Medication Guide App

Betamethasone

Pronunciation: BAY-ta-METH-a-sone
Class: Glucocorticoid

Trade Names

Celestone
- Solution, oral 0.6 mg per 5 mL

Betnesol (Canada)
Betamethasone Sodium Phosphate and Betamethasone Acetate

Celestone Soluspan
- Injection 3 mg of betamethasone acetate and 3 mg of betamethasone sodium phosphate per mL suspension

Betaject (Canada)
Betamethasone Valerate

Beta-Val
- Cream 0.1%
- Lotion 0.1%

Luxiq
- Foam 1.2 mg/g

Betaderm (Canada)
Prevex B (Canada)
ratio-Ectosone (Canada)
Valisone Scalp Lotion (Canada)
Betamethasone Dipropionate

Betamethasone Dipropionate
- Cream 0.05%
- Ointment 0.05%

Del-Beta
- Lotion 0.05%

Diprolene Glycol (Canada)
ratio-Topilene (Canada)
ratio-Topisone (Canada)
Taro-Sone (Canada)
Betamethasone Dipropionate, Augmented

Diprolene
- Ointment 0.05%
- Lotion 0.05%

Diprolene AF
- Cream 0.05%

Pharmacology

Synthetic, long-acting glucocorticoid that depresses formation, release, and activity of endogenous mediators of inflammation, including prostaglandins, kinins, histamine, liposomal enzymes, and complement system. Also modifies body's immune response.

Pharmacokinetics

Absorption

Readily absorbed from GI tract after oral administration.

Distribution

Distributes to all body tissues and crosses the placenta.

Metabolism

Metabolized mainly in the liver.

Elimination

The half-life is at least 300 min.

Special Populations

Renal Function Impairment

No data available.

Hepatic Function Impairment

No data available.

Indications and Usage

Systemic treatment of rheumatic disorders, endocrine disorders, collagen diseases, dermatologic diseases, allergic states, allergic and inflammatory ophthalmic conditions, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states (resulting from nephrotic syndrome), GI diseases, multiple sclerosis, cerebral edema, tuberculous meningitis and trichinosis with neurologic or myocardial involvement.

Topical

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Hypersensitivity to any component of the product.

Injection

Systemic fungal infections; IM use in idiopathic thrombocytopenic purpura.

Topical

Monotherapy in primary bacterial infections. Do not use on face, groin, or axilla, or for ophthalmic treatments.

Dosage and Administration

Betamethasone
Adults

PO 0.6 to 7.2 mg/day.

Children

PO 0.02 to 0.3 mg/kg/day in 3 or 4 divided doses (0.6 to 9 mg/m 2 /day).

Betamethasone Sodium Phosphate and Betamethasone Acetate

Intrabursal/Intra-articular/Intradermal/Intralesional 0.5 to 9 mg/day, depending on site of administration or condition being treated.

Betamethasone Dipropionate, Betamethasone Valerate

Topical Apply sparingly to affected areas 2 to 4 times/day.

General Advice

Oral
  • Use the lowest dosage possible to maintain an adequate response.
  • Dosage increases may be needed during periods of stress.
  • If long-term therapy must be discontinued, withdraw the drug gradually rather than abruptly.

Storage/Stability

Store between 36° and 86°F. Protect from excessive moisture.

Drug Interactions

Aldesleukin

The pharmacologic effects of aldesleukin may be reduced, decreasing the therapeutic effects. Coadministration should be avoided.

Anticholinesterases (eg, neostigmine)

May antagonize anticholinesterase effects in myasthenia gravis. If possible, withdraw anticholinesterase therapy at least 24 h before starting betamethasone.

Anticoagulants (eg, warfarin)

May alter anticoagulant dose requirements. Monitor anticoagulant activity and adjust the warfarin dose as needed.

Antidiabetic agents

Because betamethasone may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be needed. Monitor blood glucose.

