betamethasone

Betamethasone is a synthetic steroid medication used to treat inflammation from disorders of many organs. Betamethasone is a corticosteroid analog drug with chemical structure similar to the naturally occurring corticosteroid produced by the cortical region of the adrenal gland.

Betamethasone works in the following ways to control inflammation:

• Controls the rate of protein synthesis
• Prevents migration and aggregation of polymorphonuclear leukocytes (PMN), types of white cells such as neutrophils, eosinophils and basophils that release inflammatory substances
• Inhibits pro-inflammatory signals and promotes anti-inflammatory signals
• Reduces capillary permeability to prevent the leakage of inflammatory cells and proteins (cytokines) into the inflammation site
• Stabilizes the membranes of cells, and lysosomes, the organelles inside cells that contain digestive enzymes
• Prevents migration of fibroblasts, cells that form extracellular matrix, the supportive structure of tissue, and prevents scar tissue formation

Systemic betamethasone is administered orally or as injections into the skin (intradermal), muscle (intramuscular), joints (intra-articular) and skin lesions (intralesional) and is also used as a topical application to treat inflammatory skin conditions. Betamethasone is used to treat inflammation in the following conditions:

• Allergic states: Asthma, atopic and contact dermatitis, drug hypersensitivity reactions, allergic rhinitis
• Dermatologic diseases: Bullous dermatitis herpetiformis, mycosis fungoides, exfoliative erythroderma, pemphigus, Stevens-Johnson syndrome
• Endocrine disorders: Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis
• Gastrointestinal diseases: Regional enteritis, ulcerative colitis
• Blood disorders: acquired hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia
• Neoplastic diseases: Lymphomas and leukemias (palliative management)
• Nervous system disorders: Multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor or craniotomy
• Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and other inflammatory eye conditions that do not respond to topical corticosteroids
• Renal diseases: To increase urine output and reduce urinary protein excretion (proteinuria) in idiopathic nephrotic syndrome or lupus erythematosus
• Respiratory diseases: Berylliosis, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis, fulminating or disseminated tuberculosis along with antituberculosis therapy
• Rheumatic disorders: Acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, dermatomyositis, polymyositis, systemic lupus erythematosus, bursitis, tenosynovitis, tendinitis
• Miscellaneous conditions: Tuberculous meningitis, trichinosis with neurological or myocardial involvement
• Other conditions (intralesional administration): Lesions of granuloma annulare, lichen planus, lichen simplex and psoriatic plaques, alopecia areata, discoid lupus erythematosus, keloids

• Do not administer betamethasone intravenously
• Do not administer to patients with hypersensitivity to betamethasone or other components in betamethasone
• Do not use intramuscular administration in patients with idiopathic thrombocytopenic purpura
• Do not administer live or live attenuated vaccines in patients receiving immunosuppressive doses of betamethasone
• Killed or inactivated vaccines may be administered with caution; however, the response to such vaccines cannot be predicted
• Use with caution in cirrhosis, ocular herpes simplex, hypertension, diverticulitis, hypothyroidism, myasthenia gravis, peptic ulcer disease, pregnancy, osteoporosis, ulcerative colitis, psychotic tendencies, untreated systemic infections, renal insufficiency
• Do not administer in patients with systemic fungal infections, betamethasone may exacerbate symptoms
• Do not use for the treatment of eye nerve inflammation (ocular neuritis)

Common side effects of betamethasone include:

• Allergic reactions including:
  • Swelling of tissue under skin and mucous membranes (angioedema)
  • Severe allergic reaction (anaphylaxis)
• Skin reactions such as:
  • Acne
  • Allergic dermatitis
  • Skin atrophy
  • Stretch marks (striae)
  • Dry scaly skin
  • Thin and fragile skin
  • Rash and redness (erythema)
  • Hives (urticaria)
  • Itching
  • Changes in pigmentation
• Cardiac effects such as:
  • Irregular heart rhythms (arrhythmia)
  • Heart enlargement
  • Hypertrophic cardiomyopathy in premature infants
  • Rapid heart rate (tachycardia)
  • Slow heart rate (bradycardia)
  • Congestive heart failure
  • High blood pressure (hypertension)
• Fainting (syncope)
• Fat globules in blood vessel (fat embolism)
• Fluid in the lungs (pulmonary edema)
• Blood clot blockage in a blood vessel (thromboembolism)
• Vein inflammation with blood clots (thrombophlebitis)
• Blood vessel inflammation (vasculitis)
• Fluid and electrolyte disturbances including:
  • Sodium and fluid retention
  • Potassium loss (hypokalemia)
  • Hypokalemic alkalosis
• Endocrine disorders including:
  • Reduced carbohydrate and glucose tolerance
  • Increased requirement for insulin
  • Glucose in urine (glucosuria)
  • Abnormal male pattern hair growth in women (hirsutism)
  • Abnormal excessive hair growth in men and women (hypertrichosis)
  • Growth suppression in children
• Negative nitrogen balance due to protein catabolism
• Cushing syndrome, a condition caused by excessive corticosteroid use over a long period with symptoms such as:
  • Abnormal fat deposits
  • Moon face
• Gastrointestinal effects that include:
  • Abdominal distention
  • Increased appetite
  • Nausea
  • Peptic ulcer with possible perforation and hemorrhage
  • Inflammation of the esophagus (ulcerative esophagitis)
• Weight gain
• Inflammation of the pancreas (pancreatitis)
• Liver enlargement (hepatomegaly)
• Elevated liver enzymes
• Damage to bone tissue and bone loss (osteoporosis)
• Fractures
• Tendon rupture
• Muscle damage and weakness
• Loss of muscle mass
• Delayed wound healing
• Headache
• Vertigo
• Malaise
• Convulsions
• Increased intracranial pressure (pseudotumor cerebri) on withdrawal of drug
• Insomnia
• Nerve damage and inflammation
• Abnormal skin sensations (paresthesia)
• Depression
• Emotional instability
• Euphoria
• Psychotic disorders
• Bulging eyes (exophthalmos)
• Cataracts
• Increase in intraocular pressure
• Glaucoma, a condition with high intraocular pressure that damages the optic nerve
• Decreased resistance to infection
• Hiccups
• Changes in sperm number and motility
• Serious side effects of betamethasone may include:
• Cardiac arrest
• Circulatory collapse
• Myocardial rupture (in patients who have had a heart attack)
• Perforation of the intestines (especially in people with inflammatory bowel disease)

