Evigrade

Betamethasone

AEMPS

Glucocorticoid for systemic use

ATC code: H02AB01

Brand names: Celestone Soluspan

Updated · Methodology

Indications

B

Knee osteoarthritis

Second line

The AEMPS Celestone Cronodose label describes intra-articular use in osteoarthritis: 1 ml into a large joint such as the knee, repeated as required at one to four week intervals, with pain and stiffness easing 2–4 hours after the injection. The 2019 and Arthritis Foundation guideline keeps intra-articular glucocorticoid among the options for knee osteoarthritis while noting that the effect is short-lived and that movement, strength work and weight form the base of treatment. The practical reading for a patient: the injection carries you through a flare rather than replacing rehabilitation, and frequent repeats into the same joint are unwelcome. Part of the drug reaches the bloodstream after injection, so in someone with diabetes glucose can climb over the following days.

ICD-10: M17 · ICD-11: FA01

B

Rheumatoid arthritis

Adjunct

The AEMPS Celestone Cronodose label allows intra-articular and periarticular injection in rheumatoid arthritis and intramuscular use in rheumatic conditions where a sustained effect is needed. Within the regimen betamethasone covers a flare and buys time until disease-modifying therapy works, while methotrexate and biologics drive the disease itself. The label warns that part of the dose is absorbed systemically after an intra-articular injection, which is counted in for anyone already on oral or parenteral corticosteroids. The same point leads to the central rheumatology interaction: an NSAID next to a systemic corticosteroid raises the risk of gastrointestinal ulcer and bleeding, and gastroprotection is discussed for the period of the combination.

ICD-10: M06.9 · ICD-11: FA20

B

Severe allergic reactions

Adjunct

The AEMPS Betametasona Sonphar label names severe hypersensitivity reactions and anaphylaxis among its indications, while Celestone Cronodose allows intramuscular injection in allergic conditions when oral or local treatment does not fit or is not enough. The drug's place here is supporting. The 2021 anaphylaxis guideline puts intramuscular adrenaline first and treats corticosteroids and antihistamines as second line: they do not replace adrenaline and do not remove the need for observation because of a possible biphasic reaction. A systemic corticosteroid meanwhile lowers potassium and raises glucose, and together with an NSAID it raises ulcer and bleeding risk, both of which show up in patients with diabetes or heart failure.

ICD-10: T78.2 · ICD-11: 4A84

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Allergic rhinitis

Not recommended

A depot betamethasone injection is offered, in Russia and elsewhere, as a shot that covers the whole allergy season: one injection in spring and no drops or tablets afterwards. The AEMPS Celestone Cronodose label describes something else: intramuscular use in allergic conditions where oral or local treatment does not fit or is not enough, 1 ml roughly once a week as required rather than once for a season. ARIA 2020 frames allergic rhinitis treatment as a stepwise algorithm, stepped up and down by symptoms. The price of a systemic corticosteroid in a seasonal disease sits in the adverse reactions section: potassium loss, rising glucose, osteoporosis and vertebral compression fractures, posterior subcapsular cataract, glaucoma, and adrenal suppression that lasts for months. If a depot injection is offered as a routine seasonal answer, consider seeking a second opinion.

ICD-10: J30.9 · ICD-11: CA08.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Betamethasone binds the intracellular glucocorticoid receptor; the complex moves into the nucleus and switches transcription: inflammatory cytokine genes go quiet, anti-inflammatory protein genes switch on. Hence the rapid suppression of oedema, leucocyte migration and the immune response. Anti-inflammatory potency is about 25 times that of hydrocortisone with almost no mineralocorticoid action, so sodium retention is weaker than with prednisolone. Potassium loss remains: the label warns explicitly about hypokalaemic alkalosis and calls for potassium monitoring alongside a diuretic or amphotericin B. The depot dipropionate form holds its effect for weeks, and systemic effects last just as long.

Safety

Contraindications

  • Hypersensitivity to betamethasone or to any excipient
  • Systemic infection without appropriate anti-infective treatment
  • Local injection into an infected area
  • Injection into an unstable joint

Serious adverse effects

  • Cushingoid state and secondary adrenal insufficiency that persists for months after withdrawal
  • Gastrointestinal ulcer with perforation and bleeding, pancreatitis, ulcerative oesophagitis
  • Osteoporosis, vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, tendon rupture
  • Posterior subcapsular cataract, glaucoma, raised intraocular pressure
  • Seizures, raised intracranial pressure with papilloedema
  • Congestive heart failure, hypertension
  • Anaphylactic reactions with parenteral use
  • Growth retardation in children

Common adverse effects

  • Sodium and fluid retention, potassium loss, hypokalaemic alkalosis
  • Rising glucose and reduced carbohydrate tolerance
  • Menstrual irregularities
  • Euphoria, mood swings, insomnia
  • Increased sweating, thin fragile skin, petechiae and bruising

Pregnancy: can you take Betamethasone?