Azole antifungal agents (eg, fluconazole, itraconazole, ketoconazole), estrogens, including hormonal contraceptives, macrolide antibiotics (eg, clarithromycin)

Betamethasone metabolism may be inhibited, increasing plasma concentrations and the risk of adverse reactions. Betamethasone dosage may need to be reduced.

Barbiturates, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin)

May decrease pharmacologic effect of betamethasone. Betamethasone dosage may need to be increased.

Cyclosporine

Pharmacologic effects of both betamethasone and cyclosporine may be increased. Convulsions have been reported. Use with caution.

Digitalis glycosides (eg, digoxin)

The risk of arrhythmias due to betamethasone-induced hypokalemia may be increased. Monitor cardiac function.

Isoniazid

Isoniazid serum concentrations may be reduced, decreasing the therapeutic effect. Closely monitor the clinical response. Isoniazid dosage may need to be increased.

Mifepristone

Coadministration of betamethasone with mifepristone is contraindicated in patients receiving concurrent long-term corticosteroid therapy.

NSAIDs (eg, ibuprofen)

The risk of GI side effects may be increased. Use with caution.

Potassium-depleting agents (eg, amphotericin B, diuretics)

Coadministration may increase the risk of hypokalemia. Monitor serum potassium concentrations.

Quinolones (eg, ciprofloxacin)

The risk of tendon rupture may be increased. If tendon-related problems are suspected, quinolones should be stopped and a nonquinolone antibiotic should be used if further antimicrobial treatment is necessary.

Ritodrine

The risk of maternal pulmonary edema may be increased when ritodrine and betamethasone are coadministered. If maternal pulmonary edema develops, both drugs should be stopped.

Salicylates (eg, aspirin)

The risk of GI adverse effects may be increased. In addition, salicylate concentrations may be reduced because of increased Cl. Use with caution. Monitor salicylate concentrations and adjust the dose as needed.

Toxoids

The response to toxoids may be diminished because of inhibition of antibody response by betamethasone. Routine administration of toxoids should be deferred until betamethasone therapy is discontinued.

Vaccines

The response to live or inactivated vaccines may be diminished because of inhibition of antibody response by betamethasone. In addition, some organisms in live, attenuated vaccines may be potentiated. Administration of live, attenuated vaccines is contraindicated in patients receiving betamethasone. Killed or inactivated vaccines may be administered; however, the response cannot be predicted. Routine administration of vaccines should be deferred until betamethasone therapy is discontinued.

Laboratory Test Interactions

False-negative nitroblue-tetrazolium test.

Adverse Reactions

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent MI, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

CNS

Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, malaise, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Dermatologic

Acne; allergic dermatitis; dry, scaly skin; ecchymoses and petechiae; edema; erythema; impaired wound healing; increased sweating; rash; striae; suppressed reactions to skin tests; thin, fragile skin; thinning scalp hair; urticaria. Topical application may cause allergic contact dermatitis, burning, dryness, erythema, folliculitis, hypertrichosis, irritation, itching, maceration of skin, miliaria, numbness of fingers, perioral dermatitis, pruritus, secondary infections, skin atrophy, stinging and cracking/tightening of skin, striae, telangiectasia.

EENT

Exophthalmos, glaucoma, increased IOP, posterior subcapsular cataracts.

Endocrine

Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, such as trauma, surgery, or illness), suppression of growth in pediatric patients.

GI

Abdominal distention, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Hepatic

Elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly.

Hypersensitivity

Anaphylactoid reaction, anaphylaxis, angioedema.

Metabolic

Fluid retention, hypokalemic alkalosis, negative nitrogen balance due to protein catabolism, potassium loss, sodium retention.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures.

Miscellaneous

Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, moonface, weight gain.

Precautions

Monitor

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary because reactivation of this disease may occur. If steroid therapy is continued for more than 6 weeks, IOP should be monitored. Carefully observe patients with frequent measurements of BP, weight, height, IOP, clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Growth and development of infants and children on prolonged therapy must be monitored, even with topical treatment.

Elderly

May require lower doses. Consider benefits relative to risks.

