Betamethasone

Pronunciation

U.S. Brand Names

Beta-Val®; Celestone®; Celestone® Soluspan®; Diprolene®; Diprolene® AF; Luxiq®; Maxivate®

Synonyms

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

Generic Available

Yes: Excludes foam, injection, syrup

Canadian Brand Names

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

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

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

Adverse Reactions

Systemic:

>10%:

Central nervous system: Insomnia, nervousness

Gastrointestinal: Increased appetite, indigestion

1% to 10%:

Central nervous system: Dizziness or lightheadedness, headache

Dermatologic: Hirsutism, hypopigmentation

Endocrine & metabolic: Diabetes mellitus

Neuromuscular & skeletal: Arthralgia

Ocular: Cataracts, glaucoma

Respiratory: Epistaxis

Miscellaneous: Diaphoresis

<1% (Limited to important or life-threatening): Vertigo, seizure, 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%:

Dermatologic: Itching, allergic contact dermatitis, erythema, dryness papular rash, folliculitis, furunculosis, pustules, pyoderma, vesiculation, hyperesthesia, skin infection (secondary)

Local: Burning, irritation

<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

Inhibits CYP3A4 (weak)

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/Nutrition/Herb Interactions

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

Food: Betamethasone interferes with calcium absorption.

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

Compatibility

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

Pharmacodynamics/Kinetics

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)

I.M.: 0.0175-0.125 mg base/kg/day divided every 6-12 hours or 0.5-7.5 mg base/m² /day divided every 6-12 hours

Oral: 0.0175-0.25 mg/kg/day divided every 6-8 hours or 0.5-7.5 mg/m² /day divided every 6-8 hours

Topical:

12 years: Use is not recommended.

>12 years: Apply a thin film twice daily; use minimal amount for shortest period of time to avoid HPA axis suppression

Adolescents and Adults:

Oral: 2.4-4.8 mg/day in 2-4 doses; range: 0.6-7.2 mg/day

I.M.: Betamethasone sodium phosphate and betamethasone acetate: 0.6-9 mg/day (generally, ¹ /3 to ¹ /2 of oral dose) divided every 12-24 hours

Foam: Apply twice daily, once in the morning and once at night to scalp

Adults:

Intrabursal, intra-articular, intradermal: 0.25-2 mL

Intralesional: Rheumatoid arthritis/osteoarthritis:

Very large joints: 1-2 mL

Large joints: 1 mL

Medium joints: 0.5-1 mL

Small joints: 0.25-0.5 mL

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.

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

Administration

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 Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take exactly as directed; do not increase dose or discontinue abruptly without consulting prescriber. Take oral medication with or after meals. Avoid alcohol and limit intake of caffeine or stimulants. Prescriber may recommend increased dietary vitamins, minerals, or iron. If you have diabetes, 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). You may be more susceptible to infection (avoid crowds and exposure to infection and do not have any vaccination without consulting prescriber). Some forms of this medication may cause GI upset (small, frequent meals and frequent mouth care may help or oral medication may be taken with meals to reduce GI upset). Report promptly excessive nervousness or sleep disturbances; signs of infection (eg, sore throat, unhealed injuries); excessive growth of body hair or loss of skin color; vision changes; excessive or sudden weight gain (>3 lb/week); swelling of face or extremities; respiratory difficulty; muscle weakness; change in color of stools (tarry) or persistent abdominal pain; or worsening of condition or failure to improve.

Topical: For external use only. Do not use for eyes, mucous membranes, or open wounds. Use exactly as directed. Before using, wash and dry area gently. 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. Avoid exposing treated area to direct sunlight. Inform prescriber if condition worsens (redness, swelling, irritation, signs of infection, or open sores) or fails to improve.

Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Anesthesia and Critical Care Concerns/Other Considerations

Neuromuscular Effects: ICU-acquired paresis was recently studied in 5 ICUs (3 medical and 2 surgical ICUs) at 4 French hospitals. All ICU patients without pre-existing neuromuscular disease admitted from March 1999 through June 2000 were evaluated (de Jonghe, 2002). Each patient had to be mechanically ventilated for 7 days and was screened daily for awakening. The first day the patient was considered awake was Study Day 1. Patients with severe muscle weakness on Study Day 7 were considered to have ICU-acquired paresis. Among the 95 patients who were evaluable, about 25% developed ICU-acquired paresis. Independent predictors included: female gender, the number of days with 2 organ dysfunction, and administration of corticosteroids. Further studies may be required to verify and characterize the association between the development of ICU-acquired paresis and use of corticosteroids. Concurrent use of a corticosteroid and muscle relaxant appear to increase the risk of certain ICU myopathies; avoid or administer the corticosteroid at the lowest dose possible.

Adrenal Insufficiency: Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. When 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). Guidelines for glucocorticoid replacement during various surgical procedures has been published (Salem, 1994; Coursin, 2002).

Septic Shock: A recent randomized, double-blind, placebo controlled trial assessed whether low dose corticosteroid administration could improve 28-day survival in patients with septic shock and relative adrenal insufficiency. Relative adrenal insufficiency was defined as an inappropriate response to corticotropin administration (increase of serum cortisol of 9 mcg/dL from baseline). Cortisol levels were drawn immediately before corticotropin administration and 30-60 minutes afterwards. Three hundred adult septic shock patients requiring mechanical ventilation and vasopressor support were randomized to either hydrocortisone (50 mg IVP every 6 hours) and fludrocortisone (50 mcg tablet daily via nasogastric tube) or matching placebos for 7 days. In patients who did not appropriately respond to corticotropin (nonresponders), there were significantly fewer deaths in the active treatment group. Vasopressor therapy was withdrawn more frequently in this subset of the active treatment group. Adverse events were similar in both groups. Patients who lack adrenal reserve and thus have relative adrenal insufficiency during the stress of septic shock may benefit from physiologic steroid replacement. However, there was a trend for increased mortality in patients who responded to the corticotropin test (increase serum cortisol >9 mcg/dL from baseline). These patients may not benefit from physiologic steroid replacement. Further study is required to better characterize the patient populations who may benefit.

