(bay ta METH a sone)
- Betamet Acet/Betamet Na pH
- Betamethasone Acetate
- Betamethasone Sod Phos/Acetate
- Betamethasone Sodium Phosphate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Pod-Care 100C: Betamethasone sodium phosphate 3 mg and betamethasone acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]
ReadySharp Betamethasone: Betamethasone sodium phosphate 3 mg and betamethasone acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]
Solution, Oral, as base:
Celestone: 0.6 mg/5 mL (118 mL [DSC])
Celestone Soluspan: Betamethasone sodium phosphate 3 mg and betamethasone acetate 3 mg per 1 mL (5 mL) [contains benzalkonium chloride, edetate disodium]
Generic: Betamethasone sodium phosphate 3 mg and betamethasone acetate 3 mg per 1 mL (5 mL)
Brand Names: U.S.
- Celestone Soluspan
- Celestone [DSC]
- Pod-Care 100C
- ReadySharp Betamethasone
- Corticosteroid, Systemic
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
Hepatic (Peterson 1983)
Urine (<5% as unchanged drug) (Peterson 1983)
Time to Peak
Serum: IV: 10 to 36 minutes (Peterson 1983)
6.5 hours (Peterson 1983)
64% (Peterson 1983)
Use: Labeled Indications
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome)
Endocrine disorders: Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia
Neoplastic diseases: Palliative management of leukemias and lymphomas
Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Note: Treatment guidelines recommend the use of high-dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).
Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis
Rheumatic disorders: Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy
Intra-articular or soft tissue administration:
Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis
Treatment of alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum
Off Label Uses
Accelerate fetal lung maturation
In a systematic review of available evidence comparing any 2 corticosteroid regimens, no clear advantages of one corticosteroid over another was found. However, dexamethasone, in comparison to betamethasone, may have some additional benefits (eg, less intraventricular hemorrhage) [Brownfoot 2013].
Based on the American Congress of Obstetricians and Gynecologists (ACOG) practice bulletin for the management of premature rupture of membranes or preterm labor, the antenatal use of corticosteroids (eg, betamethasone) to accelerate fetal lung maturation is effective and recommended [ACOG 171 2016], [ACOG 172 2016], [ACOG 677 2016].
Hypersensitivity to any component of the formulation; IM administration contraindicated in immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura).
Documentation of allergenic cross-reactivity for glucocorticoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Note: Dosages expressed as combined amount of betamethasone sodium phosphate and betamethasone acetate; 1 mg is equivalent to betamethasone sodium phosphate 0.5 mg and betamethasone acetate 0.5 mg. Base dosage on severity of disease and patient response.
Usual dosage range: IM: Initial: 0.25 to 9 mg daily
Antenatal fetal maturation (off-label use): IM: 12 mg every 24 hours for a total of 2 doses (ACOG 171 2016). A single course of betamethasone is recommended for women between 24 and 34 weeks of gestation, including those with ruptured membranes or multiple gestations, who are at risk of delivering within 7 days. A single course may be appropriate in some women beginning at 23 weeks gestation or late preterm (between 34 0/7 weeks and 36 6/7 weeks gestation). A single repeat course may be considered in some women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior (ACOG 171 2016; ACOG 172 2016; ACOG 677 2016).
Bursitis (other than of foot), tenosynovitis, peritendinitis: Intrabursal: 3 to 6 mg (0.5 to 1 mL) for one dose; several injections may be required for acute exacerbations or chronic conditions; reduced doses may be warranted for repeat injections.
Dermatologic: Intralesional: 1.2 mg/cm2 (0.2 mL/cm2) for one dose (maximum: 6 mg [1 mL] weekly).
Foot disorders: Intra-articular: 1.5 mg to 6 mg (0.25 to 1 mL) per dose at 3 to 7 day intervals. Dose is based upon condition:
Bursitis: 1.5 mg to 3 mg (0.25 to 0.5 mL)
Tenosynovitis: 3 mg (0.5 mL)
Acute gouty arthritis: 3 mg to 6 mg (0.5 to 1 mL)
Multiple sclerosis: Note: Treatment guidelines recommend the use of high-dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).
IM: 30 mg daily for 1 week, followed by 12 mg every other day for 4 weeks.
Rheumatoid and osteoarthritis: Intra-articular: 3 mg to 12 mg (0.5 to 2 mL) for one dose. Dose is based upon the joint size:
Very large (eg, hip): 6 to 12 mg (1 to 2 mL)
Large (eg, knee, ankle, shoulder): 6 mg (1 mL)
Medium (eg, elbow, wrist): 3 mg to 6 mg (0.5 to 1 mL)
Small (eg, inter- or metacarpophalangeal, sternoclavicular): 1.5 mg to 3 mg (0.25 to 0.5 mL)
Refer to adult dosing. Use the lowest effective dose.
Note: Dosages expressed as combined amount of betamethasone sodium phosphate and betamethasone acetate; 1 mg is equivalent to betamethasone sodium phosphate 0.5 mg and betamethasone acetate 0.5 mg. Base dosage on severity of disease and patient response.
Inflammatory conditions: Children and Adolescents: IM: 0.02 to 0.3 mg/kg/day (0.6 to 9 mg/m2/day) in 3 or 4 divided doses
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
If suspension is coadministered with a local anesthetic, it may be mixed in syringe with 1% or 2% lidocaine HCl (without parabens) or similar parabens-free local anesthetic. Withdraw the dose of betamethasone suspension from the vial into the syringe, then draw up the local anesthetic into the syringe and shake the syringe briefly. Do not inject the local anesthetic directly into the suspension vial.
IM: Do not give injectable sodium phosphate/acetate suspension IV or epidurally
Intrabursal: Tendinitis, tenosynovitis: Inject into affected tendon sheaths (not directly into tendons).
