Betamethasone

Pronunciation (bay ta METH a sone)

• Corticosteroids

U.S. Brand Names Alphatrex®; Betatrex®; Beta-Val®; Celestone®; Celestone® Phosphate; Celestone® Soluspan®; Diprolene®; Diprolene® AF; Diprosone®; Luxiq^TM; Maxivate®; Valisone® [DSC]

Synonyms Betamethasone Dipropionate; Betamethasone Dipropionate, Augmented; Betamethasone Sodium Phosphate; Betamethasone Valerate; Flubenisolone

Generic Available Yes

Canadian Brand Names Betaderm; Betaject^TM; Betnesol®; Betnovate®; Celestoderm®-EV/2; Celestoderm®-V; Celestone® Soluspan®; Diprolene® Glycol; Diprosone®; Ectosone; Prevex® B; Taro-Sone®; Topilene®; Topisone®; Valisone® Scalp Lotion

Pharmacologic Category Corticosteroid, Systemic; Corticosteroid, Topical

Use Inflammatory dermatoses such as seborrheic or atopic dermatitis, neurodermatitis, anogenital pruritus, psoriasis, inflammatory phase of xerosis

Use - Dental Treatment of a variety of oral diseases of allergic, inflammatory, or autoimmune origin

Pregnancy Risk Factor C

Pregnancy Implications There are no reports linking the use of betamethasone with congenital defects in the literature; betamethasone is often used in patients with premature labor [26-34 weeks gestation] to stimulate fetal lung maturation

Lactation Excretion in breast milk unknown/use caution

Contraindications Hypersensitivity to betamethasone or any component of the formulation; systemic fungal infections

Warnings/Precautions Not to be used in status asthmaticus or for the relief of acute bronchospasm; topical use in patients 12 years of age is not recommended. May cause suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving 20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Withdrawal and discontinuation of the corticosteroid should be done slowly and carefully

Controlled clinical studies have shown that orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. (In studies of orally-inhaled corticosteroids, the mean reduction in growth velocity was approximately 1 centimeter per year [range 0.3-1.8 cm per year] and appears to be related to dose and duration of exposure.) The growth of pediatric patients receiving inhaled corticosteroids, should be monitored routinely (eg, via stadiometry). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose.

May suppress the immune system, patients may be more susceptible to infection. Use with caution in patients with systemic infections or ocular herpes simplex. Avoid exposure to chickenpox and measles.

Use with caution in patients with hypothyroidism, cirrhosis, ulcerative colitis; do not use occlusive dressings on weeping or exudative lesions and general caution with occlusive dressings should be observed; discontinue if skin irritation or contact dermatitis should occur; do not use in patients with decreased skin circulation

Systemic:

>10%:

1% to 10%:

<1% (Limited to important or life-threatening): Vertigo, seizures, psychoses, pseudotumor cerebri, mood swings, delirium, hallucinations, euphoria, Cushing's syndrome, pituitary-adrenal axis suppression, growth suppression, glucose intolerance, hypokalemia, alkalosis, amenorrhea, sodium and water retention, hyperglycemia

Topical:

1% to 10%:

<1% (Limited to important or life-threatening): Cushing's syndrome, hypokalemic syndrome, glaucoma, cataracts (posterior subcapsular)

Overdosage/Toxicology When consumed in high doses for prolonged periods, systemic hypercorticism and adrenal suppression may occur. In those cases, discontinuation of the corticosteroid should be done judiciously.

Drug Interactions CYP3A3/4 enzyme substrate

Phenytoin, phenobarbital, rifampin increase clearance of betamethasone.

Potassium-depleting diuretics increase potassium loss.

Skin test antigens, immunizations: Betamethasone may decrease response and increase potential infections.

Insulin or oral hypoglycemics: Betamethasone may increase blood glucose.

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: Betamethasone interferes with calcium absorption.

Herb/Nutraceutical: Avoid cat's claw, echinacea (have immunostimulant properties).

Y-site administration: Compatible: Heparin, hydrocortisone sodium succinate, potassium chloride, vitamin B complex with C

Mechanism of Action Controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability, and lysosomal stabilization at the cellular level to prevent or control inflammation

Protein binding: 64%

Metabolism: Hepatic

Half-life elimination: 6.5 hours

Time to peak, serum: I.V.: 10-36 minutes

Excretion: Urine (<5% as unchanged drug)

Dosage Base dosage on severity of disease and patient response

Children: Use lowest dose listed as initial dose for adrenocortical insufficiency (physiologic replacement)

Adolescents and Adults:

Dosing adjustment in hepatic impairment: Adjustments may be necessary in patients with liver failure because betamethasone is extensively metabolized in the liver

Adults:

Topical: Apply thin film 2-4 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Oral: Not for alternate day therapy; once daily doses should be given in the morning.

