Dosing & Uses
Dosage Forms & Strengths
Formulation: 3 mg as betamethasone sodium phosphate and 3 mg as betamethasone acetate
injectable suspension
- 6mg/mL
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)
Ataxia Telangiectasia (Orphan)
Orphan designation for treatment of ataxia telangiectasia
Sponsor
- REGENXBIO, Inc; 9712 Medical Center Drive, Suite 100; Rockville, Maryland 20850
Dosage Forms & Strengths
3 mg betamethasone as betamethasone sodium phosphate and 3 mg as betamethasone acetate
injectable suspension
- 6mg/mL
Inflammatory Conditions
Children and adolescents: 0.02-0.3 mg/kg/day IM divided q8-12hr
Adverse Effects
>10% (selected)
Blurred vision
Increased appetite
Indigestion
Nervousness
1-10%
Itching
Frequency Not Defined (selected)
Arthralgia
Cataracts
Dizziness
DM
Edema
Erythema (topical)
Headache
Seizure
Skin dryness (topical)
Vertigo
Fluid/electrolyte disturbances
Adrenal suppression
Psychosis
Insomnia
Vertigo
Pseudotumor cerebri (on withdrawal)
Acne
Osteoporosis
Myopathy
Delayed wound healing
Warnings
Contraindications
Hypersensitivity to betamethasone
Idiopathic thrombocytopenia purpura
Live or live, attenuated vaccines, when immunisuppressive doses of corticosteroids required
Cautions
Not for IV administration
Use caution in cirrhosis, ocular herpes simplex, HTN, diverticulitis, hypothyroidism, myasthenia gravi, PUD, osteoporosis, ulcerative colitis, psychotic tendencies, untreated systemic infections, renal insufficiency, pregnancy
May cause adrenal suppresion in patients receiving high doses for prolonged periods of time
Prolonged use of corticosteroids may increase incidence of secondary infection
Kaposi sarcoma reported with prolonged treatment of corticosteroids
Thromboembolic disorders
Myopathy associated with high-dose corticosteroids
Seizures reported in patients with history of seizure disorders use caution
Corticosteroids may exacerbate systemic fungal infections
Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated
Restrict the use of corticosteroids in active tuberculosis to cases of fulminating or disseminated tuberculosis when it is used in conjunction with appropriate anti-tuberculous regimen
Monitor closely patients with latent tuberculosis or tuberculin reactivity, if corticosteroid therapy necessary; reactivation of the disease may occur
Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted
Prolonged corticosteroid use may result in glaucoma and/or cataracts
Intraocular pressure may become elevated in some individuals; monitor if treatment is continued for >6 weeks
Not recommended for treatment of optic neuritis; may lead to an increase in risk of new episodes; should not be used in active ocular herpes simplex
Special consideration should be given to patients at increased risk of osteoporosis (ie, postmenopausal women) before initiating corticosteroid therapy
Pregnancy & Lactation
Pregnancy Category: C
Lactation: systemically administered corticosteroids enter breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other effects; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Potent glucocorticoid with minimal to no mineralocorticoid activity
Controls or prevents inflammation by controling rate of protein synthesis, suppressing migration of PMNs and fibroblasts, reversing capillary permeability, and stabilizing lysosome at cellular level
Pharmacokinetics
Peak plasma time: IV: 10-36 min
Protein bound: 64%
Vd: 75-90 L
Metabolism: Extensively metabolized in liver
Half-life: 6.5 hr
Renal clearance: 9.5 mL/min
Excretion: Mainly in urine, minimally in bile
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Formulary
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