Intradermal: Using a 25-gauge 1 mL (eg, tuberculin) syringe with 1/2-inch needle inject a uniform depot. Do not inject subcutaneously.
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light.
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Corticosteroids (Systemic). Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification
Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic effect of Desmopressin. Avoid combination
DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Consider therapy modification
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy
Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination
Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination
Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Consider therapy modification
Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Monitor therapy
NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Monitor therapy
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Quinolone Antibiotics: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Consider therapy modification
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification
Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Monitor therapy
May suppress the wheal and flare reactions to skin test antigens
Frequency not defined.
Cardiovascular: Cardiac failure, edema, hypertension, hypotension
Central nervous system: Dizziness, headache, increased intracranial pressure, insomnia, myasthenia, nervousness, pseudotumor cerebri, seizure, vertigo
Dermatologic: Atrophic striae, diaphoresis, ecchymoses, facial erythema, fragile skin, hyperpigmentation, hypopigmentation, perioral dermatitis (oral)
Endocrine & metabolic: Amenorrhea, Cushing's syndrome, diabetes mellitus, fluid retention growth suppression, hirsutism, HPA-axis suppression, hyperglycemia, hypokalemia, menstrual disease, protein catabolism, sodium retention
Gastrointestinal: Abdominal distention, dyspepsia, hiccups, increased appetite, pancreatitis, peptic ulcer, ulcerative esophagitis
Hematologic & oncologic: Petechia
Hypersensitivity: Anaphylactoid reaction, hypersensitivity reaction
Infection: Secondary infection, sterile abscess
Local: Injection site reaction (intra-articular use)
Neuromuscular & skeletal: Amyotrophy, arthralgia, bone fracture, myopathy, osteonecrosis (femoral and humeral heads), osteoporosis
Ophthalmic: Cataract, glaucoma, increased intraocular pressure
Miscellaneous: Wound healing impairment
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. In stressful situations, HPA axis-suppressed patients should receive adequate supplementation with natural glucocorticoids (hydrocortisone or cortisone) rather than betamethasone (due to lack of mineralocorticoid activity).
• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate infections, or limit response to killed or inactivated vaccines. Special pathogens (Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Strongyloides, or Toxoplasma) may be activated or an infection exacerbation may occur (may be fatal). Amebiasis or Strongyloides infections should be particularly ruled out. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.
• Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been associated with electrolyte disturbances, fluid retention, and hypertension. Dietary modifications may be necessary. Use with caution in patients with a recent history of myocardial infarction (MI); left ventricular free wall rupture has been reported after the use of corticosteroids.
• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.
• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis,fresh intestinal anastomoses, peptic ulcer, ulcerative colitis) due to perforation risk. Avoid ethanol may enhance gastric mucosal irritation.
• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone; high-dose corticosteroids should not be used for the management of head injury.
• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.
• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroidism and decreases in hypothyroidism.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.
• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.
• Appropriate use: For intramuscular, intra-articular or intralesional use only, do not administer intravenously or epidurally (see Epidural injection).
• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.
• Epidural injection: Corticosteroids are not approved for epidural injection. Serious neurologic events (eg, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke), some resulting in death, have been reported with epidural injection of corticosteroids, with and without use of fluoroscopy.
• Intra-articular injection: May produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. Avoid injection into an infected site. Do not inject into unstable joints. Intra-articular injection may result in damage to joint tissues.
Growth in children
Pregnancy Risk Factor
Adverse events have been observed with corticosteroids in animal reproduction studies. Betamethasone crosses the placenta (Brownfoot 2013); and is partially metabolized by placental enzymes to an inactive metabolite (Murphy 2007). Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may have an effect on fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids during pregnancy; monitor.
Because antenatal corticosteroid administration may reduce the incidence of intraventricular hemorrhage, necrotizing enterocolitis, neonatal mortality, and respiratory distress syndrome, the injection is often used for antenatal fetal lung maturation in patients with preterm premature rupture of membranes or preterm labor who are at risk of preterm delivery. A single course of betamethasone is recommended for women between 24 and 34 weeks gestation who are at risk of delivering within 7 days, including those with ruptured membranes or multiple gestations. A single course of betamethasone may be considered for women beginning at 23 weeks gestation, who are at risk of delivering within 7 days, in consultation with the family. In addition, a single course of betamethasone may be given to women between 34 0/7 weeks and 36 6/7 weeks who are at risk of preterm delivery within 7 days and who have not previously received corticosteroids; use of concomitant tocolytics is not currently recommended and administration of late preterm corticosteroids has not been evaluated in women with intrauterine infection, multiple gestations, pregestational diabetes, or women who delivered previously by cesarean section at term. Multiple repeat courses are not recommended. However, in women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior, a single repeat course may be considered; use of a repeat course in women with premature rupture of membranes is controversial (ACOG 171 2016; ACOG 172 2016; ACOG 677 2016).
When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010; Makol 2011; Østensen 2009).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea, vomiting, or agitation. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of Cushing’s disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), signs of skin changes (pimples, stretch marks, slow healing, or hair growth), signs of infection, signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of bleeding (vomiting blood or vomit that looks like coffee grounds, coughing up blood, hematuria, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, bruises without a reason or that get bigger, or any severe or persistent bleeding); signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss); signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes); signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities); severe loss of strength and energy; tremors; irritability; tachycardia; confusion; sweating a lot; severe dizziness; paralysis, blindness, shortness of breath; excessive weight gain; swelling of arms or legs; bradycardia; angina; menstrual changes; joint pain; bone pain; behavioral changes; seizures; depression; burning or numbness feeling; or vision changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about betamethasone
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