Betamethasone sodium phosphate parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections of Betamethasone sodium phosphate.
Adrenal insufficiency - cortical
Inflammatory or allergic conditions
Shock - severe (adjunct)
Soft tissue lesion
Used systemically in conditions where parenteral corticosteroid therapy may be necessary, for example:
- Status asthmaticus (adjunctive)
- Acute allergic reactions including anaphylactic reactions (adjunctive)
- Severe shock due to accidental or surgical trauma or infection
- Acute adrenal crisis in Addison's disease or Simmond's disease, hypopituitarism following adrenalectomy and when adrenocortical function has been suppressed by prolonged corticosteroid therapy
Betamethasone sodium phosphate is also used locally for soft tissue injuries, for example:
- Tennis elbow
Betamethasone is a glucocorticoid approximately 8 to 10 times as active as prednisolone.
Adverse reactions 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 a single morning dose on alternate days. This is particularly important in children. Divided dosage may be employed and the lowest dose to produce an acceptable response should be administered.
4mg to 20mg administered by slow intravenous injection over 30 to 60 seconds. This may be repeated 3 or 4 times in 24 hours. Betamethasone may also be administered at the same dose by deep intramuscular injection or as an intravenous infusion.
4mg to 8mg injected locally may be used when treating soft tissue lesions and repeated on 2 or 3 occasions depending on the patient's response. A single subconjunctival injection of 0.5 to 1ml has also been administered.
Consider administration of a single dose on alternate days.
Children aged 6 to 12 years: 4mg intravenously.
Children aged 1 to 6 years: 2mg intravenously.
Infants aged up to 1 year: 1mg intravenously.
These doses may be repeated 3 or 4 times in 24 hours, depending on the patient's response.
When treating soft tissue lesions, children may require smaller doses than the adult doses.
Additional Dosage Information
Gradual withdrawal of therapy will be required in patients who have received more than 1mg betamethasone (approximate physiological dose) for greater than 3 weeks. How dose reduction should be carried out depends upon on the likelihood of disease relapse on withdrawal and likelihood of hypothalamic-pituitary-adrenal (HPA) suppression. If disease is unlikely to relapse but HPA suppression is uncertain, a rapid reduction of dosage to 1mg daily may be effected, then dose reduction should be slowed down to allow the HPA-axis to recover.
Abrupt withdrawal of betamethasone therapy of up to 3 weeks duration is appropriate if the disease is unlikely to relapse. Abrupt withdrawal of doses up to 6mg daily for up to 3 weeks is unlikely to lead to clinically relevant adrenal suppression.
For systemic use it may be administered by:
Slow intravenous injection
Deep intramuscular injection
Local sites administration including subconjunctival injection and soft tissue sites injections.
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
Congestive cardiac failure
Herpes simplex keratitis
History of peptic ulcer
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Recent myocardial infarction
Severe affective disorders
Severe hepatic impairment
Administration of live vaccines is not recommended
Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
Disease reactivation may occur in patients with latent TB
Exposure to measles may require prophylaxis with normal immunoglobulin
May mask symptoms or signs of infections
Not all routes are licensed for all age groups
Passive immunisation of chicken pox / herpes zoster may be required
Contains sodium metabisulfite. Caution,may cause allergic reactions
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor regularly the height of children receiving prolonged treatment
Neonates exposed in utero: Monitor for adrenal suppression
Post menopausal women at increased risk of osteoporosis
Pregnancy: Monitor closely patients with pre-eclampsia or fluid retention
Prolonged or high dose may lead to adrenal suppression
Psychological changes may occur during initiation & withdrawal of treatment
Supervise patient closely during drug withdrawal
Adrenal cortical atrophy may persist for years after stopping drug
Antibody response to vaccines may be reduced
Breastfeeding: Risk of adrenal suppression in breastfed infant
Corticosteroids may cause growth retardation in children under 18 years
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Sudden withdrawal may be inadvisable -see product information/SPC
Advise patient not to take St John's wort concurrently
Advise patients to avoid aspirin and NSAID use
Advise patient to avoid exposure to measles
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Consider issuing Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have has them in the past 3 months; this should be given within 10 days of exposure to chicken pox. Corticosteroids should not be stopped and the dose may need to be increased.
The treatment of elderly patients particularly if long term, needs to be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypokalaemia, hypertension, susceptibility to infection and thinning of skin. Close clinical supervision is necessary to avoid life threatening reactions.
Pregnancy and Lactation
Use betamethasone with caution during pregnancy.
The manufacturer states that corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. Patients with normal pregnancies may be treated as though they were in the non-gravid state. Animal studies have shown abnormal foetal development. Available data following use in human pregnancy does not indicate developmental effects, however, a possible association cannot be excluded.
When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure 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. It is recommended that foetal growth should be observed sonographically if the maternal treatment occurs over many weeks.
Use betamethasone with caution during breastfeeding.
The manufacturer states that the presence of betamethasone in human breast milk is unknown but due to its molecular weight, transfer is expected. It is recommended to wait at least 4 hours after administration before breastfeeding (Schaefer, 2015). Infants of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.
LactMed suggests that local injections of betamethasone would not be expected to cause adverse effects in breastfed infants. However, a temporary loss of milk supply may occur.
Aggravation of schizophrenia
Elevated serum LDL cholesterol
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Growth retardation (children)
Hypersensitivity reactions including anaphylaxis
Increase in HDL cholesterol
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Vertebral and long bone fractures
Withdrawal syndrome - see product information
Withdrawal Symptoms and Signs
Withdrawal symptoms due to a rapid reduction of corticosteroids may lead to adrenal insufficiency, hypotension and death.
A withdrawal syndrome may occur which include the following:
Itchy skin nodules
Loss of weight
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2019
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Betamethasone 4mg/ml Solution for Injection. RPH Pharmaceuticals AB. Revised March 2018.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 08 November 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Betamethasone. Last revised: 31 October 2018
Last accessed: 08 November 2019
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