PANDEL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PANDEL (PANDEL).
Pandel (hydrocortisone probutate) is a topical corticosteroid that acts by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins inhibit the release of arachidonic acid from membrane phospholipids, thereby reducing the synthesis of prostaglandins, leukotrienes, and other inflammatory mediators. This results in vasoconstriction, decreased edema, and suppression of the inflammatory and pruritic responses.
| Metabolism | Hydrocortisone probutate is metabolized primarily in the skin and liver via ester hydrolysis to inactive metabolites. |
| Excretion | Primarily renal (90% as unchanged drug); biliary/fecal excretion negligible (<5%). |
| Half-life | 2-4 hours (terminal); clinical context: requires frequent dosing due to rapid elimination. |
| Protein binding | 20-30% bound to albumin; low binding minimizes drug interactions. |
| Volume of Distribution | 0.3-0.5 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 70-90% (high, with minimal first-pass effect); Intravenous: 100%. |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes. |
| Duration of Action | Intravenous: 4-6 hours; Oral: 6-8 hours (dose-dependent). |
| Molecular Weight | 362.46 |
Topical: Apply a thin film to affected skin areas twice daily. Maximum: 15 g per application; not to exceed 60 g per week.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for topical use; systemic absorption is minimal. |
| Liver impairment | No dosage adjustment required for topical use; systemic absorption is minimal. |
| Pediatric use | Children (≥12 years): Same as adult. Children (2-11 years): Apply a thin film to affected area once daily. Maximum: 7.5 g per application; not to exceed 30 g per week. |
| Geriatric use | No specific dose adjustment; use caution due to increased risk of skin atrophy and systemic absorption with prolonged use. |
| 1st trimester | Hydrocortisone (Pandel) is generally avoided in first trimester unless benefit outweighs risk; limited data suggest low teratogenic risk but topical use preferred. |
| 2nd trimester | May be used cautiously; systemic absorption is minimal with topical application, but chronic high-dose use may cause fetal adrenal suppression. |
| 3rd trimester | Avoid prolonged use of high-potency preparations near term due to risk of neonatal adrenal suppression; short-term low-potency use is considered safe. |
Clinical note
Comprehensive clinical and safety monograph for PANDEL (PANDEL).
| Placental transfer | Crosses placenta; degree depends on potency and application area. With topical use, systemic absorption is <1%, but with large area/occlusion, absorption increases. In animal studies, high doses cause fetal abnormalities. |
| Breastfeeding | Hydrocortisone is excreted into breast milk in small amounts; with topical application, systemic absorption is negligible, unlikely to affect the infant. Avoid applying to breast area before nursing. |
■ FDA Black Box Warning
None
| Serious Effects |
Untreated bacterial, fungal, or viral skin infectionsHypersensitivity to hydrocortisone or any componentPerioral dermatitisRosacea
| Precautions | Topical use only; not for ophthalmic, oral, or intravaginal use., Systemic absorption may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria, especially with prolonged use, large surface area application, occlusive dressings, or in pediatric patients., Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body-mass ratio., Local adverse reactions include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, maceration, and miliaria., May mask signs of infection; use caution in the presence of infection and discontinue if infection develops., Prolonged use may lead to development of tolerance or tachyphylaxis. |
| Food/Dietary | No significant food interactions. Grapefruit juice does not affect hydrocortisone probutate. Maintain a balanced diet as usual. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | Insufficient human data; animal studies not available. Based on drug class (topical corticosteroid), systemic absorption is minimal with short-term use on limited areas. Avoid prolonged use on large areas, occluded skin, or in first trimester due to theoretical risk of orofacial clefts (1st trimester) and intrauterine growth restriction or adrenal suppression (2nd/3rd trimester) with high-potency agents. |
| Fetal Monitoring | Monitor for signs of maternal systemic absorption (hyperglycemia, hypertension, electrolyte imbalances) if used extensively. Fetal monitoring: ultrasound for growth restriction if high-dose or prolonged use. |
| Fertility Effects | No known effects on fertility in humans; animal studies with systemic corticosteroids showed impaired fertility at high doses. |
| Clinical Pearls | PANDEL (hydrocortisone probutate) is a topical corticosteroid of medium potency. Apply sparingly to affected areas; avoid use on face, groin, axillae, or under occlusive dressings unless directed. Systemic absorption may occur with prolonged use on large areas or under occlusion, especially in pediatric patients. Monitor for skin atrophy, telangiectasias, and striae. Limit treatment duration to 2 weeks continuous therapy. Do not use in patients with untreated bacterial, fungal, or viral infections at the application site. |
| Patient Advice | Apply a thin layer to the affected skin only, usually twice daily. · Wash hands after application unless treating the hands. · Do not cover the treated area with bandages or other occlusive dressings unless instructed by your healthcare provider. · Avoid contact with eyes, mouth, and mucous membranes. · Do not use on broken or infected skin without consulting a doctor. · Tell your doctor if you are pregnant, breastfeeding, or planning to become pregnant. · Do not use for longer than prescribed; long-term use can cause skin thinning and other side effects. |