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Injectable Suspension

• 6 mg/ml

Oral Solution

• 0.6 mg/5 ml

Adult

Endocrine Disorders

• 0.6-7.2 mg orally divided twice daily/four times daily or 0.6-9 mg/day intramuscularly each day divided twice daily

Inflammatory Conditions

• 0.6-7.2 mg orally divided twice daily/four times daily or 0.6-9 mg/day intramuscularly each day divided twice daily

Tenosynovitis, Peritendinitis, Bursitis (except on the foot)

• 3-6 mg (0.5-1 mL) intrabursal once; for acute exacerbations or chronic conditions may require several injections; for repeat injections may use reduced doses

Dermatologic

• 1.2 mg/cm² (0.2 mL/cm²) intralesional once; not to exceed 6 mg (1 mL) per week

Multiple Sclerosis

• 30 mg/day IM for 1 week; then 12 mg every other day for 1 week

Rheumatoid Arthritis/Osteoarthritis

• Intrabursal, intra-articular, intradermal: 0.25-2 mL (3 mg-12 mg)
• Intralesional: (6 mg/mL)
• Very large joints: 1-2 mL (6-12 mg)
• Large joints: 1 mL (6 mg)
• Medium joints: 0.5 - 1 mL (3-6 mg)
• Small joints: 0.25-0.5 mL (1.5-3 mg)

Pediatric

Inflammatory conditions

• Children under 12 years old: 0.0175-0.25 mg/kg/day intramuscular/orally divided every 6-12 hours
• Children over 12 years old: As in adults

Adrenal Insufficiency

• Children under 12 years old: 0.0175-0.25 mg/kg/day divided every 6-12 hours intramuscularly/orally; use the lowest dose as an initial dose
• Children over 12 years old: As in adults; use the lowest dose as an initial dose

Administration

• Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• Acute overdose is treated with supportive and symptomatic therapy.
• For chronic overdosage in the face of severe disease requiring continuous steroid therapy, corticosteroid dosage may be temporarily reduced, or alternate treatment introduced.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

Interactions of betamethasone include:

• aminoglutethimide
• amphotericin B injection and potassium-depleting agents
• antibiotics, specifical macrolide
• anticholinesterases
• oral anticoagulants
• antidiabetics
• antitubercular drugs
• cholestyramine
• cyclosporine
• digitalis glycosides
• estrogens, including oral contraceptives
• hepatic enzyme inducers (barbiturates, phenytoin, carbamazepine, rifampin)
• ketoconazole
• nonsteroidal anti-inflammatory agents (NSAIDs)
• diminished response to vaccines

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Betamethasone should be used in pregnancy only if potential benefits outweigh potential risks to the fetus.
• Use with caution in breastfeeding women; systemically administered corticosteroids enter breast milk and can suppress growth, interfere with natural (endogenous) corticosteroid production, or cause other effects.

• High doses of betamethasone for prolonged periods of time can cause adrenal suppression
• Prolonged use of corticosteroids may increase incidence of secondary infections
• Betamethasone can cause blood clotting (thromboembolic) disorders
• High-dose corticosteroids can cause muscle damage (myopathy)
• Occurrence of Kaposi sarcoma, a type of cancer, is associated with prolonged corticosteroid treatment
• Seizures have been reported in patients with history of seizure disorders
• Patients on corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated
• Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored). Restrict the use of corticosteroids in active tuberculosis to cases of fulminating or disseminated tuberculosis
• Prolonged corticosteroid use may result in eye conditions such as elevated intraocular pressure, glaucoma, or cataracts
• Betamethasone use can delay wound healing
• High dose corticosteroids are associated with increased bone loss and must be used with caution in patients at higher risk for osteoporosis (post-menopausal women)