betamethasone (systemic)
Betnelan ◆, Celestone

betamethasone sodium phosphate
Betnesol ◆, Celestone Phosphate

betamethasone sodium phosphate and betamethasone acetate
Celestone Soluspan

Available forms
Available by prescription only
betamethasone
Syrup: 0.6 mg/5 ml
Tablets: 0.6 mg
betamethasone sodium phosphate
Enema: 5 mg (base) ◆
Injection: 4 mg (3 mg base)/ml in 5-ml vials
Tablets (effervescent): 500 mcg ◆
betamethasone sodium phosphate and
betamethasone acetate suspension
Injection: betamethasone acetate 3 mg and betamethasone sodium phosphate (equivalent to 3 mg base)/ml (not for I.V. use)

Indications and dosages
 Severe inflammation or immunosuppression.
betamethasone
Adults: 0.6 to 7.2 mg P.O. daily; usually 2.4 to 4.8 mg daily divided into two to four doses.
Children: 0.0175 to 0.25 mg/kg P.O. daily or 0.5 to 7.5 mg/m² daily in three to four divided doses.
betamethasone sodium phosphate
Adults: 0.5 to 9 mg I.M., I.V., or into joint or soft tissue daily.
betamethasone sodium phosphate and
betamethasone acetate suspension
Adults: 0.25 to 2 ml into joint or soft tissue q 1 to 2 weeks, p.r.n. Effects may last a few days or 1 to 2 weeks depending on the joint condition being treated.
 Prevention of hyaline membrane disease in premature infants ◇ .
betamethasone sodium phosphate and
betamethasone acetate suspension
Adults: Give 2 ml I.M. daily to expectant mothers for 2 to 3 days before delivery.

Pharmacodynamics
Anti-inflammatory action: Stimulates the synthesis of enzymes needed to decrease the inflammatory response. It’s a long-acting corticosteroid with an anti-inflammatory potency 25 times that of an equal weight of hydrocortisone. It has essentially no mineralocorticoid activity. Betamethasone tablets and syrup are used as oral anti-inflammatories.
 Betamethasone sodium phosphate is highly soluble, has a prompt onset of action, and may be given I.V. Betamethasone sodium phosphate and betamethasone acetate (Celestone Soluspan) combine the rapid-acting phosphate salt and the slightly soluble, slowly released acetate salt to provide rapid anti-inflammatory effects with a sustained duration of action. It’s a suspension and isn’t to be given I.V. It’s particularly useful as an anti-inflammatory in intra-articular, intradermal, and intralesional injections.

Pharmacokinetics
Absorption: Absorbed readily after oral administration. Systemic absorption occurs slowly following intra-articular injections.
Distribution: Removed rapidly from the blood and distributed to muscle, liver, skin, intestines, and kidneys. Betamethasone is bound weakly to plasma proteins (transcortin and albumin). Only the unbound portion is active. Adrenocorticoids are distributed into breast milk and through the placental barrier.
Metabolism: Metabolized in the liver to inactive glucuronide and sulfate metabolites.
Excretion: Inactive metabolites and small amounts of unmetabolized drug are excreted by the kidneys. Insignificant quantities of drug also are excreted in feces. Biological half-life of drug is 36 to 54 hours.

Contraindications and precautions
Contraindicated in patients hypersensitive to drug and in those with viral or bacterial infections (except in life-threatening situations) or systemic fungal infections.
  Use cautiously in patients with renal disease, hypertension, osteoporosis, diabetes mellitus, hypothyroidism, cirrhosis, diverticulitis, nonspecific ulcerative colitis, recent intestinal anastomoses, thromboembolic disorders, seizures, myasthenia gravis, heart failure, tuberculosis, ocular herpes simplex, emotional instability, and psychotic tendencies.

