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

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

Topical foam

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

Topical ointment

  • Taclonex, generic
  • 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

  • Taclonex, generic
  • 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
    • Taclonex, generic
    • 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
    • Taclonex, generic
    • 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
    • Enstilar
    • 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 achieved
    • Do not to exceed 60 grams every 4 days
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Interactions

Interaction Checker

and calcipotriene/betamethasone

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              Serious - Use Alternative (9)

              • adenovirus types 4 and 7 live, oral

                betamethasone decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Corticosteroids may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of corticosteroid therapy.

              • axicabtagene ciloleucel

                betamethasone decreases effects of axicabtagene ciloleucel by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid prophylactic use of systemic corticosteroids as premedication before axicabtagene ciloleucel. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.

              • influenza virus vaccine quadrivalent, adjuvanted

                betamethasone decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                betamethasone decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • lonafarnib

                betamethasone will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • macimorelin

                betamethasone, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH growth hormone release before administering prior to administration of macimorelin. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.

              • testosterone intranasal

                testosterone intranasal, betamethasone. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration increases risk for edema, particularly in patients with cardiac, renal, or hepatic disease.

              • tisagenlecleucel

                betamethasone decreases effects of tisagenlecleucel by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid using corticosteroids as premedication or during treatment with tisagenlecleucel, except for life-threatening emergence (eg, cytokine release syndrome).

              • tofacitinib

                betamethasone, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (58)

              • albiglutide

                betamethasone decreases effects of albiglutide by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully. .

              • atogepant

                betamethasone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • atracurium

                atracurium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              • avapritinib

                betamethasone will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                betamethasone increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belatacept

                belatacept and betamethasone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                betamethasone decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • ciprofloxacin

                betamethasone, ciprofloxacin. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • cisatracurium

                cisatracurium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              • cyclosporine

                betamethasone, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may increase or decrease cyclosporine concentrations. Also, cyclosporine may increase the plasma concentrations of the corticosteroids. Monitor for changes in cyclosporine concentrations and for toxicities of corticosteroids and/or cyclosporine.

              • deferasirox

                betamethasone, deferasirox. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.

              • dengue vaccine

                betamethasone decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                betamethasone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dichlorphenamide

                dichlorphenamide and betamethasone both decrease serum potassium. Use Caution/Monitor.

              • exenatide injectable solution

                betamethasone decreases effects of exenatide injectable solution by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully. .

              • exenatide injectable suspension

                betamethasone decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully.

              • finerenone

                betamethasone will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • flibanserin

                betamethasone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • gemifloxacin

                betamethasone and gemifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • glycerol phenylbutyrate

                betamethasone decreases effects of glycerol phenylbutyrate by Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels; monitor ammonia levels closely when glycerol phenylbutyrate is coadministered with corticosteroids.

              • hemin

                betamethasone decreases effects of hemin by pharmacodynamic antagonism. Use Caution/Monitor. Drugs that increase delta-aminolevulinic acid synthetase may decrease hemin effect.

              • indacaterol, inhaled

                betamethasone, indacaterol, inhaled. serum potassium. Use Caution/Monitor. Combination may increase risk of hypokalemia.

              • influenza A (H5N1) vaccine

                betamethasone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                betamethasone decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.

              • insulin degludec

                betamethasone decreases effects of insulin degludec by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Endogneous cortisol is a regulatory hormone that increases blood glucose levels; exogenous systemic corticosteroids have been associated with hyperglycemia and may cause diabetes with chronic, high dose use; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

              • insulin degludec/insulin aspart

                betamethasone decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Endogneous cortisol is a regulatory hormone that increases blood glucose levels; exogenous systemic corticosteroids have been associated with hyperglycemia and may cause diabetes with chronic, high dose use; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

              • insulin inhaled

                betamethasone decreases effects of insulin inhaled by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Endogneous cortisol is a regulatory hormone that increases blood glucose levels; exogenous systemic corticosteroids have been associated with hyperglycemia and may cause diabetes with chronic, high dose use; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

              • isavuconazonium sulfate

                betamethasone will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                betamethasone and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • ivacaftor

                betamethasone increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lemborexant

                betamethasone will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • levofloxacin

                betamethasone and levofloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • liraglutide

                betamethasone decreases effects of liraglutide by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids may diminish hypoglycemic effect of antidiabetic agents. Monitor blood glucose levels carefully. .

              • lomitapide

                betamethasone increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • lonapegsomatropin

                lonapegsomatropin decreases effects of betamethasone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.

                betamethasone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.

              • meningococcal group B vaccine

                betamethasone decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • metformin

                betamethasone decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

              • midazolam intranasal

                betamethasone will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • moxifloxacin

                betamethasone and moxifloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • ocrelizumab

                betamethasone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.

              • ofatumumab SC

                ofatumumab SC, betamethasone. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • ofloxacin

                betamethasone and ofloxacin both increase Other (see comment). Use Caution/Monitor. Coadministration of quinolone antibiotics and corticosteroids may increase risk of tendon rupture.

              • olodaterol inhaled

                betamethasone and olodaterol inhaled both decrease serum potassium. Use Caution/Monitor.

              • ozanimod

                ozanimod, betamethasone. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • pancuronium

                pancuronium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              • ponesimod

                ponesimod and betamethasone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • rocuronium

                rocuronium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              • sipuleucel-T

                betamethasone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                betamethasone, sodium picosulfate/magnesium oxide/anhydrous citric acid. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: May be associated with fluid and electrolyte imbalances such as hypokalemia.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of betamethasone by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of betamethasone by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol

                betamethasone and sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol both decrease serum potassium. Modify Therapy/Monitor Closely.

              • somapacitan

                somapacitan decreases effects of betamethasone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.

              • succinylcholine

                succinylcholine, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              • tazemetostat

                betamethasone will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tinidazole

                betamethasone will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, betamethasone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, betamethasone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • vecuronium

                vecuronium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.

              Minor (1)

              • ruxolitinib

                betamethasone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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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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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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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.
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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.