betamethasone (systemic)

REMS

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.

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);
Pheochromocytoma (↑ risk of pheochromocytoma crisis);
OB: Safety not established in pregnancy;
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, neonatal hypoglycemia

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), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION, KAPOSI SARCOMA

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inhibitors, including clarithromycin, cobicistat, itraconazole, and ritonavir, may ↑ levels and risk of toxicity.
Additive hypokalemia with thiazide diuretics, 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.

Availability ⬆ ⬇

(Generic available)

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

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.

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: corticosteroids

Pharmacologic Classification: corticosteroids

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 to tissues.

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

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Explain need for continued medical follow-up to assess effectiveness, periodic lab tests and eye exams may be needed.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Stopping the medication suddenly may result in adrenal insufficiency. Notify health care professional immediately if symptoms appear as 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.
- Instruct patient to inform health care professional promptly if severe abdominal pain or tarry stools occur. Patient 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.
- Advise women 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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Indications ⬇