Betamethasone topical

Absorption

Bioavailability

Topically applied betamethasone dipropionate and valerate can be absorbed through normal intact skin.101 102 103 104 105 106 108 112 113 114 115 116 b

Extent of systemic absorption of the drug is increased with lotion preparations and those formulated with an optimized (augmented) vehicle.101 102 103 104 105 106 b

Percutaneous penetration can be altered by using different vehicles and increases with decreasing age.101 102 103 104 105 106 108 112 113 114 115 116 b

Percutaneous penetration also can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).101 102 103 104 105 106 108 112 113 114 115 116 117 b

Distribution

Extent

Not known whether topical betamethasone is distributed into milk.101 102 103 104 105 108 112 113 114 115 116 117 b

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.101 102 103 104 105 106 108 112 113 114 115 b

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.101 102 103 104 105 106 108 112 113 114 115 116 b

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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 manufacturer's labeling.

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism 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.

Betamethasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Betamethasone topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as eczema, psoriasis, or allergic reactions.

Betamethasone topical may also be used for purposes not listed in this medication guide.

You should not use betamethasone topical if you are allergic to it.

To make sure betamethasone topical is safe for you, tell your doctor if you have:

• diabetes; or

• any type of skin infection.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether betamethasone topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use betamethasone topical on a child without a doctor's advice. Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects. Steroid medicine can also affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Diprolene is not approved for use by anyone younger than 13 years old. Sernivo is not approved for use by anyone younger than 18 years old.

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use betamethasone topical on broken or infected skin. Also avoid using this medicine in open wounds.

Avoid applying betamethasone topical to the skin of your face, underarms, or groin area without your doctor's instruction.

Do not use betamethasone topical to treat any condition that has not been checked by your doctor.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Stop using betamethasone topical and call your doctor if you have:

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• tired feeling.

Also stop using betamethasone topical and call your doctor at once if you have:

• severe skin irritation where the medicine was applied; or

• signs of skin infection (swelling, redness, warmtth, oozing).

Common side effects may include:

• burning, stinging, or itching of treated skin;

• skin dryness, irritation, or reddish-purple discoloration;

• acne, skin rash;

• lightened color of treated skin; or

• folliculitis (redness or crusting around your hair follicles).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.