Indications And Clinical Uses: Betamethasone is used orally in the management of disorders responsive to adrenocortical hormone therapy such as:
Endocrine Disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; nonsuppurative thyroiditis; hypercalcemia associated with cancer.
Musculoskeletal Disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis, rheumatoid arthritis (selected cases may require low dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis.
Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis.
Dermatologic Disease: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis.
Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment such as seasonal or perennial allergic rhinitis, bronchial asthma (including status asthmaticus), contact dermatitis, atopic dermatitis, serum sickness, angioedema and urticaria.
Ophthalmic Diseases: severe, acute and chronic allergy and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus (but not herpes simplex), iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, retrobulbar neuritis, sympathetic ophthalmia.
Respiratory Diseases: symptomatic sarcoidosis, Leffler’s syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, pulmonary emphysema where bronchospasm or bronchial edema plays a significant role, diffuse interstitial pulmonary fibrosis (Hamman-Rich syndrome).
Hematologic Disorders: idiopathic and secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: for palliative management of leukemias and lymphomas in adults, acute leukemia of childhood.
Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. In conjunction with diuretic agents, to induce a diuresis in cirrhosis of the liver with refractory ascites, refractory congestive heart failure.
Gastrointestinal Diseases: to tide the patient over a critical period of the disease in ulcerative colitis, regional enteritis, intractable sprue.
Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy, dental postoperative inflammatory reactions.
Contra-Indications: Systemic fungal infections; hypersensitivity to betamethasone or to other corticosteroids or to any component of the tablets.
Precautions: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice. This is of particular importance in children.
While on corticosteroid therapy patients should not be vaccinated against smallpox because of potential complications. Conversely, patients with vaccinia should not receive corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and a lack of antibody response.
Pregnancy and Lactation: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Corticosteroids may mask some signs of infection and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If corticosteroids have to be used in the presence of bacterial infections, institute appropriate vigorous anti-infective therapy.
Use corticosteroids cautiously in patients with ocular herpes simplex because of possible corneal ulceration and perforation.
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Corticosteroid therapy may cause hyperacidity or peptic ulcer. Since appearance of peptic ulcer may be asymptomatic until perforation or hemorrhage occurs, take x-rays when treatment is prolonged or when there is gastric distress. An ulcer regimen including an antacid should be considered as a prophylactic measure during prolonged therapy.
Use the lowest possible dose of corticosteroid to control the condition under treatment, and when dosage reduction is possible, the reduction should be gradual.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased potassium excretion. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Drug induced secondary adrenocortical insufficiency may be minimized by gradual dosage reduction. This type of relative insufficiency may persist for months after discontinuation of therapy, therefore, in any stress situation occurring during that period, reinstitute hormone therapy. If the patient is receiving steroids already, the dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
Use ASA cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Use steroids with caution in: nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis, fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Phenytoin may enhance the rate of metabolism and clearance of corticosteroids and this may increase steroid dosage requirements.
Advise patients to inform subsequent physicians of the prior use of corticosteroids.
Corticosteroids may suppress reactions to skin tests.
Drug Interactions: Concurrent use of phenobarbital, phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.
Adverse Reactions: Fluid and electrolyte disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension.
Musculoskeletal: muscle weakness; steroid myopathy; loss of muscle mass; aggravation of myasthenic symptoms in myasthenia gravis; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture of long bones.
Gastrointestinal: hiccups; peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis.
Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; may suppress reactions to skin tests; reactions such as allergic dermatitis, urticaria and angioneurotic edema.
Neurological: convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache.
Endocrine; menstrual irregularities, development of Cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements of insulin or oral hypoglycemic agents in diabetes.
Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos.
Metabolic: negative nitrogen balance due to protein catabolism.
Other: hypersensitivity, thromboembolism, anaphylactoid and hypotensive or shock-like reactions.
Symptoms And Treatment Of Overdose: Symptoms: Acute overdosage with glucocorticosteroids, including betamethasone, is not expected to lead to a life-threatening situation. Except at the most extreme dosages, a few days of excessive glucocorticosteroid dosing is unlikely to produce harmful results in the absence of specific contraindications, such as in patients with diabetes mellitus, glaucoma, or active peptic ulcer, or in patients on medications such as digitalis, coumarin-type anticoagulants or potassium-depleting diuretics.
Treatment: Acute overdosage should be treated immediately by inducing emesis or by the administration of gastric lavage. Otherwise complications resulting from the metabolic effects of the corticosteroid or from deleterious effects of the basic or concomitant illnesses or resulting from drug interactions should be handled as appropriate.
Dosage: Dosage must be determined and adjusted to the individual requirements of the patient, i.e. severity of the condition, anticipated duration of therapy, tolerance to the steroid and response obtained. The lowest dose that will produce the desired clinical effect should be employed. Starting dose should vary from 1 to 8 mg daily in divided doses. Should the physician prefer, total daily intake may be given in a single dose once every 24 to 48 hours.
Availability And Storage: Each blue, scored tablet contains: betamethasone USP 500 g. Nonmedicinal ingredients: cornstarch, dye, FD & C Blue No. 2, gelatin, lactose and magnesium stearate. Tartrazine-free. Bottles of 100. Store between 2 and 30°C. Protect from light.
CELESTONE® Schering Betamethasone Glucocorticoid