I.M.: Do not give injectable sodium phosphate/acetate suspension I.V.

Topical: Apply topical sparingly to areas. Not for use on broken skin or in areas of infection. Do not apply to wet skin unless directed. Do not apply to face or inguinal area. Do not cover with occlusive dressing.

Dietary Considerations May be taken with food to decrease GI distress.

Patient Information Take exactly as directed; do not increase dose or discontinue abruptly, consult prescriber. Take oral medication with or after meals. Avoid alcohol. Limit intake of caffeine or stimulants. Prescriber may recommend increased dietary vitamins, minerals, or iron. Diabetics should monitor glucose levels closely (antidiabetic medication may need to be adjusted). Inform prescriber if you are experiencing greater than normal levels of stress (medication may need adjustment). Some forms of this medication may cause GI upset (oral medication may be taken with meals to reduce GI upset; small frequent meals and frequent mouth care may reduce GI upset). You may be more susceptible to infection (avoid crowds and persons with contagious or infective conditions). Report promptly excessive nervousness or sleep disturbances; signs of infection (sore throat, unhealed injuries); excessive growth of body hair or loss of skin color; changes in vision; excessive or sudden weight gain (>3 lb/week); swelling of face or extremities; difficulty breathing; muscle weakness; change in color of stools (tarry) or persistent abdominal pain; or worsening of condition or failure to improve. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Topical: For external use only, Not for eyes or mucous membranes or open wounds. Apply in a thin layer (may rub in lightly). Apply light dressing (if necessary) to area being treated. Do not use occlusive dressing unless so advised by prescriber. Avoid prolonged or excessive use around sensitive tissues, genital, or rectal areas. Inform prescriber if condition worsens (redness, swelling, irritation, open sores) or fails to improve.

Nursing Implications Apply topical sparingly to areas; not for use on broken skin or in areas of infection; do not apply to wet skin unless directed; do not apply to face or inguinal area. Not for alternate day therapy; once daily doses should be given in the morning; do not administer injectable sodium phosphate/acetate suspension I.V.

Anesthesia and Critical Care Concerns/Other Considerations Long-acting corticosteroid with minimal sodium-retaining potential

Corticosteroid and muscle relaxants appear to trigger some types of ICU myopathy; avoid or administer at the lowest dose possible.

Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. In discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that the steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia. Patients on long-term steroid supplementation will require higher corticosteroid doses when subject to stress (ie, trauma, surgery, severe infection).

Oral and intravenous steroid therapy in patients with heart failure should be administered cautiously with special attention given to signs and symptoms of fluid retention.

Cardiovascular Considerations Long-term steroid therapy is associated with fluid retention and hypertension. Glucocorticoid agents have some mineralocorticoid activity with consequent hemodynamic effects. Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. In discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that the steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia.

Oral and intravenous steroid therapy in patients with heart failure should be administered cautiously with special attention given to signs and symptoms of fluid retention.

Dental Health: Effects on Dental Treatment No effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions No information available to require special precautions

Mental Health: Effects on Mental Status Insomnia is common

Mental Health: Effects on Psychiatric Treatment Enzyme inducers (barbiturates) may decrease the effects of corticosteroids

Cream, topical, as dipropionate: 0.05% (15 g, 45 g, 60 g)

Cream, topical, as dipropionate augmented (Diprolene® AF): 0.05% (15 g, 50 g)

Cream, topical, as valerate: 0.1% (15 g, 45 g)

Foam, topical, as valerate (Luxiq^TM): 0.12% (50 g, 100 g) [contains alcohol 60.4%]

Gel, topical, as dipropionate augmented (Diprolene®): 0.05% (15 g, 50 g)

Injection, solution, as sodium phosphate (Celestone® Phosphate): 4 mg/mL (5 mL) [equivalent to 3 mg betamethasone/mL]

Injection, suspension (Celestone® Soluspan®): Betamethasone sodium phosphate 3 mg/mL and betamethasone acetate 3 mg/mL [6 mg/mL] (5 mL)

Lotion, topical, as dipropionate: 0.05% (20 mL, 60 mL)

Lotion, topical, as dipropionate augmented (Diprolene®): 0.05% (30 mL, 60 mL)

Lotion, topical, as valerate (Beta-Val®, Betatrex®, Valisone® [DSC]): 0.1% (60 mL)

Ointment, topical, as dipropionate: 0.05% (15 g, 45 g)

Ointment, topical, as dipropionate augmented: 0.05% (15 g, 45 g, 50 g)

Ointment, topical, as valerate (Betatrex®, Valisone® [DSC]): 0.1% (15 g, 45 g)

Syrup, as base (Celestone®): 0.6 mg/5 mL (118 mL)

Tablet, as base (Celestone®): 0.6 mg

Gamsu HR, Mullinger BM, Donnai P, et al, "Antenatal Administration of Betamethasone to Prevent Respiratory Distress Syndrome in Preterm Infants: Report of a UK Multicentre Trial,"Br J Obstet Gynaecol, 1989, 96(4):401-10.

