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calcipotriene/betamethasone (Taclonex Ointment, Enstilar, Taclonex Topical Suspension)

 

Classes: Antipsoriatics, Topical

Dosing and uses of Taclonex, Enstilar (calcipotriene/betamethasone)

 

Adult dosage forms and strengths

calcipotriene/betamethasone

topical ointment

  • 0.005%/0.064%

topical suspension

  • 0.005%/0.064%

topical foam (Enstilar)

  • 0.005%/0.064%

 

Plaque Psoriasis

Suspension (scalp and body): Apply to affected area(s) qDay for up to 8 weeks; may discontinue treatment earlier, if cleared; not to exceed 100 g/week

Ointment: Apply topical layer of ointment to affected area(s) qDay for up to 4 weeks; do not exceed 100 g/week

Foam: Apply topically to affected area(s) qDay for up to 4 weeks

 

Pediatric dosage forms and strengths

calcipotriene/betamethasone

topical suspension

  • 0.005%/0.064%

 

Plaque Psoriasis

Indicated for plaque psoriasis of the scalp

<12 years: Safety and efficacy not established

Suspension (12-17 years): Apply to affected area(s) qDay for up to 8 weeks; may discontinue treatment earlier, if cleared; do not exceed 60 g/week

 

Taclonex, Enstilar (calcipotriene/betamethasone) adverse (side) effects

1-10%

Pruritus (7.2%)

Worsening psoriasis (3.4%)

Skin atrophy (1.9%)

Folliculitis (1.4%)

Burning sensation (1.4%)

Skin depigmentation (1.4%)

Ecchymosis (1%)

Erythema (1%)

Hand dermatitis (1%)

 

Warnings

Contraindications

Hypersensitivity

Known or suspected disorders of calcium metabolism

Erythrodermic, exfoliative, and/or pustular psoriasis

 

Cautions

Hypercalcemia observed with use of calcipotriene

Discontinue if irritation develops

Do not apply to on face, axillae, or groin

Do not apply to areas of pre-existing skin atrophy

If concomitant skin infection present/develops, apply appropriate antifungal or antibacterial agent

Systemic absorption of topical corticosteroids

  • Avoid application over large surface areas, prolonged use, and occlusive dressings that may increase risk for corticosteroid adverse effects
  • Pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs and at greater risk of HPA axis suppression and adrenal insufficiency upon topical corticosteroid use
  • Excessive systemic absorption may cause HPA axis suppression, Cushing syndrome, hyperglycemia, glucosuria

 

Pregnancy and lactation

Pregnancy category: C

Lactation: unknown whether distributed in breast milk, safety during breast feeding not established

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Taclonex, Enstilar (calcipotriene/betamethasone)

Mechanism of action

Calcipotriene: In vitro evidence suggests drug is roughly equipotent to natural vitamin D in its effects on proliferation & differentiation of various cell types

Betamethasone: Corticosteroid; elicits anti-inflammatory, antipruritic, and vasoconstrictive properties

 

Administration

Instructions

Do not apply to face, axillae, or groin, or if skin atrophy is present at treatment site

Wash hands after application

Topical ointment

  • Rub ointment into skin gently and completely
  • Do not treat >30% of body surface area

Topical suspension

  • Shake bottle prior to use
  • Do not use with occlusive dressings unless directed by a physician