Drugs List

Therapeutic Indications

Uses

Adrenal insufficiency - cortical
Inflammatory or allergic conditions
Shock - severe (adjunct)
Soft tissue lesion
Status asthmaticus

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
- Tenosynovitis
- Bursitis

Administration

For systemic use it may be administered by:
Slow intravenous injection
Intravenous infusion
Deep intramuscular injection
Local sites administration including subconjunctival injection and soft tissue sites injections.

Contraindications

Uncontrolled systemic infection

Precautions and Warnings

Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Fluid retention
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
Herpes simplex keratitis
History of peptic ulcer
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Osteoporosis
Peptic ulcer
Pre-eclampsia
Pregnancy
Recent myocardial infarction
Renal impairment
Severe affective disorders
Severe hepatic impairment
Thromboembolic disorder
Tuberculosis

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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Candidiasis
Cognitive impairment
Confusion
Corneal thinning
Cushing's syndrome
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Dyspepsia
Elevated serum LDL cholesterol
Emotional lability
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Glaucoma
Growth retardation (children)
Hallucinations
Hiccups
Hirsutism
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Impaired healing
Increase in HDL cholesterol
Increased appetite
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Irritability
Leucocytosis
Malaise
Mania
Menstrual disturbances
Myocardial rupture
Nausea
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Oesophageal ulceration
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Psychological dependence
Psychosis
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Scleral thinning
Sleep disturbances
Sodium/water retention
Stevens-Johnson syndrome
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Vertebral and long bone fractures
Weight gain
Withdrawal syndrome - see product information

Presentation

Injections of Betamethasone sodium phosphate.

Drugs List

Therapeutic Indications

Uses

Adrenal insufficiency - cortical
Inflammatory or allergic conditions
Shock - severe (adjunct)
Soft tissue lesion
Status asthmaticus

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
- Tenosynovitis
- Bursitis

Dosage

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.

Adults

Children

Additional Dosage Information

Administration

For systemic use it may be administered by:
Slow intravenous injection
Intravenous infusion
Deep intramuscular injection
Local sites administration including subconjunctival injection and soft tissue sites injections.

Contraindications

Uncontrolled systemic infection

Precautions and Warnings

Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Fluid retention
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
Herpes simplex keratitis
History of peptic ulcer
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Osteoporosis
Peptic ulcer
Pre-eclampsia
Pregnancy
Recent myocardial infarction
Renal impairment
Severe affective disorders
Severe hepatic impairment
Thromboembolic disorder
Tuberculosis

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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Candidiasis
Cognitive impairment
Confusion
Corneal thinning
Cushing's syndrome
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Dyspepsia
Elevated serum LDL cholesterol
Emotional lability
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Glaucoma
Growth retardation (children)
Hallucinations
Hiccups
Hirsutism
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Impaired healing
Increase in HDL cholesterol
Increased appetite
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Irritability
Leucocytosis
Malaise
Mania
Menstrual disturbances
Myocardial rupture
Nausea
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Oesophageal ulceration
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Psychological dependence
Psychosis
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Scleral thinning
Sleep disturbances
Sodium/water retention
Stevens-Johnson syndrome
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Vertebral and long bone fractures
Weight gain
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:
Fever
Myalgia
Arthralgia
Rhinitis
Conjunctivitis
Itchy skin nodules
Loss of weight

Overdosage

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 ).

Further Information

Last Full Review Date: November 2019

Reference Sources

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