Betamethasone

Generic Name:

Betamethasone

Dosage Form:

tablet

Drug Dose

Therapeutic Indications:

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of

conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions,

perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions

Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome)

Endocrine disorders: Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Note: Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance

Gastrointestinal diseases: During acute episodes in regional enteritis and ulcerative colitis Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia

Neoplastic diseases: Palliative management of leukemias and lymphomas

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Note: Treatment guidelines recommend the use of high-dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis

Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids

Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus

Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis

Rheumatic disorders: Adjunctive therapy for short-term administration in acute gout flares; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

 

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.

Method of Administration:

The dose used will depend on the disease, its severity and the clinical response obtained.

Notes

Contraindications:

Hypersensitivity to any component of the formulation; IM administration contraindicated in immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura).

Interactions:

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Betamethasone (Systemic). Risk C:

Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Betamethasone (Systemic). Risk C:

Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically,

the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Pregnancy and Lactation:

Betamethasone crosses the placenta, some studies have shown an association between first trimester systemic corticosteroid use and oral clefts or decreased birth weight; however, information is conflicting and may be influenced by maternal dose/indication for use

Corticosteroids are present in breast milk.

Warning and Precaution:

  • Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been

associated with electrolyte disturbances, fluid retention, and hypertension. Dietary modifications may

be necessary. Use with caution in patients with a recent history of myocardial infarction (MI); left

ventricular free wall rupture has been reported after the use of corticosteroids.

  • Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation

leading to hyperglycemia.

  • Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal

anastomoses, peptic ulcer, ulcerative colitis) due to perforation risk. Avoid ethanol may enhance

gastric mucosal irritation.

  • Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone;

high-dose corticosteroids should not be used for the management of head injury.

  • Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; longterm use has been associated with fluid retention.
  • Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2

weeks of treatment); monitor for worsening MG

  • Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular

pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Not recommended

for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye

exams in chronic users.

  • Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of

corticosteroids have been associated with increased bone loss and osteoporotic fractures.

Adverse Reactions:

Bradycardia, cardiac arrhythmia, cardiomegaly, circulatory shock, edema, embolism (fat), hypertension, hypertrophic cardiomyopathy, myocardial rupture (following recent MI), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, Abnormal sensory symptoms, arachnoiditis, depression, emotional lability, euphoria, headache, increased intracranial pressure, insomnia, malaise, meningitis, myasthenia, neuritis, neuropathy, paraplegia, paresthesia, personality changes, pseudotumor cerebri, psychic disorder, seizure, spinal cord compression, vertigo, Amenorrhea, calcinosis, cushingoid state, decreased glucose tolerance, decreased serum potassium, fluid retention, glycosuria, growth suppression (pediatric), hirsutism, HPA-axis suppression, hypokalemic alkalosis, impaired glucose tolerance/prediabetes, insulin resistance (increased requirements for insulin or oral hyperglycemic agents), moon face, negative nitrogen balance, protein catabolism, sodium retention, weight gain

Storage:

Store below 30 and protect from light and moisture.