There are no adequate controlled studies in pregnancy and corticosteroids cross the placenta, so the drug is used only where the expected benefit justifies the risk to the fetus. Neonates whose mothers received substantial doses during pregnancy are watched for adrenal insufficiency. The label calls prophylactic use beyond week 32 controversial and asks for a separate risk-benefit weighing. In pre-eclampsia, eclampsia and signs of placental damage the drug is not given. After a short antenatal course of betamethasone in women at risk of late preterm birth, a higher rate of neonatal hypoglycaemia has been described.

Breastfeeding: can you take Betamethasone?

Systemic corticosteroids pass into breast milk and can slow an infant's growth, suppress endogenous hormone production and cause other adverse reactions, so the AEMPS Celestone Cronodose label calls for caution when treating a breastfeeding woman.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions38 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «En caso de tratamiento con corticoides a largo plazo: Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • «Medicamentos inductores de torsades de pointes (astemizol, bepridil, eritromicina IV, pentamidina, halofantrina, esparfloxacino, sultoprida, terfenadina y vincamina).»

    AEMPS, section 4.5 · Open on CIMA

  • Majorinhibidores del CYP3A4class named in the label
    «En caso de tratamiento con corticoides a largo plazo: Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • «Inductores e inhibidores enzimáticos: Los inhibidores enzimáticos CYP3A4 como ketoconazol e itraconazol y ciertos medicamentos antirretrovirales (como ritonavir, cobicistat) pueden intensificar el…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores e inhibidores enzimáticos: Los inhibidores enzimáticos CYP3A4 como ketoconazol e itraconazol y ciertos medicamentos antirretrovirales (como ritonavir, cobicistat) pueden intensificar el…»

    AEMPS, section 4.5 · Open on CIMA

  • Majormedicamentos que prolongan el QTclass named in the label
    «Medicamentos inductores de torsades de pointes (astemizol, bepridil, eritromicina IV, pentamidina, halofantrina, esparfloxacino, sultoprida, terfenadina y vincamina).»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores e inhibidores enzimáticos: Los inhibidores enzimáticos CYP3A4 como ketoconazol e itraconazol y ciertos medicamentos antirretrovirales (como ritonavir, cobicistat) pueden intensificar el…»

    AEMPS, section 4.5 · Open on CIMA

  • «Ácido acetilsalicílico por vía general y por extrapolación otros salicilatos: Disminución de la salicilemia durante el tratamiento con corticoides y riesgo de sobredosis de salicilatos tras su…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAINEclass named in the label
    «Alcohol, ácido acetilsalicílico y AINES: La incidencia de RAS ulceración, hemorragia gastrointestinal aumenta en pacientes que reciben fármacos antiinflamatorios no corticoesteroideos de forma…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAmiodarone
    «Antiarrítmicos inductores de torsades de pointes (amiodarona, bretilio, disopiramida, quinidínicos, sotalol).»

    AEMPS, section 4.5 · Open on CIMA

  • «Otros hipokalemiantes (diuréticos hipokalemiantes solos o en asociación, laxantes estimulantes, anfotericina B IV).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiarrítmicosclass named in the label
    «Antiarrítmicos inductores de torsades de pointes (amiodarona, bretilio, disopiramida, quinidínicos, sotalol).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «Anticoagulantes orales: Posible efecto de la corticoterapia en el metabolismo del anticoagulante oral y en el metabolismo de los factores de la coagulación.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantidiabéticosclass named in the label
    «Insulina, metformina, sulfamidas hipoglucemiantes: Elevación de la glucemia y a veces con cetosa (los corticoides disminuyen la tolerancia a los glúcidos).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebarbitúricosclass named in the label
    «Inductores e inhibidores enzimáticos: Inductores enzimáticos CYP3A4 como la rifampicina, fenitoína, carbamazepina, barbitúricos,»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores e inhibidores enzimáticos: Inductores enzimáticos CYP3A4 como la rifampicina, fenitoína, carbamazepina, barbitúricos,»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiclosporin
    «Ciclosporina: Se puede originar un aumento de actividad tanto de la ciclosporina como de los corticosteriodes cuando ambos se administran conjuntamente. Se han descrito casos de convulsiones con su…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatedigitálicosclass named in the label
    «Vigilar la kalemia y corregirla si procede, especialmente en caso de tratamiento con digitálicos.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDigoxin
    «Glucósidos cardiotónicos (digoxina): Hipokalemia que favorece los efectos tóxicos de los digitálicos, pueden tener un riesgo más elevado de arritmias .»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDisopyramide
    «Antiarrítmicos inductores de torsades de pointes (amiodarona, bretilio, disopiramida, quinidínicos, sotalol).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatediuréticosclass named in the label
    «Otros hipokalemiantes (diuréticos hipokalemiantes solos o en asociación, laxantes estimulantes, anfotericina B IV).»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateInsulin
    «Insulina, metformina, sulfamidas hipoglucemiantes: Elevación de la glucemia y a veces con cetosa (los corticoides disminuyen la tolerancia a los glúcidos).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinsulinaclass named in the label
    «Insulina, metformina, sulfamidas hipoglucemiantes: Elevación de la glucemia y a veces con cetosa (los corticoides disminuyen la tolerancia a los glúcidos).»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatelaxantesclass named in the label
    «Otros hipokalemiantes (diuréticos hipokalemiantes solos o en asociación, laxantes estimulantes, anfotericina B IV).»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateMetformin
    «Insulina, metformina, sulfamidas hipoglucemiantes: Elevación de la glucemia y a veces con cetosa (los corticoides disminuyen la tolerancia a los glúcidos).»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores e inhibidores enzimáticos: primidona, fenobarbital, rifabutina, efedrina y aminoglutetimida, pueden reducir el efecto.»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «Inductores e inhibidores enzimáticos: Inductores enzimáticos CYP3A4 como la rifampicina, fenitoína, carbamazepina, barbitúricos,»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifabutin
    «Inductores e inhibidores enzimáticos: primidona, fenobarbital, rifabutina, efedrina y aminoglutetimida, pueden reducir el efecto.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «Inductores e inhibidores enzimáticos: Inductores enzimáticos CYP3A4 como la rifampicina, fenitoína, carbamazepina, barbitúricos,»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSomatropin
    «Somatropina: Puede reducirse el efecto de la somatropina.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSotalol
    «Antiarrítmicos inductores de torsades de pointes (amiodarona, bretilio, disopiramida, quinidínicos, sotalol).»

    AEMPS, section 4.5 · Open on CIMA

  • Minoranticonceptivos hormonalesclass named in the label
    «Estrógenos, incluyendo anticonceptivos orales: Los estrógenos pueden disminuir el metabolismo hepático de ciertos corticosteroides, incluso aumentar su efecto.»

    AEMPS, section 4.5 · Open on CIMA

  • Minormacrólidosclass named in the label
    «Antibióticos: Se han notificado que los antibióticos macrólidos producen una reducción significativa en el aclaramiento de corticosteroides.»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Established and Other Potentially Significant Interactions: Corticosteroids: e.g., betamethasone budesonide ciclesonide dexamethasone fluticasone methylprednisolone mometasone triamcinolone ↓…»

    FDA, section 7 · Open on DailyMed

  • «CORTICOSTEROIDES: Corticosteroides metabolizados principalmente por CYP3A (incluyendo betametasona, budesonida, fluticasona, mometasona, prednisona, triamcinolona).»

    AEMPS, section 4.5 · Open on CIMA

  • «Established and Other Potentially Significant Drug Interactions: Corticosteroids: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: eg. betamethasone budesonide ciclesonide…»

    FDA, section 7 · Open on DailyMed

  • ModerateRitonavir
    «Established and Other Potentially Significant Drug Interactions: Systemic/Inhaled/Nasal/Ophthalmic Corticosteroids: e.g., betamethasone budesonide ciclesonide dexamethasone fluticasone…»

    FDA, section 7 · Open on DailyMed

  • «Estudios farmacocinéticos de interacciones en humanos, revelaron que la absorción percutánea de minoxidil se ve reforzada con el uso de tretinoína y ditranol, como resultado de un incremento en la…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Betamethasone used for?

Betamethasone is evaluated for the following indications with varying evidence strength: Severe allergic reactions (evidence tier B), Rheumatoid arthritis (evidence tier B), Knee osteoarthritis (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Betamethasone?

Common side effects of Betamethasone (≥ 1 in 100): Sodium and fluid retention, potassium loss, hypokalaemic alkalosis, Rising glucose and reduced carbohydrate tolerance, Menstrual irregularities, Euphoria, mood swings, insomnia, Increased sweating, thin fragile skin, petechiae and bruising. See the Safety section for uncommon and serious reactions.

Is Betamethasone safe during pregnancy?

There are no adequate controlled studies in pregnancy and corticosteroids cross the placenta, so the drug is used only where the expected benefit justifies the risk to the fetus. Neonates whose mothers received substantial doses during pregnancy are watched for adrenal insufficiency. The label calls prophylactic use beyond week 32 controversial and asks for a separate risk-benefit weighing. In pre-eclampsia, eclampsia and signs of placental damage the drug is not given. After a short antenatal course of betamethasone in women at risk of late preterm birth, a higher rate of neonatal hypoglycaemia has been described.

Is Betamethasone compatible with breastfeeding?

Systemic corticosteroids pass into breast milk and can slow an infant's growth, suppress endogenous hormone production and cause other adverse reactions, so the AEMPS Celestone Cronodose label calls for caution when treating a breastfeeding woman.

Who should not take Betamethasone?

Betamethasone is contraindicated in: Hypersensitivity to betamethasone or to any excipient; Systemic infection without appropriate anti-infective treatment; Local injection into an infected area; Injection into an unstable joint. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Deflazacort, Dexamethasone, Fludrocortisone, Hydrocortisone, Methylprednisolone, Prednisolone, Prednisone