betamethasone (systemic)

REMS

Management of adrenocortical insufficiency; chronic use in other situations is limited because of mineralocorticoid activity.
Used systemically and locally in a wide variety of chronic diseases including:
- Inflammatory,
- Allergic,
- Hematologic,
- Neoplastic,
- Autoimmune disorders.
Replacement therapy in adrenal insufficiency.

Unlabeled Use:

Short-term administration to high-risk mothers before delivery to prevent respiratory distress syndrome in the newborn.

Action ⬆ ⬇

In pharmacologic doses, suppresses inflammation and the normal immune response.
Suppresses adrenal function at chronic doses of 0.6 mg/day.
Has negligible mineralocorticoid activity.

Therapeutic effects:

Suppression of inflammation and modification of the normal immune response.
Replacement therapy in adrenal insufficiency.

Pharmacokinetics ⬆ ⬇

Absorption: Sodium phosphate salt is rapidly absorbed after IM administration. Acetate salt is slowly but completely absorbed after IM administration. Absorption from local sites (intra-articular, intralesional) is slow but complete.

Distribution: Widely distributed; crosses the placenta and probably enters breast milk.

Metabolism/Excretion: Metabolized mostly by the liver.

Half-Life: 3–5 hr (plasma), 36–54 hr (tissue); adrenal suppression lasts 3.25 days.

Time/Action Profile ⬆ ⬇

(anti-inflammatory activity)

ROUTE	ONSET	PEAK	DURATION
IM (sodium phosphate/acetate)	1–3 hr	unknown	1 wk

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active untreated infections (may be used in patients being treated for tuberculous meningitis);
Traumatic brain injury (high doses may ↑ mortality);
Epidural use (may result in serious neurological injury or death);
Some products contain bisulfites and should be avoided in patients with known hypersensitivity.
Lactation: Lactation;

Use Cautiously in:

Chronic treatment (will lead to adrenal suppression; use lowest possible dose for shortest period of time);
Hypothyroidism;
Cirrhosis;
Ulcerative colitis;
Stress (surgery, infections); supplemental doses may be needed;
Potential infections may mask signs (fever, inflammation);
OB: Safety not established;
Pedi: Chronic use in children will result in growth; use lowest possible dose for shortest period of time.

Adv. Reactions/Side Effects ⬆ ⬇

Adverse reactions/side effects are much more common with high-dose/long-term therapy

CV: hypertension

Derm: ↓wound healing, acne, ecchymoses, fragility, hirsutism, petechiae

EENT: ↑intraocular pressure, cataracts

Endo: adrenal suppression, hyperglycemia

F and E: fluid retention (long-term high doses), hypokalemia, hypokalemic alkalosis

GI: anorexia, nausea, PEPTIC ULCERATION, vomiting

Hemat: THROMBOEMBOLISM, thrombophlebitis

Metab: weight gain, weight loss

MS: muscle wasting, osteoporosis, avascular necrosis of joints, muscle pain

Neuro: depression, euphoria, ↑intracranial pressure (children only), headache, personality changes, psychoses, restlessness

Misc: cushingoid appearance (moon face, buffalo hump), ↑susceptibility to infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inhibitors, including clarithromycin, cobicistat, itraconazole, and ritonavir may ↑ levels and risk of toxicity.
Additive hypokalemia withthiazide and loop diuretics, or amphotericin B.
Hypokalemia may ↑ risk of digoxin toxicity.
May ↑ requirement for insulins or oral hypoglycemic agents.
Phenytoin,phenobarbital, and rifampin stimulate metabolism; may ↓ effectiveness.
Oral contraceptives may block metabolism.
↑risk of adverse GI effects with NSAIDs (including aspirin).
At chronic doses that suppress adrenal function, may ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines.

Route/Dosage ⬆ ⬇

IM (Adults ): 0.5–9 mg/day as betamethasone sodium phosphate/acetate suspension in 1–2 divided doses. Prevention of respiratory distress syndrome in newborn: 12 mg daily for 2–3 days before delivery (unlabeled).
IM (Children ): Adrenocortical insufficiency: 17.5 mcg/kg (500 mcg/m²)/day in 3 divided doses every 3rd day or 5.8–8.75 mcg/kg (166–250 mcg/m²)/day as a single dose. Other uses: 20.8–125 mcg/kg (0.625–3.75 mg/m²) of the base every 12–24 hr.

Availability ⬆ ⬇

(Generic available)

Suspension for injection (sodium phosphate and acetate): 6 mg (total)/mL

Assessment ⬆ ⬇

Indicated for many conditions. Assess involved systems before and periodically during therapy.
Assess patient for signs of adrenal insufficiency (hypotension, weight loss, weakness, nausea, vomiting, anorexia, lethargy, confusion, restlessness) before and periodically during therapy.
Monitor intake and output ratios and daily weights. Observe patient for peripheral edema, steady weight gain, rales/crackles, or dyspnea. Notify health care professional if these occur.
Pedi: Children should have periodic growth evaluations.

Lab Test Considerations:

Monitor serum electrolytes and glucose. May cause hyperglycemia, especially in persons with diabetes. May cause hypokalemia. Patients on prolonged courses of therapy should routinely have hematologic values, serum electrolytes, and serum glucose evaluated. May ↓ WBC counts. May ↓ serum potassium and calcium and ↑ serum sodium concentrations.
- Guaiac-test stools periodically during therapy. Promptly report presence of guaiac-positive stools.
- May ↑ serum cholesterol and lipid values. May ↓ uptake of thyroid ¹²³I or ¹³¹I.
- Suppress reactions to allergy skin tests.
- Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal axis suppression in systemic and chronic topical therapy.

Implementation ⬆ ⬇

If dose is ordered daily or every other day, administer in the morning to coincide with the body’s normal secretion of cortisol.
IM: Shake suspension well before drawing up. Do not dilute with other solution or admix. Do not administer suspensions IV.

Patient/Family Teaching ⬆ ⬇

Stopping the medication suddenly may result in adrenal insufficiency (anorexia, nausea, weakness, fatigue, dyspnea, hypotension, hypoglycemia). If these signs appear, notify health care professional immediately. This can be life-threatening.
- Glucocorticoids cause immunosuppression and may mask symptoms of infection. Instruct patient to avoid people with known contagious illnesses and to report possible infections immediately.
- Caution patient to avoid vaccinations without first consulting health care professional.
- Review side effects with patient. Instruct patient to inform health care professional promptly if severe abdominal pain or tarry stools occurPatient should also report unusual swelling, weight gain, tiredness, bone pain, bruising, nonhealing sores, visual disturbances, or behavior changes.
- Advise patient to notify health care professional of medication regimen before treatment or surgery.
- Discuss possible effects on body image. Explore coping mechanisms.
- Instruct patient to inform health care professional if symptoms of underlying disease return or worsen.
- Advise patient to carry identification describing disease process and medication regimen in the event of an emergency in which patient cannot relate medical history.
- Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests and eye exams may be needed.
- Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Long-term Therapy: Encourage patient to eat a diet high in protein, calcium, and potassium, and low in sodium and carbohydrates (see Food Sources for Specific Nutrients). Advise patient to avoid alcohol during therapy.

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