(bay ta METH a sone)
Dermatoses: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dermatoses of the scalp (foam): Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
Plaque psoriasis (spray; patch [Canadian product]): Treatment of mild to moderate plaque psoriasis in patients 18 years and older.
Hypersensitivity to betamethasone, other corticosteroids, or any component of the formulation
Patch [Canadian product]: Additional contraindications: Viral (eg, herpes or varicella) lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations; <18 years of age
Note: Base dosage on severity of disease and patient response. Use lowest dose possible for shortest period of time to avoid HPA axis suppression. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical:
Cream, augmented formulation: Betamethasone dipropionate 0.05%: Apply once or twice daily (maximum: 50 g weekly).
Cream, unaugmented formulation:
Betamethasone dipropionate 0.05%: Apply once daily; may increase to twice daily if needed
Betamethasone valerate 0.1%: Apply 1 to 3 times daily. Note: Once- or twice-daily applications are usually effective.
Foam: Apply to the scalp twice daily, once in the morning and once at night. Note: Reassess if no improvement after 2 weeks of treatment.
Gel, augmented formulation: Apply once or twice daily; rub in gently (maximum: 50 g weekly). Note: Reassess if no improvement after 2 weeks of treatment.
Lotion, augmented formulation: Betamethasone dipropionate 0.05%: Apply a few drops once or twice daily (maximum: 50 mL weekly). Note: Reassess if no improvement after 2 weeks of treatment.
Lotion, unaugmented formulation:
Betamethasone dipropionate 0.05%: Apply a few drops twice daily
Betamethasone valerate 0.1%: Apply a few drops twice daily; may consider increasing dose for resistant cases. Following improvement, may apply once daily.
Ointment, augmented formulation: Betamethasone dipropionate 0.05%: Apply once or twice daily (maximum: 50 g weekly). Note: Reassess if no improvement after 2 weeks of treatment.
Ointment, unaugmented formulation:
Betamethasone dipropionate 0.05%: Apply once daily; may increase to twice daily if needed
Betamethasone valerate 0.1%: Apply 1 to 3 times daily. Note: Once- or twice-daily applications are usually effective.
Plaque psoriasis: Topical:
Patch [Canadian product]: Betamethasone valerate: Apply 1 patch (2.25 mg) to each affected area once daily [up to 5 patches (11.25 mg) may be applied daily]; maximum duration of therapy: 30 days.
Spray, unaugmented formulation: Betamethasone dipropionate 0.05%: Apply twice daily for up to 4 weeks
Refer to adult dosing. Use the lowest effective dose.
Note: Base dosage on severity of disease and patient response. Use lowest dose possible for shortest period of time to avoid HPA axis suppression. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical:
Children: Cream, lotion or ointment: Unaugmented formulation: Refer to adult dosing.
Adolescents: Cream, gel, lotion, or ointment: Augmented formulation: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Topical:
Cream, ointment: Apply topical sparingly to affected areas. Not for use on broken skin or in areas of infection. Do not apply to wet skin unless directed; do not cover with occlusive dressing. Do not apply very high potency agents to face, groin, axillae, or diaper area. Not for oral, ophthalmic, or intravaginal use.
Lotion: Apply topical sparingly to affected areas. Massage in gently until lotion disappears. Not for use on broken skin or in areas of infection. Do not apply to wet skin unless directed; do not cover with occlusive dressing. Do not apply very high potency agents to face, groin, axillae, or diaper area. Not for oral, ophthalmic, or intravaginal use.
Foam: Invert can and dispense a small amount onto a saucer or other cool surface. Do not dispense directly into hands. Pick up small amounts of foam and gently massage into affected areas until foam disappears. Repeat until entire affected scalp area is treated. Do not cover with occlusive dressing unless directed otherwise by health care provider. Not for ophthalmic use. Avoid getting into eyes.
Patch [Canadian product]: Clean and dry area to be treated prior to each application. May cut patch to size to cover lesion. Peel off protective film and apply adhesive medicated side to affected area; patch should be worn for 20 to 24 hours. After removing patch wait at least 30 minutes before applying a new one. Keep dry; if patch becomes wet, remove and wait until next scheduled dose before applying a new one. Do not cover with occlusive dressing. Patch should not be reused if it comes off; if edges of patch start to lift, apply medical adhesive tape to detached part only.
Spray: Spray directly onto affected areas (spray only enough to sufficiently cover the area); rub in gently and wash hands after applying. Shake well before use. Do not use if atrophy is present at the treatment site. Do not cover with occlusive dressing unless directed otherwise by health care provider. For topical use only; not for oral, ophthalmic or vaginal use; avoid use on the face, scalp, axilla, groin, or other intertriginous areas.
Cream, lotion, ointment, spray: Store at 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Discard any unused spray after 4 weeks.
Foam: Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Avoid fire, flame, or smoking during use. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 49 ‚ °C (120 ‚ °F).
