Calcipotriene and Betamethasone Ointment

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using calcipotriene and betamethasone ointment while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Itching.
• Burning.
• Redness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Apply an adequate layer of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment to the affected area(s) once daily for up to 4 weeks. Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment. Therapy should be discontinued when control is achieved.

Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Treatment of more than 30% body surface area is not recommended.

Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment is not for oral, ophthalmic, or intravaginal use.

Ointment, 0.005%/0.064%

Each gram of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in off-white to yellow paraffin ointment base.

 Hypercalcemia and Hypercalciuria

Hypercalcemia and hypercalciuria have been observed with use of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment. If hypercalcemia or hypercalciuria develops, treatment should be discontinued until parameters of calcium metabolism have normalized. In the trials that included assessment of the effects of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment on calcium metabolism following treatment durations of longer than 4 weeks have not been evaluated. [See Clinical Pharmacology (12.2)]  

Effects on Endocrine System

Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, concomitant use of more than one corticosteroid-containing product, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the cosyntropin stimulation test. [See Clinical Pharmacology (12.2)]

In a trial evaluating the effects of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Scalp Topical Suspension and Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment on the HPA axis, 32 adult subjects were treated with Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Scalp Topical Suspension on the scalp and Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment [see Clinical Pharmacology (12.2)]. The effects of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Cushing's syndrome and hyperglycemia may also occur due to the systemic effects of topical corticosteroids. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their higher skin surface to body mass ratios [see Use in Specific Populations (8.4), Clinical Pharmacology (12.2)].

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Allergic Contact Dermatitis with Topical Calcipotriene

Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Skin Irritation

If irritation develops, treatment with Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment should be discontinued and appropriate therapy instituted.

Risk of Ultraviolet Light Exposure

Patients who apply Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy in patients who use Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment.

Topically applied Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment can be absorbed in sufficient amounts to produce systemic effects [See Warnings and Precautions (5.1, 5.2)].

Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% contains calcipotriene hydrate and betamethasone propionate. It is intended for topical use only.

Calcipotriene hydrate is a synthetic vitamin D3 analogue.

Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene hydrate is a white to almost white crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to almost white odorless powder.

Each gram of Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum.

Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis

In an international, multi-center, double-blind, vehicle- and active-controlled, parallel-group trial, 1603 subjects with mild to very severe plaque psoriasis on trunk and limbs were treated once daily for 4 weeks. Subjects were randomized to one of four treatment arms: Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment, calcipotriene hydrate 50 mcg/g in the same vehicle, betamethasone dipropionate 0.64 mg/g in the same vehicle, and vehicle alone. The mean age of the subjects was 48.4 years and 60.5% were male. Most subjects had disease of moderate severity at baseline.

Efficacy was assessed as the proportion of subjects with absent or very mild disease according to the Investigator's Global Assessment of Disease Severity at end of treatment (4 weeks). "Absent" disease was defined as no evidence of redness, thickness, or scaling. "Very mild disease" was defined as controlled disease, but not entirely cleared: lesions with some discoloration with absolutely minimal thickness, i.e. the edges to the lesions(s) could just be felt. Table 3 contains the response rates for this trial.

Table 3

Percentage of Subjects with Absent or Very Mild Disease According to the Investigator's Global Assessment of Disease Severity at End of Treatment (4 weeks).*

*Subjects with mild disease at baseline were required to have "Absent" disease to be considered a success.


In addition to the pivotal trial (N = 490), four randomized, double-blind, vehicle- or active-controlled, parallel-group trials were conducted and provided supportive evidence of efficacy. These trials included a total of 1058 subjects treated with Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment once daily for up to 4 weeks.

Clinical Trial Conducted in Subjects 12 to 17 years with Plaque Psoriasis

A prospective, uncontrolled trial (N=33) was conducted in pediatric subjects ages 12 to 17 years with plaque psoriasis involving 5-30% of the body surface area. Approximately 91% of subjects had moderate disease at baseline. Subjects were treated once daily for up to 4 weeks with Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment. All subjects were evaluated for safety including calcium metabolism (N=33) and 32 subjects were evaluated for HPA axis suppression. [see Clinical Pharmacology (12.2)]