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Pronunciation |
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(bay
ta METH a
sone) |
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U.S. Brand
Names |
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Alphatrex®; Betatrex®;
Celestone®; Celestone®
Soluspan®; Cel-U-Jec®; Diprolene®;
Diprolene® AF; Diprosone®; Maxivate®;
Teladar®; Valisone® |
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Generic
Available |
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Yes |
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Canadian Brand
Names |
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Betnesol®[Disodium Phosphate];
Diprolene® Glycol [Dipropionate]; Occlucort®; Rhoprolene;
Rhoprosone; Taro-Sone; Topilene; Topisone |
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Synonyms |
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Betamethasone Dipropionate; Betamethasone Dipropionate, Augmented; Betamethasone
Sodium Phosphate; Betamethasone Valerate; Flubenisolone |
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Pharmacological Index |
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Corticosteroid, Oral; Corticosteroid, Parenteral; Corticosteroid,
Topical |
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Use |
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Dental: Treatment of a variety of oral diseases of allergic, inflammatory or
autoimmune origin
Medical: Inflammatory dermatoses such as seborrheic or atopic dermatitis,
neurodermatitis, anogenital pruritus, psoriasis, inflammatory phase of xerosis
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Pregnancy Risk
Factor |
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C |
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Pregnancy/Breast-Feeding
Implications |
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Clinical effects on the fetus: There are no reports linking the use of
betamethasone with congenital defects in the literature; betamethasone is often
used in patients with premature labor [26-34 weeks gestation] to stimulate fetal
lung maturation |
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Contraindications |
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Systemic fungal infections; hypersensitivity to betamethasone or any
component |
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Warnings/Precautions |
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Fatalities have occurred due to adrenal insufficiency in asthmatic patients
during and after transfer from systemic corticosteroids to aerosol steroids;
several months may be required for recovery of this syndrome; during this
period, aerosol steroids do not provide the systemic steroid needed to
treat patients having trauma, surgery, or infections; use with caution in
patients with hypothyroidism, cirrhosis, ulcerative colitis; do not use
occlusive dressings on weeping or exudative lesions and general caution with
occlusive dressings should be observed; discontinue if skin irritation or
contact dermatitis should occur; do not use in patients with decreased skin
circulation |
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Adverse
Reactions |
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>10%:
Central nervous system: Insomnia
Gastrointestinal: Increased appetite, indigestion
Ocular: Temporary mild blurred vision
1% to 10%:
Dermatologic: Erythema, itching
Endocrine & metabolic: Diabetes mellitus
Local: Dryness, irritation, papular rashes, burning
Ocular: Cataracts
<1%: Hypertension, convulsions, vertigo, confusion, headache, thin fragile
skin, hyperpigmentation or hypertrichosis, hypopigmentation, impaired wound
healing, acneiform eruptions, perioral dermatitis, maceration of skin, skin
atrophy, striae, miliaria, cushingoid state, sodium retention, peptic ulcer,
sterile abscess, myalgia, osteoporosis, glaucoma, sudden blindness
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Overdosage/Toxicology |
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When consumed in excessive quantities for prolonged periods, systemic
hypercorticism and adrenal suppression may occur; in those cases,
discontinuation and withdrawal of the corticosteroid should be done
judiciously |
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Drug
Interactions |
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CYP3A enzyme substrate |
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Mechanism of
Action |
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Controls the rate of protein synthesis, depresses the migration of
polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability, and
lysosomal stabilization at the cellular level to prevent or control
inflammation |
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Pharmacodynamics/Kinetics |
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Protein binding: 64%
Metabolism: Extensively in the liver
Half-life: 6.5 hours
Time to peak serum concentration: I.V.: Within 10-36 minutes
Elimination: <5% of dose excreted renally as unchanged drug
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Usual Dosage |
