Calcipotriene/​Betamethasone

DEA Class; Rx

Common Brand Names; Taclonex Ointment, Enstilar, Taclonex Topical Suspension, Wynzora

Topical combination product containing a synthetic corticosteroid and vitamin D3 analog
Available as an ointment, foam, cream, and suspension
Ointment and foam approved for use up to 4 weeks; cream and suspension can be applied for up to 8 weeks

Indicated for topical treatment of plaque psoriasis

Hypersensitivity

Known or suspected disorders of calcium metabolism

Erythrodermic, exfoliative, and/or pustular psoriasis

Topical cream, adults

• Headache (20%)

• Nausea (13%)

Topical cream, 7 years and older

• Enuresis (18%)

• Nausea (17%)

• Headache (16%)

• Vomiting (16%)

• Weight decreased (12%)

• Decreased appetite (8%)

• Dizziness (6%)

Topical cream

• Dizziness (10%)

• Decreased appetite (8%)

• Parasomnia (6%)

• Diarrhea (6%)

• Hyperhidrosis (6%)

• Anxiety (5%)

• Vomiting (5%)

• Fatigue (4%)

• Dry mouth (4%)

• Depressed mood (4%)

• Enuresis (4%)

• Irritability (3%)

• Paresthesia (3%)

• Depression (3%)

• Tremor (3%)

• Somnolence (2%)

• Muscle spasms (2%)

Topical suspension

• Folliculitis (1%)

• Burning (1%)

• Topical ointment H4

• Pruritus (7.2%)

• Psoriasis (3.4%)

• Pruritus (2.8%)

• Skin atrophy (1.9%)

• Folliculitis (1.4%)

• Burning sensation (1.4%)

• Skin depigmentation (1.4%)

• Rash scaly (1.2%)

• Ecchymosis (1%)

• Erythema (1%)

• Hand dermatitis (1%)

Topical foam, adults

• Application site irritation (<1%)

• Application site pruritus (<1%)

• Folliculitis (<1%)

• Skin hypopigmentation (<1%)

• Hypercalcemia (<1%)

• Urticaria (<1%)

• Exacerbation of psoriasis (<1%)

• Topical foam, 12-17 years H4

• Acne, erythema, application site pain, and skin reactions (<1%)

Topical ointment

• Application site pruritus (0.5%)

• Erythema (0.4%)

• Skin irritation (0.4%)

• Burning sensation (0.2%)

• Skin atrophy, telangiectasia and skin hyperpigmentation (0.1%)

Hypercalcemia and hypercalciuria observed with use of calcipotriene

Allergic contact dermatitis observed; such an observation should be corroborated with appropriate diagnostic patch testingDiscontinue 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

Use of topical corticosteroids may increase risk of posterior subcapsular cataracts and glaucoma; avoid contact with eyes; may cause eye irritation; instruct patients to report visual symptoms to physician

There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; observational studies suggest an increased risk of low birthweight infants with use of potent or very potent topical corticosteroid during pregnancy

Advise a woman to apply drug to smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply drug directly to nipple and areola to avoid direct infant exposure