CLODERM

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CLODERM (CLODERM).

How it works

Cloderm (clocortolone pivalate) is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 inhibitory proteins (lipocortins), which inhibit arachidonic acid release, reducing prostaglandin and leukotriene synthesis.

What the body does with it

Metabolism	Topical corticosteroids undergo hepatic metabolism primarily via cytochrome P450 enzymes, followed by renal excretion of metabolites.
Excretion	Primarily hepatic metabolism followed by renal excretion of inactive metabolites; minimal unchanged drug excreted renally (<1%). Biliary/fecal excretion accounts for approximately 20% of total clearance.
Half-life	Terminal elimination half-life is 72-120 hours (3-5 days) for clobetasol propionate, reflecting slow release from skin depot after topical application; systemic half-life after intravenous administration is approximately 2-3 hours.
Protein binding	Highly protein-bound (98-99%), primarily to albumin and corticosteroid-binding globulin.
Volume of Distribution	After topical application, Vd is not clinically applicable due to local action. Systemic Vd after intravenous administration in small studies is approximately 1.0-1.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Topical bioavailability is variable and depends on skin condition, site, and occlusion; estimated at 1-5% through intact skin, but may increase to 20-30% with compromised skin barrier or occlusion.
Onset of Action	Topical: Improvement in pruritus and erythema noted within 1-2 days of twice-daily application; maximal effect on plaque thickness and scaling seen after 1-2 weeks.
Duration of Action	Topical: Therapeutic effect persists for 12-24 hours after a single application; with regular use, disease suppression may last days to weeks. Prolonged use (>2 weeks) increases risk of skin atrophy and systemic absorption.

Classification & Brands

Action Class	Glucocorticoids
Brand Substitutes	Topinate Cream, Lozivate Cream, Cortent Cream, Clobital Cream, Cortirate Cream

Dosing & administration

Topical: Apply a thin film to affected skin areas twice daily (morning and evening). Duration depends on severity and response.

Dosage form	CREAM
Renal impairment	No dosage adjustment required for renal impairment due to negligible systemic absorption with topical use.
Liver impairment	No dosage adjustment required for hepatic impairment due to negligible systemic absorption with topical use.
Pediatric use	Children ≥12 years: Same as adult dose. Children <12 years: Safety and efficacy not established, use only if potential benefit outweighs risk.
Geriatric use	Use with caution due to higher risk of skin atrophy and systemic side effects from prolonged use. Limit treatment duration and monitor closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CLODERM (CLODERM).

Breastfeeding	Excretion in human milk unknown; risk to infant cannot be excluded. Use with caution, weigh benefits vs risks. M/P ratio not reported.
Teratogenic Risk	FDA Pregnancy Category C. No adequate human studies; animal studies show fetal harm at high doses. Avoid in first trimester unless benefit outweighs risk.
Fetal Monitoring	Monitor fetal growth via ultrasound if used long-term during pregnancy; assess maternal blood pressure and glucose levels as corticosteroids may elevate both.

Warnings & precautions

■ FDA Black Box Warning

No FDA black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component of the formulation","untreated bacterial, fungal, or viral infections at the treatment site"]

Clinical Precautions

Precautions

["Systemic absorption may cause reversible HPA axis suppression","Cushing's syndrome","hyperglycemia","glucosuria","hypothalamic-pituitary-adrenal axis suppression","pediatric patients may be more susceptible to systemic toxicity","do not use on infected lesions unless anti-infective therapy is given"]

Clinical Tips & Counseling

Drug interactions

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CLODERM

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CLODERM (CLODERM).

How it works

What the body does with it

Metabolism	Topical corticosteroids undergo hepatic metabolism primarily via cytochrome P450 enzymes, followed by renal excretion of metabolites.
Excretion	Primarily hepatic metabolism followed by renal excretion of inactive metabolites; minimal unchanged drug excreted renally (<1%). Biliary/fecal excretion accounts for approximately 20% of total clearance.
Half-life	Terminal elimination half-life is 72-120 hours (3-5 days) for clobetasol propionate, reflecting slow release from skin depot after topical application; systemic half-life after intravenous administration is approximately 2-3 hours.
Protein binding	Highly protein-bound (98-99%), primarily to albumin and corticosteroid-binding globulin.
Volume of Distribution	After topical application, Vd is not clinically applicable due to local action. Systemic Vd after intravenous administration in small studies is approximately 1.0-1.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Topical bioavailability is variable and depends on skin condition, site, and occlusion; estimated at 1-5% through intact skin, but may increase to 20-30% with compromised skin barrier or occlusion.
Onset of Action	Topical: Improvement in pruritus and erythema noted within 1-2 days of twice-daily application; maximal effect on plaque thickness and scaling seen after 1-2 weeks.
Duration of Action	Topical: Therapeutic effect persists for 12-24 hours after a single application; with regular use, disease suppression may last days to weeks. Prolonged use (>2 weeks) increases risk of skin atrophy and systemic absorption.

Classification & Brands

Action Class	Glucocorticoids
Brand Substitutes	Topinate Cream, Lozivate Cream, Cortent Cream, Clobital Cream, Cortirate Cream

Dosing & administration

Topical: Apply a thin film to affected skin areas twice daily (morning and evening). Duration depends on severity and response.

Dosage form	CREAM
Renal impairment	No dosage adjustment required for renal impairment due to negligible systemic absorption with topical use.
Liver impairment	No dosage adjustment required for hepatic impairment due to negligible systemic absorption with topical use.
Pediatric use	Children ≥12 years: Same as adult dose. Children <12 years: Safety and efficacy not established, use only if potential benefit outweighs risk.
Geriatric use	Use with caution due to higher risk of skin atrophy and systemic side effects from prolonged use. Limit treatment duration and monitor closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for CLODERM (CLODERM).

Breastfeeding	Excretion in human milk unknown; risk to infant cannot be excluded. Use with caution, weigh benefits vs risks. M/P ratio not reported.
Teratogenic Risk	FDA Pregnancy Category C. No adequate human studies; animal studies show fetal harm at high doses. Avoid in first trimester unless benefit outweighs risk.
Fetal Monitoring	Monitor fetal growth via ultrasound if used long-term during pregnancy; assess maternal blood pressure and glucose levels as corticosteroids may elevate both.

Warnings & precautions

■ FDA Black Box Warning

No FDA black box warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component of the formulation","untreated bacterial, fungal, or viral infections at the treatment site"]