TEMOVATE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEMOVATE (TEMOVATE).

How it works

Corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to inhibit inflammatory mediators (prostaglandins, leukotrienes) and suppress immune response.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; metabolites are excreted in urine and feces.
Excretion	Primarily renal; less than 10% as unchanged drug, majority as metabolites. Fecal elimination is minimal (<5%).
Half-life	Terminal half-life approximately 36-54 hours, with clinical context indicating prolonged skin retention due to high lipophilicity and slow release from stratum corneum.
Protein binding	Extensive (>99%) binding to plasma proteins, including albumin and corticosteroid-binding globulin.
Volume of Distribution	Volume of distribution not well characterized for topical administration due to limited systemic absorption; for iv data, Vd approximately 0.5-1 L/kg, indicating distribution into total body water and some tissue binding.
Bioavailability	Topical: Systemic bioavailability varies widely (1-5% in intact skin, up to 30-50% in inflamed or occluded skin).
Onset of Action	Topical: within 24-48 hours for reduction of inflammation and pruritus.
Duration of Action	Duration of action after single topical application lasts 1-2 weeks, but clinical improvement often requires daily application for 2-4 weeks; note that prolonged use may lead to tachyphylaxis.

Classification & Brands

Dosing & administration

Apply a thin layer to affected skin areas twice daily (morning and evening). Maximum duration of treatment is 2 consecutive weeks. Do not use more than 50 g per week.

Dosage form	SOLUTION
Renal impairment	No data available; no specific dose adjustment recommendations for renal impairment.
Liver impairment	No data available; caution advised in severe hepatic impairment due to potential for increased systemic absorption.
Pediatric use	Safety and efficacy not established in pediatric patients below 12 years of age. For children 12 years and older, same adult dosing applies with caution (maximum 2 weeks, limited to small areas).
Geriatric use	Use with caution; apply sparingly to smallest affected area for shortest duration due to increased skin atrophy risk.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TEMOVATE (TEMOVATE).

Breastfeeding	Systemic absorption is low after topical application, but avoid application to breast area. No M/P ratio available. Use with caution; monitor infant for signs of HPA suppression (e.g., poor weight gain, growth retardation).
Teratogenic Risk	Insufficient human data; animal studies show cleft palate and fetal growth retardation at topical doses. Risk cannot be excluded; use only if benefit outweighs risk. First trimester: avoid if possible. Second/third trimesters: avoid prolonged use on large areas or occluded skin due to potential fetal HPA suppression.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to clobetasol propionate or any component","Untreated bacterial, fungal, viral, or parasitic skin infections","Prolonged use in children (risk of growth suppression)"]

Clinical Precautions

Precautions

["Reversible HPA axis suppression with prolonged use or large surface area","Cushing's syndrome from systemic absorption","Local adverse reactions: skin atrophy, striae, telangiectasias, acneiform eruptions","Prolonged use may increase risk of secondary infections","Avoid use on face, groin, axillae, or under occlusive dressings unless directed"]

Clinical Tips & Counseling

Drug interactions

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TEMOVATE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEMOVATE (TEMOVATE).

How it works

Corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to inhibit inflammatory mediators (prostaglandins, leukotrienes) and suppress immune response.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4; metabolites are excreted in urine and feces.
Excretion	Primarily renal; less than 10% as unchanged drug, majority as metabolites. Fecal elimination is minimal (<5%).
Half-life	Terminal half-life approximately 36-54 hours, with clinical context indicating prolonged skin retention due to high lipophilicity and slow release from stratum corneum.
Protein binding	Extensive (>99%) binding to plasma proteins, including albumin and corticosteroid-binding globulin.
Volume of Distribution	Volume of distribution not well characterized for topical administration due to limited systemic absorption; for iv data, Vd approximately 0.5-1 L/kg, indicating distribution into total body water and some tissue binding.
Bioavailability	Topical: Systemic bioavailability varies widely (1-5% in intact skin, up to 30-50% in inflamed or occluded skin).
Onset of Action	Topical: within 24-48 hours for reduction of inflammation and pruritus.
Duration of Action	Duration of action after single topical application lasts 1-2 weeks, but clinical improvement often requires daily application for 2-4 weeks; note that prolonged use may lead to tachyphylaxis.

Classification & Brands

Dosing & administration

Apply a thin layer to affected skin areas twice daily (morning and evening). Maximum duration of treatment is 2 consecutive weeks. Do not use more than 50 g per week.

Dosage form	SOLUTION
Renal impairment	No data available; no specific dose adjustment recommendations for renal impairment.
Liver impairment	No data available; caution advised in severe hepatic impairment due to potential for increased systemic absorption.
Pediatric use	Safety and efficacy not established in pediatric patients below 12 years of age. For children 12 years and older, same adult dosing applies with caution (maximum 2 weeks, limited to small areas).
Geriatric use	Use with caution; apply sparingly to smallest affected area for shortest duration due to increased skin atrophy risk.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TEMOVATE (TEMOVATE).

Breastfeeding	Systemic absorption is low after topical application, but avoid application to breast area. No M/P ratio available. Use with caution; monitor infant for signs of HPA suppression (e.g., poor weight gain, growth retardation).
Teratogenic Risk	Insufficient human data; animal studies show cleft palate and fetal growth retardation at topical doses. Risk cannot be excluded; use only if benefit outweighs risk. First trimester: avoid if possible. Second/third trimesters: avoid prolonged use on large areas or occluded skin due to potential fetal HPA suppression.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to clobetasol propionate or any component","Untreated bacterial, fungal, viral, or parasitic skin infections","Prolonged use in children (risk of growth suppression)"]