DERMOVATE CREAM 25G

Indications

Approved Uses

Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older; moderate to severe plaque-type psoriasis in patients 16 years of age or older

Dosage & Administration

Dosing by Condition

Severe psoriasis/eczema: Apply thin layer to affected area twice daily for up to 4 weeks. Scalp psoriasis (scalp application): Apply to scalp twice daily for up to 4 weeks. Maximum weekly dose: 50g per week across all formulations

Initial Dose

Apply a thin layer to the affected area once or twice daily.

Maintenance Dose

Once control is achieved, frequency may be reduced or treatment changed to a less potent steroid. For some conditions, intermittent dosing (e.g., twice weekly) may be used to prevent relapse.

Maximum Dose

50 g per week; maximum treatment duration 4 consecutive weeks

Children's Dosage

Use is not recommended in children younger than 12 years of age

Dose Adjustment Notes

Use the smallest effective amount for the shortest duration; do not use under occlusion unless directed; avoid use on large body surface areas

How to Take

Wash hands before and after application. Apply a thin layer to the affected skin area and rub in gently. Avoid contact with eyes, face, and mucous membranes. Do not cover with occlusive dressings unless instructed by a physician.

Side Effects

Common Side Effects

Local burning, stinging, itching, skin atrophy, striae, telangiectasia, dryness, folliculitis, hypertrichosis, hypopigmentation, perioral dermatitis, contact dermatitis

Side Effect Frequency

Common: burning, stinging, irritation, itching, skin atrophy. Less common: dryness, folliculitis, hypopigmentation, telangiectasia, secondary infection. Incidence not known: HPA axis suppression, Cushing's syndrome

Safety & Warnings

Contraindications

Hypersensitivity to clobetasol propionate or any excipient, rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, primary cutaneous viral infections (herpes simplex, chickenpox), primary bacterial or fungal skin infections, dermatoses in children under 1 year including napkin eruptions and infantile eczema, use on the face

Warnings & Precautions

Do not use on the face, groin, or axillae; avoid contact with eyes; do not use under occlusive dressings unless directed by physician; prolonged use can cause skin atrophy, striae, and telangiectasia; monitor for HPA axis suppression with extensive or prolonged use; withdraw gradually after long-term use; not for ophthalmic use; contains cetostearyl alcohol which may cause local skin reactions

Age Restriction

Not recommended in children younger than 12 years of age

Driving Warning

Safe

Drug Interactions

Drug Interactions

Other topical corticosteroids (additive systemic absorption risk); immunosuppressants (increased infection risk); ritonavir and itraconazole (CYP3A4 inhibitors may increase systemic exposure if significant absorption occurs)

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Use is not recommended in children younger than 12 years of age

Elderly

Use with caution; elderly patients have thinner, more fragile skin increasing risk of atrophy and systemic absorption; use minimum effective dose for shortest duration

Kidney Impairment

The greater frequency of decreased renal function in the elderly may delay elimination if systemic absorption occurs; the minimum quantity should be used for the shortest duration.

Storage & Patient Advice

Missed Dose

Apply as soon as remembered; if close to the time of the next application, skip the missed dose and resume the regular schedule; do not double the amount applied

Stopping the Medicine

Do not stop abruptly after prolonged use - taper frequency gradually to avoid rebound flare and adrenal insufficiency

Overdose

Topically applied clobetasol propionate can be absorbed in sufficient amounts to produce systemic effects like HPA axis suppression and Cushing's syndrome. Treatment is symptomatic and supportive.

Patient Counseling

Use only on the affected skin area as directed; do not apply to the face, underarms, or groin unless specifically instructed. Apply a thin layer only - more is not better. Do not use for longer than 4 weeks without medical review. Do not cover the treated area with bandages or wraps unless told to do so. Wash hands after each application. Avoid contact with eyes. Report any signs of skin thinning, stretch marks, or worsening of the condition. Do not use on infected skin without appropriate antimicrobial treatment. Keep out of reach of children.

Monitoring Requirements

Monitor for signs of HPA axis suppression (fatigue, weakness, hypotension) with prolonged or extensive use; monitor for local skin atrophy; periodic reassessment of treatment necessity

Pharmacology

Mechanism of Action

Binds to intracellular glucocorticoid receptors, suppressing transcription of pro-inflammatory cytokines and mediators; reduces capillary permeability, inhibits leukocyte migration, and decreases proliferation of keratinocytes

Bioavailability

Topical absorption is low under normal conditions; significantly increased with occlusion, inflamed skin, or large surface area application

Metabolism

Hepatic metabolism; metabolized to less active compounds

Excretion

Renal and fecal excretion of metabolites

Product Information

Available Dosage Forms

Cream

Composition per Dose

Each gram of cream: 0.5 mg clobetasol propionate (0.05%) in a cream base

Generic Availability

Yes

OTC Alternatives

Hydrocortisone 1% cream (mild corticosteroid for less severe conditions); emollients for symptomatic relief

Skin Condition

Eczema, Psoriasis

Steroid Potency

Very Potent

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