betamethasone (Rx)

Brand and Other Names:Celestone, Celestone Soluspan, more...Betaject, Betamethasone IM/PO
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Dosing & Uses

AdultPediatric

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

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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

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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

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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.

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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

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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