CALMURID HC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CALMURID HC (CALMURID HC).
Calmurid HC contains hydrocortisone, a corticosteroid that suppresses inflammatory responses by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis, and modulating cytokine production. Urea acts as a keratolytic agent, softening and hydrating the stratum corneum.
| Metabolism | Hydrocortisone is metabolized primarily in the liver via reduction, conjugation (glucuronidation and sulfation), and oxidation. Urea is metabolized via the urea cycle in the liver. |
| Excretion | Renal excretion of unchanged drug and metabolites accounts for approximately 70-80% of the administered dose. Biliary/fecal elimination constitutes 20-30%, primarily as glucuronide conjugates and oxidized metabolites. |
| Half-life | Terminal elimination half-life is 3-5 hours in adults with normal renal function. Clinically, this supports a dosing interval of 6-8 hours to maintain therapeutic plasma concentrations. |
| Protein binding | Approximately 85-90% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.5-0.8 L/kg, indicating distribution into total body water and some tissue binding. |
| Bioavailability | Oral: 60-70% (due to first-pass metabolism); Topical: 5-10% (dependent on formulation and application site); Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-15 minutes; Topical: 1-2 hours. |
| Duration of Action | Oral/IV: 6-8 hours, with analgesic effects lasting up to 12 hours in some patients. Topical: 4-6 hours. |
| Molecular Weight | 362.46 Da (for hydrocortisone; CALMURID HC is a combination, but active steroid component is hydrocortisone) |
10 mg orally three times daily; topical: apply thin film to affected area twice daily.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment necessary for GFR ≥30 mL/min; avoid use in GFR <30 mL/min due to lack of data. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Not recommended for children under 12 years; for ages 12-18, same as adult dosing. |
| Geriatric use | Initiate at 5 mg twice daily; titrate cautiously due to increased risk of adverse effects. |
| 1st trimester | No adequate studies in pregnant women; benefits may outweigh risks in severe conditions. |
| 2nd trimester | Use only if clearly needed; potential for fetal adrenal suppression with prolonged use. |
| 3rd trimester | Avoid chronic use; risk of neonatal adrenal suppression if used near term. |
Clinical note
Comprehensive clinical and safety monograph for CALMURID HC (CALMURID HC).
| Placental transfer | Crosses placenta; readily transferred to fetal circulation. |
| Breastfeeding | Excreted in human milk; use with caution, especially with high doses or prolonged use. Monitor infant for growth and development. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any componentUntreated bacterial, viral, or fungal infections
| Precautions | Prolonged use may lead to skin atrophy, striae, and systemic absorption. Avoid use on infected skin unless appropriate antimicrobial therapy is concurrently administered. Use with caution in pediatric patients due to higher risk of HPA axis suppression. |
| Food/Dietary | No clinically significant food interactions known for topical corticosteroids or pramoxine. No dietary restrictions required. |
| Clinical Pearls |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | Pregnancy Category C. No adequate studies in pregnant women. In animal studies, corticosteroids have been shown to be teratogenic at low doses. First trimester: Increased risk of cleft palate. Second and third trimesters: Fetal adrenal suppression, intrauterine growth restriction. Consider risk vs benefit. |
| Fetal Monitoring | Monitor fetal growth (ultrasound) and adrenal function in neonates. Assess maternal blood glucose, blood pressure, and signs of infection. Consider fetal heart rate monitoring during prolonged use. |
| Fertility Effects | Corticosteroids may impair fertility by affecting gonadotropin secretion and ovarian function. Reversible upon discontinuation. |
| CALMURID HC (hydrocortisone acetate 1% with pramoxine HCl 1%) is a topical corticosteroid combined with an anesthetic for relief of inflammatory and pruritic dermatoses. Avoid use on infected lesions unless concurrent anti-infective therapy is given. Limit use to 2 weeks; prolonged use may cause skin atrophy. Do not use on face, groin, or axillae without caution. |
| Patient Advice | Apply thin layer to affected area as directed; do not overuse. · Avoid contact with eyes; if occurs, rinse thoroughly with water. · Do not cover with bandage or occlusive dressing unless instructed. · Report any signs of infection (redness, swelling, pus) or worsening symptoms. · Do not use for more than 2 weeks unless directed by a healthcare provider. |