Patch [Canadian product]: Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F). Use immediately after opening sachet.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as dipropionate [strength expressed as base]:
Generic: 0.05% (15 g, 45 g)
Cream, External, as dipropionate augmented [strength expressed as base]:
Diprolene AF: 0.05% (15 g, 50 g)
Generic: 0.05% (15 g, 50 g)
Cream, External, as valerate [strength expressed as base]:
Generic: 0.1% (15 g, 45 g)
Emulsion, External, as dipropionate [strength expressed as base]:
Sernivo: 0.05% (120 mL) [contains cetostearyl alcohol, methylparaben, propylparaben]
Foam, External, as valerate:
Luxiq: 0.12% (50 g, 100 g) [contains alcohol, usp, cetyl alcohol, propylene glycol]
Generic: 0.12% (50 g, 100 g)
Gel, External, as dipropionate augmented [strength expressed as base]:
AlphaTrex: 0.05% (15 g, 50 g)
Generic: 0.05% (15 g, 50 g)
Lotion, External, as dipropionate [strength expressed as base]:
Generic: 0.05% (60 mL)
Lotion, External, as dipropionate augmented [strength expressed as base]:
Diprolene: 0.05% (30 mL, 60 mL) [contains isopropyl alcohol, propylene glycol]
Generic: 0.05% (30 mL, 60 mL)
Lotion, External, as valerate [strength expressed as base]:
Generic: 0.1% (60 mL)
Ointment, External, as dipropionate [strength expressed as base]:
Generic: 0.05% (15 g, 45 g)
Ointment, External, as dipropionate augmented [strength expressed as base]:
Diprolene: 0.05% (15 g, 50 g)
Generic: 0.05% (15 g, 45 g, 50 g)
Ointment, External, as valerate [strength expressed as base]:
Generic: 0.1% (15 g, 45 g)
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
HPA axis suppression and adrenal insufficiency, especially in children or with augmented formulation use. Foam, gel, lotion (augmented), and ointment (augmented): reassess if no improvement after 2 weeks of treatment.
May suppress the wheal and flare reactions to skin test antigens
>10%: Local: Application site reactions (2% to 44%; includes burning, stinging, and itching; most reactions were mild)
1% to 10%:
Central nervous system: Tingling (2%; paresthesia at application site)
Dermatologic: Skin atrophy (children: 10%), acneiform eruption (2%), alopecia (2%), pruritus ( ≤2%), dermatitis (<1%)
Ophthalmic: Conjunctivitis (2%)
Frequency not defined: Endocrine & metabolic: HPA axis suppression
<1% (Limited to important or life-threatening): Application-site infection, atrophic striae, bullous dermatitis, capillary fragility, contact dermatitis, dermal ulcer (of psoriatic lesions), dyshidrotic eczema, eczema, edema, epidermolysis, exacerbation of psoriasis, herpes zoster, hirsutism, hypersensitivity reaction, pain, skin hypertrophy
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
- Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue use if irritation occurs and treat appropriately.
- Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to varicella zoster (chickenpox) should be avoided; corticosteroids should not be used to treat ocular herpes simplex.
- Skin reactions: Discontinue if skin irritation or contact dermatitis occurs; do not use in patients with decreased skin circulation.
- Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome (rare), hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, application to large surface areas, or prolonged use.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Pediatric: Use of augmented formulations in patients <13 years of age is not recommended. For all formulations, children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Use lowest dose possible for shortest period of time to avoid HPA axis suppression.
Dosage form specific issues:
- Appropriate use: Do not use occlusive dressings on weeping or exudative lesions and general caution with occlusive dressings should be observed; adverse effects may be increased. In the presence of a fungal or bacterial dermatologic infection, institute appropriate antifungal or antibacterial therapy. If the infection does not resolve promptly, discontinue use until the infection has been adequately controlled.
- Augmented (eg, very high potency) products: Use of augmented formulations in patients <13 years of age is not recommended. Not for treatment of rosacea, perioral dermatitis, or if skin atrophy is present at treatment site; not for facial, groin, axillary, oral, ophthalmic, or intravaginal use; not for use in a diapered area. Avoid concurrent use of other corticosteroids.
- Flammable contents: Foam contains flammable propellants. Avoid fire, flame and smoking during and immediately following administration.
- Patch [Canadian product]: Has not been studied in psoriasis of the face, scalp or intertriginous areas; contains methyl and propyl parahydroxybenzoate, which may cause hypersensitivity (sometimes delayed).
Other warnings/precautions:
- Discontinuation of therapy: Withdraw therapy with gradual tapering of dose by reducing the frequency of application or substitution of a less potent steroid.
C
Adverse events have been observed with corticosteroids in animal reproduction studies. Topical corticosteroids are preferred over systemic for treating conditions, such as psoriasis or atopic dermatitis in pregnant women; high potency corticosteroids are not recommended during the first trimester. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women (Bae, 2011; Koutroulis, 2011; Leachman, 2006). Refer to the Betamethasone systemic monograph for additional information.
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Betamethasone has intermediate to very high range potency (dosage-form dependent).
Topical corticosteroids are absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children.
Hepatic
Urine and bile
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry skin, stinging, burning, or itching. Have patient report immediately to prescriber signs of Cushing 's disease (weight gain in upper back or stomach; moon face; severe headache; or slow healing), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), , signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of skin changes (pimples, stretch marks, slow healing, or hair growth), skin thinning, or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.