Interactions
Drug-drug. Amphotericin B, diuretics: Betamethasone may enhance hypokalemia. Monitor serum potassium level and observe patient carefully.
Antacids, cholestyramine, colestipol: Decrease effect of betamethasone by adsorbing the corticosteroid, decreasing amount absorbed. Use together cautiously.
Antidiabetics, insulin: Causes hyperglycemia, requiring dosage adjustment in diabetic patients. Monitor serum glucose level.
Barbiturates, phenytoin, rifampin: Decrease corticosteroid effects because of increased hepatic metabolism. Monitor patient for clinical effect.
Cardiac glycosides: Increases risk of toxicity in patients receiving cardiac glycosides. Use together cautiously.
Estrogens: Reduce corticosteroid metabolism by increasing transcortin level. Monitor patient for adverse effects.
Isoniazid, salicylates: Increases metabolism of these drugs. Monitor patient for clinical effect.
Oral anticoagulants: In rare cases, may decrease effects of oral anticoagulants. Monitor PT and INR.
Ulcerogenic drugs, such as NSAIDs: May increase risk of GI ulceration. Use together cautiously.

Adverse reactions
CNS: euphoria, insomnia, psychotic behavior, pseudotumor cerebri, vertigo, headache, paresthesia, seizures.
CV: heart failure, hypertension, edema, arrhythmias, thrombophlebitis, thromboembolism.
EENT: cataracts, glaucoma.
GI: peptic ulceration, GI irritation, increased appetite, pancreatitis, nausea, vomiting.
GU: menstrual irregularities.
Hepatic: liver dysfunction.
Metabolic: hypokalemia, hyperglycemia, and carbohydrate intolerance, hypocalcemia.
Musculoskeletal: muscle weakness, osteoporosis.
Skin: delayed wound healing, acne, various skin eruptions, hirsutism.
Other: cushingoid state (moonface, buffalo hump, central obesity); susceptibility to infections; growth suppression in children; acute adrenal insufficiency, which may follow increased stress (infection, surgery, or trauma) or abrupt withdrawal after long-term therapy.

Effects on lab test results
• May increase glucose, AST, ALT, and alkaline phosphatase levels. May decrease potassium and calcium levels.

Overdose and treatment
Acute ingestion, even in massive doses, rarely occurs. Toxic signs and symptoms rarely occur if drug is used for less than 3 weeks, even at large doses. However, long-term use causes adverse physiologic effects, including suppression of the hypothalamic-pituitary-adrenal axis, cushingoid appearance, muscle weakness, and osteoporosis.

Special considerations
• Betamethasone acetate suspension shouldn’t be given I.V.
• Adrenocorticoid therapy suppresses reactions to skin tests; causes false-negative results in the nitroblue tetrazolium tests for systemic bacterial infections.
• Monitor patient continuously for effect and dosage adjustment, remissions, exacerbations, and stress.
• Most adverse reactions to corticosteroids are dose- or duration-dependent.
• Gradually reduce dose after long-term use.
 ALERT After abrupt withdrawal, patient may experience rebound inflammation, fatigue, weakness, arthralgia, fever, dizziness, lethargy, depression, fainting, orthostatic hypotension, dyspnea, anorexia, and hypoglycemia. After prolonged use, sudden withdrawal may be fatal.
• Store tablets in a well-closed container and protected from light at temperatures of 36° to 86° F (2° to 30° C).
• Protect betamethasone sodium phosphate injection from light and store at a temperature between 59° and 86° F (15° and 30° C). Avoid freezing.
• Protect betamethasone sodium phosphate and betamethasone acetate sterile solution from light and store at 36° to 77° F (2° to 25° C); avoid freezing. Don’t mix the sterile solution with diluents or local anesthetics containing preservatives because flocculation of the suspension may occur.
Breast-feeding patients
• Information is incomplete. Risk versus benefits must be determined and reviewed with patient.
Pediatric patients
• Long-term use of betamethasone in children and adolescents may delay growth and maturation.

Patient education
• Warn patient not to stop drug abruptly.
• Instruct patient to take drug with food or milk.
• Tell patient to report symptoms of corticosteroid withdrawal, including fatigue, weakness, arthralgia, orthostatic hypotension, and dyspnea.
• Instruct patient to wear or carry medical identification that indicates need for supplemental glucocorticoid therapy during stress.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use