Calcipotriene/Betamethasone

Calcipotriene-Betamethasone is a prescription medication used for the topical treatment of plaque psoriasis. 

• Calcipotriene-Betamethasone is available under the following different brand names: Taclonex Ointment, Enstilar, Taclonex Topical Suspension, Wynzora

Common side effects of Calcipotriene-Betamethasone include:

• Itching,
• burning,
• redness,
• skin irritation

Serious side effects of Calcipotriene-Betamethasone include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Skin thinning,
• Skin discoloration,
• Stretch marks,
• Swelling or inflammation of the hair pores,
• Worsening of psoriasis,
• Mood changes,
• Unexplained constipation,
• Unusual or extreme tiredness,
• Weight loss,
• Headache,
• Swelling of the ankles or feet,
• Increased thirst and urination,
• Vision problems, and
• Severe dizziness

Rare side effects of Calcipotriene-Betamethasone include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cream

• 0.005%/0.064% (Wynzora)

Topical ointment

• 0.005%/0.064% (Taclonex, generic)

Topical suspension

• 0.005%/0.064% (Taclonex)

Topical foam

• 0.005%/0.064% (Enstilar)

Plaque Psoriasis

Adult dosage

• Topical cream
• Wynzora
  • Apply to affected areas once a day for up to 8 weeks.
  • Discontinue when control is achieved.
  • Not to exceed 100 grams per week
• Topical foam
• Enstilar
  • Apply to affected areas once a day for up to 4 weeks.
  • Discontinue when control is achieved.
  • Not to exceed 60 grams every 4 days
• Topical ointment
• Taclonex, generic
  • Apply to the affected area(s) once a day for up to 4 weeks.
  • Not to exceed 100 grams per week
  • Not recommended for treatment of above 30% body surface area
• Topical suspension
• Taclonex, generic
  • Apply to the affected area(s) once a day for up to 8 weeks.
  • Not to exceed 100 grams per week

Pediatric dosage

• Below 12 years: Safety and efficacy not established.
• 12 years and above:
  • Topical suspension
  • Taclonex, generic
    • Apply to the affected area(s) once daily for up to 8 weeks; not exceeding 60 g per week.
  • Topical ointment
  • Taclonex, generic
    • Apply topically to the affected area(s) once a day for up to 4 weeks; not to exceed 60 g per week.
    • Not recommended for treatment of above 30% body surface area
• Topical foam
• Enstilar
  • Apply to affected areas once a day for up to 4 weeks.
  • Discontinue when control is achieved.
  • Do not exceed 60 grams every 4 days.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Calcipotriene-Betamethasone has severe interactions with no other drugs.
• Calcipotriene-Betamethasone has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • lisocabtagene maraleucel
  • lonafarnib
  • macimorelin
  • testosterone intranasal
  • tisagenlecleucel
  • tofacitinib
• Calcipotriene-Betamethasone has moderate interactions with at least 62 other drugs.
• Calcipotriene-Betamethasone has minor interactions with the following drugs:
  • ruxolitinib
  • ruxolitinib topical

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed in the manufacturer's labeling.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Calcipotriene-Betamethasone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Calcipotriene-Betamethasone?”

Cautions

• Hypercalcemia and hypercalciuria observed with the use of calcipotriene; if hypercalcemia or hypercalciuria develops, discontinue treatment until parameters of calcium metabolism have normalized.
• The propellants in foam formulation are flammable; instruct the patient to avoid fire, flame, and smoking during and immediately following application.
• Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids; allergic contact dermatitis to topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation; corroborate such an observation with appropriate diagnostic patch testing; if irritation develops, treatment should be discontinued, and appropriate therapy instituted.
• Do not apply it to on face, axillae, or groin.
• Do not apply to areas of pre-existing skin atrophy.
• If a concomitant skin infection is present/develops, apply an appropriate antifungal or antibacterial agent.
• Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma; avoid contact with eyes; may cause eye irritation; instruct patients to report visual symptoms to the physician.
• Patients who apply 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 the use of phototherapy in patients who use ointment.
• Effects on the endocrine system
  • Therapy can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical Gluco corticosteroid 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; 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 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.
  • Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pregnancy and Lactation

• Available data are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes.
• However, systemic exposure to calcipotriene after topical administration is likely to be low.
• Lactation
  • There is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, its effects on the breastfed infant, or milk production.
  • Unknown whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
  • To minimize potential exposure to the breastfed infant via breast milk, use the drug on the smallest area of skin and for the shortest duration possible while breastfeeding.
  • Advise breastfeeding females not to apply drugs directly to the nipple and areola to avoid direct infant exposure.