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 significant 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

Dosage Forms

[DSC] = Discontinued product

Note: Potency expressed as betamethasone base.

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

Maxivate®: 0.05% (45 g)

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

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

Beta-Val®: 0.1% (15 g, 45 g)

Foam, topical, as valerate (Luxiq®): 0.12% (50 g, 100 g, 150 g) [contains alcohol 60.4%]

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

Diprolene® [DSC]: 0.05% (15 g, 50 g)

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% (60 mL)

Maxivate®: 0.05% (60 mL)

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

Lotion, topical, as valerate (Beta-Val®): 0.1% (60 mL)

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

Maxivate®: 0.05% (45 g)

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

Diprolene®: 0.05% (15 g, 50 g)

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

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

References

Abraham E and Evans T, "Corticosteroids and Septic Shock [editorial]," JAMA , 2002, 288(7):886-7.

Annane D, Sebille V, Charpentier C, et al, "Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock," JAMA , 2002, 288(7):862-71.

Boot AM, Nauta J, Hokken-Koelega AC, et al, "Renal Transplantation and Osteoporosis," Arch Dis Child , 1995, 72(6):502-6.

Bowman H and Lennard TW, "Immunosuppressive Drugs," Br J Hosp Med , 1992, 48(9):570-3.

Cooper MS and Stewart PM, "Corticosteroid Insufficiency in Acutely Ill Patients," N Engl J Med , 2003, 348(8):727-34.

Coursin DB and Wood KE, "Corticosteroid Supplementation for Adrenal Insufficiency," JAMA , 2002, 287(2):236-40.

de Jonghe B, Sharshar T, Lefaucheur JP, et al, "Paresis Acquired in the Intensive Care Unit. A Prospective Multicenter Study," JAMA , 2002, 288(22):2859-67.

Frey BM and Frey FJ, "Clinical Pharmacokinetics of Prednisone and Prednisolone," Clin Pharmacokinet , 1990, 19(2):126-46.

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.

Grotz WH, Mundinger FA, Gugel B, et al, "Bone Mineral Density After Kidney Transplantation: A Cross-Sectional Study in 190-Graft Recipients Up to 20 Years After Transplantation," Transplantation , 1995, 59(7):982-6.

Gutin PH, "Corticosteroid Therapy in Patients With Brain Tumors," Natl Cancer Inst Monogr , 1977, 46:151-6.

Hotchkiss RS and Karl IE, "The Pathophysiology and Treatment of Sepsis," N Engl J Med , 2003, 348(2):138-50.

Kimberly RP, "Glucocorticoids," Curr Opin Rheumatol , 1994, 6(3):273-80.

Liggins GC and Howie RN, "A Controlled Trial of Antepartum Glucocorticoid Treatment of Respiratory Distress Syndrome in Premature Infants," Pediatrics , 1972, 50(4):515-25.

Lowenthal RM and Jestrimski KW, "Corticosteroid Drugs: Their Role in Oncological Practice," Med J Aust , 1986, 144(2):81-5.

Murphy CM, Coonce SL, and Simon PA, "Treatment of Asthma in Children," Clin Pharm , 1991, 10(9):685-703.

Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians, "Consensus Statement on Management and Audit Potential for Steroid Responsive Nephrotic Syndrome," Arch Dis Child , 1994, 70(2):151-7.

Salem M, Tainsh RE Jr, Bromberg J, et al, "Perioperative Glucocorticoid Coverage. A Reassessment 42 Years After Emergence of a Problem," Ann Surg , 1994, 219(4):416-25.

International Brand Names

Alersan® (BR); Androcort® (CL); Benoson® (ID); Betacorten® (SG); Betaderm (CA); Betaject™ (CA); Betametasona Biocrom® (AR); Betametasona® (CL); Betametasona Genfar® (EC); Betametasona Lafedar® [compr.] (AR); Betametasona L.CH.® (CL); Betamethasone YSP® (SG); Betamethason "Pasteur Merieux Connaught"® (AT); Betamethason Pharmafrid® (DE); Betanoid Syrup® (ZA); Betasone-G® [compr.] (AR); Betason® (ID); Bethasone® (TH); Betnelan® (BD, BR, GB, IE, IN, KW); Betnesol® (AT, CA, LU); Betnovate® (CA); Butasona Fabra® (AR); Celestamin® (AT); Celestamine N® (DE); Celestan® (AT); Célestène® (FR); Celestoderm®-EV/2 (CA); Celestoderm®-V (CA); Celestone® (AR, BE, BR, CH, CO, CZ, DO, GT, HK, HN, HU, IT, LU, MX, PA, PL, RU, SG, SV); Celestone Oral® (ES); Celestone® Soluspan® (CA); Cidoten® (CL); Corteroid® (AR); Dermesone® (HK, JO, KW, LB, MT, MY, RO); Diprolene® Glycol (CA); Diprosalic® (NO); Diprosone® (CA); Ectosone (CA); Exabet® (ID); Oftasona-P® (EC); Prevex® B (CA); Seroderm® (TR); Spel® (CL); Taro-Sone® (CA); Topilene® (CA); Topisone® (CA); Unicort® (IL); Valisone® Scalp Lotion (CA)

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