DAIVOBET OINTMENT 60G

Indications

Approved Uses

Topical treatment of stable plaque psoriasis vulgaris in adults

Dosage & Administration

Dosing by Condition

Plaque psoriasis (adults): apply once daily to affected areas for up to 4 weeks; do not exceed 100 g/week and avoid treating >30% body surface area; further/maintenance use only after clinical reassessment (intermittent or as directed).

Initial Dose

Apply a thin layer to affected areas once daily for up to 4 weeks

Maintenance Dose

Apply once daily; reassess after 4 weeks; may continue with clinical supervision up to 52 weeks

Maximum Dose

Maximum 15 g/day and 100 g/week; do not treat more than 30% body surface area

Children's Dosage

Approved for pediatric patients 12 to 17 years; instruct not to use more than 60 g per week

Dose Adjustment Notes

No routine renal/hepatic dose adjustment for topical use; limit total exposure (e.g., avoid large areas/occlusion), and reduce frequency or stop if hypercalcaemia (calcipotriol) or HPA-axis suppression/skin atrophy (betamethasone) is suspected; avoid face/groin/skin folds.

How to Take

Apply a thin layer to affected psoriasis plaques once daily and rub in gently; wash hands after use; avoid eyes/mucosa, face, groin/genitals, and skin folds; do not use under occlusion unless directed; allow to absorb and avoid washing/showering soon after application.

Side Effects

Common Side Effects

Application-site reactions such as pruritus, burning/stinging, irritation, erythema, dry skin, rash/exfoliation; with prolonged/excessive use: folliculitis and skin atrophy/striae.

Side Effect Frequency

Common (≥1% to <10%): application-site reactions such as pruritus, burning/irritation, erythema, and skin exfoliation. Uncommon (≥0.1% to <1%): folliculitis, contact dermatitis/dermatitis, worsening psoriasis (including pustular), skin infection, and longer-term steroid effects such as skin atrophy, telangiectasia, and striae. Rare: hypercalcaemia/hypercalciuria and HPA-axis suppression (risk increases with excessive dose/area/occlusion).

Safety & Warnings

Contraindications

Hypersensitivity to betamethasone dipropionate, calcipotriol, or excipients; disorders of calcium metabolism (e.g., hypercalcaemia/vitamin D toxicity); erythrodermic, exfoliative or pustular psoriasis; skin atrophy at treatment site.

Warnings & Precautions

Topical use only; avoid eyes and mucosa; avoid face/groin/axillae/skin folds unless specifically directed; do not use under occlusion; do not exceed 15 g/day, 100 g/week, or 30% BSA; avoid use on infected or significantly damaged skin unless infection is treated; prolonged/large-area use increases risk of HPA-axis suppression and hypercalcaemia-monitor if extensive use; wash hands after application and prevent transfer to others/infants

Age Restriction

Approved for use in patients 12 years and older

Drug Interactions

Food Interaction

No known food interactions (not applicable for topical administration).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Children

Approved for pediatric patients 12 to 17 years; instruct not to use more than 60 g per week

Storage & Patient Advice

Stopping the Medicine

Abrupt stopping is generally acceptable after short courses, but after prolonged/high-dose or extensive-area use, withdraw gradually to reduce rebound psoriasis and systemic corticosteroid effects

Overdose

Excessive topical use may cause hypercalcaemia and HPA-axis suppression/Cushingoid effects; management is to stop (or taper if prolonged steroid exposure), monitor calcium and adrenal function if symptomatic, and provide supportive care/medical evaluation

Patient Counseling

Apply a thin layer to psoriatic plaques once daily and rub in gently. Use on affected skin only; avoid face/eyes, genitals/groin, and skin folds, and do not apply to broken/infected skin. Wash hands after application. Do not use under occlusive dressings/bandages unless directed. Do not exceed 100 g per week and avoid treating large areas (e.g., >30% body surface) to reduce risk of systemic corticosteroid effects and hypercalcaemia. Limit UV/sun exposure on treated areas. Seek medical advice if severe irritation occurs or if symptoms of hypercalcaemia develop (e.g., excessive thirst/urination, constipation, weakness, confusion). Store below 30°C and keep the tube tightly closed.

Monitoring Requirements

Routine lab monitoring is not required for typical short-course use; if prolonged use, large surface area, high weekly amounts, or occlusion: monitor for local steroid effects (atrophy/striae), consider serum/urine calcium for hypercalcaemia risk, and assess for HPA-axis suppression if clinically indicated.

Pharmacology

Onset of Action

Improvement is often seen within 1-2 weeks, with maximal/near-maximal response typically by 4 weeks.

Bioavailability

Systemic absorption is generally low with recommended topical use; absorption increases with damaged/inflamed skin, large treated areas, prolonged use, or occlusion. Calcipotriol systemic absorption is typically <1% under normal conditions; betamethasone dipropionate absorption is variable and condition-dependent.

Product Information

Available Dosage Forms

Ointment (Daivobet, Taclonex); Gel (Daivobet gel); Cutaneous foam (calcipotriol/betamethasone marketed as Enstilar).

Composition per Dose

Per gram of ointment: Calcipotriol 50 µg + Betamethasone dipropionate 500 µg

OTC Alternatives

No OTC alternative

Skin Condition

Psoriasis

Steroid Potency

Potent

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