calcitriol topical (Rx)

>10%

Hypercalcemia (24%)

1-10%

Urine abnormality (4%)

Psoriasis (4%)

Hypercalciuria (3%)

Skin discomfort (3%)

Pruritus (1%)

Postmarketing Reports

Acute blistering dermatitis

Erythema

Skin burning sensation

Contraindications

None

Cautions

In controlled clinical trials hypercalcemia was observed; increased absorption may occur with occlusive dressings; caution if coadministered with medications known to increase serum calcium level (eg, thiazide diuretics, calcium supplements, high-dose vitamin D)

Pregnancy

Available data of oral and IV calcitriol use in pregnant females have not identified a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes

Animal data

• Topical administration of calcitriol to pregnant rabbits during organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities
• Available data do not allow the calculation of relevant comparisons between the systemic exposures of calcitriol observed in animal studies to the systemic exposures that would be expected in humans after topical use

Lactation

No data available on presence in human milk, effects on breastfed infants, or on milk production

Advise breastfeeding women not to apply ointment directly to nipple and areola to avoid direct infant exposure

Unknown whether topical administration could result in sufficient systemic absorption to produce detectable quantities in human milk

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.

Mechanism of Action

Vitamin D analog

Mechanism of action for psoriasis has not established

Topical Administration

Do not apply to the eyes, lips, or facial skin

Topical use only

Not for oral, ophthalmic, or intravaginal use

Storage H3

Store at room temperature 68-77ºF (20-25ºC); excursions permitted to 59-86ºF (15-30ºC)

Do not freeze or refrigerate