Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (13)
- 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, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Consider the use of prophylactic corticosteroid in patients after weighing the potential benefits and risks. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- brexucabtagene autoleucel
betamethasone, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- ciltacabtagene autoleucel
betamethasone, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- idecabtagene vicleucel
betamethasone, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. 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.
- lisocabtagene maraleucel
betamethasone, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- 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, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid prophylactic use of systemic corticosteroids as premedication before CAR-T cell therapy. Corticosteroids may, however, be required for treatment of cytokine release syndrome or neurologic toxicity.
- tofacitinib
betamethasone, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (62)
- 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: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - 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.
- nirmatrelvir
nirmatrelvir will increase the level or effect of betamethasone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).
- nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will increase the level or effect of betamethasone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).
- 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. .
- ublituximab
ublituximab and betamethasone both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- vecuronium
vecuronium, betamethasone. Other (see comment). Use Caution/Monitor. Comment: Coadministration of corticosteroids and neuromuscular blockers may increase risk of developing acute myopathy.
- warfarin
betamethasone increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (2)
- ruxolitinib
betamethasone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ruxolitinib topical
betamethasone will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
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
Warnings
Contraindications
None listed in manufacturer's labeling
Cautions
Hypercalcemia and hypercalciuria observed with 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 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 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
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 use of phototherapy in patients who use ointment
Effects on endocrine system
- Therapy can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with 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 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 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 & 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.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
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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