APR BECLORICH

S-18:

INFORMATION FOR THE USER

Betamethasone Injection

Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1. COMPOSITION:
Eachvial contains:
Betamethasone – 4mg

For IV/IM use only.

2. DESCRIPTION:
Betamethasone is a glucocorticoid.

3. PHARMACOLOGICAL ACTION:
Betamethasone is an active corticosteroid with topical anti-inflammatory activity. It is a glucocorticoid which is about 8-10 times as active as prednisolone on a weight-for-weight basis
4. CLINICAL PHARMACOKINETICS:
Betamethasone is bound to plasma proteins in varying degrees. It is metabolised primarily by the liver & excreted by the kidneys.
5. INDICATIONS:
Betamethasone injection is indicated for the treatment of:
– Status asthmaticus & acute allergic reactions, including anaphylactic reactions to drugs
– Severe shock arising from surgical/accidental trauma/overwhelming infection
– Acute adrenal crisis caused by abnormal stress in Addison’s disease, Simmonds’ disease, hypopituitarism following adrenalectomy & when adrenocortical function has been suppressed by prolonged corticosteroid therapy.
– Soft tissue lesions such as tennis elbow, tenosynovitis & bursitis.

6. CONTRAINDICATIONS:
– Hypersensitivity to the active substance or to any of the excipients
– Systemic infections, unless specific anti-infective therapy is employed
– Should not be injected directly into tendons.

7. WARNINGS AND PRECAUTIONS:
A patient information leaflet should be supplied with this product.
Undesirable effects may be minimised by using the lowest effective dose for the minimum period & by administering the daily requirement as a single morning dose or whenever possible as a single morning dose on alternate days.
Caution is advised in patients who have suffered a recent myocardial infarction because of the risk of myocardial rupture.
Caution is advised on the use of corticosteroids in patients with hypothyroidism or myasthenia gravis.
Suppression of the inflammatory response & immune function increases the susceptibility to infections & their severity. The clinical presentation may often be atypical & serious infections such as septicaemia & tuberculosis may be masked & may reach an advanced stage before being recognised).
Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.
Patients should be advised to take particular care to avoid exposure to measles & to seek immediate medical advice if exposure occurs. Prophylaxis with IM normal immunoglobulin may be needed.
Should not be used for management of head injury/stroke because it is unlikely to be of benefit & may even be harmful.
In the treatment of cerebral oedema due to tumour GI bleeding may occur & stool examination may be helpful in diagnosis.
Adrenal suppression: Adrenal cortical atrophy develops during prolonged therapy & may persist for years after stopping treatment.
In patients who have received more than physiological doses of systemic corticosteroids for greater than 3 weeks withdrawal should not be abrupt.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses of up to 6mg daily of betamethasone, or eq. for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses particularly if taken for greater than 3 weeks,
• When a short course has been prescribed within 1 year of cessation of long-term therapy (months/years),
• Patients who have reasons for adrenocortical insufficiency other than exogenous corticosteroids therapy,
• Patients receiving doses of systemic corticosteroid greater than 6mg daily
• Patients repeatedly taking doses in the evening.
During prolonged therapy any intercurrent illness, trauma/surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced.
8. ADVERSE EFFECTS:

9. DRUG INTERACTIONS:
May reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media & non-steroidal anti-inflammatory agents.
Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and ephedrine enhance the metabolism of corticosteroids; thus the corticosteroid therapeutic effect may be reduced.
Desired effects of hypoglycaemic agents (including insulin), anti-hypertensives & diuretics are antagonised by corticosteroids & the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics & carbenoxolone are enhanced.
Efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy.
Renal clearance of salicylates is increased by corticosteroids & steroid withdrawal may result in salicylate intoxication.
Risk of hypokalaemia is increased with theophylline, ulcer healing drugs such as carbenoxolone & antifungals such as amphotericin B.
Increased toxicity may result if hypokalaemia occurs in patients on cardiac glycosides.
Ritonavir & oral contraceptives may result in increased plasma conc. or corticosteroids.
Effect of corticosteroids may be reduced for 3-4 days after mifepristone.
Growth promoting effect of somatropin may be inhibited by corticosteroids.
Increase in the incidence of GI bleeding may occur if NSAIDS are taken concomitantly.
May antagonise the effects of neuromuscular blocking drugs such as vecuronium.
Concurrent use with fluoroquinolones may result in increased risk of tendon rupture.
Concomitant use with quetiapine may result in the increased metabolism of quetiapine.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
May enhance the metabolism of tretinoin resulting in decreased levels of tretinoin.

10. DOSAGE:The recommended dose is4-20mg administered by slow IV over ½ – 1 minute. The dose can be repeated 3-4 times in 24 hours.

11. ADMINISTRATION:
For IV/IM use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile & hospital setting only.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.

13. MANUFACTURED BY:

14. MARKETED BY:

Last revised on August 2020.