Liggins GC and Howie RN, "A Controlled Trial of Antepartum Glucocorticoid Treatment of Respiratory Distress Syndrome in Premature Infants,"Pediatrics, 1972, 50:515-25.

International Brand Names Androcort® (CL); Antroquoril (AU); Beben (IT); Bebyderm (BR); Bedermin (IT); Bemon (DE); Bentelan (IT); Beta 21 (IT); Betacap (IE); Betacort (DE); BetaCreme (DE); Betaderm (BR, CA); Betagalen (DE); Betaject^TM (CA); Betalone® (IT); Betamamallet® (JP); Betamatil (ES); Betamesol (IT); Betametasona® (CL); Betametasona Lafedar® [compr.] (AR); Betametasona L.CH.® (CL); Betamethason Pasteur Merieux Connaught® (AT); Betamethason Pharmafrid® (DE); Betam-Ophtal (DE); Betanoid (ZA); Betapred (SE); BetaSalbe (DE); Betasone-G® [compr.] (AR); Beta-Stulln (DE); Betnasol (PT); Betnelan® (BR, GB, IN, IE); Betnelan (NL, ZA, TR); Betnelan-V (BE); Betnesol (AT, BE, CA, FR, DE, IE, LU, NL, ZA, CH); Betnesol-V (DE); Betnesol-WL (DE); Betneval (FR); Betnovat (DK, NO, SE); Betnovate (AU, AT, BR, CA, IE, PT, ZA, ES, CH); Betoid (DK, NO, SE); Bettamousse (DK, IE, IT, ES, SE); Butasona Fabra® [compr.] (AR); Celesdepot (PT); Celestamine N® (DE); Celestan (AT, DE); Celestan solubile (DE); Celestan-V (DE); Celestene (FR); Celestene Chronodose (FR); Celestoderm (FR, NL, ES); Celestoderm®-EV/2 (CA); Celestoderm®-V (CA); Celestoderm-V (IT, ZA, ES, CH); Celeston (DK, NO, SE); Celestone® (AR); Celestone (AU, BE, BR, CA, CZ, HK, HU, IT, LU, MX, NL, PT, ZA, ES, CH, TR); Celestone Chronodose (AU, BE, NL, CH); Celestone Cronodose (IT, ES); Celestone M (AU); Celestone Oral® (CA, ES); Celestone Soluspan (BR); Celestone® Soluspan® (CA); Celestone Soluspan (ZA); Celestone V (AU); Celeston valerat (SE); Cilestoderme (PT); Clenil (BR); Célestène® (FR); Cordes Beta (DE); Corteroid® (AR); Cuantona® (ES); Dermoval (BR); Dermovate (BR); Desacort-Beta® (IT); Dibetop (PT); Diproderm (AT, DK, NO, ES, SE); Diproforte (AT); Diprofos (PT); Diprolen (DK); Diprolene (BE, FR, NL, ZA, CH); Diprolene® Glycol (CA); Diprophos (AT); Diprosalic® (NO); Diprosis (DE); Diprosone (AU, BE, BR, CA, FR, DE, IE, IT, NL, PT, ZA, CH); Diprospan (DK); durabetason (DE); Ecoval (IT); Ectosone (CA); Eleuphrat (AU); Epidermil (BR); Euvaderm (DE); Exabet® (ID); Hormezone® (JP); Lenasone (ZA); Lenovate (ZA); Lygal E Creme (DE); Minisone (IT); Novovate® (TR); P 10 (IT); Paucisone (IT); Pentacort (DE); Persivate (ZA); Prevex® B (CA); Sanbetason® (JP); Sclane (ES); Sensitex (BR); Seroderm® (TR); Soderm (DE); Solu-Celestan (AT); Soluderme (PT); Steromien (ZA); Taro-Sone® (CA); Topilene® (CA); Topisone® (CA); Topivate (ZA); Tuplix (ES); Unicort® (IL); Vabeta (PT); Valisone® Scalp Lotion (CA); Walacort® (IN)