prolonged use. |
| Geriatric use | Use with caution; apply sparingly and avoid prolonged use due to increased risk of skin atrophy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.
| FDA category | Positive |
| Breastfeeding | Hydrocortisone is excreted into breast milk in low amounts (M/P ratio approximately 0.25-0.5). Doses ≤ 20 mg/day topical or physiologic replacement are considered compatible with breastfeeding. Monitor infant for signs of adrenal suppression if high-potency or prolonged maternal use. |
| Teratogenic Risk |
■ FDA Black Box Warning
None. Topical corticosteroids do not have FDA boxed warnings.
| Common Effects | adrenal insufficiency |
| Serious Effects |
["Hypersensitivity to hydrocortisone or any component of Absorbase","Uncontrolled infections (viral, fungal, bacterial) at application site","Perioral dermatitis","Rosacea","Acne vulgaris","Vaccinia or varicella","Ophthalmic use (not for eyes)"]
| Precautions | ["May cause systemic absorption leading to HPA axis suppression, especially in children and with occlusive therapy","Local adverse reactions include skin atrophy, striae, telangiectasias, and secondary infections","May exacerbate or mask fungal or bacterial infections","Use caution in patients with impaired skin integrity or diabetes","Avoid use on face, axillae, or groin unless specifically indicated","Prolonged use may cause irreversible skin changes"] |
Loading safety data…
| First trimester: Increased risk of orofacial clefts (odds ratio 1.3-3.3) with systemic exposure. Second/third trimesters: Associated with intrauterine growth restriction, preterm birth, and adrenal suppression in the neonate. Topical absorption via Absorbase vehicle is minimal but prolonged use over large areas may pose risk. |
| Fetal Monitoring | Maternal: Blood pressure, blood glucose, serum electrolytes, and signs of infection. Fetal: Serial ultrasound monitoring for growth (fundal height, estimated fetal weight) if prolonged systemic exposure. Neonatal: Assess for adrenal suppression (hypoglycemia, hypotension) in infants exposed to high doses in utero. |
| Fertility Effects | No direct impairment of fertility at physiologic doses. Supraphysiologic doses may disrupt hypothalamic-pituitary-ovarian axis, leading to ovulatory dysfunction or menstrual irregularities. |