betamethasone (Celestone, Celestone Soluspan, Betaject, Betamethasone IM/PO)

Dosing and uses of Celestone, Celestone Soluspan (betamethasone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

injectable suspension

• 6mg/mL

oral solution

• 0.6mg/5mL

 

Endocrine Disorders

0.6-7.2 mg PO divided BID/QID or 0.6-9 mg/day IM qDay/divided BId

 

Inflammatory Conditions

0.6-7.2 mg PO divided BID/QID or 0.6-9 mg/day IM qDay/divided BId

 

Rheumatoid Arthritis/Osteoarthritis

Intrabursal, intra-articular, intradermal: 0.25-2 mL (6 mg/mL)

Intralesional (6 mg/mL)

• Very large joints: 1-2 mL
• Large joints: 1 mL
• Medium joints: 0.5 - 1 mL
• Small joints: 0.25-0.5 mL

 

Administration

Base dosage on severity of disease and patient response

 

Other Indications & Uses

Adrenal insufficiency, conditions treated with immunosuppression, corticosteroid responsive dermatoses

Off-label: prophylaxis of neonatal respiratory distress syndrome

Various autoimmune diseases, collagen vascular disease, allergic states, hypersensitivity reactions, respiratory disease, hematologic disorders, neoplastic disease, ophthalmic disorders, edematous states, GI disease, & nervous system disorders. Also used in bacterial meningitis, acute mountain sickness, Graves' ophthalmopathy, severe alcoholic hepatitis, hirsutism, septic shock, spinal cord injury, as antiemetics.

 

Pediatric dosage forms and strengths

injectable suspension

• 6mg/mL

oral solution

• 0.6mg/5mL

 

Adrenal Insufficiency

<12 years old: 0.0175-0.25 mg/kg/day divided q6-12hr IM/PO; use lowest dose as initial dose

>12 years old: As in adults; use lowest dose as initial dose

 

Inflammatory Conditions

<12 years old: 0.0175-0.25 mg/kg/day IM/PO divided q6-12hr

>12 years old: As in adults

 

Celestone, Celestone Soluspan (betamethasone) adverse (side) 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

Systemic fungal infection

Hypersensitivity to betamethasone

TBI (high doses)

Untreated serious infections

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

 

Cautions

Cirrhosis, ocular herpes simplex, HTN, diverticulitis, hypothyroidism, myasthenia gravi, PUD, osteoporosis, ulcerative colitis, psychotic tendencies, untreated systemic infections, renal insufficiency, pregnancy

NOT effective in treatment of RDS in premature neonates

Minimal sodium retention activity: however, may increase with high doses

If used to treat adrenocortical insufficiency should also use mineralocorticoid

Thromboembolic disorders

Myopathy,

Delayed wound healing

Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated

Latent TB may be reactivated (monitor patients with positive tuberculin test)

Some suggestion of slightly increased cleft palate risk if corticosteroids used in pregnancy, but not fully substantiated

Prolonged corticosteroid use may result in elevated IOP, glaucoma, and/or cataracts

Killed or inactivated vaccines may be administered; however, the response to such vaccines cannot be predicted

Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy in physiologic doses (eg, for Addison’s disease)

Epidural injection

• Serious neurologic events, some resulting in death, have been reported with epidural injection
• Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
• These serious neurologic events have been reported with and without use of fluoroscopy
• Safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use

 

Pregnancy and 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 of Celestone, Celestone Soluspan (betamethasone)

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 & fibroblasts, reversing capillary permeability, & 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