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Base dosage on severity of disease and patient response
I.M.: 0.0175-0.125 mg base/kg/day divided every 6-12 hours or 0.5-7.5
mg base/m2/day divided every 6-12 hours
Oral: 0.0175-0.25 mg/kg/day divided every 6-8 hours or 0.5-7.5
mg/m2/day divided every 6-8 hours
Adolescents and Adults:
Oral: 2.4-4.8 mg/day in 2-4 doses; range: 0.6-7.2 mg/day
I.M.: Betamethasone sodium phosphate and betamethasone acetate: 0.6-9 mg/day
(generally, 1/3
to 1/2
of oral dose) divided every 12-24 hours
Foam: Apply twice daily, once in the morning and once at night
Dosing adjustment in hepatic impairment: Adjustments may be necessary
in patients with liver failure because betamethasone is extensively metabolized
in the liver
Intrabursal, intra-articular, intradermal: 0.25-2 mL
Intralesional: Rheumatoid arthritis/osteoarthritis:
Very large joints: 1-2 mL
Large joints: 1 mL
Medium joints: 0.5-1 mL
Small joints: 0.25-0.5 mL
Topical: Apply thin film 2-4 times/day. Therapy should be discontinued when
control is achieved; if no improvement is seen, reassessment of diagnosis may be
necessary. |
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Dietary
Considerations |
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May be taken with food to decrease GI distress |
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Mental Health: Effects
on Mental Status |
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Insomnia is common |
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Mental Health:
Effects on Psychiatric
Treatment |
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Enzyme inducers (barbiturates) may decrease the effects of
corticosteroids |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Take exactly as directed; do not increase dose or discontinue abruptly,
consult prescriber. Take oral medication with or after meals. Limit intake of
caffeine or stimulants. Prescriber may recommend increased dietary vitamins,
minerals, or iron. Diabetics should monitor glucose levels closely (antidiabetic
medication may need to be adjusted). Inform prescriber if you are experiencing
greater than normal levels of stress (medication may need adjustment). Some
forms of this medication may cause GI upset (oral medication may be taken with
meals to reduce GI upset; small frequent meals and frequent mouth care may
reduce GI upset). You may be more susceptible to infection (avoid crowds and
persons with contagious or infective conditions). Report promptly excessive
nervousness or sleep disturbances; signs of infection (sore throat, unhealed
injuries); excessive growth of body hair or loss of skin color; changes in
vision; excessive or sudden weight gain (>3 lb/week); swelling of face or
extremities; difficulty breathing; muscle weakness; change in color of stools
(tarry) or persistent abdominal pain; or worsening of condition or failure to
improve. Pregnancy/breast-feeding precautions: Inform prescriber if you
are or intend to be pregnant. Consult prescriber if breast-feeding.
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Nursing
Implications |
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Apply topical sparingly to areas; not for use on broken skin or in areas of
infection; do not apply to wet skin unless directed; do not apply to face or
inguinal area. Not for alternate day therapy; once daily doses should be given
in the morning; do not administer injectable sodium phosphate/acetate suspension
I.V. |
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Dosage Forms |
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Base (Celestone®), Oral:
Syrup: 0.6 mg/5 mL (118 mL)
Tablet: 0.6 mg
Dipropionate (Diprosone®)
Aerosol: 0.1% (85 g)
Cream: 0.05% (15 g, 45 g)
Lotion: 0.05% (20 mL, 30 mL, 60 mL)
Ointment: 0.05% (15 g, 45 g)
Dipropionate augmented (Diprolene®)
Cream: 0.05% (15 g, 45 g)
Gel: 0.05% (15 g, 45 g)
Lotion: 0.05% (30 mL, 60 mL)
Ointment, topical: 0.05% (15 g, 45 g)
Valerate (Betatrex®, Valisone®)
Cream: 0.01% (15 g, 60 g); 0.1% (15 g, 45 g, 110 g, 430 g)
Lotion: 0.1% (20 mL, 60 mL)
Ointment: 0.1% (15 g, 45 g)
Valerate (Beta-Val®)
Cream: 0.01% (15 g, 60 g); 0.1% (15 g, 45 g, 110 g, 430 g)
Lotion: 0.1% (20 mL, 60 mL)
Valerate (Luxiq™): Foam: 100 g aluminum can (box of 1)
Injection: Sodium phosphate (Celestone® Phosphate,
Cel-U-Jec®): 4 mg betamethasone phosphate/mL (equivalent
to 3 mg betamethasone/mL) (5 mL)
Injection, suspension: Sodium phosphate and acetate
(Celestone® Soluspan®): 6 mg/mL (3
mg of betamethasone sodium phosphate and 3 mg of betamethasone acetate per mL)
(5 mL) |
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References |
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Gamsu HR, Mullinger BM, Donnai P, et al,
"Antenatal Administration of Betamethasone to Prevent Respiratory Distress Syndrome in Preterm Infants: Report of a UK Multicentre Trial,"
Br J Obstet Gynaecol, 1989, 96(4):401-10.
Liggins GC and Howie RN,
"A Controlled Trial of Antepartum Glucocorticoid Treatment of Respiratory Distress Syndrome in Premature Infants,"
Pediatrics, 1972, 50:515-25. |
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