Pronunciation:

(bay ta METH a sone)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Use - Dental:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

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:

Drug Interactions:

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:

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:

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:

Patient Education:

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:

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:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

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)

International Brand Names: