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Potent Systemic Corticosteroid Pregnancy: §4.6, verbatim: 'The ability of corticosteroids to cross the placenta varies between individual drugs, however, betamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Myocardial hypertrophy and gastroesophageal reflux have been reported in association with in-utero exposure to betamethasone. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring. Betamethasone, systemically administered to a woman during pregnancy may result in a transient suppression of the foetal heart rate parameters and biophysical activities that are widely used for the assessment of foetal well-being. These characteristics can include a reduction in foetal breathing movements, body movements and heart rate. Studies have shown an increased risk of neonatal hypoglycaemia following antenatal administration of a short course of betamethasone to women at risk for late preterm delivery.' Breast-feeding: 'Corticosteroids may pass into breast milk, although no data are available for betamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.'

Betamethasone (Systemic)

Brand names: Betnesol (IV/IM), Celestone (IM depot)

Betamethasone given systemically (oral or by injection) is a potent long-acting corticosteroid used for a range of inflammatory, allergic and autoimmune conditions and in some obstetric indications. This page covers systemic use, distinct from topical or inhaled preparations.

Adult dose

Dose: Systemic corticosteroid therapy — 4 to 20 mg betamethasone per dose (1 to 5 ml of the 4 mg/ml injection). §4.2, verbatim: 'Systemic therapy in adults 4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous injection over half to one minute. This dose can be repeated three or four times in 24 hours, or as required, depending upon the condition being treated and the patient's response.' The same dose may be given intramuscularly — verbatim: 'The same dose can be given by deep intramuscular injection but the response is likely to be less rapid, especially in shock.' SCOPE: this is the injection SPC's systemic regimen. It does NOT cover oral betamethasone tablets, and it does NOT contain the antenatal fetal-lung-maturation regimen — that indication has its own dedicated antenatal betamethasone entry and no dose for it appears anywhere in this bundle.
Route: Slow intravenous injection over half to one minute; alternatively by intravenous infusion; or by deep intramuscular injection. §4.2, verbatim: 'Betnesol Injection/Betamethasone Injection may be administered by slow intravenous injection, deep intramuscular injection or subconjunctival injection. Alternatively, Betnesol Injection/Betamethasone Injection may be given by intravenous infusion.' §4.2 also states: 'Intrathecal use is not recommended.' §4.3 states: 'Betnesol Injection/Betamethasone Injection should not be injected directly into tendons.'
Frequency: Up to three or four times in 24 hours. §4.2, verbatim: 'This dose can be repeated three or four times in 24 hours, or as required, depending upon the condition being treated and the patient's response.' §4.4 adds, verbatim: 'Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose or whenever possible as a single morning dose on alternate days. Frequent patient review is required to appropriately titrate the dose against disease activity.'
Max: 20 mg (5 ml) is the top of the stated per-dose range, repeatable three or four times in 24 hours. The source states no absolute 24-hour total — dose is titrated against disease activity using the lowest effective dose for the minimum period.
OTHER ROUTES DOSED IN THE SAME §4.2, recorded here rather than in the main dose field. Soft-tissue/local injection, verbatim: 'Local injections of 4 to 8mg Betnesol Injection/Betamethasone Injection may be used when treating soft tissue lesions in adults; children may require smaller doses. This dose can be repeated on two or three occasions depending upon the patient's response.' Subconjunctival, verbatim: 'Betnesol Injection/Betamethasone Injection has also been administered sub-conjunctivally as a single injection of 0.5 to 1ml.' Intrathecal, verbatim: 'Intrathecal use is not recommended.' The only antenatal mention in the SPC is a safety statement in §4.6 with no dose, verbatim: 'Studies have shown an increased risk of neonatal hypoglycaemia following antenatal administration of a short course of betamethasone to women at risk for late preterm delivery.' PRODUCT STRENGTH: the injection is 4 mg/ml — §4.2 pairs '4 to 20mg (1 to 5ml)' and '4mg (1ml)'. WITHDRAWAL, §4.4 verbatim as far as it was fetched: 'Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. In patients who have received more than physiological doses of systemic corticosteroids (approximately 1mg betamethasone or equivalent) for greater than 3 weeks, withdrawal should not be' [truncated at the source-fetch limit — read the complete §4.4 before withdrawing therapy]. PRESERVATIVE, §4.3: the injection 'contains sodium metabisulphite (0.1% w/v) as a preservative'. INFECTION RISK, §4.4: 'Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity... serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.'

Paediatric dose

Route: Intravenous — the SPC gives its paediatric figures for intravenous administration
Frequency: Up to three or four times in 24 hours
Max: 4 mg per dose in children aged 6 to 12 years — the SPC's paediatric doses are age bands, not weight-based figures
⚠️ dosePerKg is null on purpose: this SPC's paediatric doses are AGE-BANDED FIXED DOSES, not per-kilogram figures, so a weight calculation would be wrong. §4.2, verbatim: 'Systemic therapy in paediatric population Infants up to 1 year may be given 1mg betamethasone intravenously; children aged 1 to 5 years, 2mg; 6 to 12 years, 4mg (1ml). This dose can be repeated three or four times in 24 hours, depending upon the condition being treated and the patient's response.' The injection is 4 mg/ml, and the SPC itself pairs '4mg (1ml)' — draw the stated milligram dose from that strength. concentration is left null so that no automatic volume is calculated from an age-banded dose. For soft-tissue lesions §4.2 gives no paediatric figure at all, saying only that 'children may require smaller doses'. §4.8 lists 'growth suppression in infancy, childhood and adolescence' among endocrine effects, and psychiatric reactions that 'are common and may occur in both adults and children'. §4.4 warns that 'Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention.' Verify against a children's formulary and seek specialist paediatric advice.

Dose adjustments

Renal

Not stated — no renal-impairment dosing statement appears in any fetched section of this SPC (§4.2, §4.3, §4.4, §4.6, §4.8). Note that §4.8 lists 'Fluid and electrolyte disturbance (Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis)' among undesirable effects, which is a monitoring rather than a dosing point.

Hepatic

Not stated — no hepatic-impairment dosing statement appears in any fetched section of this SPC. §4.4 is truncated at the source-fetch limit, so check the complete section before advising.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • [§4.3] 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
  • [§4.3] 'Systemic infections, unless specific anti-infective therapy is employed.'
  • [§4.3] 'Betnesol Injection/Betamethasone Injection contains sodium metabisulphite (0.1% w/v) as a preservative and therefore should not be used to treat patients with known hypersensitivity to bisulphite, metabisulphite.'
  • [§4.3] 'Betnesol Injection/Betamethasone Injection should not be injected directly into tendons.'
  • [§4.2 — a route bar rather than a formal contraindication] 'Intrathecal use is not recommended.'
  • [§4.4 — explicit bars rather than formal contraindications] 'Live vaccines should not be given to individuals with impaired immune responsiveness.' and 'Corticosteroids should not be used for management of head injury or stroke because it is unlikely to be of benefit and may even be harmful.'
  • [§4.4] Use only after risk/benefit evaluation in suspected or identified phaeochromocytoma — 'Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids.'

Side effects

  • [§4.8] Infections — 'Increased susceptibility to and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.' §4.4 singles out chickenpox: 'this normally minor illness may be fatal in immunosuppressed patients.'
  • [§4.8] Endocrine — 'Suppression of the HPA axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea.'
  • [§4.8] Metabolic — 'Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy', plus 'Negative protein, nitrogen and calcium balance. Increased appetite. Hyperhidrosis... Fluid and electrolyte disturbance (Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis).'
  • [§4.8] Psychiatric — COMMON, the only effect with a stated frequency: 'A wide range of psychiatric reactions', including 'affective disorder (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia... In adults, the frequency of severe reactions has been estimated to the 5-6%.'
  • [§4.8] Eye — 'Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases. Vision, blurred.'
  • [§4.8] Cardiac — 'Myocardial rupture following recent myocardial infarction.' §4.4 accordingly advises caution 'in patients who have suffered a recent myocardial infarction'.
  • [§4.8] Gastrointestinal — 'Abdominal distension, oesophageal ulceration, nausea, dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis.'
  • [§4.8] Skin — 'Impaired healing, skin atrophy, bruising, telangiectasia, striae, acne, Stevens-Johnson syndrome.'
  • [§4.8] Musculoskeletal — 'Osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, proximal myopathy.'
  • [§4.8] General — 'Hypersensitivity including anaphylaxis has been reported. Leucocytosis, Thrombo-embolism, Malaise, Hiccups.' In children, 'Increased intra-cranial pressure with papilloedema' is reported [text truncated at the source-fetch limit].
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • [§4.4] 'Frequent patient review is required to appropriately titrate the dose against disease activity', using 'the lowest effective dose for the minimum period'.
  • [§4.4] Adrenal suppression on withdrawal — 'Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment', and applies to anyone given more than physiological doses (approximately 1mg betamethasone or equivalent) for greater than 3 weeks.
  • [§4.4] Chickenpox and measles exposure in non-immune patients — 'Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox.' For measles, 'Prophylaxis with intramuscular normal immunoglobulin may be needed.'
  • [§4.4] Vaccination — live vaccines must not be given to the immunosuppressed, and 'The antibody response to other vaccines may be diminished.'
  • [§4.4] Watch for masked infection — clinical presentation 'may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.'
  • [§4.8] Blood glucose — 'impaired carbohydrate tolerance with increased requirement for antidiabetic therapy'; and blood pressure, sodium, potassium and fluid balance for 'Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis'.
  • [§4.8] Psychiatric state — psychiatric reactions are the only COMMON adverse effect in this SPC and occur in adults and children; 'Psychological effects have been reported on withdrawal of corticosteroids.'
  • [§4.4] In cerebral oedema due to tumour, 'gastrointestinal bleeding may occur and stool examination may be helpful in diagnosis.'

Clinical monograph

How it works

It is a synthetic glucocorticoid with high anti-inflammatory and immunosuppressive potency and minimal mineralocorticoid effect, acting on glucocorticoid receptors to suppress inflammatory gene expression.

Prescribing in practice

  • Do not stop prolonged therapy abruptly — systemic corticosteroids suppress the adrenal axis, so taper the dose and provide a steroid treatment card and sick-day advice.
  • Long-term use causes immunosuppression, hyperglycaemia, osteoporosis, hypertension and neuropsychiatric effects, and can mask or worsen infection.
  • Use the lowest effective dose for the shortest period and review the need for gastric, bone and infection prophylaxis.

Monitoring

Monitor blood glucose, blood pressure, weight, mood and signs of infection, with bone health review during prolonged courses.

Counselling the patient

  • Never stop the steroid suddenly and carry your steroid card at all times.
  • Seek advice if you develop signs of infection or feel acutely unwell, and take extra steroid cover when ill if instructed.
  • Report mood changes, marked thirst or new indigestion.

Evidence & guidelines

Systemic corticosteroid use is supported by extensive clinical experience and trial data across many inflammatory and immune-mediated conditions.

Reference: NICE NG25 (Preterm Labour); Royal College of Obstetricians and Gynaecologists (RCOG) Antenatal Corticosteroids Guideline; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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