calcipotriene/betamethasone (Rx)

Brand and Other Names:Taclonex Ointment, Enstilar, more...Taclonex Topical Suspension, Wynzora
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

calcipotriene/betamethasone

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

Indicated for topical treatment of plaque psoriasis

Topical cream

  • Apply to affected areas qDay for up to 8 weeks
  • Discontinue when control is achieved
  • Not to exceed 100 grams/week

Topical foam

  • Apply to affected areas qDay for up to 4 weeks
  • Discontinue when control is achieved
  • Not to exceed 60 grams every 4 days

Topical ointment

  • Apply to affected area(s) qDay for up to 4 weeks
  • Not to exceed 100 grams/week
  • Not recommended for treatment of >30% body surface area

Topical suspension

  • Apply to affected area(s) qDay for up to 8 weeks
  • Not to exceed 100 grams/week

Dosage Forms & Strengths

calcipotriene/betamethasone

topical ointment

  • 0.005%/0.064% (Taclonex, generic)

topical suspension

  • 0.005%/0.064% (Taclonex)

topical foam

  • 0.005%/0.064% (Enstilar)

Plaque Psoriasis

<12 years: Safety and efficacy not established

≥12 years

  • Topical suspension
    • Indicated for plaque psoriasis of the scalp and body in patients aged ≥12 years
    • Apply to affected area(s) qDay for up to 8 weeks; not to exceed 60 g/week
  • Topical ointment
    • Indicated for topical treatment of plaque psoriasis in patients aged ≥12 years
    • Apply topically to affected area(s) qDay for up to 4 weeks; not to exceed 60 g/week
    • Not recommended for treatment of >30% body surface area ;
  • Topical foam
    • Indicated for topical treatment of plaque psoriasis in patients aged ≥12 years
    • Apply to affected areas qDay for up to 4 weeks
    • Discontinue when control is achieved
    • Do not to exceed 60 grams every 4 days
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Interactions

Interaction Checker

and calcipotriene/betamethasone

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            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%)

            1-10%

            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%)

            <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%)

            Postmarketing Reports

            For topical corticosteroid: Atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria

            Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported during use of topical corticosteroids, including topical betamethasone products

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            Warnings

            Contraindications

            Hypersensitivity

            Known or suspected disorders of calcium metabolism

            Erythrodermic, exfoliative, and/or pustular psoriasis

            Cautions

            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

            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
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            Pregnancy & Lactation

            Pregnancy

            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 ot be low

            Animal data

            • Observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids
            • Advise pregnant females may increase the potential risk of having a low birth weight infant and to use on the smallest area of skin and for the shortest duration possible

            Lactation

            There is no information regarding presence of topically administered calcipotriene and betamethasone dipropionate in human milk, effects on breastfed infant, or on 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 breastfed infant via breast milk, use drug on smallest area of skin and for shortest duration possible while breastfeeding

            Advise breastfeeding females not to apply drug directly to nipple and areola to avoid direct infant exposure

            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.

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            Pharmacology

            Mechanism of Action

            Topical agent combines the pharmacological effects of calcipotriene as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid

            However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in plaque psoriasis are unknown

            Absorption

            Calcipotriene

            • Peak plasma concentration: 30 pg/mL (Week 4); 30 pg/mL (MC1080 [major metabolite])
            • AUC: 229 pg·hr/mL (Week 4); 224 pg·hr/mL (MC1080)

            Betamethasone

            • Peak plasma concentration: 22 pg/mL (Week 4); 96 pg/mL (B17P [major metabolite])
            • AUC: 160 pg·hr/mL (Week 4); 419 pg·hr/mL (B17P)

            Metabolism

            Calcipotriene

            • Metabolism following systemic uptake is rapid and occurs in the liver
            • Primary metabolites of calcipotriene are less potent than the parent compound
            • Metabolized to MC1046 (the α,ß-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog)
            • MC1080 is the major metabolite in plasma; slowly metabolized to calcitroic acid

            Betamethasone

            • Metabolized by hydrolysis to betamethasone 17-propionate and betamethasone, including the 6ß-hydroxy derivatives of those compounds
            • Betamethasone17­propionate (B17P) is the primary metabolite
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            Administration

            Topical Administration

            Not for oral, ophthalmic, or intravaginal use

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

            Do not use with occlusive dressings unless directed by a healthcare provider

            Wash hands after application

            Topical cream

            • Apply to affected areas
            • Rub in gently to ensure that the plaques are saturated with the cream

            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
            • Do not apply to scalp within 12 hr before or after any chemical treatment to the hair

            Topical foam

            • Rub foam into affected area(s) gently

            Storage

            • Topical foam, suspension, cream, or ointment: Store at 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.