SYNALAR-HP
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SYNALAR-HP (SYNALAR-HP).
Corticosteroid that binds to glucocorticoid receptors, altering gene expression to inhibit inflammatory mediators (e.g., prostaglandins, leukotrienes) and suppress immune cell activity.
| Metabolism | Metabolized in the liver via CYP3A4; undergoes reduction, hydroxylation, and conjugation. |
| Excretion | Renal: 90% as metabolites; biliary/fecal: minimal (<5%) |
| Half-life | Terminal half-life: 2-3 hours (topical) due to rapid clearance; systemic half-life: 1-2 hours |
| Protein binding | 98% bound to albumin and corticosteroid-binding globulin |
| Volume of Distribution | 0.5-1.0 L/kg; reflects extensive tissue distribution with limited systemic exposure after topical use |
| Bioavailability | Topical: 1-5% systemic absorption (intact skin); 10-30% with occlusion or inflamed skin |
| Onset of Action | Topical: 2-7 days for clinical response (psoriasis, eczema) |
| Duration of Action | Topical: 1-2 weeks of sustained effect after discontinuation; clinical improvement continues with regular application |
| Molecular Weight | 394.46 |
Apply a thin film to the affected area once or twice daily for up to 2 weeks, using the lowest effective dose. Not for use under occlusive dressings or on large areas.
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for renal impairment as systemic absorption is minimal. |
| Liver impairment | No dose adjustment required for hepatic impairment due to minimal systemic absorption. |
| Pediatric use | Not recommended for use in children under 12 years of age due to increased risk of systemic toxicity. For children 12 years and older, apply a thin film to affected area once daily for a maximum of 5 days, using the smallest amount necessary. |
| Geriatric use | Use with caution in elderly patients due to increased risk of skin atrophy and systemic effects. Apply the smallest effective amount for the shortest duration necessary, not exceeding 2 weeks. |
| 1st trimester | Topical corticosteroids are generally avoided during the first trimester due to potential teratogenic risk, though the risk is low with short-term, low-potency use. Fluorinated corticosteroids like fluocinolone acetonide should be used only if clearly needed. |
| 2nd trimester | Use with caution; lowest potency and shortest duration necessary. Fluorinated corticosteroids may increase risk of fetal growth restriction with prolonged use. |
| 3rd trimester | Use with caution; avoid prolonged use or large areas to minimize systemic absorption and potential fetal effects (e.g., adrenal suppression). |
Clinical note
Comprehensive clinical and safety monograph for SYNALAR-HP (SYNALAR-HP).
| Placental transfer | Fluorinated corticosteroids cross the placenta to a variable extent; systemic absorption from topical application is generally low (<1%), but extensive use or broken skin may increase transfer. |
| Breastfeeding |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to any component of the formulationUntreated bacterial, fungal, or viral skin infectionsPerioral dermatitisRosaceaAcne vulgaris
| Precautions | Systemic absorption may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression., Local adverse reactions including atrophy, striae, and telangiectasia., Avoid use on face, groin, or axillae unless directed., Use caution in patients with impaired hepatic function., May mask signs of infection. |
| Food/Dietary | No known food interactions with topical fluocinolone acetonide. |
| Clinical Pearls |
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| Topical application to small areas for short periods is likely compatible with breastfeeding. Avoid application to the breast or nipple area to prevent infant ingestion. Risk of systemic effects in the infant is minimal with limited use. |
| Lactation Rating | L2: Safer |
| Teratogenic Risk | Corticosteroids, including fluocinolone acetonide, cross the placenta. Topical application may cause fetal growth restriction, adrenal suppression, and cleft palate in animal studies. First trimester: avoid unless benefit justifies risk (FDA Pregnancy Category C). Second/third trimester: use lowest potency, smallest amount, shortest duration due to risk of low birth weight and adrenal suppression. |
| Fetal Monitoring | Monitor for signs of adrenal suppression (e.g., hypotension, fatigue) in mother. For prolonged use (>2 weeks) or large areas, consider fetal ultrasound for growth assessment. In neonates exposed in utero, evaluate for transient adrenal suppression and hypoglycemia. |
| Fertility Effects | No specific human data on fertility impact. Animal studies with corticosteroids have shown reduced fertility and impaired implantation. Topical fluocinolone acetonide is unlikely to affect fertility due to minimal systemic absorption, but high-potency or prolonged use may theoretically cause hypothalamic-pituitary-adrenal axis suppression, potentially affecting ovulation. |
| SYNALAR-HP (fluocinolone acetonide, 0.2%) is a high-potency topical corticosteroid. Use cautiously on face, intertriginous areas, or for prolonged periods due to risk of atrophy and systemic absorption. Limit treatment to 2 weeks; do not exceed 60 g/week in adults. Occlusion significantly increases penetration and risk of adverse effects. |
| Patient Advice | Apply a thin film to affected area once or twice daily as directed. · Do not use on face, groin, or underarms unless specifically instructed. · Avoid covering the treated area with bandages or wraps unless advised. · Do not use for more than 2 weeks without re-evaluation. · Wash hands after application unless treating hands. · Inform your doctor if symptoms persist or worsen. |