Hypersensitivity

Anaphylactoid reactions have occurred rarely.

Hepatic Function

There is an enhanced effect in patients with cirrhosis.

Special Risk Patients

Use with caution in patients with CHF, hypertension, or renal insufficiency. Literature reports suggest an association between use of corticosteroids and left ventricular free wall rupture after a recent MI; use corticosteroids with great caution in these patients. Use with caution in patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis because risk of perforation may be increased.

Acute myopathy

Has been observed with high doses of corticosteroids, most often in patients with disorders of neuromuscular transmission, or in patients receiving concomitant therapy with neuromuscular blocking drugs.

CNS effects

May appear, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. May aggravate existing emotional instability or psychotic tendencies.

Fluid and electrolyte balance

Can cause elevated BP, salt and water retention, and increased potassium and calcium excretion. Dietary salt restriction and potassium supplementation may be necessary.

GI perforation

Signs of peritoneal irritation following a GI perforation in patients on corticosteroids may be minimal or absent.

Hypothalamic-pituitary-adrenal suppression

May occur with prolonged therapy.

Infections

May mask signs of infection, exacerbate existing systemic infections, and activate latent infections.

Immunosuppression

May decrease host defense mechanisms against infections.

Kaposi sarcoma

Has been reported in patients receiving corticosteroids, most often for chronic conditions.

Multiple sclerosis

Relatively high doses of corticosteroids are needed to demonstrate a significant effect on acute exacerbations of multiple sclerosis and the ultimate outcome and natural history of the disease are not affected.

Ocular effects

Use cautiously in ocular herpes simplex because of possible corneal perforation. Use may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.

Osteoporosis

Bone formation is decreased and resorption is increased, while there is a decrease in the protein matrix of the bone and in sex hormone production. May lead to inhibition of bone growth in pediatric patients and development of osteoporosis at any age.

Stress

Increased dosage of rapidly acting corticosteroid may be needed before, during, and after stressful situations.

Sulfites

Some products contain sulfites, which may cause allergic-type reactions in susceptible individuals.

Thyroid status

Metabolic Cl of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients; changes in thyroid status may necessitate dosage adjustment.

Withdrawal

Abrupt discontinuation may result in adrenal insufficiency. Use is discontinued gradually, while supplementation is increased during times of stress.

Overdosage

Symptoms

Anorexia, arthralgia, dizziness, dyspnea, fainting, fever, malaise, myalgia, nausea, orthostatic hypotension, skin desquamation, hypoglycemia (acute overdosage); acne, central obesity, cushingoid changes, diabetes, ecchymoses, electrolyte and fluid imbalance, hirsutism, hyperlipidemia, hypertension, infarction, moonface, myopathy, osteoporosis, peptic ulcer, sexual dysfunction, striae (chronic overdosage).

Patient Information

  • Tell patient to take with meals or snacks to avoid nausea.
  • If patient has diabetes, discuss importance of closely monitoring blood glucose for possible increase in insulin dosage.
  • If patient is receiving long-term therapy, tell patient to carry identification containing notification of steroid therapy.
  • Tell patient not to stop taking medication suddenly.
  • Instruct patient to report the following symptoms to health care provider: unusual weight gain or weight loss; swelling of lower extremities; muscle weakness; black, tarry stools; vomiting blood; puffing face; prolonged sore throat, fever, or cold; anorexia; nausea; vomiting; diarrhea; weakness; dizziness.
  • Advise patients to avoid exposure to chickenpox or measles and to seek medical advice immediately if they are exposed.
  • Topical
  • Demonstrate proper technique for cleaning affected area before applying medication and for applying sparingly as a thin film.
  • Tell patient to avoid contact with eyes and to avoid tight-fitting clothing on treated area.
  • Explain that alcohol-containing preparations should not be applied to area because of drying/irritation.
  • Caution patient to discontinue medication and notify health care provider if affected area worsens or develops irritation, redness, burning, swelling, or stinging.

Copyright © 2009 Wolters Kluwer Health.

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